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Home » Newsletters » BioWorld

BioWorld

June 12, 2024

View Archived Issues
Person holding weight with assistance

Avidity shares rise on FSHD data, plans for registrational study

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
Woman sleeping

Doze about to rock as orexin sleep players tune up

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
NLRP3 inflammasome

Nodthera's NLRP3 inflammasome inhibitor targets cardiometabolic space

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
FDA Orange Book

US court adopts FTC stance in Orange Book listing challenge

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
Australian coins and bills

Opthea raising AU$227M, enters final phase III stretch for OPT-302

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

Appointments and advancements for June 12, 2024

New hires and promotions in the biopharma industry, including: Alzheon, Neurona, Newcells, Nimble, Regenxbio, Treveni, T-Therapeutics, Vera, Zai Lab. Read More

Financings for June 12, 2024

Biopharmas raising money in public or private financings, including: Actuate, Bright Peak, Tacalyx. Read More

In the clinic for June 12, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinium, Annovis, Arcutis, Coya, Gannex, Processa, Sage, Tracon, Ultimovacs, Viridian. Read More

Other news to note for June 12, 2024

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 actions for June 12, 2024

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

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