Shares of Praxis Precision Medicines Inc. (NASDAQ:PRAX) tumbled 66%, or $1.93, to trade midday at 99 cents on word of top-line phase IIb data from the Essential-1 study testing the efficacy, safety and tolerability of ulixacaltamide (PRAX-944) for the treatment of essential tremor. The drug brought about improvements in the modified Activities of Daily Living (ADL) primary efficacy endpoint relative to placebo that fell short of statistical significance (p=0.126). Nominal statistical significance turned up in the TETRAS-ADL secondary endpoint (p=0.026), as well as the Clinical Global Impression-Severity and in Patient Global Impression-Change measures. Boston-based Praxis said plans are in the works for an end-of-phase II meeting with the FDA, and the company hopes to proceed directly into phase III based on the latest findings.
Revolution mitigates future milestone losses with $300M stock offer
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. The Redwood City, Calif.-based company (NASDAQ:RVMD) is selling 13.6 million shares of common stock for $22 per share and has also granted underwriters a 30-day option to buy up to an additional 2 million shares. The offering is expected to close on March 7.
Abbisko out-licenses preclinical EGFR candidate to Allist for $188M
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 (TKI) for $188 million plus royalties. Under the terms of the deal, Allist gains rights to the preclinical candidate in China, including Hong Kong, Macau and Taiwan, and the license could be expanded to include other territories for a limited time. In exchange, Abbisko will receive an undisclosed up-front payment and potential development and commercial milestones up to $187.9 million plus tiered sales-based royalties.
Immorna nets $100M in two financing rounds to develop RNA therapies
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. It also has RNA delivery vehicles, including polymers and lipid nanoparticles, which feature multiple ionizable cationic lipids that can be used for intramuscular, intravenous and tissue-targeting delivery.
Biocom 2023: Venture capitalists spill the beans
According to venture capitalists on three different panels at Biocom California’s Global Life Science Partnering & Investor Conference, there’s money still 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. Plans to go from a large series A to a crossover round to an IPO won’t fly anymore. Instead, VCs are expecting companies will need to remain private longer and/or look to pharmaceutical companies for cash from licensing deals or outright acquisitions.
As Lilly caps insulin prices, Sanders nudges Sanofi and Novo Nordisk
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. Sanders, the chair of the U.S. Senate Committee on Health, Education, Labor, and Pensions, wrote that the price of insulin “has gone up by over 1,000% since 1996,” resulting in 1.3 million diabetics having to ration insulin.
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