Even though Cytokinetics Inc. received applause for testing its heart failure drug, omecamtiv mecarbil, in the second largest global heart disease clinical trial ever, the drug didn’t get a standing ovation from the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Dec. 13.
What could be Cytokinetics Inc.’s first approved drug will take center stage Dec. 13 at a meeting of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee. But judging from the FDA’s briefing document for the meeting, the spotlight on the heart failure drug, omecamtiv mecarbil, could be harsh.
Gossamer Bio Inc. shares (NASDAQ:GOSS) fell 74.6% to $2.36 Dec. 6 after the disclosure of phase II results that, while meeting the study's primary endpoint of reducing pulmonary vascular resistance vs. placebo, failed to show the company's pulmonary arterial hypertension (PAH) candidate, seralutinib, holding its own against the performance of Merck & Co. Inc.'s PAH candidate, sotatercept, in separate PAH studies.
The age-old separation of dentistry from medicine is deeply embedded in education and professional practice. Given the great advances in both disciplines in recent decades, there is a reasonable argument to be made for maintaining the divide.
Shares of Cincor Pharma Inc. (NASDAQ:CINC) took a serious hit on top-line findings from the completed phase II Halo study with once-daily oral baxdrostat, but the clinical program with the aldosterone synthase inhibitor remains on track, and an NDA submission is targeted for 2025. The stock closed at $14.11, down $12.42, or 46.8% after Waltham, Mass.-based Cincor informed Wall Street that results from Halo, which enrolled patients taking as many as two blood pressure medications at the maximally tolerated doses without satisfactory results, missed statistical significance on its primary endpoint evaluating change from baseline in mean seated systolic blood pressure in the intent-to-treat population, which included 249 patients.
New and updated preclinical and clinical data presented by biopharma firms at the American Heart Association Scientific Sessions including: Amgen, Incarda, Innovent, Lexicon, Renibus, Silence.
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.
RSS
