Today, a brief rundown of news involving AstraZeneca and the Food and Drug Administration, as well as updates from Compass Pathways, Zura Bio and Abeona Therapeutics that you may have missed.
AstraZeneca has acquired vaccine startup and development partner Omniose. The two companies didn't disclose deal terms in their announcement Tuesday. But the transaction hands AstraZeneca "bioconjugation" technology, a more efficient way to make the conjugate vaccines that strap a protein to an immune system-provoking antigen. Omniose claimed the technology could yield "higher-quality" conjugate vaccines. AstraZeneca intends to use the approach to make shots for serious bacterial infections. The two companies first formed a vaccine-focused alliance in January 2024. — Ben Fidler
The Food and Drug Administration has called for the prescribing information for widely popular GLP-1 therapies to be updated to include the possible risk of contracting a rare condition that causes vision loss. The FDA began investigating the issue following case reports of GLP-1 recipients developing "non-arteritic anterior ischemic optic neuropathy," or "NAION." A review of animal data failed to uncover why GLP-1 drugs might be associated with NAION, but a meta-analysis of many trials found a higher rate of cases in treatment recipients. NAION's been seen with every marketed GLP-1 drug, too, the FDA said. The agency, as a result, believes there is a “potential increased risk of rare NAION events,” it said Monday. — Ben Fidler
Compass Pathways said Monday it has completed an approval application in the U.S. for a synthetic psilocybin drug it calls “COMP360” and that it’s developed for treatment-resistant depression. In clinical testing, six weeks of treatment with COMP360 was associated with, on average, a 3.8-point reduction on a 60-point scale measuring the severity of depression symptoms. The drug is part of a wave of research into psychedelic medicines and could receive a particularly speedy review following the company’s receipt of a special Food and Drug Administration voucher. — Jonathan Gardner
Shares of Zura Bio plunged by more than two-thirds on Monday following the company’s announcement that its lead product missed the main goal of a Phase 2 trial in people with the autoimmune skin condition hidradenitis suppurativa. Neither of two tested doses of the dual-pronged antibody drug tibulizumab significantly reduced the number of abscesses and inflammatory nodules in enrollees after 16 weeks, nor were secondary trial goals met. Zura will halt development in hidradenitis suppurativa, but continue studying tibulizumab in other immune diseases. The stock plunge dropped Zura’s market valuation to $93 million, below the $188 million in cash and cash equivalents it held on Sept. 30. — Jonathan Gardner
Abeona Therapeutics has acquired a Phase 3-ready treatment for eosinophilic esophagitis from Ellodi Pharmaceuticals, a six-year-old startup TPG Capital formed after selling off most of Adare Pharmaceuticals. Per deal terms, Abeona issued Ellodi $20 million worth of shares, and promised to pay Ellodi another $60 million should its drug win FDA approval and hit certain sales milestones. Abeona raised $30 million in a private share sale alongside the deal. Previously called APT-1011 and now ABO-801, the drug is an oral form of the steroid fluticasone that dissolves in the mouth and is delivered directly to the esophagus. — Jonathan Gardner
