The odds are that parts of the U.S. government will shut down at midnight, as Senate Democrats refuse to support a clean continuing resolution already passed by the House and Republicans reject Democratic demands to reinstate pandemic-era subsidies to cover ever-increasing Affordable Care Act insurance premiums. What will be shuttered if neither side yields are activities funded by annual appropriations that are not excepted by law. Generally, that would mean the staff assigned to those activities would be furloughed for the duration of the shutdown. But this time, some of those staff are at risk of termination. The impact at the Department of Health and Human Services (HHS) translates into about 41% of the nearly 80,000 employees being furloughed or terminated. That’s at a department whose health agencies already have been rocked this year by massive reductions in force.

A house dividing: Anaptysbio wants separate pipeline and royalty companies

Anaptysbio Inc. said it intends to split into two publicly traded companies, one for developing a pipeline, the other for managing royalties, each with its own business model. The royalty company will hold and manage the rights to Jemperli (dostarlimab) royalties from collaborator GSK plc, along with imsidolimab milestones and royalties from Vanda Pharmaceuticals Inc. The pipeline company is designed to develop and commercialize therapies for treating autoimmune and inflammatory diseases. Neither of the companies have been given names yet. The market liked the split, as shares (NASDAQ:ANAB) were going for $29.77 each, a jump of 28% at midday.

Gene therapy from Opus yields positive phase I/II data in LCA5

Opus Genetics Inc. offered positive three-month data from the pediatric cohort of its ongoing phase I/II trial called OPGx-LCA5-1001 evaluating OPGx-LCA5, a gene augmentation therapy for Leber congenital amaurosis type 5 (LCA5). Three patients, ages 16 to 17, with severe baseline vision impairment from LCA5 were given a single subretinal injection of OPGx-LCA5. All turned up better vision across multiple measures of visual function, Opus said.

Gilead signs $34.5M deal for Hanmi/HHP’s I.V.-to-oral drug tech

Hanmi Pharmaceutical Co. Ltd. and Health Hope Pharma Ltd. (HHP) may be getting a second wind for encequidar and the Orascovery platform, with Gilead Sciences Inc. picking up exclusive global rights to develop and commercialize encequidar in the field of virology for $2.5 million up front. Under the terms of the deal, disclosed aftermarket on the Korea Exchange Sept. 29, Hanmi and HHP will supply encequidar to Gilead, share technical know-how and participate as key project partners. In turn, Hanmi will get the up-front payment, along with up to $32 million tied to development, regulatory and commercial milestone payments, and low single-digit royalty payments based on net sales.

Novo ends Heartseed deal for iPS cell-derived cardiomyocytes

Novo Nordisk A/S terminated its global licensing deal with Japan’s Heartseed Inc. for its allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocytes. Heartseed signed the deal with Novo Nordisk in June 2021, under which Novo gained exclusive rights to develop, manufacture and commercialize HS-001 worldwide, except in Japan. HS-001 is an allogeneic iPSC-derived cardiomyocyte spheroid product for advanced heart failure due to ischemic heart disease. The deal with Novo was the first global partnership in the field of iPSCs. Heartseed said the deal termination was not due to the development program. Instead, Novo Nordisk said it was concentrating on its core business areas of diabetes and obesity.

After Pfizer offer, strong data, Metsera’s lead GLP-1 heads to phase III

Phase IIb data of Metsera Inc.’s lead GLP-1 receptor agonist, MET-097i, showed significant weight loss and good tolerability, supporting a phase III start later this year, and validating Pfizer Inc.’s decision a week ago to buy the obesity-focused company for $7.3 billion. “Given that Pfizer indicated it had already seen some data from these trials, these results are not overly surprising,” noted Cantor analyst Carter Gould, “but still support the acquisition as a credible (re)entry point into obesity.” A fully biased, ultra-long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, MET-097i is subcutaneously injected and has shown weight loss equivalent to market leaders such as Eli Lilly and Co.’s GLP-1/GIP receptor agonist, Zepbound (tirzepatide), at lower doses and at fewer titration steps. In the latest results from the Vesper-1 trial in obese/overweight participants without type 2 diabetes, MET-097i demonstrated mean placebo-subtracted weight loss of up to 14.1% after 28 weekly doses.

Also in the news

Aarvik, Allrock, Amgen, Applied, Arrivent, Bioarctic, Biolinerx, Cue, Dogwood, Dyne, Eisai, Expert Systems, Gilead, GSK, Hanmi, Health Hope, Hemispherian, IO, Johnson & Johnson, Kala, Kedrion, Lisata, Lupin, Mediwound, Mindrank AI, Mondego, Pepgen, Nanomi, Novo Nordisk, Nrx, Outlook, Precision Medicines, Recode, Revagenix, Revolution Medicines, Serpin, Veranova, Visufarma