Zevra Therapeutics Inc. will acquire Acer Therapeutics Inc. in a $91 million deal. 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. The agreement had Acer paying Relief 60% of the net profits in the U.S., Canada, Brazil, Turkey and Japan, while Acer received a 15% royalty on Relief’s net sales in the rest of the world. Acer’s stock (NASDAQ:ACER) opened big and was staying that way at midday as shares were up 123% to $1.37 each.

As GERD research marches on, so does Phathom with new mechanism

New findings in gastroesophageal reflux disease (GERD) put a spotlight on the indication, in which Phathom Pharmaceuticals Inc. has been striving for some time with a novel approach. Standard of care for GERD is proton pump inhibitors (PPIs), and a study published Aug. 9 in the journal Neurology found that people 45 years old and beyond who took PPIs for more than four years showed a 33% higher risk of developing dementia than those never exposed to the drugs. Florham Park, N.J.-based Phathom recently submitted six-month stability data from its long-term and accelerated stability program for its reformulated vonoprazan tablets. The drug, which has been the subject of two compete response letters, is a first-in-class potassium-competitive acid blocker for the treatment of erosive GERD.

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. As of Feb. 8, 2023, the company said it had 689 full-time employees, suggesting the cut will result in about 275 lost jobs. Sage received U.S. FDA approval of Zurzuvae on Aug. 7 for postpartum depression (PPD), but it also received a complete response letter for the larger indication of major depressive disorder.

U.K. 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. “I feel optimistic that the science is beginning to give us real insights into what the causes are, and potential treatments,” said Chris Brightling, professor of respiratory medicine at Leicester University and leader of the Phosp study (Post-hospitalization COVID-19), in which the biomarkers were uncovered.

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,” CEO of Acuitas Therapeutics, Thomas Madden, told BioWorld. “When injected into the body without a delivery system, messenger RNA, for example, is rapidly destroyed.”

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Abeona, Alzamend, Asieris, Biomea Fusion, Coeptis, Denali, Fibrogen, Inflarx, Intelgenx, Inventiva, Inxmed, Menarini, Netris, Northwest, Nrx, Okyo, Outlook, Pardes, Peak, Regenxbio, Sage, Sanofi, Sparingvision, Twist, Xbiotech, Zealand, Verona