5 Biotech Stocks To Watch Ahead Of Major Clinical Trial Data Readouts In September 2025

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(RTTNews) - September 2025 could be a make-or-break month for some biotech stocks, as the companies prepare to release critical clinical trial data.

The following are some of the biotech stocks to watch in September, with potential catalysts that may drive major market moves.

KALA BIO Inc. (KALA)

KALA is expected to release topline data from its CHASE trial of KPI-012 by the end of September 2025.

CHASE is a Phase 2b trial evaluating lead investigational topical biologic therapy, KPI-012, for the treatment of persistent corneal epithelial defect.

Persistent corneal epithelial defect is a rare, non-healing corneal defect or wound that is refractory to conventional treatments, often leading to corneal ulceration, perforation, stromal scarring, secondary infections, and significant vision loss. Currently, there are no FDA-approved drugs for treating broad Persistent corneal epithelial defect (PCED). The estimated incidence of PCED is 100,000 patients in the US and 238,000 patients combined in the US, EU, and Japan.

If the results are positive, the CHASE study could serve as the first of two pivotal trials to support the submission of a Biologics License Agreement for KPI-012 to the FDA.

When we alerted readers to KALA on July 14, 2025, it was trading at $5.98. The stock touched an intraday high of $9.39 yesterday, before closing at $9.31, up 6.04%.

Kairos Pharma Ltd. (KAPA)

Kairos is scheduled to report interim efficacy data from its Phase 2 trial of ENV-105 in patients with metastatic castration-resistant prostate cancer (advanced prostate cancer) in September.

Last month, the company reported positive safety results from this ongoing Phase 2 clinical trial of ENV-105 from the first ten enrolled patients. The interim safety analysis of the trial demonstrated that ENV-105 was well tolerated when combined with standard-of-care hormone therapy, Apalutamide. Thus far, there have been no dose-limiting toxicities or unexpected adverse events reported to date. In addition, the treatment-related side effects were manageable with standard supportive care.

The Phase 2 trial is designed to enroll 100 patients in total.

On February 4, 2025, when we alerted readers to KAPA, the opening price that day was $1.73. The stock closed yesterday's trading at $1.20, down 2.44%.

Rapport Therapeutics Inc. (RAPP)

Rapport is on track for topline results of its Phase 2a trial of investigational drug RAP-219 in patients with drug-resistant focal onset seizures in September 2025.

The upcoming data analysis will focus on the primary endpoint, the key secondary endpoint, and the safety of the treatment.

When we first alerted readers to RAPP on May 21, 2025, it was at $10.26. We issued a follow-up alert on July 14, 2025, at which point the stock had risen to $14.56. The stock closed yesterday's trading at $16.01. up 9.43%.

Metsera Inc. (MTSR)

Metsera is expected to report key findings from two studies under its VESPER program in September 2025.

VESPER is a phase IIb program evaluating the company's lead drug candidate MET-097i for the treatment of obesity and overweight. The VESPER program includes three ongoing Phase 2b trials, namely VESPER-1, VESPER-2, and VESPER-3.

In September, the company plans to release topline results from VESPER-1, along with interim data from the titration phase of VESPER-3.

When we first profiled MTSR on June 10, 2025, it was trading at $32.35. The stock touched an all-time high of $47.40 on July 18, 2025. It closed yesterday's trading at $33.19, up 1.84%.

Cullinan Therapeutics Inc. (CGEM)

Cullinan is developing a drug for non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutation by the name Zipalertinib. Discovered by Japan-based Taiho Pharmaceutical, Zipalertinib was licensed to Cullinan Therapeutics in 2019. The two companies have a co-development and co-commercialization agreement for this drug candidate.

Taiho plans to share initial data from the REZILIENT2 cohort exploring Zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC - going to be held September 6 to 9, 2025.

REZILIENT2 is a phase IIb global multicentre cohort trial of Zipalertinib in patients with locally advanced or metastatic non-small cell lung cancer with Exon 20 insertion and uncommon/single or compound epidermal growth factor receptor mutations. This trial includes 4 cohorts - A, B, C, and D.

When we alerted readers to CGEM on June 29, 2025, it was trading at $7.93. The stock closed yesterday's trading at $7.64.