Showing a significant efficacy signal in a phase II trial, Relay Therapeutics Inc.’s zovegalisib (RLY-2608) achieved a 60% volumetric response – more than double than expected – in patients with PIK3CA-driven vascular anomalies (VAs). Shares of Relay rose 10% to $13.31 in early trading May 19. The isoform-selective P13Ka inhibitor is in late-stage clinical trials with various combinations for P13Ka-mutated, HR+/HER2- advanced breast cancer, with VAs representing a second indication for which Leerink Partners analyst Andrew Berens forecasts $2.8 billion in peak revenues.

Vincentage’s oral GLP-1 meets phase III obesity endpoints

Vincentage Pharma Co. Ltd.’s once-daily oral small-molecule GLP-1 receptor agonist, VCT-220, met the primary endpoints in a pivotal phase III trial in overweight or obese patients in China. Based on the top-line data, the company plans to submit an NDA for chronic weight management to China’s National Medical Products Administration. At 52 weeks, VCT-220 achieved mean body weight reduction of -12.2% and -12.4% in the 120-mg and 160-mg groups, respectively, both significantly greater than -1.3% for the placebo.

Create Medicines secures $122M for in vivo CARs

Create Medicines Inc. closed a $122 million series B financing round to support its pipeline of therapies that use mRNAs delivered via liquid nanoparticles to express chimeric antigen receptors (CARs) in T cells, NK cells and myeloid cells inside the body. The capital, which will get the company through 2028, will be used to support four clinical programs expressing CARs targeting TROP2, GPC3, HER2 and HER2 x TROP2 combined. The company is also working on using its technology to deplete B cells in autoimmune diseases, with plans to enter the clinic in 2026.

Boston Scientific reports Seismiq IVL data from Fracture study

Boston Scientific Corp. reported positive results from the Fracture investigational device exemption trial which evaluated its Seismiq 4CE coronary intravascular lithotripsy (IVL) catheter in patients with severely calcified coronary artery disease. Late-breaking data presented at the EuroPCR conference in Paris showed that the pivotal study met its primary safety and effectiveness endpoints, with high rates of freedom from major adverse cardiac events at 30 days and strong procedural success.

Elixir Dynamx system sees lower event rates than drug-eluting stent

Elixir Medical Corp.’s reported four-year data from the Bioadaptor randomized controlled trial, presented at EuroPCR conference in Paris, showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system experienced significantly lower event rates compared to those treated with Medtronic plc’s Resolute Onyx drug-eluting stent, including reduction in cardiovascular death.

CDC vaccines panel to be ‘re-established’

It’s back to the drawing board for the U.S. CDC’s Advisory Committee on Immunization Practices. After a year of Health and Human Services Secretary Robert Kennedy gutting the panel and restocking it mostly with people who share his views on vaccines, the CDC published a notice today that it’s withdrawing the amended charter renewal issued last month and is instead “re-establishing” the committee. Explaining the need for the action, the CDC acknowledged an administrative error in meeting the revised public notification timing requirements of the Federal Advisory Committee Act. As a result of that error, “the charter lapsed and the committee must be re-established,” the agency said.

Supreme Court upholds FCA’s ‘whistle while you work’

Eli Lilly and Co. lost its bid to have the U.S. Supreme Court strike down the whistleblower provisions in the False Claims Act (FCA) as unconstitutional. In denying cert yesterday to Lilly’s petition, the court left the drug company on the hook for a jury award of nearly $200 million in a case brought by Ronald Streck, whom the company referenced as a “serial bounty hunter.” Lilly’s petition also questioned the Seventh Circuit’s conclusion that the company’s legal interpretation could be “deemed so ‘objectively unreasonable’ as to constitute ‘highly probative’ evidence of scienter” under the FCA even though that interpretation was “widely held throughout the industry, no government actor rejected it, and four [other] federal judges expressly found it reasonable.”

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