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Home » Newsletters » BioWorld

BioWorld

Aug. 31, 2023

View Archived Issues
Hands holding gears

Acer stabilizes with Zevra merger and Relief deal

Zevra Therapeutics Inc. will acquire Acer Therapeutics Inc. in a $91 million deal that combines two companies with expertise in rare diseases. Acer has struggled since its hot flash drug, ACER-801 (osanetant), failed to hit statistical significance in a phase IIa proof-of-concept study in March 2023. The stumble came amidst the launch of Acer’s Olpruva, a sodium phenylbutyrate for oral suspension therapy approved by the U.S. FDA in late December 2022 for treating urea cycle disorders. The day before the Zevra merger was announced, Acer reacquired the worldwide development, commercialization and economic rights to Olpruva from its development partner, Relief Therapeutics Inc. Read More

Aria ready for this, PPIs? Phathom opera with GERD prospect nearing finale

Phathom Pharmaceuticals Inc. made recent headway with its new mechanism of action in gastroesophageal reflux disease (GERD) even as further, disturbing discoveries in the space are seeing daylight. Florham Park, N.J.-based Phathom turned over to the U.S. FDA the requested six-month stability data related to reformulated vonoprazan tablets, and the numbers remained consistent with three-month data, reflecting N-nitroso-vonoprazan nitrosamine control and levels comfortably more than tenfold below the acceptable daily intake limit. Read More
Layoff illustration

Sage extends runway with staff cuts, targets Q4 for Zurzuvae launch in PPD

Sage Therapeutics Inc. is reducing its workforce by 40% and pausing its earlier-stage programs, just a few weeks after receiving mixed news of both a U.S. FDA approval and a complete response letter for its depression drug Zurzuvae (zuranolone). The move offers the Cambridge, Mass.-based company an annualized net savings of approximately $240 million, 60% of which is related to R&D, and will extend its runway into 2026. Read More
COVID-19 mental health illustration

UK Phosp study finds biomarkers predictive of long COVID cognitive defects

Blood biomarkers have been found in patients hospitalized with acute COVID-19 that are predictive of the cognitive defects of long COVID. Post COVID-19 deficits in cognition, including brain fog, are common and debilitating. They are also clinically complex, with both objective and subjective components. In the U.K., one in eight patients received their first ever neurological or psychiatric diagnosis within six months following COVID-19. Read More
mRNA on digital background

Acuitas tackles mRNA drug delivery challenges with lipid nanoparticles

Messenger RNA, or mRNA, represents a relatively new class of therapeutics with the potential to prevent and treat a wide range of diseases. A well-known success story is of the mRNA vaccines that controlled the COVID-19 pandemic, which has fueled enthusiasm for the field. But biotechs are also developing mRNA candidates for several other infectious diseases, including malaria, tuberculosis and HIV, as well for cancer, autoimmune and allergic diseases. However, delivering nucleic acid therapeutics can be challenging, since mRNA cannot get into cells on its own. “Nucleic acid therapeutics can be incredibly fragile,” Thomas Madden, CEO of Acuitas Therapeutics, told BioWorld. “When injected into the body without a delivery system, messenger RNA, for example, is rapidly destroyed.” Read More

Appointments and advancements for Aug. 31, 2023

New hires and promotions in the biopharma industry, including: Biomea Fusion, Coeptis, Peak, Sanofi, Verona. Read More

Financings for Aug. 31, 2023

Biopharmas raising money in public or private financings, including: Inventiva. Read More

In the clinic for Aug. 31, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Denali, Fibrogen, Netris, Okyo, Regenxbio, Sparingvision, Xbiotech. Read More

Other news to note for Aug. 31, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Pardes, Medipacific, Ono Pharmaceutical, Twist Bioscience. Read More

Regulatory actions for Aug. 31, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Alzamend, Asieris, Inflarx, Menarini, Northwest, Nrx, Oncomatryx, Outlook, Zealand. Read More

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