A very good day for Lilly, and a bad day for Novo

From my colleague Elaine Chen: Eli Lilly's stock shot up 14% yesterday, after the pharma giant reported the first Phase 3 results of its GLP-1 pill orforglipron. The small molecule helped patients with type 2 diabetes improve their blood sugar levels and shed weight, results that were nearly comparable to the benefits of available injectable GLP-1 drugs.

If approved, orforglipron would be the first small molecule GLP-1 drug on the market, and would likely allow Lilly to reach many more patients across the world.

At the same time, American depository receipts of rival Novo Nordisk plunged nearly 8% yesterday, as investors view Lilly to be even more competitive with the new orforglipron data. (Lilly is up about 16.5% over the last five trading days vs. Novo, which is down about 5.1%.)

vTFET-diverging-glp-1-prospects

Novo doesn't have any small molecule obesity drug that as close to approval. It does have an approved GLP-1 pill on the market, but it's a peptide that's difficult to manufacture.

The next big catalyst to watch isn the third quarter, when Lilly is expected to announce Phase 3 results of orforglipron in obesity.

artificial intelligence

Sanofi bets big on a mysterious AI startup

From my colleague Brittany Trang: Sanofi yesterday signed a deal with Earendil Labs for $125 million upfront and $1.72 billion in milestone payments — a fairly large deal for AI-related drug discovery, made even more intriguing by the fact that the mysterious Earendil has only a bare-bones website and didn't leave any contact information in its press release.

The French drugmaker is acquiring worldwide rights to two bispecific antibodies from Earendil. The first candidate, for moderate to severe ulcerative colitis and Crohn's disease, targets α4β7 and TL1A. The other candidate, which has shown promise for colitis and skin inflammation, targets TL1A and IL23.

Though Earendil says it is U.S.-based, it also says that it has an affiliate, Helixon Therapeutics, which raised a 500 million yuan series A in 2023 (roughly $72.5 million at the time), largely from Chinese investors. Earendil and Helixon, which also uses AI to discover protein-based therapeutics, share the same CEOs, Jian Peng and Zhu Zhenping.

antibody-drug conjugates

Blenrep gets a second shot in the U.K.

GSK's multiple myeloma drug Blenrep has regained U.K. approval, now as part of a combination therapy, after being pulled from global markets in 2022 due to disappointing solo-trial results. New data show that the antibody-drug conjugate is effective when used with other medicines.

Though competition from CAR-T and bispecific therapies remains fierce, Blenrep's outpatient-friendly delivery offers a practical alternative for some patients. Its reentry into the U.S. market is under FDA review, STAT's Andrew Joseph writes, with a decision expected by July.

fda

FDA to remove industry reps from advisory panels

New FDA Commissioner Marty Makary said yesterday that the agency will remove industry representatives from advisory committees and replace them with patients and caregivers.

Industry representatives on the panels are not permitted to vote, and can't serve on a panel while it is reviewing products developed by their companies. But Makary's boss, health secretary Robert F. Kennedy Jr., has made clear he thinks conflicts of interest are deeply entrenched at the agency.

His predecessor, Robert Califf, told STAT's John Wilkerson he was "not too worked up" about Makary's proposal. "It's OK with me. It's not what I would do," he said, adding that Makary is now the boss.

fda

Five priorities for Makary at a time of deep uncertainty

Speaking of the new commissioner, infectious disease specialists Luciano Borio and Phil Krause have some advice for Makary.

In a new First Opinion essay, Borio and Krause, both once top FDA officials, say the commissioner made a "rookie misstep" in his early days, permitting an 11th-hour delay of an uncontroversial vaccine approval, despite months of expert review and a clear path to market.

The pair argue the agency Makary inherited was riddled with holes after sweeping budget cuts mandated by DOGE, and outline five measures he should focus on — which include a renewed focus on regulatory clarity, clinical trial competitiveness, and smarter post-market evaluation to preserve FDA's credibility, and global leadership in drug oversight.