Astellas Pharma Inc. announced it plans to acquire Iveric Bio Inc. in an all-cash deal in which it will pay $40 per Iveric share for a total equity value of roughly $5.9 billion. “Iveric Bio has promising programs including avacincaptad pegol (Zimura), an important program for geographic atrophy secondary to age-related macular degeneration, and capabilities across the entire value chain in the ophthalmology field,” said Naoki Okamura, Astellas’ president and CEO. Read More
A mid-stage prospect for Pompe disease (PD) – this one from Maze Therapeutics Inc. – caught the eye of Sanofi SA, and the pair signed a potential $750 million deal to move along the oral glycogen synthase (GYS1) inhibitor MZE-001, a substrate reduction therapy.
Despite posting positive phase IIa data, Pliant Therapeutics Inc. stock (NASDAQ:PLRX) took a punch May 1 as shares closed 21% downward at $22.31 each. Still, the stock is in far better shape than it was a year ago when shares were going for about $5 each.
The U.S. Centers for Medicare and Medicaid Services’ years-long musing over a streamlined coverage policy specifically for breakthrough medical devices is now taking a toll on breakthrough medications that could provide a cure or arrest the progression of debilitating diseases. Read More
It’s not often that getting an NDA rejected by the U.S. FDA is cause for a company’s stock to rise. But in the case of Ascendis Pharma A/S, the agency’s anticipated complete response letter (CRL) for Transcon PTH (palopegteriparatide) offered some much-needed clarity and a potentially optimistic time frame for an NDA resubmission seeking approval of the once-daily hormone replacement therapy for hypoparathyroidism, news that sent the company’s shares (NASDAQ:ASND) up 24%, or $16.78, to close May 1 at $86.74. Read More
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New hires and promotions in the biopharma industry, including: Alladapt, Avrobio, Biora, Cognition, Esperovax, Galera, Immunovia, In8bio, Inspirna, Repare, Ring. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D Molecular, Actinium, Avidity, Inmagene, Kiora, Nanoscope, Olix, Ovid, Takeda, Tempest. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 2seventy, BMS, Gaviton, Immatics, Leidos, Novo Nordisk, Ovid, Sangamo, Silk Road, Soligenix, TFF, Vyne. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bristol Myers Squibb, H. Lundbeck, Moderna, Otsuka, Pfizer, Rnaimmune, Senhwa. Read More
