The U.S. FDA approved Corcept Therapeutics Inc.’s oral, selective glucocorticoid receptor antagonist Lifyorli (relacorilant) nearly four months ahead of schedule for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. The Redwood City, Calif.-based company’s stock (NASDAQ:CORT) shot up more than 20% to $40.76 midday on March 25. The PDUFA date was scheduled for July 11, 2026. A few hours after announcing the Lifyorli approval, Denali Therapeutics Inc.’s Avlayah (tividenofusp) was cleared for mucopolysaccharidosis type II (MPS II), or Hunter syndrome, ahead of its April 5 PDUFA. Denali’s shares (NASDAQ:DNLI) were up 8% to $22.72 midday.

Merck adds Terns’ promising CML drug in $6.7B buyout

Only a few months after reporting what it called “unprecedented” phase I data for its BCR-ABL1 tyrosine kinase inhibitor in chronic myeloid leukemia, Terns Pharmaceuticals Inc. agreed to an acquisition by Merck & Co. Inc. valued at about $6.7 billion. For Tern, the deal validates the decision last year to switch focus from its metabolic pipeline to oncology and, for Merck, it’s the latest move as the big pharma looks to shore up its offerings ahead of patent expirations for cancer blockbuster Keytruda (pembrolizumab).

Phase II AMKD results encourages Maze pivotal bid

Shares of Maze Therapeutics Inc. (NASDAQ:MAZE) were trading at $31.29, down $17.71, or 36%, after the South San Francisco-based firm disclosed positive top-line data from the phase II Horizon trial with MZE-829, an oral, small-molecule, dual-mechanism APOL1 inhibitor, in patients with broad APOL1-mediated kidney disease (AMKD). The drug turned up a clinically meaningful mean reduction in proteinuria measured by urinary albumin-to-creatinine ratio (uACR) of 35.6% at week 12, with 50% of patients achieving a greater than 30% reduction in uACR. Maze expects to continue sign-ups in Horizon and is advancing MZE-829 into an AMKD pivotal program.

Drama encases ACIP, CDC amid lawsuit, deadline

Chaos continues at the U.S. CDC and its Advisory Committee on Immunization Practices (ACIP) with the resignation of ACIP member Robert Malone and the impending deadline for the president to nominate a new CDC director following the dramatic exit of his first choice and months of acting directors. Malone’s resignation comes on the heels of a preliminary injunction that prevents the ACIP from meeting and puts on hold all the decisions the committee has made since it was reconstituted last June.

Innovent’s IBI-302 meets phase III endpoints in neovascular AMD

Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration, and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration. “As the world's first innovative anti-VEGF/anti-complement dual-target molecule, IBI-302 met the primary endpoint in the phase III Star study, demonstrating noninferiority to aflibercept in vision improvement [an average gain of about 10.37 letters],” said principal investigator Xiaodong Sun, who is also deputy director and head of the National Center for Clinical Ophthalmology at Shanghai General Hospital.

Unapproved Anktiva claims earn Immunitybio FDA warning

Repeated promotional claims Patrick Soon-Shiong made about Immunitybio Inc.’s Anktiva (nogapendekin alfa inbakicept) – such as “We have now discovered and developed this drug … approved for bladder cancer, but it actually can treat all cancers” – landed the Culver City, Calif., company a strongly worded warning letter from the U.S. FDA. The March 13 letter, posted yesterday, specifically calls out comments Soon-Shiong, the company’s executive chairman and global chief/medical officer, made in a TV ad and on a direct-to-consumer podcast. Normally, promotional violations lead to untitled letters from the agency’s Office of Prescription Drug Promotion (OPDP), but Immunitybio already had received two of those, in September and January, voicing similar concerns. The offending podcast cited in the warning letter aired just 12 days after OPDP sent the January untitled letter.

UK’s MHRA sets out scheme to promote replacement of animal models

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is to offer an early review of nonanimal data to give companies more confidence that evidence generated with new approach methodologies, such as organoids and microphysiological systems, will be accepted as part of marketing authorization applications. In a scheme to be in place by the end of 2026, companies will be able to submit all nonclinical data on toxicology, pharmacology and pharmacokinetics generated without the use of animals, for review in advance of submitting the full file.

FDA reclassifies skin lesion diagnostic devices

The U.S. FDA has issued a final order to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III to class II, with special controls required. The order, effective April 24, 2026, allows companies to use the 510 (k) pathway, which is a shorter route to market, than premarket approval.

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