July 15, 2026

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.

regulation

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.

So far, Karim Mikhail has taken an even-keeled approach that's been a lifeline for staff at the Center for Biologics Evaluation and Research, five agency officials told STAT's Lizzy Lawrence.

Under Mikhail and acting commissioner Kyle Diamantas, the agency has reversed at least five decisions made under Prasad and former commissioner Marty Makary.

Mikhail and Diamantas also met with rare disease patient advocacy groups at a closed-door meeting in June, and promised to listen to patients and stay consistent.

obesity

One new obesity drug startup is forgoing GLP-1s

Mwyngil Therapeutics stands out not just for its unusual name.

Unlike dozens of obesity drug startups, the company is not developing any GLP-1 treatments, but is instead focused on studying candidates that can help patients shed fat while maintaining healthy lean muscle.

Its first two drug candidates include one that inhibits the protein tyrosine phosphatase 1B, and another that is an inverse agonist of a receptor called GPR75.

Torrey Pines Investment and venture capital firm OrbiMed have invested $60 million into the comapny.

Read more from STAT's Allison DeAngelis.

FDA

Celcuity's breast cancer drug approved, its first

The FDA yesterday approved a new drug from Celcuity that treats the most common type of breast cancer. It's the the biotech's first marketed medicine and will be sold under the brand name Revtorpyk.

The approval was based on a study in which Revtorpyk in combination with standard treatment significantly reduced the risk of tumor progression or death compared to standard treatment alone. The study enrolled patients with with advanced HR-positive, HER2-negative breast cancer that lacks a mutation in a gene called PIK3CA.

Celcuity said the commercial launch of Revtorpyk will begin later this quarter. The drug's price was not disclosed but the company said it will charge more than competing drugs.

The company is also planning another submission to the FDA later this quarter that, if granted, will expand the drug's use to cover breast cancer that carries the PIK3CA mutation.

neuroscience

Biogen is at the center of another Alzheimer's debate

Biogen yesterday presented detailed Phase 2 data on its drug that targets the tau protein, showing that the lowest dose level of the therapy slowed patients’ cognitive decline at roughly comparable rates as approved medicines.

Investors, however, were disappointed, sending shares of the company down 8%. At issue is whether targeting the tau protein can actually be an effective mechanism.

Biogen earlier this year said the study failed to achieve its primary goal of a dose effect, meaning people who received a lower dose of the drug appeared to derive greater benefits. The detailed results raised more questions, as they showed that those on the higher doses experienced greater drops in tau, yet that didn't translate to greater benefits on cognition and function.

Still, Biogen, no stranger to such debates, is advancing the drug into Phase 3 testing.

pharma

Drug sales in controversial 340B program have surged

Prescription medicines purchased under the 340B government discount program rose to $100 billion last year, a 22.8% increase from the previous year, according to the Health Resources and Services Administration, which oversees the program.

Expensive medicines made up a growing proportion of spending, accounting for nearly 62% of all prescription drugs purchased through the program. Nearly $8.9 billion was spent on Merck’s Keytruda immunotherapy treatment, followed by more than $4.47 billion on Biktarvy, an HIV medicine sold by Gilead Sciences.

Thanks for reading! Until next time,