Shares of Essa Pharma Inc. tanked Nov. 1 after the company said it is terminating all trials of masofaniten, its N-terminal domain androgen receptor inhibitor and sole clinical-stage program, following a disappointing readout from a phase II study in metastatic castration-resistant prostate cancer. The stock (NASDAQ:EPIX) hit a 52-week low, closing at $1.40, down $3.80, or 73%.
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York.
Equillium Inc. plans to continue on its own with itolizumab – now the top pipeline priority – as Ono Pharmaceutical Co. Ltd. Is letting expire the option for rights to the monoclonal antibody, designed to target the CD6-ALCAM signaling pathway.
The first year of data from the TRISCEND II study of the Evoque tricuspid valve by Edwards Lifesciences Corp. confirm the notion that reduced regurgitation has a big impact on patient well-being. While one-year data support the device’s safety, cardiovascular mortality at one year does not seem to decisively favor the device over medical management.
The ACURATE study of the Accurate neo2 TAVR device by Boston Scientific Corp., failed to demonstrate the device is non-inferior to established devices, but the COVID-19 pandemic threw up some roadblocks.
Phase III Scorpio-PEP study results showed Shionogi & Co. Ltd.’s oral antiviral ensitrelvir fumaric acid (Xocova) reduced risk of symptomatic COVID-19 infection in subjects who were exposed to the virus by infected household members.
The prospect of a gene therapy for Alzheimer’s disease has kept Wall Street steadily interested in Lexeo Therapeutics Inc., and another increment of intrigue was added when the New York-based firm offered positive interim results from the 52-week, 15-subject phase I/II study of LX-1001 for the treatment of the condition when APOE4-associated.
Cell and gene therapy companies are the beneficiaries of positive changes along the regulatory path that the U.S. FDA is paving for them, according to a panel of executives who spoke at the BioFuture 2024 conference in New York. The agency is trying to set up cell and gene companies for success and that’s a very different agency than what it was years ago, said Paul Bresge, CEO of Ray Therapeutics Inc.
The contest between the two main classes of antiproliferatives for circulatory system use continues as seen in a presentation at this year’s Transcatheter Cardiovascular Therapeutics.
Atherectomy devices play a key role in dealing with calcified coronary arteries. But a study presented at this year’s Transcatheter Cardiovascular Therapeutics demonstrates that angioplasty balloons made a lot of headway in this clinical area, potentially pushing atherectomy devices into the fringes of routine practice.
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