Gene&Cell Therapy >> Sanofi's $1.7B rare disease gambit; CAR-T boxed warning
saga; New biotechs on Nasdaq; A seller's market for M&A?;
and more: Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.
Will the first two biotech IPOs of the year — both upsized — pave the way for a rosy public market? How about the outlook for buyouts? Don’t miss our analysis on these topics, and stay tuned as we find out Big Pharma’s view at earnings next week.
Sanofi’s $1.7B rare disease gambit
In its first M&A move of 2024, Sanofi is snapping up Inhibrx’s lead rare disease drug in a $1.7 billion deal that will vault it into the alpha-1 antitrypsin deficiency (AATD) space. The rest of Inhibrx’s antibody pipeline will get spun into a new company, in which Sanofi will also hold a stake. All told, the deal could be worth $2.2 billion if a regulatory milestone is met. As for Arecor, which developed the technology behind the key drug, said royalty obligations won’t change with the acquisition.
CAR-T boxed warning saga
Capping a safety review on CAR-Ts that surprised the field, the FDA told Novartis, Gilead, Bristol Myers Squibb and Johnson & Johnson to add boxed warnings on the labels of six CAR-T therapies, noting the risks of secondary cancer. There was some back-and-forth on Gilead’s Tecartus — its boxed warning initially carried different wording from the rest, and it was dropped from the list before the FDA posted a new, updated letter for it. Following those changes, the FDA’s Peter Marks and Nicole Verdun shared new details about the cancer cases the agency had investigated.
Nasdaq rings in first biotechs of 2024
Bladder cancer drugmaker CG Oncology debuted on the Nasdaq Thursday morning with an upsized $380 million listing — expected to be the first of at least half a dozen biotech IPOs before the spring and a barometer for the year to come. ArriVent Biopharma, which originally planned for a $135 million IPO, also ended up raising more, landing at a $175 million offering.
A seller’s market for M&A?
Despite being a hot ticket in biopharma, neuroscience companies have attracted few bidders in the multibillion-dollar deals struck in recent months. As a new filing indicates, Bristol Myers Squibb’s $14 billion buyout for Karuna Therapeutics had only one other bidder in the mix. But as Max Gelman writes, the premiums they command are also a reflection of how, for biotechs in the industry’s few hot areas, sellers have all the leverage right now.
R&D
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Gilead’s antibody-drug conjugate Trodelvy failed to significantly extend survival in a late-stage lung cancer study, in a blow to its ADC expansion plans.
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Biopharma industry’s vaccine pipeline lacks… #lucidquest #genetherapy #celltherapy
Senior Medical Science Liaison, Rare Disease at Ipsen
6moPhuong was critical to the team's success at Albireo-love to see her spotlighted:)