Following a day of deals that collectively bring a potential $3.75 billion into three biopharma companies – namely Ascidian Therapeutics Inc., Belharra Therapeutics Inc. and Mabcare Therapeutics – researchers will be busy discovering new therapies for neurological and immunological diseases, and advancing globally a candidate for solid tumors. Read More
Becoming the first pneumococcal conjugate vaccine specifically designed for adults 18 and older, Merck & Co. Inc.’s 21-valent candidate, Capvaxive (V-116), gained U.S. FDA approval on its June 17 PDUFA date. The Rahway, N.J.-based company expects to take significant market share based on positive phase III findings from the Stride-3 trial. Analysts have estimated the product could reach $2 billion in annual global sales. Read More
The deaths of two cancer patients treated with the small molecule azenosertib has prompted the U.S. FDA to place a partial clinical hold on a phase I study and two phase II studies from Zentalis Pharmaceuticals Inc. The deaths are presumed by Zentalis to be from sepsis. Both patients who died were in the phase II Denali study of platinum-resistant ovarian cancer. Read More
South Korea’s Imbiologics Inc. scored a potential $940 million (₩1.3 trillion) technology transfer deal with U.S. biotech Navigator Medicines Inc. for its bispecific antibody drug candidate, IMB-101 (Oxtima), to treat autoimmune diseases. Read More
Marea Therapeutics came out of stealth mode on June 18, after raising a combined $190 million through its series A and B financings. The series A round was led by Third Rock Ventures, and the series B round was led by Sofinnova Investments and co-led by Forbion, Perceptive Xontogeny Venture Fund and Venbio. Read More
For the time being, Madrigal Pharmaceuticals Inc.’s Rezdiffra (resmetirom) stands alone as the only U.S. FDA approved treatment for treating nonalcoholic steatohepatitis (NASH). But new and positive data from multiple companies show Madrigal may soon have company. Read More
Fledgling biotech Ternarx Pty Ltd. has emerged from stealth mode and is the first of its kind in Australia to develop targeted protein degrader technology to destroy disease-causing proteins that cannot be targeted by conventional drugs. The Melbourne-based company will initially develop targeted protein degraders against currently undrugged transcription factors in cancers with significant unmet need, starting with neuroblastoma and prostate cancer. Read More
New hires and promotions in the biopharma industry, including: Amarna, Arvinas, Cytomx, Enterprise, Keros, Kriya, Seaport, Shuttle, Spybiotech. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biontech, Grifols, J&J, Medilink. Read More
