Shares of Avidity Biosciences Inc. hit a 52-week high on reports of promising data from the first efficacy cohort of its phase I/II Fortitude study testing delpacibart braxlosiran (del-brax) in facioscapulohumeral muscular dystrophy (FSHD), including impressive biomarker results that could indicate a path for potential accelerated approval. Read More
Evercore ISI analyst Umer Raffat recently called orexin a “red hot neuropsychiatry target,” and the recent Sleep 2024 meeting in Houston bolstered such a view. Also known as hypocretin, the neuropeptide orexin is known to play a crucial role in regulating wakefulness, arousal, and appetite. It’s made in the hypothalamus, and was discovered in the late 1990s. Investigators found that people with narcolepsy can show a deficiency of orexin due to the loss of neurons. Read More
After delivering animal data to show that inhibiting the NLRP3 inflammasome induces weight loss in mice, Nodthera Ltd. has now demonstrated this effect translates to humans. In a phase Ib/II study of NT-0796, an orally available, brain-penetrant drug, subjects in both the active and placebo arms all lost weight, due to the calorie-restricted diet they received in the 28-day trial. Read More
The U.S. FTC’s campaign against the Orange Book listing of patents claiming device components gained momentum when a federal judge in New Jersey ordered Teva Pharmaceuticals USA Inc. to delist five device patents pertaining to its Proair HFA (albuterol sulfate) inhaler. Read More
Opthea Ltd. announced it plans to raise up to AU$227.3 million (US$150 million) to extend its cash runway through the data readout for its two phase III pivotal trials of sozinibercept (OPT-302) in wet age-related macular degeneration. Read More
New hires and promotions in the biopharma industry, including: Alzheon, Neurona, Newcells, Nimble, Regenxbio, Treveni, T-Therapeutics, Vera, Zai Lab. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinium, Annovis, Arcutis, Coya, Gannex, Processa, Sage, Tracon, Ultimovacs, Viridian. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Alvotech, Amgen, Deciphera, Dong-A, Hudson, Janssen, Ono, Regeneron, Shaperon, Stada. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 60 Degrees, Capricor, Destiny, Eli Lilly, Ipsen, Regeneron, Tiziana. Read More
