Rezolute Inc.’s phase III Sunrize study of its only candidate, ersodetug, a fully human monoclonal antibody that binds to allosteric site on insulin receptors, missed its primary and secondary endpoints in treating congenital hyperinsulinism. The top-line results, which sank the stock at midday, showed a 45% reduction in hypoglycemia events at the highest dose, 10 mg/kg, compared to a 40% improvement in placebo arm. The U.S. FDA granted ersodetug breakthrough therapy designation in May. The company’s stock (NASDAQ:RZLT) had plummeted 88% to $1.25 per share in early afternoon trading. Rezolute’s development partner, Xoma Royalty Corp., also saw a stock drop, with shares down 22% at $26.70 apiece.

Petition claims FDA oops! means COVID-19 vaccines misbranded

Restricting the recommended use of COVID-19 vaccines in the U.S. wasn’t enough. Now the Children’s Health Defense (CHD) is trying to get the FDA to revoke the BLAs for all versions of the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 vaccines. Citing a technicality in how the FDA licensed the vaccines, the anti-vax group founded by Robert Kennedy filed a citizen petition this week asking FDA Commissioner Marty Makary to determine that the two mRNA vaccines, Comirnaty and Spikevax, are misbranded and adulterated. “The FDA granted full licensure to these vaccines without requiring the manufacturers to meet the legal standards that typically govern licensed vaccines,” CHD CEO Mary Holland said. “It’s critical that the FDA follow its own rules.”

China introduces new reimbursement list for innovative drugs

China unveiled its first Commercial Health Insurance Innovative Drug List (CIIDL), reimbursing 19 high-value innovative drugs, including all five domestically developed CAR T therapies as well as treatments for rare diseases and Alzheimer's disease. The National Healthcare Security Administration reviewed 121 drugs for the inaugural list, with 24 entering price negotiations. Cancer drugs dominate, accounting for 14 of the 19 therapies. In 2025, China’s National Medical Product Administration approved 69 innovative drugs, while outbound licensing deals exceeded $100 billion in value. The CIIDL serves as a reference for commercial insurers and other stakeholders in China’s multitiered insurance system, which includes basic medical insurance, commercial insurers, charities and patient assistance programs.

Formation loads new Bleecker division with Lynk’s TYK2 inhibitor

Formation Bio Inc. acquired ex-China rights to Lynk Pharmaceuticals Co. Ltd.’s oral TYK2-inhibitor, LNK-01006, for up to $605 million. The phase I-ready central nervous system candidate will be developed at Formation’s newly formed subsidiary, Bleecker Bio. Under the agreement, Lynk will gain a minority stake in Bleecker and up to $605 million in up-front, development regulatory and commercial milestone payments, along with royalties tied to potential future sales. Formation gains global rights outside of China to develop and commercialize the candidate. The oral TYK2 allosteric inhibitor has been in development for multiple sclerosis, according to Cortellis.

Disco closes €36M seed round to advance surfaceome technology

Disco Pharmaceuticals GmbH announced the final close of its seed round at €36 million (US$42 million), as it shapes up novel targets it has discovered with its surfaceome platform technology for formal preclinical development. The surfaceome technology enables the discovery of pairs of cancer cell surface proteins that Disco plans to drug with antibody-drug conjugates (ADCs) and T-cell engagers. The seed money will be used to advance ADC programs in small-cell lung cancer and microsatellite-stable colorectal cancer.

Lilly’s retatrutide shows solid weight loss, reduced knee pain

Eli Lilly and Co.’s latest phase III results for the obesity and overweight populations suggest its triple agonist, retatrutide, can deliver significant weight loss that, in turn, leads to reduced osteoarthritis knee pain. Each dose, 9 mg and 12 mg, of the Triumph-4 trial met all primary and key secondary endpoints at 68 weeks using both efficacy and treatment-regimen estimands. Retatrutide, a first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, lowered weight by up to an average of 28.7%, or 71.2 pounds, and it reduced pain by up to an average of 75.8%, or 4.5 points, using the Western Ontario and McMaster Universities Osteoarthritis Index pain score. Cantor analyst Carter Gould called the weight loss “clearly above expectations,” and the reduction on pain “impressive … essentially matching or modestly exceeding impacts on pain seen typically with NSAIDs in this setting.”

Teva yields to FTC on Orange Book listings

The U.S. FTC is taking a bow after Teva Pharmaceutical Industries Ltd. asked the FDA to remove more than 200 patent listings from the agency’s Orange Book. The request followed a series of warning letters the FTC sent to Teva and several other biopharma companies, which also have withdrawn most of their disputed listings. For the most part, those listings referenced patents protecting the device components of combination products. The removal of the listings, which reference many of the same patents, “will pave the way for greater competition for generic alternatives for more than 30 asthma, diabetes and COPD drugs, and epinephrine autoinjectors,” the FTC said.

The BioWorld Insider podcast: Finding a better, longer-lasting fix in opioid overdose

The opioid crisis may not be front and center anymore, but it’s raging still. A major problem is that overdose-reversal drugs don’t last long enough to help users who opt out of hospital treatment after they are revived. Elysium Therapeutics Inc. CEO Greg Sturmer talks with Randy Osborne about his firm’s candidate for a solution to the medical and societal problem. The NIH – which has been helpful to Elysium since the company’s founding – the FDA, and others are working to advance a longer-lasting reversal agent. Experiments already done with approved reversers, as well as computer modeling that’s been used by regulators previously, will help in the push, Sturmer said.

Also in the news

Ajax, Allegria Therapeutics, Amneal, Apimeds, Atossa Therapeutics, Aukera Therapeutics, Azafaros, Barinthus, Basilea, Beone, Beren, Bioxodes, Blossomhill, BMS, Boehringer Ingelheim, Briacell, Cellenkos, Citius Oncology, Expression, Faron, Fondazione Telethon, Geovax, Geron, GRI Bio, GSK, Hemostemix, Idorsia, Igyxos, Immunovant, Indupro, Innocare, Journey, Kane, Karolinska, Kazia, Kymera, Kyowa Kirwin, Libbs, Lynk, Medicenna, Mendus, Mindwave Innovations, Moleculin, Nanology, Neurenati Therapeutics, Nuvalent, Oxford, Phare Bio, Polpharma, Psithera, Praxis, Prolynx, Roche, Sagimet, Serina, Sanofi, Senhwa Biosciences, Telix, Tuhura, USAntibiotics, Varian.