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.
As they matured from prenatal to adult, heart cells reduced the number of nuclear pores by more than 60%. That decrease protected them from the consequences of stress, but also impaired their ability to regenerate. “These findings are an important advance in fundamental understanding of how the heart develops with age and how it has evolved to cope with stress,” senior author Bernhard Kühn, professor of pediatrics and director of the Pediatric Institute for Heart Regeneration and Therapeutics at the University of Pittsburgh School of Medicine, said in a press release. Kühn and his colleagues published those findings in the Oct. 24, 2022, issue of Developmental Cell.
Vivasc Therapeutics Inc. has initiated work under a second National Institutes of Health (NIH) phase I STTR research grant, in conjunction with Georgetown University.
Sino Medical Sciences Technology Inc. received marketing approval from China’s NMPA for its drug eluting stent system to improve vascular stenosis in patients with localized ischemic heart disease. The product is designed to improve the speed of wound healing and accelerate the recovery of vascular endothelium after stent implantation. It fits vessels with a diameter of 2.25 mm to 4.00 mm and a lesion length of less than or equal to 40 mm.
Cordis Corp. entered an agreement to acquire M.A. Med Alliance SA (Medalliance) in a transaction valued at up to $1.135 billion. Cordis will invest $35 million initially and provide an upfront payment of $200 million at closing in 2023. Meeting regulatory milestones will kick in $125 million and commercial milestones through 2029 are tied to an additional $775 million.
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.
Shire Human Genetic Therapies Inc. has discovered new plasma kallikrein (KLKB1) inhibitors reported to be useful for the treatment of hereditary angioedema and diabetic macular edema.
Researchers from the International Centre for Genetic Engineering and Biotechnology and colleagues have worked on the systematic identification of cellular proteins that can exert cardioprotective activity after a myocardial infarction (MI).
RSS
