STAT+: Celcuity’s breast cancer drug approved, its first

STAT PlusNewsletterThe Readout Celcuity’s breast cancer drug approved, its first FDA’s new CBER chief promises normalcy, an weight loss drug without GLP-1s, and more biotech news from The Readout Manage alerts for this article Email this article Share this article By Elaine ChenJuly 15, 2026 National Biotech Reporter Elaine Chen[email protected]Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70. Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. Wash your lettuce extra thoroughly! There’s never been a better reason to get a salad spinner.Advertisement The need-to-know this morning Johnson & Johnson reported second-quarter earnings. Another Phase 3 study win for sac-TMT, the targeted chemotherapy drug from China-based Kelun Biotech and partner Merck. In the OptiTROP-Lung05 study conducted in China, sac-TMT plus Keytruda significantly delayed tumor progression compared to chemotherapy plus Keytruda in patients with first-line, PDL1-negative, non-squamous lung cancer. A preliminary survival benefit favoring the sac-TMT arm was also reported. This is the second China-run Phase 3 study of sac-TMT to show superiority over standard treatments in patients with lung cancer. Veradermics said its oral, extended-release formulation of minoxidil induced hair growth in women with mild-to-moderate pattern hair loss, achieving the goal of a single-arm midstage study. The company is enrolling female participants in a Phase 2/3 study with results expected next year. FDA’s new CBER chief is seeking a return to normalcy After the FDA’s former biologics chief, Vinay Prasad, pushed out several subordinates, overruled career scientists, and earned the ire of the rare disease community, his acting replacement is now tasked with calming the waters. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In Alzheimer’s, Cancer, drug pricing, Pharmaceuticals, research, STAT+ Submit a correction requestReprints Elaine Chen National Biotech Reporter Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70. Newsletter Your morning rundown of the science, politics, and money driving biotech today Recommended Biotech July 15, 2026 STAT Plus: A new biotech startup tries to tackle obesity, but not in the way you might expect Biotech July 14, 2026 STAT Plus: Anthropic’s Claude Science is coming for Kendall Square Advertisement The Readout July 14, 2026 STAT Plus: Akero team, backed by Fairmount, launches new immunology company Biotech July 14, 2026 STAT Plus: Biogen Alzheimer’s drug slowed decline at rates on par with approved therapies, study shows Biotech July 14, 2026 STAT Plus: Drug metabolism AI competition results show that bigger may not always be better Subscriber Picks