Despite an outcome that TD Cowen analyst Tyler Van Buren called ”fantastic,” shares of Tyra Biosciences Inc. (NASDAQ:TYRA) closed Oct. 25 at $21.93, down $6.68, or 23%, as Wall Street digested new phase I/II data with FGFR3 inhibitor TYRA-300 in metastatic urothelial cancer from the Surf301 phase I/II study in progress.
Bayer AG has entered into an exclusive licensing agreement with Dewpoint Therapeutics Inc. for a heart disease program to treat dilated cardiomyopathy (DCM) patients characterized by specific mutations.
For a company that was running out of money, a missed phase III endpoint for its only development product knelled a death blow for Marinus Pharmaceuticals Inc., tanking its stock by 82%. The Radnor, Pa.-based company will no longer develop oral ganaxolone for seizures associated with tuberous sclerosis complex, or for any other indication, as it reduces its workforce and explores strategic alternatives.
The approval of Ascendis Pharma A/S’ hormone replacement therapy Yorvipath (palopegteriparatide) hypoparathyroidism – the first and only treatment for adults with the rare endocrine disease – did little to sate the market’s appetite for new drugs in the indication, where a number of players are busy in various stages of development.
Modifi Biosciences Inc. has come a long way very quickly. Spun out of Yale University in 2021, it published data on DNA in Science in July 2022, and now it’s being acquired by Merck & Co. Inc. for $30 million up front. Ultimately, Modifi shareholders could receive milestones of up to $1.3 billion.
Despite positive findings from an earlier trial, Alto Neuroscience Inc.’s BDNF-targeting candidate, ALTO-100, failed to best placebo in a phase IIb study in major depressive disorder, sending shares of the company to their lowest price since going public in a February 2024 IPO, as investors worried about readthrough to Alto’s biomarker-based approach for treating psychiatric disorders.
Modifi Biosciences Inc. has come a long way very quickly. Spun out of Yale University in 2021, it published data on DNA in Science in July 2022, and now it’s being acquired by Merck & Co. Inc. for $30 million up front. Ultimately, Modifi shareholders could receive milestones of up to $1.3 billion.
Camurus AB received a complete response letter (CRL) from the U.S. FDA for CAM-2029 (octreotide), its extended-release injection for acromegaly, due to “facility-related deficiencies” identified during a cGMP inspection of a third-party manufacturer. The Lund, Sweden-based company noted that the CRL did not indicate any concerns related to clinical efficacy or safety. Camurus will work with the FDA and the third-party manufacturer to address the concerns, said Fredrik Tiberg, president and CEO.
It’s a go for the two phase III Ensure studies of Immunic Inc.’s lead asset in treating relapsing multiple sclerosis. An unblinded data monitoring committee’s interim futility analysis concluded that the placebo-controlled, pivotal studies using vidofludimus calcium may continue as planned, with the program expected by the company to be completed in 2026.
Targeting NMDA in mental health has chalked wins but not universally, as shown by Sage Therapeutics Inc.’s failure of the placebo-controlled phase II Lightwave study testing dalzanemdor in Alzheimer's disease, which missed the primary outcome measure, another bit of bad luck from the company that was disclosed Oct. 8.
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