Two Janus kinase (JAK) inhibitors, Abbvie Inc.'s Rinvoq (upadacitinib) and Pfizer Inc.'s Cibinqo (abrocitinib), have won U.S. FDA approvals for the treatment of people with moderate to severe atopic dermatitis. Reviews of both products for the indication were delayed due to FDA concerns about class risks. Accordingly, each is labeled with a boxed warning regarding risks of serious infection, mortality, malignancy, major adverse cardiovascular events and thrombosis.
Salarius Pharmaceuticals Inc. is joining the red-hot protein degradation space with an acquisition of a portfolio of oral small-molecule protein degraders and IP from Deuterx LLC it’s calling "transformative." The lead asset, SP-3164, is a cereblon-binding molecular glue that Salarius plans to move to the clinic in 2023 as a potential treatment for hematological cancers and solid tumors. Salarius paid Deuterx $1.5 million in cash and 1 million shares of restricted stock (NASDAQ:SLRX) up front, worth about $487,900 at market close on Jan. 13.
Merck & Co. Inc., building on a year-old deal with Aligos Therapeutics Inc., has moved to in-license an early stage nonalcoholic steatohepatitis (NASH) oligonucleotide program Aligos had previously advanced independently. The amended deal also gives Merck the right to add a new NASH target to the partnership, in addition to those already part of the agreement. With Aligos eligible to receive up to $460 million in development and commercialization milestones as well as tiered royalties on net sales per target, its rewards could reach $1.38 billion.
A raft of potentially high-value drug development collaborations, most for gene and RNA therapies, led the first day of the 40th Annual J.P. Morgan Healthcare Conference Monday. Pfizer Inc. enlisted Beam Therapeutic Inc. to advance in vivo base editing programs for up to $1.35 billion, while Bayer AG tapped Mammoth Biosciences Inc.’s in vivo CRISPR systems expertise in a potential $1 billion-plus deal. Selecta Biosciences Inc. inked a new $1.1 billion partnership with Ginkgo Bioworks Inc. to develop next-generation gene therapy capsids, while Acadia Pharmaceuticals Inc. agreed to pay Stoke Therapeutics Inc. as much as $967 million to develop RNA-based medicines. Work on new mRNA vaccines and therapies is also proceeding, with both Pfizer and Biontech SE announcing new collaborations in the space.
FDA commissioners past, present and likely future gathered together for a rare joint discussion Jan. 9, as part of the third annual Innovations in Regulatory Science Summit.
Three biopharma IPOs rounded out the first week of the new year, with Amylyx Pharmaceuticals Inc., Cincor Pharma Inc. and Vigil Neuroscience Inc. all pricing new Nasdaq issues Dec. 7. Taken together, the offerings raised about $482 million, though all received cool receptions, with only the most mature among them, Amylyx, (NASDAQ:AMLX) holding its ground at midday.
Making good on ambitions to increase its say in the development of drug candidates from its AI-driven discovery platform, as well as the breadth of roles the system serves, Exscientia plc said Jan. 7 it will work with longtime partner Sanofi SA to develop up to 15 new small-molecule candidates for oncology and immunology indications. Sanofi will pay Exscientia $100 million up front and up to $5.2 billion in total milestones, plus tiered royalties, it said.
Avrobio Inc., stung by variable outcomes in a phase II test of its investigational Fabry disease therapy, is quitting further enrollment in the program, one of the first from its gene therapy platform, Plato. The team's attention will shift instead to other clinical-stage lysosomal disorder programs amid "an increasingly challenging market and regulatory environment for Fabry disease," the company said.
Pfizer Inc.'s oral antiviral for the treatment of mild to moderate COVID-19 will soon be available in Great Britain after the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional authorization for the medicine, called Paxlovid (PF-07321332, ritonavir).
Less than three months after completing its acquisition of Strongbridge Biopharma plc, Xeris Biopharma Holdings Inc. secured FDA approval of Recorlev (levoketonconazole), a second-generation drug cleared for use in Cushing’s syndrome, just ahead of its Jan. 1 PDUFA date. Indicated specifically for patients with endogenous forms of the disease for whom surgery isn’t an option or hasn’t worked, the therapy is expected to be available commercially in the first quarter of 2022.
