Ticker | Status | Jurisdiction | Filing Date | CP Start | CP End | CP Loss | Deadline |
---|
Ticker | Case Name | Status | CP Start | CP End | Deadline | Settlement Amt |
---|
Ticker | Name | Date | Analyst Firm | Up/Down | Target ($) | Rating Change | Rating Current |
---|
Monday, Relay Therapeutics Inc. (NASDAQ:RLAY) shared interim data for RLY-2608 from ReDiscover study, an ongoing first-in-human study, to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of RLY-2608 alone, in combination with fulvestrant, and combination with fulvestrant and ribociclib or atirmociclib (Pfizer Inc‘s (NYSE: PFE) selective CDK4 inhibitor).
The data showed that despite heavy pre-treatment, patients with PI3Kα-mutated, HR+, HER2- locally advanced or metastatic breast cancer who received RLY-2608 600mg BID+fulvestrant demonstrated clinically meaningful progression-free survival (PFS).
As of the August 12 interim data cut-off, among the 52 patients who received the recommended Phase 2 dose and did not have a PTEN or AKT co-mutation:
RLY-2608 + fulvestrant was generally well tolerated in the 118 patients treated across all doses as of the data cut-off date.
The company met with the FDA regarding the regulatory path for lirafugratinib. The FDA suggested that the company first file a new drug application (NDA) in cholangiocarcinoma, followed by a tumor-agnostic supplemental NDA for FGFR2 fusions with data from more patients and more follow-up.
The company plans to seek a global commercialization partner for lirafugratinib while remaining focused on the remainder of the portfolio.
As of the end of the second quarter of 2024, cash, cash equivalents and investments were approximately $688 million, which the company expects to be sufficient to fund its current operating plan into the second half of 2026.
Price Action: RLAY stock is up 55.6% at $9.71 at last check Monday.
Image by PDPics from Pixabay
Read Next: