Verve Therapeutics Inc.’s heart disease candidate, VERVE-101, is the latest gene editing-based therapy to hit a snag at the FDA, which issued a clinical hold, delaying the start of phase I testing in the U.S. News of the hold, which followed preclinical presentations over the weekend at the American Heart Association 2022 meeting, sent shares of Verve (NASDAQ:VERV) falling 30.5% to close Nov. 7 at $21.75.
Milestone Pharmaceuticals Inc. saw a premarket surge in its share price value after a phase III trial of the company’s self-administered, heart rhythm-restoring nasal spray, etripamil, hit its target in a phase III trial, setting up a potential filing with the U.S. FDA in mid-2023.
At the third time of asking, Scpharmaceuticals Inc. has seen its subcutaneous loop diuretic, Furoscix (furosemide), approved by the U.S. FDA for patients with worsening heart failure, although the news was greeted initially by a shock slump in the firm’s share price.
The closely watched pivotal phase III trial called Stellar by Merck & Co. Inc. with sotatercept delivered in a big way for the company, helping to validate the firm’s $11.5 billion buyout about a year ago of Acceleron Pharma Inc.
Shares of Renovacor Inc. (NYSE:RCOR) closed at $2.18, up 28 cents, or 14.7%, on word that Rocket Pharmaceuticals Inc. is acquiring the firm in an all-stock transaction valued at $53 million. Rocket, of Cranbury, N.J., said “compelling” preclinical data generated by Cambridge, Mass.-based Renovacor validates an AAV-based transgene replacement strategy for BLC2 athanogene 3 dilated cardiomyopathy.
Bearish investors dwelling on a single grade 4 liver enzyme elevation seemed to be the cause for Intellia Therapeutics Inc.’s sinking stock Sept. 16, despite the company reporting impressive, though early stage, data for its leading systemically administered CRISPR candidates targeting hereditary angioedema (HAE) and amyloid transthyretin (ATTR) amyloidosis.
New and updated preclinical and clinical data presented by biopharma firms at the European Society of Cardiology, including: Amarin, Amgen, Astrazeneca, BMS, Daiichi, Tranquis.
Factor XIa inhibitors milvexian and asundexian, hailed as the next-generation class of anticoagulants, earned mixed reviews on phase II data presented during the European Society of Cardiology Congress 2022. However, developers Bristol Myers Squibb Co./Janssen Pharmaceutical Co. and Bayer AG, respectively, are moving into late-stage testing, citing clear mechanisms of action that put the FXIa drugs at least on par with approved factor Xa drugs in terms of efficacy while offering potentially better safety profiles that could give physicians an option for patients with stroke or atrial fibrillation who are currently undertreated with anticoagulants due to bleeding risks.
Doctors will “unequivocally view as a major advance” Cincor Pharma Inc.’s oral baxdrostat for patients with treatment-resistant hypertension, said Deepak Bhatt, director of interventional cardiovascular programs at Brigham and Women’s Hospital and professor at Harvard Medical School. “There are a lot of these folks out there, and physicians don’t know what to do with them right now,” he said, noting that many end up in emergency rooms.
Structure Therapeutics Inc. raised $33 million in a financing round to speed up clinical trials of its lead assets targeting chronic diseases and to improve its technology platform. Previously known as Shouti Inc., the company also has rebranded itself as Structure to “reflect its foundation in structural biology and computational design.”
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