As Sanofi SA gets ready to welcome a new CEO, the company along with partner Regeneron Pharmaceuticals Inc. said a happy hello as well to robust sales of Dupixent (dupilumab, dupi) and gained U.S. FDA clearance for the IL-4 receptor alpha antagonist to treat children, ages 2 to 11, with chronic spontaneous urticaria who remain symptomatic despite histamine-1 antihistamine treatment.
Optimism rose for what could be the first CAR T therapy in autoimmune disease as Kyverna Therapeutics Inc. made public a positive primary analysis from its registrational trial, KYSA-8, of mivocabtagene autoleucel (miv-cel, KYV-101) in stiff-person syndrome. Kyverna plans to submit a BLA to the U.S. FDA in the first half of this year.
With rezpegaldesleukin (rezpeg) phase IIb data in alopecia areata holding strong over time, backers of Nektar Therapeutics Inc. are hopeful that the biologic can do for the hair loss market what Dupixent (dupilumab, Regeneron Pharmaceuticals Inc./Sanofi SA) did in atopic dermatitis.
The already-thriving CAR T space took another big stride forward as Eli Lilly and Co. disclosed its plan to acquire Boston-based Kelonia Therapeutics Inc. for as much as $7 billion in cash, including an up-front payment of $3.25 billion, with the rest coming if clinical, regulatory and commercial goals are reached.
The quest by psychedelic drugs for full legitimacy in the pharmaceutical world has seen marked progress as well as (fewer) setbacks of late, and developers are hopeful that an important corner has been turned.
Wall Street met with satisfaction but not surprise Eli Lilly and Co.’s undeniably positive top-line results from the phase III Achieve-4 study testing the efficacy and safety of Foundayo (orforglipron) compared to insulin glargine in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk.
Eli Lilly and Co.’s buyout of Ventyx Biosciences Inc. for $1.2 billion at the start of the year brought to the forefront NLR family pyrin domain containing 3 (NLRP3) inhibitors, on which a handful of developers have been working – and research in the space continues to roll out, as with the paper published March 26 in Nature that delved into mechanisms that rev up the NLRP3 inflammasome.
“Home-run” efficacy and what Cowen analyst Tyler Van Buren called “pristine” safety in the phase II Alpha3 study with CAR T therapy cemacabtagene ansegedleucel (cema-cel) sent shares of Allogene Therapeutics Inc. (NASDAQ:ALLO) skyward to a $4.46 high, up nearly 64%, on April 13. Shares eventually closed at $3.06, up 34 cents.
Abstracts released ahead of the American College of Cardiology meeting held in late March in New Orleans, along with the start of dosing near the end of January in Novartis AG’s phase IIb trial with siRNA therapy DII-235, also known as BW-20829, perked up the already-lively lipids/heart space.
C4 Therapeutics Inc.’s degrader-antibody conjugate (DAC) strategy gathered more steam with a new collaboration between the firm and Roche AG that brings $20 million up front with the potential for more than $1 billion in discovery, regulatory and commercial milestone payments.
