Top-line data from Seelos Therapeutics Inc.’s phase II/III study of SLS-005 in amyotrophic lateral sclerosis (ALS) failed to meet statistical significance in its primary and secondary endpoints, continuing the stock’s nearly half-year downward trajectory.
Clearing the way for a U.S. regulatory bid in the second half of this year are positive top-line results from Pathfindr-2, the second of two successful phase III studies testing the efficacy and safety of Crinetics Pharmaceuticals Inc.’s oral, once-daily paltusotine for acromegaly.
Asieris Pharmaceuticals Co. Ltd plans to submit a China NDA in the second quarter following positive phase III data for its cold light photodynamic drug-device combination product, Cevira, which is used as nonsurgical therapy for treating high-grade cervical dysplasia.
China’s National Medical Products Administration (NMPA) approved Kechow Pharma Inc.’s MEK inhibitor, tunlametinib, for treatment of patients with NRAS-mutated advanced melanoma who were previously treated with PD-1/PD-L1 inhibitors. The Center for Drug Evaluation granted tunlametinib a priority review. The approval marks the first targeted therapy for this patient population and the first product that originated from Kechow, a privately held firm founded in 2014 to develop small-molecule therapeutics against cancer.
Affluent Medical SA said that its artificial sphincter, Artus, which treats stress urinary incontinence, was successfully implanted into the first patient. The company hopes that the device, which is the first artificial urinary sphincter that can be activated by the patient with a remote control, will be able to improve the quality of life of the millions of people suffering from urinary incontinence.
Aquestive Therapeutics Inc.’s oral epinephrine prodrug to treat life-threatening allergic reactions, Anaphylm, produced a faster time to maximum concentration than currently available autoinjectors in healthy adults, early pivotal phase III data show, meeting both pharmacokinetic (PK) primary and secondary endpoints.
Top-line phase II results of privately held Ocuterra Therapeutics Inc.’s novel selective small-molecule RGD integrin inhibitor, nesvategrast (OTT-166), showed it failed to meet primary and key secondary endpoints in patients with diabetic retinopathy, prompting the Boston-based company to seek strategic alternatives.
Spruce Biosciences Inc.’s results from two studies with tildacerfont in adult and pediatric classic congenital adrenal hyperplasia (CAH) spurred Wall Street to speculate – further, again – about the prospect’s odds against a drug in the works from Neurocrine Biosciences Inc.
Atrogi AB is raising a €30 million to €35 million (US$32.9 million to $38.4 million) series B round after announcing positive clinical data for ATR-258, a novel beta-2 adrenergic receptor agonist that is being lined up as a potential first-in-class insulin-independent treatment for type 2 diabetes.
Silence Therapeutics plc disclosed positive top-line 36-week data from the Alpacar-360 phase II study with zerlasiran, a short interfering RNA gene muter that targets lipoprotein(a), but also said Mallinckrodt plc has quit development of a separate prospect.
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