Praxis Precision Medicines Inc. CEO Marcio Souza said it would be “disingenuous not to move forward” – U.S. FDA willing – into a phase III effort with an alternate design targeted for the second half of this year, given top-line results from the phase IIb Essential-1 study with ulixacaltamide (PRAX-944) for essential tremor. Read More
Targeted oncology firm Revolution Medicines Inc. is seeking $300 million through a public offering as it prepares to say farewell to Sanofi SA, partner for its most advanced RAS program, and with it the prospect of earning more than $500 million in developmental and regulatory milestone payments and tiered royalties on annual net sales. Read More
Abbisko Therapeutics Co. Ltd. and Allist Pharmaceuticals Co. Ltd. signed an exclusive licensing deal that gives Allist rights to develop, manufacture and commercialize Abbisko’s ABK-3376, an EGFR tyrosine kinase inhibitor for $188 million plus royalties. Read More
Immorna Biotechnology Co. Ltd. raised nearly $100 million in series A+ and A++ financing rounds to speed up the clinical development and commercialization of its RNA-based therapeutics. Founded in 2019, Immorna develops therapeutics and vaccines based on its RNA platforms, including conventional, self-replicating and circular RNA. Read More
According to venture capitalists on three different panels at Biocom California’s Global Life Science Partnering & Investor Conference, there’s still money available for newcos looking to get started. But the pitch they’re going to have to make to VCs is a little different than what would have worked a few years ago. Read More
U.S. Sen. Bernie Sanders (I-Vt.) sent letters to Sanofi SA and Novo Nordisk A/S executives on March 1, urging them to follow Eli Lilly and Co.’s example in cutting prices for their insulin products, offering more affordable access for Americans with diabetes. Industry leaders, however, have long argued that the problem goes far beyond list price, as pharmacy benefit managers and health plans have simply not passed their rebates onto consumers. Read More
Shares of Veru Inc. hit a 52-week low March 3 after the U.S. FDA declined to grant an emergency use authorization (EUA) for sabizabulin for use in hospitalized adults with moderate to severe COVID-19 who are at high risk for acute respiratory distress syndrome. The decision comes as little surprise, given the negative advisory panel vote in November, but the agency’s wording might suggest potential use for the microtubule disruptor in the future. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amniotics, Biovie, BMS, Brim, Inovio, Janssen, Organogenesis, Poolbeg, Sanofi, Sobi. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Augustine, Cormedix, Oculis, Sisaf. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Alvotech, Astrazeneca, Checkpoint, Genenta, Intellia, Santhera, Serda, Valneva. Read More
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