Tag: LianBio

LianBio Announces Marketing Approval of CAMZYOS® (mavacamten) in Singapore

SHANGHAI, China and PRINCETON, N.J., June 26, 2023 (GLOBE NEWSWIRE) — LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other Asian markets, today announced that CAMZYOS® (mavacamten) has received marketing approval for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from the Singapore Health Sciences Authority. “Clinical […]

LianBio Reports First Quarter 2023 Financial Results and Provides Corporate Update

Phase 3 trial of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) met primary endpoint China National Medical Products Administration (NMPA) accepted mavacamten New Drug Application (NDA) with priority review Mavacamten commercial launch preparations continue in China, supported by the promotion of Pascal Qian to Chief Commercial Official Cash, cash equivalents and marketable securities of $286.5 million […]

LianBio Announces Marketing Approval of CAMZYOS® (mavacamten) in the Macau Special Administrative Region (SAR) of China

SHANGHAI, China and PRINCETON, N.J., May 11, 2023 (GLOBE NEWSWIRE) — LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, today announced that CAMZYOS® (mavacamten) has received marketing approval for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from the Pharmaceutical Administration Bureau of […]

LianBio Announces Positive Topline Results from Phase 3 EXPLORER-CN Trial Evaluating Mavacamten in Chinese Patients

• Mavacamten met the primary endpoint for the treatment of Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy • Mavacamten demonstrated a safety profile consistent with previous studies • If approved, mavacamten is expected to be the first cardiac myosin inhibitor approved in China for the treatment of oHCM • LianBio to host a live virtual analyst and investor […]

LianBio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

Phase 3 trial of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) ongoing, with data expected mid-year 2023 Phase 3 registrational trial of TP-03 in Chinese patients with Demodex blepharitis ongoing, with data expected in the fourth quarter of 2023 Entered into commercial agreement with Pfizer, with Pfizer opting into LianBio rights to […]

LianBio Reports Third Quarter 2022 Financial Results and Provides Corporate Update

Enrollment completed in registrational Phase 3 EXPLORER-CN trial of mavacamten, with data expected mid-2023 Mavacamten patient education and physician awareness activities underway in China with inclusion in HCM treatment guidelines, disease awareness campaign launch, and key commercial leadership hired Pivotal Phase 3 LIBRA trial of TP-03 for the treatment of Demodex blepharitis initiated in China, […]

LianBio Completes Enrollment in Pivotal Phase 3 EXPLORER-CN Trial of Mavacamten in Chinese Obstructive Hypertrophic Cardiomyopathy Patients

• Topline data expected mid-2023 • EXPLORER-CN trial, together with PK study conducted in healthy Chinese volunteers, expected to support registration of mavacamten in China SHANGHAI, China and PRINCETON, N.J., Aug. 10, 2022 (GLOBE NEWSWIRE) — LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian […]

LianBio Reports First Quarter 2022 Financial Results and Provides Corporate Update

LianBio’s partner, Bristol Myers Squibb, has received U.S. FDA approval of mavacamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM) Registrational Phase 3 EXPLORER-CN clinical trial of mavacamten in Chinese patients with symptomatic oHCM ongoing LianBio’s partner, Tarsus, announced positive topline data from the Phase 3 Saturn-2 clinical trial of TP-03 in patients with […]

LianBio Completes Phase 1 Pharmacokinetic Study of Mavacamten in Healthy Chinese Volunteers

Mavacamten demonstrated a favorable safety, tolerability and pharmacokinetic profile in healthy Chinese volunteers Study was conducted in parallel with ongoing Phase 3 EXPLORER-CN trial of mavacamten in obstructive hypertrophic cardiomyopathy to support regulatory approval in China SHANGHAI, China and PRINCETON, N.J., May 09, 2022 (GLOBE NEWSWIRE) — LianBio (Nasdaq: LIAN) a biotechnology company dedicated to […]