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Not a month after reports of three deaths in autoimmune trials for Novartis’ CAR T cell therapy ignited a debate about the use of these treatments in nonfatal diseases, Kyverna Therapeutics reported data bolstering its case to bring to market the first CAR T for an autoimmune disease.
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After a frantic second quarter, M&A steadied with just under $30 billion across 22 total transactions, according to a BioSpace analysis.
IPO
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
Last year, 11 major M&A deals were signed with women-led biotechs. The industry is nowhere near on track to meet that bar for 2026.
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Follow along as BioSpace tracks job cuts and restructuring initiatives.
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Read our takes on the biggest stories happening in the industry.
Big Pharma needs more—not fewer—bold bets on rare and difficult diseases after Novartis’ efforts to invest in muscular dystrophy and ALS hit major roadblocks this month.
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Jefferies analysts made the prediction after Sarepta Therapeutics, which has endured nothing short of a saga with the Duchenne muscular dystrophy gene therapy Elevidys, presented data this week showing its clinically meaningful benefit in older patients who are able to walk.
Capitalizing on space’s microgravity, the United Therapeutics–partnered Varda Space Industries aims to make medicines with better bioavailability and stability than Earth-produced molecules.
Kailera Therapeutics and Hengrui Pharma’s weekly injection showed benefits beyond weight loss in a mid-stage trial, leading to more regular menstrual cycles in patients with polyendocrine metabolic ovarian syndrome.
Novartis is licensing an mRNA-based therapy designed to produce a CD3xCD19 T cell engager inside the body. Abogen Biosciences says the in vivo approach could reduce the likelihood of dangerous cytokine release.
Merck has revealed detailed data for tulisokibart from a mid-stage trial in hidradenitis suppurativa that analysts say could help carve out a place in a crowded market that already includes AbbVie’s Humira and UCB’s Bimzelx.
Bristol Myers Squibb will soon release Phase 3 data for admilparant that could make or break Contineum Therapeutics’ rival product. But reports of a death due to liver injury in the pharma’s program have caused some unease about the drug class.
Patients had adverse events after receiving a Fresenius Kabi medicine that experienced manufacturing deviations.
Despite meeting the primary endpoints in a Phase 3 trial, shares of Zealand Pharma dropped in premarket trading Thursday as the up to 9.8% weight loss reflected inferior loss to that generated by competitors.
FDA
Amid rising industry concerns about U.S. competitiveness with China, the Trump administration is rolling out four ARPA-H initiatives to modernize clinical trial design, site activation, consent and patient data collection.
Sanofi and Regeneron have had a long and “sometimes contentious” partnership, BMO Capital Markets noted, as the companies contend with the looming loss of exclusivity of their blockbuster drug Dupixent.