Baxdrostat

Plus, news about Tenaya, AtaiBeckley, Galecto, Damora, A2 Biotherapeutics, AstraZeneca and Evommune: 📉 AnaptysBio’s lead drug fails ulcerative colitis study: The company said the T cell depleter called rosnilimab showed a “lack of adequate efficacy,” and the Phase 2 trial will be discontinued. In September, AnaptysBio said it was weighing a split of its pipeline from its royalty business. Anaptys’ stock $ANAB fell 16% on Monday. — Lei Lei Wu 🤝 Lyell Immunopharma licenses CAR-T cell candidate: The company will pay Innovative Cellular Therapeutics $40 million upfront to take the global rights to LYL273 (formerly codenamed GCC19CART) except for mainland China, Hong Kong, Macau and Taiwan. ICT will also receive 1.9 million shares of Lyell’s common stock, with further cash and equity consideration on the table if the asset reaches certain milestones. LYL273 is under investigation for cancers with guanylyl cyclase C (GCC) protein receptors; it has Phase 1 data in metastatic colorectal cancer. – Reynald Castaneda 🛑 FDA slaps hold on Tenaya heart drug trial: Tenaya said regulators had requested the company take measures to “standardize” patient monitoring activities across sites in a Phase 1b/2a study. The trial is looking at TN-201 in MYBPC3-associated hypertrophic cardiomyopathy. Tenaya said the hold won’t impact the drug’s development timelines. — Max Gelman 📊 AtaiBeckley debuts psychedelic redosing data : The recently-merged psychedelic biotech found that a second dose of the company’s intranasal 5-MeO-DMT psychedelic helped further reduce patients’ depression symptoms. The data were collected in an open-label portion of the Phase 2b study that included more than 100 patients. There was a drug-related serious adverse event reported in one patient eight days after a second dose was administered. The company did not detail the case, but said it resolved after “additional in-patient monitoring and support.” AtaiBeckley expects to launch a Phase 3 study in the second quarter of 2026. — Max Bayer 💰 Galecto acquires Damora, raises $285M: Galecto bought out its counterpart for an undisclosed sum and said the deal will boost development of drugs for blood cancers. The $285 million raise came in the form of a private placement from investors who participated in Galecto’s Series C, giving the company runway into 2029. — Max Gelman 🫁 Cell therapy clears lung cancer patient’s disease completely : A cell therapy from A2 Biotherapeutics cleared all signs of cancer down to the molecular level in a lung cancer patient, marking a rare case in which a cell therapy has resulted in a complete response in a solid tumor patient. It was a surprising result, given the patient’s lung cancer had high-risk markers, according to investigator Salman Punekar of New York University. Last year, Stanford researchers also showed that a CAR-T therapy led to a complete response in a brain cancer patient. A2 Biotherapeutics’ trial was complex, as patients needed to have a certain HLA signature to enroll in the early-stage study. The cell therapy uses “logic-gating,” which is meant to help the treatment target cancer cells while sparing healthy ones. — Lei Lei Wu 🫀AstraZeneca touts more data for potential heart disease blockbuster: The company said its drug baxdrostat reduced average blood pressure by a statistically significant margin compared to placebo after 12 weeks. Researchers were evaluating baxdrostat, acquired from the 2023 CinCor buyout, in 218 patients with resistant hypertension. The data build on two successful pivotal studies for baxdrostat announced in July and October , respectively. — Max Gelman 💵 Evommune closes IPO with $172.5M raise: The biotech had planned a $150 million raise, but those with options fully exercised them , bringing the total to $172.5 million. Evommune began trading on the New York Stock Exchange last Thursday at a starting share price of $16. — Max Gelman

Strengthening last month’s top-line positive results for its investigational aldosterone synthase inhibitor baxdrostat over a 24-hour period in a treatment-resistant hypertension trial, AstraZeneca unveiled full data from the Phase III Bax24 study Sunday in a late-breaker at the American Heart Association (AHA) scientific sessions. The study enrolled 218 patients who were randomised to receive baxdrostat or placebo once daily for 12 weeks alongside standard care. The trial’s primary endpoint was met, with the detailed findings showing baxdrostat achieved a placebo-adjusted reduction in ambulatory 24-hour average systolic blood pressure (SBP) of 14.0 mmHg at 12 weeks. AstraZeneca further noted the efficacy was sustained throughout the 24-hour period, including the early morning hours when cardiovascular event risk is elevated.Furthermore, baxdrostat also gained statistically significant improvements across key secondary endpoints over placebo, including 13.9 mmHg and 10.3 mmHg reductions in night-time ambulatory SBP and seated SBP, respectively. Notably, 71% of baxdrostat-treated patients achieved ambulatory 24-hour average SBP below 130 mmHg compared with 17% of placebo recipients, yielding an odds ratio of 15.2. Meanwhile, the drug’s safety profile was favourable, consistent with a previous late-stage study."It's remarkable to see this magnitude of reduction coupled with the fact that just over 70% of baxdrostat patients achieved guideline targets, consistently over 24 hours," said principal investigator Bryan Williams, adding that the findings “could transform treatment practice.”Baxdrostat — gained through AstraZeneca's purchase of CinCor Pharma in 2023 — delivered impressive results in the Phase III BaxHTN trial involving patients with stubbornly high hypertension earlier this year, prompting the drugmaker to tee up marketing applications with regulators.Besides hypertension, the drug is also being investigated for primary aldosteronism, and in combination with Farxiga (dapagliflozin) for chronic kidney disease and heart failure prevention. For more on the company’s ambitions for baxdrostat, see – Spotlight On: Baxdrostat firms up status as foundational medicine, says AstraZeneca.