The dash for metabolic dysfunction hepatic steatohepatitis (MASH) is gaining momentum, with Roche AG acquiring 89bio Inc. and its phase III FGF21 analogue, pegozafermin, in a deal worth up to $3.5 billion. The Swiss pharma is to pay $14.50 per share, valuing 89Bio at $2.4 billion, a premium of approximately 52% to 89bio’s 60-day price on Sept. 17, 2025. The remaining $1.1 billion of the headline figure comes as up to $6 per share in non-tradeable contingent value rights that will be triggered by future milestones. Pegozafermin, a glycopegylated analogue of fibroblast growth factor 21, which has shown a statistically significant benefit on fibrosis in a number of phase II trials, began a 1,000-patient global phase III study in biopsy-confirmed non-cirrhotic MASH (stages F2 and F3) in March 2024. More immediately, headline data from a phase III trial of pegozafermin in treating severe hypertriglyceridemia are expected at the start of 2026.

Shape cuts a $1.2B deal with Vectory

Shape Therapeutics Inc. could bring in as much as $1.2 billion in a new option and license deal with Vectory Therapeutics BV. Vectory is getting the exclusive option to evaluate Shape’s brain-penetrating adeno-associated virus capsid, SHP-DB1, against three targets. Vectory is eligible to receive an exclusive license for the capsid should it produce vectorized antibodies against the targets. If the option is exercised, Shape could receive regulatory, development and commercial milestones of up to $338 million for rare disease programs and as much as $503.5 million for non-rare disease programs, plus tiered royalties on sales of licensed products. Both companies are privately owned.

Pediatrics group absent from US CDC vaccine discussion

The American Academy of Pediatrics (AAP) and a few other medical professional groups were no-shows at today’s meeting of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP). The absence of the liaison groups was noted, especially that of the AAP. In opening the two-day meeting, ACIP Chair Martin Kulldorff said he lamented that the AAP has ended its association with the committee. Echoing that sentiment, panelist Cody Meissner, a pediatrics professor at the Dartmouth Geisel School of Medicine, said the AAP was making a “grave mistake” and warned that the group was moving itself “toward irrelevance” in refusing to participate in ACIP’s vaccine conversations. Today’s discussions focus on the use of the measles, mumps, rubella and varicella (MMRV) vaccine and on the scheduling of hepatitis B vaccines.

Carsgen’s zevor-cel CAR T shows long-term survival in MM

Patients with relapsed/refractory multiple myeloma (r/r MM) treated with Carsgen Therapeutics Holdings Ltd.’s CAR T therapy, zevorcabtagene autoleucel (zevor-cel, CT-053), have shown durable responses lasting nearly five years. In a phase I study, 14 patients received a single infusion of the BCMA-targeted therapy. As of Feb. 22, 2025, median follow-up was 53.3 months. Zevor-cel achieved a 100% overall response rate, with 78.6% of patients reaching a complete or stringent complete response. Median progression-free survival was 44.1 months, and duration of response 43.2 months.

Kalexo enters dyslipidemia fray with preclinical siRNA candidate

Mabwell Bioscience Co. Ltd. and Aditum Bio Management Co. LLC announced, after-market hours Sept. 17, an agreement to forge a new company called Kalexo Bio Inc. and load the biotech with a preclinical dyslipidemia asset via a potential $1 billion global license deal. Mabwell’s shares (SSE:688062) on the Shanghai Stock Exchange opened 20% higher than the previous close before ending at ¥54.75 on Sept. 18, a 13.21% rise from the prior day.

Not alone, Kala marching ahead with PCED therapies; data soon

What Mizuho analyst Graig Suvannavejh has called “the biggest market you've probably never heard of” will be the subject of a phase IIb release any day now from Kala Bio Inc. The company is working with KPI-012 in persistent corneal epithelial defect (PCED), as are other drug developers. PCED occurs when the cornea's epithelium fails to heal within the usual two-week window after an injury or illness. Cleared by the U.S. FDA in August 2018 for neurotrophic keratitis – a cause of PCED – was Oxervate (cenegermin), the human nerve growth factor ophthalmic solution from Dompé Farmaceutici SpA, but the treatment has only penetrated about 10% of the $1 billion-plus market.

Also in the news

Adarx, Alteogen, Arch, Arthex, Ascletis, Astrazeneca, Astria, Biocon, Celldex, Character, Cidara, Cytokinetics, Eisai, Eli Lilly, Elicio, Enveric, Frame, Hemostemix, Hightide, Hillevax, Incyte, Innate, Invivyd, Johnson & Johnson, Lipdro, Luxa, Merck, Mercury, Navigator, Oncopeptides, Oruka, Palisade, Priovant, Quetzal, Regeneron, Rgenta, Roivant, Rubedo, Sagimet, Sanofi, Skyhawk, Theratechnologies, Tonix, UCB