Cyclobenzaprine hydrochloride

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

iStock, Deagreez In Phase III studies, Tonmya showed significantly superior analgesic effects in patients with fibromyalgia versus placebo. The sublingual pill also led to better clinical outcomes. After more than a decade of waiting for a new therapy, patients with fibromyalgia will now have access to an oral pill in the form of Tonix Pharmaceuticals’ Tonmya, which the FDA s igned off on this past Friday. Given sublingually—under the tongue—before sleep, Tonmya is a non-opioid analgesic designed to be quickly absorbed into the bloodstream. The New Jersey biotech expects to launch Tonmya in the U.S. in the fourth quarter of this year, addressing a market of approximately 10 million patients, according to its Friday release. Common fibromyalgia symptoms include chronic widespread pain and poor sleep. Two double-blinded, randomized and placebo-controlled Phase III studies supported Tonmya’s approval, providing evidence of efficacy across nearly 1,000 patients. A readout in April showed that the pill significantly lowered pain and improved clinical outcomes in patients with fibromyalgia versus placebo. Common side-effects, established from three late-stage studies, included mouth numbness, oral discomfort, drowsiness, fatigue, mouth pain and canker sores. Tonmya’s approval is a “landmark advancement” for patients with fibromyalgia, Tonix CEO Seth Lederman said in a prepared statement on Friday, noting that these patients often suffer from the “debilitating pain” that comes with the disease. “We are hopeful that effectively treating pain with Tonmya could help improve the lives of people with this chronic condition.” Tonix’s regulatory win for Tonmya comes as a pain powerhouse stumbles. Earlier this month, Vertex Pharmaceuticals announced that its next-generation pain medicine VX-993, an investigational NaV1.8 blocker, was unable to significantly ease pain after bunionectomy—a surgical procedure involving the big toe. The failure pushed Vertex to abandon its acute pain program for VX-993. Vertex’s Journavx, also an ion channel blocker, in January became the first acute new pain medicine in more than 20 years—and opened up a new non-opioid analgesic pathway for moderate to severe acute pain. Journavx has already emerged as one of Vertex’s top-performing assets. In the second quarter, it brought in $12 million , which, while a relatively small contribution to the company’s $2.96-billion topline, represents a 79% beat to the analyst consensus.