(RTTNews) – September 2025 is poised to be a pivotal month for several biotech stocks, as companies are set to unveil vital clinical trial results.
The following biotech stocks are noteworthy for September, featuring potential catalysts that may lead to significant market movements.
KALA BIO Inc. (KALA)
KALA is anticipated to announce topline data from its CHASE trial of KPI-012 by the end of September 2025. CHASE is a Phase 2b study assessing the efficacy of the investigational topical biologic therapy, KPI-012, for treating persistent corneal epithelial defects.
This rare non-healing corneal issue often resists typical treatments, resulting in complications like corneal ulcers, perforations, and significant vision loss. There are currently no FDA-approved therapies for broad Persistent Corneal Epithelial Defect (PCED), which affects an estimated 100,000 patients in the US and 238,000 when including the EU and Japan. Positive trial results could position the CHASE study as the first of two critical trials needed to file a Biologics License Application for KPI-012 with the FDA.
KALA was highlighted at a trading price of $5.98 on July 14, 2025, and recently reached an intraday high of $9.39, closing at $9.31, up 6.04%.
Kairos Pharma Ltd. (KAPA)
Kairos plans to share interim efficacy data from its Phase 2 trial of ENV-105 in metastatic castration-resistant prostate cancer this September. Last month, positive safety results were reported from the trial’s first ten patients, demonstrating that ENV-105 was well-tolerated with standard hormone therapy, Apalutamide.
There have been no significant dose-related toxicities or unexpected adverse events. The trial aims to recruit a total of 100 participants. KAPA was initially noted at $1.73 on February 4, 2025, and closed at $1.20 yesterday, down 2.44%.
Rapport Therapeutics Inc. (RAPP)
Rapport is set to report topline results from its Phase 2a trial of the investigational drug RAP-219 for drug-resistant focal onset seizures this September. The upcoming findings will concentrate on primary and key secondary endpoints, as well as treatment safety.
We previously alerted readers about RAPP when it was priced at $10.26 on May 21, 2025. Following a price increase, the stock closed yesterday at $16.01, rising 9.43%.
Metsera Inc. (MTSR)
Metsera is anticipated to disclose important findings from two studies within its VESPER program this September. VESPER is a Phase IIb initiative investigating MET-097i for obesity and overweight management, comprising three ongoing trials: VESPER-1, VESPER-2, and VESPER-3.
The company plans to release topline data from VESPER-1 and interim findings from the titration phase of VESPER-3. MTSR was first profiled at $32.35 on June 10, 2025, and reached an all-time high of $47.40 on July 18, 2025. The stock closed yesterday at $33.19, up 1.84%.
Cullinan Therapeutics Inc. (CGEM)
Cullinan is developing Zipalertinib, a drug for non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations. Initially discovered by Taiho Pharmaceutical, the drug has been licensed to Cullinan, which entered a co-development agreement with Taiho.
Taiho plans to present early data from the REZILIENT2 cohort exploring Zipalertinib for patients with uncommon EGFR mutations during a session at the IASLC 2025 WCLC from September 6-9, 2025. REZILIENT2 is a Phase IIb global trial featuring four cohorts. CGEM was trading at $7.93 when we last alerted readers on June 29, 2025, and closed yesterday at $7.64.
The views and opinions expressed herein are those of the author and do not necessarily reflect those of Nasdaq, Inc.
