Catalent, Inc.

Today, a brief rundown of news involving Biohaven and Catalent, as well as updates from Stealth Biotherapeutics, Jazz Pharmaceuticals and Celldex Therapeutics that you may have missed.The Food and Drug Administration no longer plans to hold a meeting with outside experts to help evaluate an approval application for a Biohaven medicine called troriluzole. According to a regulatory filing, the agency informed Biohaven of this change on Thursday, but still expects to issue an approval verdict sometime late in the year. Canceling the advisory committee meeting “likely indicates that the FDA feels it has sufficiently resolved any difficulties in interpreting data pertaining to the safety or efficacy of the drug though whether their conclusion is positive or negative is difficult to determine,“ wrote RBC Capital Markets analyst Leonid Timashev in a note to clients. Timashev also highlighted how the history of these cancellations is “modestly encouraging“ for Biohaven, since, in roughly two-thirds of cases, the FDA subsequently green lit the drugs under review. Jacob BellContract manufacturer Catalenthas laid off 350 employees working at its Baltimore gene therapy facility due to an unexpected shift in demand from a large customer, a company spokesperson confirmed to BioPharma Dive. Our gene therapy business continues to see strong growth and we look forward to working on behalf of customers to deliver novel therapies for patients with genetic diseases, the spokesperson added. Catalent is now owned by Novo Holdings, the parent company of Novo Nordisk. Ned PagliaruloThe FDAhas accepted a revised approval submission for a rare disease drug developed by Stealth BioTherapeutics. According to Stealth, the agency considers its new application a class 2 response to a prior rejection, meaning its treatment, a Barth syndrome therapy called elamipretide, would typically undergo a six-month review ending in February. The FDA, though, intends to make a decision by Sept. 26, Stealth said Thursday. The review of elamipretide has been flagged by conservative outlets as evidence of biotech innovation slowing down under the leadership of commissioner Martin Makary. Ben FidlerJazz Pharmaceuticals has bought rights to an experimental epilepsy medicine in a heavily back-loaded deal that could ultimately surpass $1 billion in value. Jazz gave Denmark-based Saniona almost $43 million upfront for an exclusive license to SAN2355, a small molecule drug designed to activate certain so-called potassium ion channels. While not yet in human testing, SAN2355 looks to be a highly promising asset with the potential to be the best in its drug class, said Robert Iannone, Jazzs head of research and development. TD Cowen analyst Joseph Thome wrote in a note to clients how the deal brings in a familiar, closely watched target that should fit in nicely with Jazz's current neuroscience portfolio. Thome added that Sanionas molecule is somewhat de-risked due to the clinical advancement of rival therapy from Xenon Pharmaceuticals. Jacob BellAn experimental drug from Celldex Therapeutics didnt alleviate signs and symptoms of the inflammatory condition eosinophilic esophagitis in a Phase 2 trial, the company said Wednesday. The drug, barzolvolimab, is currently in late-stage testing in people with skin hives called urticaria. Celldex had been hoping the drugs ability to deplete levels of mast cells immune cells implicated in multiple immune conditions might be beneficial in eosinophilic esophagitis too. While that didnt happen, barzolvolimab still had clean safety in the study, which bodes well for its ongoing Phase 3 trials in urticarias, wrote Leerink Partners analyst Thomas Smith. Ben Fidler '

iStock, volodyar Among the problems cited were cat hair, bacterial contamination and instrument defects. The FDA has identified critical lapses at a production facility operated by Novo Nordisk that is used by several drugmakers, raising quality concerns for companies, including Regeneron and Scholar Rock, whose therapies are manufactured there. The problems were reported on Thursday by STAT News , which obtained a copy of the FDA report . They include unaddressed instances of contamination by “atypical extrinsic particles” such as cat hair. The production plant, located in Indiana, “failed to determine a root cause of the contamination, assess the potential impact to the rest of the lot, or evaluate whether similar issues may have occurred in upstream batches,” the agency’s investigator wrote. There appear to be no commercial drug lots affected by the hair contamination. The FDA report additionally flagged bacterial contaminations and pest infestations, for which the facility was unable to adequately identify the root cause or assess the impacts on product batches. For years—with some cases dating as far back as June 2022—the plant also fielded complaints from different clients regarding “foreign matter” or “particles” detected in lots produced at the facility. The site also “failed to investigate all critical equipment failures that have the potential to impact drug products,” the investigation revealed. Just in the period from late February 2024 to May 2025, the plant opened roughly 10 work orders for “recurrent leaks and/or other failures” of a certain system, for which some repairs were substantially delayed, according to the report. According to reporting from STAT , the facility in question was once owned by Catalent and is one of the three plants handed over to Novo Nordisk when its parent company Novo Holdings acquired the CDMO giant in February last year. The takeover cost the Danish firm $16.5 billion. In a statement to STAT on Thursday, Novo said that it is taking all of the FDA’s observations “seriously” and has already filed a “comprehensive response” to the report. “Appropriate actions are being taken to address each observation promptly and holistically,” a company spokesperson said. In the meantime, these issues have already caused problems for Regeneron, which earlier this month revealed that two FDA decisions for the high-dose version of its blockbuster eye drug Eylea will be delayed due to problems at the Novo-managed manufacturing facility. On Wednesday, the pharma announced that it expects the verdicts to come in the fourth quarter . Regeneron’s applications concern the use of Eylea HD for macular edema after retinal vein occlusion, as well as a four-week dosing schedule for the drug across its approved indication. Similarly, Scholar Rock earlier this month reported the challenges at the facility as the company awaits an FDA decision for apitegromab to treat spinal muscular atrophy. Executives said on a second quarter earnings call on August 6 that the inspection was not specific to apitegromab and that so far, the FDA appears to be on track for the September decision date.

Plus, news about Benchling, Invivyd, Immuneering, Scilex and Sana Biotechnology: 📉 Sarepta’s debt refinancing: The biotech, which went through a complicated exchange with the FDA this summer over the safety of its Duchenne gene therapy, will extend its debt from 2027 to 2030 to improve its finances. “By extending the maturity of a meaningful portion of our convertible notes to 2030, we have completed a shareholder-friendly transaction,” CEO Doug Ingram said in a statement. Last week, the company had to sell its stock position in Arrowhead Pharmaceuticals to be able to pay a milestone fee to Arrowhead, which has siRNA programs that could drive the future of Sarepta’s pipeline under a $10 billion biobuck pact . — Kyle LaHucik 🏭 As expected, Regeneron says FDA decisions on Eylea HD are delayed: The regulator pushed back two decisions on Eylea’s high-dose formulations to the fourth quarter. The original decision date was Aug. 19. Regeneron is seeking approval for a pre-filled syringe, treatment for macular edema following retinal vein occlusion, and a broader dosing schedule for all indications. It previously disclosed that it expected delays following an inspection of a third-party manufacturer site in Indiana, formerly owned by Catalent and now part of Novo Nordisk. Scholar Rock , another customer of the Indiana site, has said it doesn’t expect any PDUFA delays for its experimental spinal muscular atrophy drug called apitegromab. — Anna Brown 💻 Benchling’s two deals: The life sciences software startup “acquired the teams” of ReSync Bio and Sphinx Bio. The startups create “AI tools that power scientific workflows,” Benchling said. Earlier this year, Benchling laid off 10% of its staff. The San Francisco-based company partners with biopharmas like Merck and Moderna on AI research, bioanalytics and other functions. It raised a $100 million Series F in 2021. — Kyle LaHucik 💰 Invivyd’s $50M stock sale: The company, which has an authorized Covid-19 prevention drug called Pemgarda, is selling 21.3 million shares at 52 cents apiece. — Jaimy Lee 🏥 Immuneering gets $25M from PIPE: The company said it expects to share updated overall survival and progression-free survival data from its Phase 2a trial of atebimetinib in pancreatic cancer “in the coming weeks.” — Jaimy Lee 💵 Scilex raises $20M for Phase 3 trial: Semnur Pharmaceuticals, Scilex’s parent company, and Denali Capital inked the private placement with an unnamed investor to help advance Scilex’s SP-102 into a second Phase 3 trial for lumbar radicular pain, or sciatica. — Jaimy Lee 💸 Sana Biotechnology ended up raising $86.3 million, up from the $75.0 million it intended to bring in. — Jaimy Lee