Telomir Pharmaceuticals Receives FDA IND Clearance for Telomir-Zn

The latest announcement is out from Telomir Pharmaceuticals, Inc. ( (TELO) ).

Telomir Pharmaceuticals announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for Telomir-Zn to treat patients with advanced or metastatic triple-negative breast cancer. The clearance enables the company to proceed with its first-in-human Phase 1/2 clinical trial, anchored by a leading U.S. academic medical center and expected to begin enrollment in the first half of 2026.

The planned study will enroll about 76 patients, starting with a dose-escalation Phase 1 to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity, followed by a dose-expansion Phase 2 to evaluate preliminary efficacy via objective response rate. Extensive translational biomarker work, including analyses of epigenetic regulation, gene expression, histone modification, and telomere dynamics, is intended to clarify target engagement and potential predictors of response, potentially enhancing Telomir’s position in precision oncology and telomere-related therapeutics.

The most recent analyst rating on (TELO) stock is a Buy with a $8.00 price target. To see the full list of analyst forecasts on Telomir Pharmaceuticals, Inc. stock, see the TELO Stock Forecast page.

More about Telomir Pharmaceuticals, Inc.

Telomir Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing innovative therapeutics targeting cellular aging, genomic stability, and epigenetic modulation. Its lead product candidate, Telomir-Zn, is being advanced for oncology indications, with an initial focus on treating patients with advanced or metastatic triple-negative breast cancer, a difficult-to-treat tumor subtype with limited options.

Average Trading Volume: 97,873

Technical Sentiment Signal: Hold

Current Market Cap: $49.85M

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