New York, May 19, 2026, 09:03 EDT
- Relay Therapeutics shares gained 11.3% to $13.47 in premarket trading after the company released early vascular-anomaly results for its drug zovegalisib.
- Among 20 evaluable patients in the trial, 60% saw a volumetric response rate, which means at least 20% shrinkage in target lesion volume.
- The Nasdaq hadn’t started regular trading yet. Markets are set for a standard session Tuesday, opening at 9:30 a.m. and closing at 4:00 p.m. ET.
Shares of Relay Therapeutics Inc. traded higher in early premarket Tuesday. The Cambridge biotech said its top drug zovegalisib showed initial signs of shrinking lesions in patients with rare vascular anomalies.
Shares changed hands at $13.47 in premarket trade at 09:03 EDT, gaining 11.3% from Monday’s $12.10 close, based on Investing.com data. That was before the regular Nasdaq open and with U.S. futures under pressure. S&P 500 futures were last off 0.4%, while Nasdaq futures were down 0.8%.
The results matter now that zovegalisib isn’t just a breast-cancer story. Relay is pushing to prove the drug has use in any disease linked to PIK3CA mutations, a genetic driver in abnormal growth and certain cancers.
Relay said its Phase 2 ReInspire trial enrolled 32 adults and teens. At an April 15 cut-off, 20 patients were evaluable for efficacy. Of those, 60% showed a volumetric response at 12 weeks, and 95% had some reduction in lesions, the company said in a filing.
Relay said that if a later, still unconfirmed response recorded after the data cut-off is included, the response rate goes to 65% across doses. The company also logged clinical improvement at week 12 in 89% of investigator assessments and 79% of patient assessments.
Relay’s research and development chief Don Bergstrom said the results pointed to the “promise of PI3Kα mutant-selective inhibition” in vascular anomalies. PI3Kα, an enzyme tied to cell growth signals, is Relay’s target. The company aims to block the mutated enzyme while sparing normal PI3Kα. Relay Therapeutics
The results came in above the bar at least one Wall Street analyst pointed to before the update. Andrew Berens at Leerink Partners told Investor’s Business Daily that a 20% to 25% response rate at 12 weeks “would be a strong initial signal.” Investors
Safety remains a focus for investors. Relay said that out of 22 patients given 100 mg or 300 mg twice a day, 23% needed dose cuts, no one stopped treatment due to adverse events, and two patients reported Grade 3 or higher treatment-related adverse events. Grade 3 indicates a severe side effect. The company has put less priority on the 400 mg twice-daily dose in this patient group.
Novartis is the main player in the current landscape. Its drug Vijoice, also called alpelisib, got FDA accelerated approval in 2022 for some patients with severe PIK3CA-related overgrowth spectrum. That’s part of the vascular-anomaly diseases Relay wants to treat. Relay’s trial isn’t a direct comparison with Vijoice.
Zovegalisib is being tested in Relay’s Phase 3 ReDiscover-2 study in breast cancer with fulvestrant. Relay is also planning to start a Phase 3 trial in frontline breast cancer, using zovegalisib together with Pfizer’s atirmociclib and an aromatase inhibitor, targeting early 2027 and depending on regulators. Relay reported $642.1 million in cash, cash equivalents and investments as of the end of Q1, saying that should take operations into 2029.
The data remain early and the number of patients is limited. Interim results could shift as additional scans and safety data are collected. Relay cautioned in its filing that early clinical data might not match final outcomes, and that setbacks, delays or failure to meet safety and efficacy could disrupt the program.
Next up is a basic check—can the premarket bid last into the regular session. Nasdaq has Tuesday listed as a normal day, opening premarket at 4:00 a.m. and switching to regular trading at 9:30 a.m. ET. The close is 4:00 p.m. The next U.S. market holiday for Nasdaq is Memorial Day on May 25, 2026.
