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Plus, news about SRT Therapeutics, Precigen, Enlivex, Tonix Pharmaceuticals and LakeShore Biopharma: Stealth BioTherapeutics resubmits its rare drug to the FDA: The privately held biotech’s experimental Barth syndrome drug was rejected by the regulator in May, and Stealth said it has since resolved manufacturing issues cited by the FDA. The agency had initially delayed its decision on the drug before issuing the CRL . Stealth is now seeking accelerated approval at the recommendation of the FDA. — Jaimy Lee Boehringer Ingelheim’s retinal pact: The German drug giant will work with Palatin Technologies on a melanocortin receptor agonist for diabetic retinopathy, paying up to €280 million (about $326 million). — Kyle LaHucik Former Prometheus Biosciences execs raise money for new biotech: Their startup, called SRT Therapeutics, raised $47 million, according to an SEC filing last week. The San Diego-based company was founded last year to go after “key pathways that not only modulate inflammatory pathways, but also promote tissue healing in IBD,” according to its LinkedIn page. SRT is led by Lauren Otsuki, a former operating chief at Prometheus, which Merck bought for $10 billion in 2023. Other Prometheus founders are also involved in SRT, including Cedars Sinai’s Stephan Targan and Janine Bilsborough. Several Prometheus employees followed CEO Mark McKenna to a new autoimmune biotech shortly after the acquisition. He started Mirador Therapeutics , which was unveiled in the spring of last year with $400 million for a still undisclosed pipeline . — Kyle LaHucik A course of Precigen’s therapy costs $460,000: The drugmaker announced Monday on an analyst call that the wholesale acquisition cost of its recurrent respiratory papillomatosis treatment is $115,000 per vial, and a course of treatment is four injections. The FDA approved the rare disease therapy, known as Papzimeos, on Thursday. Precigen’s shares $PGEN fell 5% premarket on Monday, though it’s up about 60% over the last five days. — Lei Lei Wu Enlivex Therapeutics’ cell therapy posts mid-stage data : In a Phase 1/2a trial in moderate-to-severe knee osteoarthritis, Allocetra showed a 24% reduction in knee pain and 26% improvement in knee function over placebo at three months. The company made no claim for statistical significance on these endpoints, and its stock $ENLV fell 25% on Monday morning after the data were announced. The therapy, composed of donor-derived mononuclear cells, also demonstrated a 72% reduction in knee pain and a 95% improvement in knee function compared with placebo among a subgroup of patients with age-related primary osteoarthritis. Enlivex called these “substantial, clinically meaningful and statistically significant” effects. There were no severe adverse events. The trial will continue to evaluate Allocetra’s effects at six and 12 months. — Elizabeth Cairns FDA approves fibromyalgia treatment: The agency on Friday greenlit Tonix Pharmaceuticals’ non-opioid analgesic for adults with the chronic pain condition. The sublingual formulation of cyclobenzaprine hydrochloride is designed for rapid absorption into the bloodstream. It will be branded as Tonmya. Tonix said it plans to launch Tonmya in the fourth quarter. It has not yet set a list price for the drug. — Ayisha Sharma LakeShore Biopharma gets an offer: Oceanpine Capital proposed a deal to buy the Beijing-based biotech for 86 cents per share $LSB , or about 8 cents per share above Friday’s closing price. LakeShore said the proposal is a preliminary, non-binding one, and the board still needs to “carefully review” Monday’s letter from Oceanpine, a life sciences and tech investment firm with about $3.5 billion in assets under management. The biotech, formerly known as YS Biopharma, is listed on the Nasdaq. It works on vaccines and biologics for infectious diseases and cancer, and it also markets a rabies vaccine in China. — Kyle LaHucik