Recognition places Heartbeat among the top 6% of America’s fastest-growing private companies NEW YORK, Aug. 11, 2026 /PRNewswire/ — Heartbeat Health, the nation’s largest virtual cardiology practice, today announced it has been ranked No. 299 on the 2026 Inc. 5000 list, earning placement…
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CVRx Announces Sales Leadership Transition
Robert John to Depart as Chief Revenue Officer; Paul Verrastro Named Interim Head of SalesMINNEAPOLIS, Aug. 11, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced that Robert John, Chief Revenue Officer, will depart the company, and that Paul Verrastro will assume the role of Interim Head of Sales, effective immediately. In his new role, Mr. Verrastro will lead CVRx’s sales organization while the company conducts a search for a permanent successor. Mr. Verrastro brings more than 30 years of medical device sales and marketing experience to the role. He has been with CVRx for over five years and recently moved into a new senior advisor role focused on commercial execution support. Prior to assuming this role, he was most recently Chief Marketing and Strategy Officer. Prior to joining CVRx, he held sales and marketing leadership positions at Guidant, Boston Scientific and Medtronic, much of that work focused on bringing novel therapies and technologies to market, including implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT). “Our revised commercial outlook and need to improve commercial execution have led us to make a change in sales leadership,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “I have full confidence in Paul’s ability to lead our sales team while we search for a new leader. He knows our business, our customers and our commercial strategy, and is well respected by the sales force. This continuity will serve us well as we work through this transition.” About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com
Orchestra BioMed Reports Second Quarter 2026 Financial Results and Highlights Recent Business Updates
The BACKBEAT global pivotal trial (“BACKBEAT Trial”), conducted in collaboration with Medtronic, is on track to reach its target of 284 evaluable randomized patients by end of Q3 2026, with primary data presentation targeted for Q2 2027, assuming those endpoints are met.Virtue pivotal trial is advancing with further site activations and patient enrollments. $110 million cash balance provides projected runway into Q4 2027 and through key upcoming milestones, following $35 million in strategic capital from Medtronic and Ligand.Company to host R&D Day on November 12, 2026, in New York City, featuring in-depth reviews of both the AVIM Therapy and Virtue SAB programs. NEW HOPE, Pa., Aug. 10, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the second quarter ended June 30, 2026, and provided a business update on its two pivotal-stage cardiovascular programs: Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of uncontrolled hypertension in pacemaker-indicated patients, being developed in strategic collaboration with Medtronic (NYSE: MDT), and Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) for the treatment of coronary in-stent restenosis. David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed, stated, “The second quarter brought clarity on both the timeline and the scope of the AVIM Therapy opportunity that we are pursuing with Medtronic. We remain on track to reach or exceed our target of 284 evaluable randomized patients in the BACKBEAT Trial by the end of the third quarter of 2026 and maintain our objective to present primary endpoint data as a major conference late-breaker in the second quarter of 2027. The second FDA Breakthrough Device Designation for AVIM Therapy earned during the second quarter strengthens potential regulatory and reimbursement upside for this high-impact program.” Hochman continued, “Our conviction that Virtue SAB offers distinctive potential clinical advantages because of its differentiated approach to arterial drug delivery continues to grow as we advance site activations and patient enrollment for the Virtue pivotal trial. With a $110 million cash balance at quarter-end following $35 million received from Medtronic and Ligand during the quarter, both pivotal programs are funded through their next major milestones. We are excited to review each in detail at our R&D Day in November.” Q2 2026 and Recent Business Highlights: BACKBEAT Trial is on track to reach target of 284 evaluable randomized patients by end of Q3 2026. Assuming primary endpoints are met, Orchestra BioMed and Medtronic intend to submit primary endpoint data as a late-breaking clinical trial presentation at a major cardiovascular conference in the second quarter of 2027, followed by marketing application submissions to the FDA and global regulatory agencies.Received $35 million in strategic capital under previously disclosed agreements with Medtronic and Ligand (Nasdaq: LGND). Including this most recent investment, Medtronic’s total capital contribution to Orchestra BioMed is nearly $82 million. Ligand has now provided $40 million in total capital to the Company.FDA granted AVIM Therapy a second FDA Breakthrough Device Designation (“BDD”) specific to patients with uncontrolled hypertension despite anti-hypertensive medication who are indicated for a pacemaker. Together, AVIM Therapy’s two BDDs now cover both the broad group of patients with uncontrolled hypertension and elevated cardiovascular risk and the pacemaker-indicated group studied in the BACKBEAT Trial.Advanced site activation and patient enrollment in the Virtue SAB in the Treatment of Coronary In-Stent Restenosis (“ISR”) Trial (“Virtue Trial”), a multi-center, prospective, randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT™ paclitaxel-coated balloon for the treatment of coronary in-stent restenosis.Added to the Russell 3000® and Russell 2000® Indexes. Effective after the U.S. market close on June 26, 2026, Orchestra BioMed joined the broad-market Russell 3000® Index and the small-cap Russell 2000® Index at the conclusion of the 2026 Russell indexes reconstitution, broadening the Company’s visibility among institutional investors and index funds benchmarked to the Russell indexes. R&D Day: November 12, 2026The Company will host an R&D Day on November 12, 2026 in New York City. The event will feature presentations from management and leading physician investigators covering the AVIM Therapy and Virtue SAB programs, including recent program and pipeline developments. Additional details, including registration and webcast information, will be announced in the future. Financial Results for the Second Quarter Ended June 30, 2026 Cash and cash equivalents and Marketable securities totaled $110.0 million as of June 30, 2026.Net cash used in operating activities and for the purchase of fixed assets was $19.6 million during the second quarter of 2026, compared with $15.6 million for the second quarter in 2025, with the primary drivers being increased research and development costs, including clinical trial activities, as well as personnel and consulting expenditures during the second quarter of 2026.Research and development expenses for the second quarter of 2026 were $16.6 million, compared with $13.9 million for the second quarter in 2025, which represents an increase of 20%. The increase was primarily due to additional costs associated with the ongoing BACKBEAT Trial and to advance the Virtue SAB program, including the Virtue Trial.Selling, general and administrative expenses for the second quarter of 2026 were $5.8 million, compared with $6.3 million for the second quarter of 2025, which represents a decrease of 7%. The decrease was primarily due to a decrease in stock-based compensation expense.Net loss attributable to common stockholders for the second quarter of 2026 was $24.1 million, or ($0.38) per share, compared with a net loss attributable to common stockholders of $19.4 million, or ($0.50) per share, for the second quarter of 2025, which represents an increase of 23%. Net loss attributable to common stockholders for the second quarter of 2026 included $2.7 million in interest expense for the second quarter of 2026 as compared to $0.5 million for the same period in 2025, of which a portion was non-cash in the current period. Non-cash stock-based compensation expense was $2.5 million as compared to $3.2 million for the same period in 2025. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one of the largest medical device companies in the world and a global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designations for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. About AVIM Therapy AVIM Therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM Therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM Therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal trial is evaluating the safety and efficacy of AVIM Therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM Therapy has been granted two Breakthrough Device Designations by the FDA for the treatment of uncontrolled hypertension in patients who have increased cardiovascular risk. About Virtue SAB Virtue SAB is designed to deliver a proprietary extended-release formulation of sirolimus, SirolimusEFR™ through a non-coated microporous AngioInfusion™ Balloon that protects the drug in transit to consistently deliver a large liquid dose overcoming certain limitations of drug-coated balloons. SirolimusEFR delivered by Virtue SAB has been shown in published preclinical series involving hundreds of arterial deliveries to achieve sustained tissue levels well above the known required therapeutic tissue concentration for inhibiting restenosis (1 ng/mg tissue) for the entire critical healing period of approximately 30 days. Virtue SAB demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multi-center prospective, independent core lab-adjudicated pilot clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the enrollment, timing, implementation, results and design of the Company’s ongoing pivotal trials, the timing of the presentation of clinical data, the timing of regulatory submissions, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, the potential benefits of Breakthrough Device Designation, the ability of the Company’s partnerships to accelerate clinical development and the Company’s projected cash runway. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 12, 2026. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Silas NewcombOrchestra BioMedsnewcomb@orchestrabiomed.com Media Contact:Nina PremuticoOrchestra BioMednpremutico@orchestrabiomed.com ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Balance Sheets(in thousands, except share and per share data)(Unaudited) June 30, December 31, 2026 2025ASSETS CURRENT ASSETS: Cash and cash equivalents $20,472 $34,690 Marketable securities 89,491 71,822 Accounts receivable, net 51 95 Inventory 250 310 Prepaid expenses and other current assets 977 994 Total current assets 111,241 107,911 Property and equipment, net 2,045 1,715 Right-of-use assets 1,171 1,496 Strategic investments — 2,495 Deposits and other assets 1,243 1,240 TOTAL ASSETS $115,700 $114,857 LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $6,132 $6,095 Accrued expenses and other liabilities 6,531 9,890 Operating lease liability, current portion 808 751 Total current liabilities 13,471 16,736 Royalty purchase agreement 34,593 16,482 Note payable 20,442 — Loan payable 14,397 14,268 Derivative liability 2,460 2,749 Operating lease liability, less current portion 520 936 Other long-term liabilities 397 308 TOTAL LIABILITIES 86,280 51,479 Series A Preferred Stock, $0.0001 par value per share; 200,000 issued and outstanding at June 30, 2026 and December 31, 2025; aggregate liquidation preference of $20,000 10,097 9,808 STOCKHOLDERS’ EQUITY Preferred stock, $0.0001 par value, 10,000,000 shares authorized; — — Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 60,105,049 and 57,032,963 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively. 6 6 Additional paid-in capital 426,423 416,083 Accumulated other comprehensive (loss) income (81) 60 Accumulated deficit (407,025) (362,579)TOTAL STOCKHOLDERS’ EQUITY 19,323 53,570 TOTAL LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY $115,700 $114,857 ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(Unaudited) Three Months Ended June 30, 2026 2025Revenue: Partnership revenue $ — 667 Product revenue 88 169 Total revenue 88 836 Expenses: Cost of product revenues 25 46 Research and development 16,590 13,853 Selling, general and administrative 5,829 6,264 Total expenses 22,444 20,163 Loss from operations (22,356) (19,327)Other (expense) income: Interest (expense) income, net (1,768) (36)Change in the fair value of derivative liability 324 — Gain on sale of strategic investments 45 — Total other (expense) income (1,399) (36)Net loss (23,755) (19,363)Adjustment to carrying value of Series A Preferred Stock (324) — Net loss attributable to common stockholders $(24,079) (19,363) Net loss attributable to common stockholders per share Basic and diluted $(0.38) (0.50)Weighted-average shares used in computing net loss attributable to common stockholders per share, basic and diluted 63,812,098 38,392,716 Comprehensive loss Net loss $(23,755) (19,363)Unrealized loss on marketable securities (41) (21)Comprehensive loss $(23,796) (19,384)
BridgeBio Reports Second Quarter 2026 Financial Results and Corporate Updates
– $243.7 million in total second quarter revenues, primarily comprised of $222.4 million of U.S. Attruby® net product revenue, with growth led by the treatment-naïve segment as physicians increasingly start and keep patients on Attruby – Attruby is the first ATTR-CM therapy associated with direct kidney protection, with post-hoc analyses published in Circulation: Heart Failure showing a profile consistent with ACE inhibitors, ARBs, and SGLT2s including an early, reversible eGFR dip, an improved chronic eGFR slope relative to placebo, and a 13.7% reduction in urinary albumin-to-creatinine ratio through Month 30; the magnitude of the acute eGFR dip was positively associated with greater early cardiovascular benefit; BridgeBio will explore the potential for Attruby to treat other orphan kidney indications – Real-world evidence continues to differentiate Attruby from tafamidis, with an independent propensity score-matched analysis of 286 patient pairs from the TriNetX network published in JSCAI associating acoramidis with a 37% reduction in composite cardiovascular events (p=0.002) and a 34% reduction in hospitalizations (p=0.002) at six months; further independent RWE using electronic health records are expected, and we are confident Attruby will consistently demonstrate clinical superiority over tafamidis to the benefit of patients and healthcare delivery systems for which heart failure remains a top concern – All three planned NDAs are now submitted to the FDA: BBP-418 for LGMD2I/R9 was accepted with Priority Review (PDUFA November 27, 2026); encaleret for ADH1 was accepted with Priority Review (PDUFA May 8, 2027), with no advisory committee planned for either; oral infigratinib for achondroplasia has been submitted, with U.S. launch expected mid-2027 – Diagnosis and awareness continue to accelerate ahead of the launches: in ADH, more than 2,200 unique patients are now identified under the dedicated ICD-10 code, at approximately 70 new diagnoses per month; in LGMD2I/R9, BridgeBio is investing in awareness and multidisciplinary care at MDA Care Center Network sites, where we expect 85% of target physicians to be familiar with the BBP-418 profile and data by launch – The oral encaleret and oral infigratinib franchises continue to expand beyond their first indications: RECLAIM-HP in chronic hypoparathyroidism has begun screening patients with topline data anticipated in late 2027 or early 2028, CALIBRATE-PEDS in pediatric ADH1 has completed enrollment in its first cohort, and a Phase 2 update in hypochondroplasia is expected in the second half of 2026 – $720.2 million in cash, cash equivalents, and marketable securities as of June 30, 2026, which does not include the $1 billion preferred equity financing that closed on July 1, 2026 – BridgeBio will host a Commercial Day in New York City on October 8, 2026, to discuss commercial readiness and launch strategy across its three upcoming launches PALO ALTO, Calif., Aug. 10, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, announced today its financial results for the second quarter ended June 30, 2026, and provided an update on Attruby’s commercial progress. Pipeline Overview: ProgramStatusNext expected milestoneAcoramidis for ATTR-CMApproved in U.S., E.U., Japan, Switzerland, Brazil, and U.K.New data to be shared at ESC 2026BBP-418 for LGMD2I/R9PDUFA date set for November 27, 2026 with Priority ReviewLaunch upon FDA approvalEncaleret for ADH1PDUFA date set for May 8, 2027 with Priority Review; MAA submitted to EMALaunch upon FDA approvalOral infigratinib for achondroplasiaNDA submitted to FDAFDA sets PDUFA dateOral Encaleret for chronic hypoparathyroidismFirst investigational sites activated for RECLAIM-HP, Phase 3 studyFirst participant dosed in Q3 2026Oral infigratinib for hypochondroplasiaACCEL 2/3 enrollment ongoingPhase 2 clinical trial update in 2H 2026Depleter for ATTR-CMDevelopment candidate nominationSubmit IND to the FDA in 2027 “I’m excited by the growing body of evidence continuing to demonstrate Attruby is the drug of choice for all ATTR-CM patients, and particularly for those who are treatment-naïve, including the first-ever demonstration of early, sustained kidney-protective effects in ATTR-CM alongside the cardiac benefit we’ve established. Furthermore, this was the quarter all three of our pipeline programs, BBP-418, encaleret, and infigratinib, moved from data into active regulatory review, with our first PDUFA date now set for November 27, 2026, which is a level of strategic execution and discipline I’m proud of. Finally, with the $1 billion preferred equity financing we completed, we have a balance sheet sized to run all three launches at full strength, without diverting resources from the development engine that produced them,” said Neil Kumar, Ph.D., Co-Founder and CEO of BridgeBio. Commercial Updates:The second quarter total revenues, net totaled $243.7 million, comprised of $222.4 million of U.S. Attruby net product revenue, $15.4 million from royalty revenue, and $5.8 million in license and services revenue. “We continue to see strong growth this quarter for Attruby with our first-line share climbing again,” said Matt Outten, Chief Commercial Officer of BridgeBio. “What comes next will continue to shape BridgeBio’s next chapter as we prepare for three potential approvals in three different diseases, all with best-in-class potential, each backed by the same commercial engine that made Attruby a success. We look forward to continuing to deliver for patients and addressing the gaps within the treatment paradigm for rare disease.” Pipeline Updates:Attruby (acoramidis) – First and only near-complete (≥90%) transthyretin (TTR) stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM): New post-hoc analyses published in Circulation: Heart Failure showed acoramidis was associated with a rapid, reversible estimated glomerular filtration rate (eGFR) dip alongside a placebo-corrected 15.5% reduction in urinary albumin-to-creatinine ratio (UACR) by Day 28, followed by a sustained improvement in chronic eGFR slope (+2.47 mL/min/1.73m²/year) and a 13.7% UACR reduction through Month 30. This profile resembles that of direct-acting kidney medicines such as ACE inhibitors, ARBs, and SGLT2 inhibitors, and has not previously been observed with any approved ATTR-CM therapy. Participants with larger eGFR dips had a 58% lower risk of death or cardiovascular hospitalization in year one, suggesting the kidney effect may contribute to acoramidis’ early cardiovascular benefit.New data from ATTRibute-CM presented in two late-breaking oral presentations at Heart Failure 2026 further demonstrated acoramidis’ differentiated clinical profile. The first showed a reduction in the risk of outpatient worsening heart failure by 41% versus placebo with separation of curves seen within 30 days and sustained through Month 30. The second showed a significant reduction in serum transthyretin variability, which is associated with lower mortality.Real-world evidence continues to demonstrate that Attruby is differentiated from other therapies in the speed and strength of benefit. An independent propensity score-matched analysis of 286 patient pairs from the TriNetX network, presented at SCAI 2026 Scientific Sessions and published in JSCAI, associated acoramidis with a 37% reduction in composite cardiovascular events (HR 0.63; p=0.002) and a 34% reduction in hospitalizations (HR 0.67; p=0.002) at six months, with effects deepening at nine months and significant reductions across heart failure exacerbation, arrhythmia, and acute kidney injury. A separate propensity score-weighted analysis observed a 43% reduction in outpatient diuretic intensification (HR 0.57; p=0.021) versus tafamidis. A third independent study conducted in EPIC COSMOS and to be published later in 2026 validated the comparative effectiveness of acoramidis over tafamidis. These three real-world datasets converge on consistent, statistically significant benefit in contemporary patients on modern background therapy, reinforcing that Attruby’s stabilization advantage is showing up in outcomes that matter to physicians, patients, and payers.BridgeBio initiated ASCEND-ATTR, a Phase 4 study using cardiac MRI and echocardiography to characterize the long-term effects of acoramidis on disease reversal as measured by cardiac structure, function, and amyloid burden over 36 months. This builds on the evidence of regression observed in ATTRibute-CM and the open-label extension.Additional data will be shared in two oral presentations and six moderated posters at the European Society of Cardiology (ESC) Congress 2026. BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9): BridgeBio believes BBP-418 is positioned to become the first approved therapy for individuals living with LGMD2I/R9, addressing a significant unmet need in this disease and potentially representing the first approval of a therapy for any form of LGMD.On May 27, 2026, the FDA accepted the Company’s New Drug Application (NDA) for BBP-418 and granted Priority Review, assigning a Prescription Drug User Fee Act (PDUFA) target action date of November 27, 2026. No advisory committee meeting is currently planned.FORTIFY, the Phase 3 clinical trial of BBP-418, successfully met all pre-specified primary and secondary endpoints of its 12-month interim analysis, supporting its potential as a disease-modifying therapy. The topline results can be found here.Additional positive results demonstrating the rapid and consistent treatment effect and favorable safety profile of BBP-418 were presented in March at the 2026 MDA Clinical and Scientific Conference in a late-breaking oral presentation.1At the 19th International Congress on Neuromuscular Diseases in July 2026, BridgeBio presented interim FORTIFY data showing favorable patient-reported outcomes for BBP-418-treated individuals compared to placebo, demonstrating that the improvements observed on functional outcomes and biomarkers translate to how patients feel and function.BridgeBio invested $100,000 to strengthen multidisciplinary LGMD care through a Muscular Dystrophy Association (MDA) Care Advance Grant supporting initiatives at Stanford Health Care and the University of Minnesota and engaged the LGMD2I/R9 community at the 2026 European LGMD2I/R9 Conference and the 2026 Iowa Wellstone Dystroglycanopathy Patient & Family Conference.BridgeBio’s neuromuscular U.S. field teams are hired, trained, and deployed across medical, commercial, and market access, engaging in scientific exchange, disease state education, and account profiling as appropriate in the pre-approval setting. Promotional activity will commence only upon FDA approval, consistent with regulatory requirements.Based on the FORTIFY interim analysis results, BridgeBio is also engaging regulatory agencies to identify an expedited path to approval for BBP-418 in Europe.The Company intends to initiate clinical studies of BBP-418 in LGMD2I/R9 for individuals less than 12 years of age in the first half of 2027, and in LGMD2M/R13 and LGMD2U/R20 in the near future. Encaleret – Calcium-sensing receptor (CaSR) antagonist for autosomal dominant hypocalcemia type 1 (ADH1) and chronic hypoparathyroidism: BridgeBio believes encaleret is positioned to become the first approved therapy specifically indicated for individuals living with ADH1, in both the U.S. and the EU.The FDA re-considered its review designation of the Company’s NDA filing for encaleret in ADH1 and has granted Priority Review, with a PDUFA target action date of May 8, 2027. No advisory committee meeting is currently planned.BridgeBio submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of encaleret in ADH1.Diagnosis of ADH1 in the U.S. continues to accelerate, with more than 2,200 unique patients identified under the dedicated ICD-10 code for ADH (E20.810) from its introduction in October 2023 through June 2026, a rate of approximately 70 new diagnoses per month.CALIBRATE-PEDS, the registrational Phase 2/3 study of encaleret in pediatric ADH1, completed enrollment in the first of four cohorts (adolescents 12 to 17 years of age).RECLAIM-HP, the Phase 3 study of encaleret in chronic hypoparathyroidism, has activated its first investigational sites and screening has initiated. Chronic hypoparathyroidism affects approximately 200,000 patients in the U.S. and EU, and represents a substantial expansion of the encaleret opportunity beyond ADH1. Oral infigratinib – FGFR3 inhibitor for achondroplasia and hypochondroplasia: BridgeBio believes oral infigratinib is positioned to become the first approved oral therapy and a potential best-in-class option for children living with achondroplasia and hypochondroplasia.The Company submitted an NDA to the FDA for oral infigratinib in achondroplasia and is on track to submit an MAA to the EMA in the fourth quarter of 2026. BridgeBio anticipates a U.S. launch in mid-2027 and an EU approval in the second half of 2027.Oral infigratinib has received Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations from the FDA, and Orphan Drug designation from both the FDA and the EMA.Results from PROPEL 3, the Phase 3 trial of oral infigratinib in achondroplasia, were published in the New England Journal of Medicine2 and simultaneously presented at the International Congress of Children’s Bone Health 2026. Oral infigratinib is the only achondroplasia program with Phase 3 results published in the New England Journal of Medicine. In these results3, oral infigratinib significantly improved arm span Z-score versus placebo (LS mean +0.37 SD; p
Autonomix Medical Congratulates Co-Founder & Chief Medical Officer Dr. Robert Schwartz on Receiving Prestigious 2026 Cardiovascular Tech Forum Lifetime Achievement Award
Recognition honors one of the medical technology industry’s most influential innovators, whose career has helped shape modern cardiovascular care THE WOODLANDS, TX, Aug. 10, 2026 (GLOBE NEWSWIRE) — Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today congratulated its Chief Medical Officer, Robert Schwartz, M.S., M.D., FACC, on being named the recipient of the 2026 Cardiovascular Tech Forum (CTF) Lifetime Achievement Award, recognizing his extraordinary career and lasting contributions to cardiovascular medicine, innovation and medical technology. Dr. Schwartz will be honored during Octane’s 2026 Cardiovascular Tech Forum on September 18, 2026, in Newport Beach, California. The annual award recognizes individuals whose pioneering work has transformed the cardiovascular technology landscape through scientific achievement, clinical innovation and entrepreneurial leadership. Throughout his distinguished career, Dr. Schwartz has authored more than 500 scientific publications, holds more than 200 patents and has founded multiple medical technology companies whose innovations have changed how the field operates, including the Watchman device, which he co-invented and which was later acquired by Boston Scientific. “Rob’s career has been defined by a relentless pursuit of innovation that has improved the lives of countless patients around the world,” said Brad Hauser, President and Chief Executive Officer of Autonomix. “Few physician innovators have had the breadth of impact that Rob has achieved across cardiovascular medicine and medical technology. From pioneering breakthrough therapies to mentoring entrepreneurs and advancing next-generation medical devices, his vision continues to shape the future of healthcare. We are honored to have him as our Co-Founder and Chief Medical Officer, where his experience and leadership are helping drive Autonomix’s mission to redefine how diseases involving the peripheral nervous system are diagnosed and treated.” Hauser continued, “This well-deserved recognition not only celebrates Rob’s extraordinary legacy but also underscores the caliber of scientific and clinical leadership guiding Autonomix as we continue advancing our first-in-class technology platform.” “I am honored to receive this recognition from the Cardiovascular Tech Forum,” said Dr. Schwartz. “Innovation in medical technology has always been driven by collaboration among physicians, engineers and entrepreneurs committed to improving patient outcomes. I’m grateful to have had the opportunity to contribute to this field throughout my career and look forward to continuing that work through organizations like Autonomix.” The Cardiovascular Tech Forum brings together leading physicians, engineers, entrepreneurs and investors focused on advancing cardiovascular innovation. For more information on CTF 2026, visit their website. About Autonomix Medical, Inc. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body. We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States. For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook. Forward Looking Statements Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.” Forward-looking statements in this press release include, but are not limited to, expectations regarding the potential effectiveness and clinical benefits of Autonomix’s nerve-targeted treatments for pancreatic cancer pain and other conditions, the versatility and scalability of the Company’s platform technology, the potential for future clinical applications across multiple organ systems, the strength and scope of the Company’s intellectual property portfolio, and the potential for the Company’s patented technologies to support patient selection, procedural guidance and post-treatment monitoring across multiple neuromodulation applications. Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 27, 2026, and from time to time, our other filings with the SEC. Forward-looking statements speak only as of the date of this press release and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. Investor and Media Contact JTC Team, LLC Jenene Thomas 908.824.0775 autonomix@jtcir.com
ACCESS Announces Multi-Year Strategic Agreement to Bring Advanced Cardiac Electrophysiology Technologies to Ambulatory Surgery Centers
NEW YORK–(BUSINESS WIRE)–ACCESS, through its physician-led group purchasing organization, ACCESS GPO, today announced a multi-year preferred portfolio agreement with Johnson & Johnson to support the adoption of advanced cardiac electrophysiology technologies in ambulatory surgery centers (ASC) across the United States. The agreement encompasses an integrated portfolio of three-dimensional mapping, intracardiac imaging, radiofrequency ablation and pulsed field ablation technologies. The co
Veru Reports Fiscal 2026 Third Quarter Financial Results and Phase 2b PLATEAU Clinical Trial Progress
— Phase 2b PLATEAU clinical trial of enobosarm and semaglutide combination for high quality weight loss is fully enrolled with 239 patients – — Phase 2b PLATEAU clinical trial interim analysis and results on track for calendar Q1 2027– — In June 2026 Company announced a clinical supply agreement with Novo Nordisk for its Phase 2b PLATEAU clinical trial — — In August 2026 Company announced USPTO notice of allowance for key U.S. patent for enobosarm and semaglutide; when issued, U.S. patent protection until at least October 2044 — — Company to host conference call and webcast today at 8:00 a.m. ET – MIAMI, FL, Aug. 10, 2026 (GLOBE NEWSWIRE) — Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced financial results for its fiscal 2026 third quarter ended June 30, 2026, and provided an update on progress of its clinical development programs. “We are extremely pleased with the continued enobosarm progress during this past quarter,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru Inc. “We reached full enrollment of the Phase 2b PLATEAU clinical trial and entered into a clinical supply agreement with Novo Nordisk for the Phase 2b PLATEAU clinical trial.* In addition, we received from the USPTO a notice of allowance for a key U.S. patent for enobosarm with semaglutide for high quality weight loss which when issued, will provide U.S. patent protection until at least October 2044.” Dr. Steiner added: “We believe these accomplishments mark important milestones in advancing enobosarm as a potential important combination therapy with GLP-1 receptor agonists. There is a significant unmet medical need to make weight reduction more tissue selective by maximizing fat loss while preserving lean mass, physical function, and bone mineral density for the highest quality weight reduction especially in older patients who have low muscle reserves and obesity. I want to thank both the patients and the investigators for their enthusiasm to expeditiously reach full enrollment for this very important study. We remain on track to achieve the near-term milestone of reporting the interim analysis results from the Phase 2b PLATEAU clinical trial in the first quarter of calendar year 2027.” Obesity ProgramEvaluating enobosarm in combination with GLP-1 RA for higher quality weight reduction in older patients with obesity Fully Enrolled Phase 2b PLATEAU Clinical StudyThe Phase 2b PLATEAU clinical trial is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in older patients (age ≥ 65 years) who have obesity (BMI ≥ 35) and are initiating semaglutide treatment for weight reduction. During the past quarter, the Company exceeded its Phase 2b PLATEAU clinical trial targeted full enrollment of 200 patients by enrolling 239 patients. The Phase 2b PLATEAU study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving GLP-1 RA treatment by preserving muscle mass and physical function to achieve clinically meaningful incremental weight reduction by 68 weeks. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), mobility disability assessment, bone mineral density, and patient reported outcome questionnaires for physical function, HbA1c, and insulin resistance. Results of an interim analysis assessing lean body mass and fat mass as measured by DXA after patients have completed 32 weeks is expected in the first quarter of calendar year 2027. Final topline clinical data is expected in the fourth quarter of calendar year 2027. The Principal Investigator for the Phase 2b PLATEAU clinical trial is Steven Heymsfield, MD, a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana. Dr. Heymsfield was also the Principal Investigator of Veru’s Phase 2 QUALITY clinical study. Completed Positive Phase 2b QUALITY Clinical StudyThe Phase 2b QUALITY clinical study was a positive multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial that evaluated the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®**) for weight reduction. After the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial was completed at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that enobosarm plus semaglutide preserved lean mass and physical function and led to greater fat loss during the 16 week active weight loss period and enobosarm monotherapy prevented the regain of weight lost when the GLP-1 RA was discontinued. Recent Developments Regarding Enobosarm Intellectual PropertyRecently the Company received from the United States Patent and Trademark Office (USPTO) a Notice of Allowance for U.S. Patent Application titled “Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Uses Thereof for Quality Weight Loss.” The Notice of Allowance indicates that the USPTO has determined that the patent application meets the requirements for patentability and is expected to issue as a U.S. patent. The Notice of Allowance encompasses treatment regimens where: (i) enobosarm is concurrently given with semaglutide; (ii) enobosarm is added to initial semaglutide monotherapy with said co-therapy continuing; and (iii) enobosarm continues or is initiated as monotherapy after semaglutide therapy is discontinued. The allowed claims are directed to the: (i) preservation, restoration, or gaining of lean body mass; (ii) preservation, restoration, or gaining of muscle mass; (iii) enhancement of fat mass loss, including reducing abdominal, subcutaneous, or intramuscular fat accumulation, improving body composition, lowering body fat content, and lowering fat mass; (iv) preservation, restoration, or improvement of physical function and the corresponding prevention or treatment of a number of conditions that can result from decreased physical function such as reducing or treating muscle weakness, poor balance, decreased gait speed, mobility disability, loss of independence, increased risk of falls, loss of physical function, physical disability, poor quality of life, high hospitalization rates, and/or increased mortality; (v) preservation, restoration, or gaining of bone, and the corresponding prevention or treatment of bone fractures; (vi) overcoming or improving of insulin resistance; (vii) improving of HbA1c; (viii) reduction of or treatment to prevent total body weight gain rebound after discontinuing semaglutide; (ix) reduction of or treatment to prevent fat mass gain rebound after discontinuing semaglutide; and (x) treatment to prevent or restore lean mass loss during rebound after discontinuing semaglutide. When issued, this U.S. patent will have a patent expiry of at least October 3, 2044, prior to the potential application of any patent term adjustment or patent term extension. These allowed claims add to the Company’s growing intellectual property portfolio for enobosarm for quality weight loss, including already issued enobosarm specific polymorph composition of matter patents, as well as a number of other pending uses of selective androgen receptor modulator compounds alone or in combination with weight loss drugs for quality weight loss and chronic weight management patent applications. In addition, the patent portfolio of Veru includes patent applications directed to a novel, oral, modified-release enobosarm formulation, which if such patent were to issue, would provide patent protection until at least May 2046. The Company owns a worldwide portfolio of patent applications directed to the methods of use of enobosarm in combination with weight loss drugs for higher quality weight loss and incremental weight loss. These claims encompass weight loss drugs including incretin containing drugs such as GLP-1 RA drugs. The Company continues to prosecute a number of pending patent applications worldwide covering a number of different weight loss drugs beyond semaglutide. Third Quarter Financial Summary: Fiscal 2026 vs Fiscal 2025 Research and development expenses increased to $4.4 million from $3.0 millionGeneral and administrative expenses decreased to $3.4 million from $5.0 millionOperating loss from continuing operations increased to $7.7 million from $7.5 millionNet loss decreased to $7.0 million, or $0.30 per share, compared to $7.3 million, or $0.50 per share Year-to-Date Financial Summary: Fiscal 2026 vs Fiscal 2025 Research and development expenses decreased to $8.8 million from $12.7 millionGeneral and administrative expenses decreased to $11.5 million from $15.4 millionOperating loss from continuing operations decreased to $20.4 million from $25.9 millionNet loss decreased to $15.1 million, or $0.68 per share, compared to $24.2 million, or $1.65 per share Balance Sheet Information Cash, cash equivalents and restricted cash were $23.9 million as of June 30, 2026 versus $15.8 million as of September 30, 2025 Event DetailsThe audio webcast will be accessible under the Home page and Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-855-669-9658 (domestic) or 1-412-317-0088 (international), passcode 2565519, for one week. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, an oral selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass to improve body composition and physical function which is expected to result in clinically meaningful incremental weight reduction versus GLP-1 RA therapy alone. Sabizabulin, a microtubule disruptor, is being developed for the treatment of chronic inflammation related to atherosclerotic cardiovascular disease. Forward-Looking StatementsThis press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to the planned design, enrollment, timing, commencement, interim, topline and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the PLATEAU Phase 2b study; express or implied statements related to the issuance and scope of coverage, including allowed claims and treatment regimens, of a method of use patent from the Notice of Allowance for US Patent Application titled “Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Uses Thereof for Quality Weight Loss”, as well as other pending methods of use and formulation patents; whether the patent application meets requirements of patentability and, if and when the patent is issued, will provide patent protection until at least October 2044; whether new indications will be discovered or granted and whether the allowed claims under said Notice of Allowance, if and when issued, will add additional coverage and protection to new indications and the Company’s growing intellectual property portfolio for enobosarm for quality weight loss, and other pending uses of selective androgen receptor modulator compounds alone or in combination with weight loss drugs; whether the pending patent applications will be approved for claims that encompass a novel, oral, modified-release enobosarm formulation and if issued, will provide patent protection until at least May 2046; the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether the PLATEAU trial will successfully meet any of its primary or secondary endpoints; whether the results of the Phase 2b QUALITY study and the extension maintenance study of enobosarm, including weight loss, preservation of lean mass and physical function and loss of fat mass and the prevention of the regain of fat mass and total body weight loss, will be replicated to the same or any degree in the PLATEAU Phase 2b study or in any future Phase 3 studies; whether and when the PLATEAU Phase 2b study of enobosarm will produce an interim analysis and/or topline data; whether enobosarm in combination with a GLP-1 RA drug will provide a higher quality and/or greater quantity weight loss in patients and whether enobosarm will be the next generation combination therapy with GLP-1 receptor agonists for older patients with obesity that makes weight reduction more tissue selective for loss of fat, preservation of lean mass, physical function, improved body composition and maintaining or increasing bone mineral density, and demonstrating favorable HbA1c and insulin resistance results, all while maintaining a favorable safety profile; whether patients treated with enobosarm in the PLATEAU Phase 2B study will break through the weight loss plateau and achieve clinically meaningful incremental weight reduction by preserving muscle mass and physical function whether enobosarm will enhance or achieve a higher quality weight loss or the preservation of muscle in, or meet any unmet need for, obesity patients, including whether it will provide important insights into quality weight loss therapy and the design of a Phase 3 clinical development program; and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and inflammatory disease. The words “anticipate,” “believe,” “could,” “expect,” “intend,” “may,” “opportunity,” “plan,” “predict,” “potential,” “estimate,” “should,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company’s current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statements contained in this press release because of new information or future events, developments, or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies, including any interim or topline analysis, possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; although the Company has sought and received feedback from the FDA on the designs of its clinical trials and intends to continue to do so, the FDA may ultimately disagree that the Company’s clinical trials support approval; the Company’s ability to reach agreement with FDA on study design requirements for the Company’s planned clinical studies, including for the Phase 2b program for enobosarm as a weight loss or body composition drug and the number of future Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of patients in clinical studies or an inability to enroll patients in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the Company plans to prioritize the use of its current internal cash to the development of enobosarm, with a primary near-term focus on funding its PLATEAU Phase 2b clinical trial, and as a result advancement of sabizabulin as a treatment for slowing progression of or promoting regression of atherosclerosis disease will depend upon the Company securing additional funding; whether the Company will be able to partner with another company in the development of enobosarm or sabizabulin; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business, including as a result of a future shutdown of the U.S. government; any products of the Company, if approved, possibly not being commercially successful; the risk that the Supply Agreement with Novo Nordisk could be terminated prior to the completion of the Company’s PLATEAU Phase 2b clinical trial, including pursuant to a provision that permits Novo Nordisk to terminate for convenience upon 60 days’ prior notice; the ability of the Company to obtain sufficient financing, including any partnership or collaboration agreements, on acceptable terms when needed to fund development and operations and to enable us to continue as a going concern; the effect of the SEC’s “baby shelf” rules on the Company’s ability to raise sufficient capital when needed; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to obtain, protect and enforce its data, intellectual property and other proprietary rights; costs and other effects of litigation, including regulatory challenges, product liability claims, intellectual property claims and challenges, securities litigation and litigation with the purchaser of the Company’s FC2 business; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company’s Form 10-K for the year ended September 30, 2025, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors. *During the past quarter the Company announced a clinical supply agreement with Novo Nordisk for its Phase 2b PLATEAU clinical study. Please see the Company’s SEC Form 8-K dated June 2, 2026 for further details. **Wegovy® is a registered trademark of Novo Nordisk A/S. FINANCIAL SCHEDULES FOLLOW Veru Inc.Condensed Consolidated Balance Sheets(unaudited) June 30, September 30, 2026 2025 Cash, cash equivalents, and restricted cash$23,880,142 $15,794,562 Investments in equity securities 1,911,386 2,525,305 Prepaid expenses and other current assets 1,436,799 595,251 Total current assets 27,228,327 18,915,118 Property and equipment, net 280,227 364,808 Operating lease right-of-use assets 2,342,186 2,746,014 Goodwill 6,878,932 6,878,932 Other assets 297,998 930,847 Total assets$37,027,670 $29,835,719 Accounts payable$1,709,689 $3,121,448 Accrued compensation 2,721,934 3,510,237 Accrued expenses and other current liabilities 949,092 394,529 Operating lease liability, short-term portion 775,157 758,946 Total current liabilities 6,155,872 7,785,160 Operating lease liability, long-term portion 1,907,735 2,358,018 Other liabilities 587,823 1,359,871 Total liabilities 8,651,430 11,503,049 Total stockholders’ equity 28,376,240 18,332,670 Total liabilities and stockholders’ equity$37,027,670 $29,835,719 Veru Inc.Condensed Consolidated Statements of Operations(unaudited) Three Months Ended Nine Months Ended June 30, June 30, 2026 2025 2026 2025 Operating expenses: Research and development$4,352,668 $3,020,563 $8,842,633 $12,669,495 General and administrative 3,361,013 5,010,528 11,514,031 15,402,074 Total operating expenses 7,713,681 8,031,091 20,356,664 28,071,569 Gain on sale of ENTADFI® assets — 484,615 — 2,154,134 Operating loss (7,713,681) (7,546,476) (20,356,664) (25,917,435) Non-operating income: Gain on extinguishment of debt — — — 8,624,778 Other non-operating income, net 725,331 223,375 4,943,185 307,260 Total non-operating income 725,331 223,375 4,943,185 8,932,038 Net loss from continuing operations (6,988,350) (7,323,101) (15,413,479) (16,985,397)Net (loss) income from discontinued operations, net of taxes — (9,719) 351,418 (7,194,389)Net loss$(6,988,350) $(7,332,820) $(15,062,061) $(24,179,786) Net loss from continuing operations per basic and diluted common shares and pre-funded warrants outstanding$(0.30) $(0.50) $(0.70) $(1.16)Net income (loss) from discontinued operations per basic and diluted common shares and pre-funded warrants outstanding$0.00 $(0.00) $0.02 $(0.49)Net loss per basic and diluted common shares and pre-funded warrants outstanding$(0.30) $(0.50) $(0.68) $(1.65) Basic and diluted weighted average common shares outstanding 23,050,320 14,657,777 22,127,243 14,644,927 Veru Inc.Condensed Consolidated Statements of Cash Flows(unaudited) Nine Months Ended June 30, 2026 2025 Net loss$(15,062,061) $(24,179,786) Adjustments to reconcile net loss to net cash used in operating activities (2,482,190) 3,920,100 Changes in operating assets and liabilities (3,007,404) (4,292,066) Net cash used in operating activities (20,551,655) (24,551,752) Net cash provided by investing activities 5,322,804 18,867,232 Net cash provided by (used in) financing activities 23,314,431 (4,221,611) Net increase (decrease) in cash, cash equivalents, and restricted cash 8,085,580 (9,906,131) Cash, cash equivalents and restricted cash at beginning of period 15,794,562 24,916,285 Cash, cash equivalents and restricted cash at end of period$23,880,142 $15,010,154 Investor and Media Contact: Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@verupharma.com
Magnendo Awarded Up to $32M by ARPA-H to Advance Autonomous Robotic Stroke Intervention
ARPA-H award supports development of magnetic robotic navigation technology designed to overcome the physical barriers limiting endovascular stroke therapy
Braveheart Bio Announces Closing of Upsized Initial Public Offering Including Full Exercise of Underwriters’ Option to Purchase Additional Shares
SAN FRANCISCO, Aug. 07, 2026 (GLOBE NEWSWIRE) — Braveheart Bio, Inc. (Nasdaq: BRVE), a clinical-stage biopharmaceutical company developing next-generation therapeutics for hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases, today announced the closing of its upsized initial public offering of an aggregate of 24,437,500 shares of its common stock at an initial public offering price of $18.00 per share, including the full exercise by the underwriters of their option to purchase 3,187,500 additional shares. All shares of common stock were offered by Braveheart Bio. The shares began trading on the Nasdaq Global Market on August 6, 2026 under the ticker symbol “BRVE”. The gross proceeds from the initial public offering, including full exercise of the underwriters’ option to purchase additional shares, before deducting underwriting discounts and commissions and offering expenses payable by Braveheart Bio, were $439.9 million. Goldman Sachs & Co. LLC, Jefferies, TD Cowen, Stifel and Cantor acted as joint book-running managers for the offering. Registration statements relating to the shares being sold in the initial public offering have been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on August 5, 2026. The offering was made only by means of a prospectus, forming part of the effective registration statement relating to these shares. Copies of the final prospectus may be obtained from the SEC’s website at www.sec.gov and may also be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at prospectus-ny@ny.email.gs.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at TDManualrequest@broadridge.com; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com. This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Braveheart BioBraveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Braveheart Bio’s lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart Bio’s goal is to improve the treatment options for these patients by enhancing speed of onset, depth of gradient response, systolic safety, reversibility and reducing prescribing complexity. Investor Relations ContactAlexander SharifNew Street Investor RelationsAlexander@NewStreetIR.com Media ContactFGS GlobalBraveheart-bio@fgsglobal.com
Greenstone Biosciences Receives NIH R61 Grant to Advance Cardiac Fibrosis Therapeutics for Duchenne Muscular Dystrophy
PALO ALTO, Calif.–(BUSINESS WIRE)– #BioPharma–Greenstone Biosciences, a biotechnology company advancing New Approach Methodologies (NAMs) for drug discovery, today announced that it has received a Catalyze R61 award from the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH). The award funds a research program to discover novel drug candidates for myocardial fibrosis and dilated cardiomyopathy in Duchenne muscular dystrophy (DMD). DMD is a rare genet



