Wall Street cheered a potential, long hoped-for breakthrough in idiopathic pulmonary fibrosis (IPF), and shares of Pliant Therapeutics Inc. (NASDAQ:PLRX) closed at $23, up $14.12, or 159%, after investors learned of positive phase IIa data with PLN-74809. The trial met its primary and secondary endpoints, proving PLN-74809, a dual integrin alpha-V/beta-1/6 antagonist, well-tolerated with a favorable pharmacokinetic (PK) profile. Exploratory efficacy endpoints measured changes in forced vital capacity (FVC) and quantitative lung fibrosis (QLF) imaging, and the drug turned up a dose-dependent treatment effect on FVC and QLF vs. placebo over 12 weeks of treatment. Serum biomarkers were examined, too. Read More
Seven fatalities that could be related to hemorrhagic events in Macrogenics Inc.’s phase II trial of the monoclonal antibody enoblituzumab for treating head and neck cancer has led to the study’s closure. Read More
European regulators and health experts have recommended a second booster dose of mRNA COVID-19 vaccines for people between 60 and 79 years of age and for vulnerable people with medical conditions, as Moderna Inc. filed fresh data from its omicron subvariant-adapted shot. Read More
Novo Nordisk A/S announced positive clinical data for its two hemophilia therapies and said each is shaping up to fill unmet needs in what is an increasingly competitive market. Read More
PDC Therapeutics SA has passed the first test of its novel nanocarrier technology, getting approval to move up from the initial dose in the phase I trial of lead product RS-0139, which targets a docetaxel payload to tumors expressing the integrin receptor. Read More
New hires and promotions in the biopharma industry, including: Allarity, Calliditas, Eyepoint, Kahr, Meissa, Nosopharm, Reata, Recce, SAB, Telix. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Inventiva, Moleculin, Myrtelle, Optinose, Regenxbio. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Emergent, Entasis, F-star, Innoviva, La Jolla, Novavax, Rational, Ridgeback, Sino, Vertex. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alimera, Horizon, MGC, Puma, Siga. Read More
