The Latest Cardiac and Vascular News
Study results favor FUROSCIX® versus “treatment as usual” in composite primary endpoint and all secondary endpoints FUROSCIX demonstrated an acceptable tolerability profile Company on track for Q4 2022 commercial launch of FUROSCIX, if approved BURLINGTON, Mass., July 12, 2022 (GLOBE NEWSWIRE) […]
PDUFA action date set for October 8, 2022 Company preparing for Q4 commercial launch, if approved BURLINGTON, Mass., May 16, 2022 (GLOBE NEWSWIRE) — scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the […]
FDA assigns PDUFA action date of October 8, 2022 Continuing to ramp up commercial readiness activities in advance of an anticipated Q4 2022 launch of FUROSCIX®, if approved Ended Q1 with cash, cash equivalents, restricted cash and investments of $65.6 […]
Anticipates Q4 2022 commercial launch, if approved BURLINGTON, Mass., April 11, 2022 (GLOBE NEWSWIRE) — scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance […]
Successfully completed all testing; plan to re-submit FUROSCIX® NDA by April 15, 2022 Commercial preparedness activities ramping up to support anticipated Q4 2022 launch of FUROSCIX, if approved Presented key FREEDOM-HF secondary endpoint data at the Cardiovascular Research Foundation Technology and […]
All additional testing of devices manufactured on the planned commercial line, as required by the FDA, has been successful to date FUROSCIX® NDA resubmission anticipated for Q1 2022 due to COVID-19 related global supply chain logistics interruptions and travel restrictions […]
Data show statistically significant and meaningful reduction in both heart failure-related and overall healthcare costs for patients treated with FUROSCIX® versus a historical comparator group Company on track to resubmit FUROSCIX NDA in the fourth quarter 2021 BURLINGTON, Mass., Sept. […]
Received minutes from Type C meeting with the FDA confirming alignment on path toward resubmission of FUROSCIX® NDA; no additional clinical data or device modifications required at this time; on track for resubmission in Q4 Announced positive top-line results from the […]
Reduced average 30-day heart failure related costs by $17,753 (p<0.0001) per study subject in FUROSCIX® arm compared to historically matched comparators Study halted early due to highly statistically significant reduction in 30-day heart failure-related costs observed during the prespecified interim analysis […]
FREEDOM clinical study on track for topline results in Q3 2021 Ended Q1 with cash, cash equivalents, restricted cash and investments of $96.5 million BURLINGTON, Mass., May 12, 2021 (GLOBE NEWSWIRE) — scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused […]
