SAN MATEO, Calif., Oct. 8, 2025 /PRNewswire/ -- Vivace Therapeutics, Inc., a small molecule discovery and development company developing first-in-class cancer therapies targeting the Hippo pathway, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to VT3989, the company's first-in-class and best-in-class transcriptional enhanced associate domain (TEAD) autopalmitoylation inhibitor. The designation pertains to VT3989's use as a treatment for patients with unresectable malignant nonpleural or pleural mesothelioma whose disease has progressed on prior immune checkpoint inhibitor therapy and platinum-based chemotherapy.
FDA's Fast Track Designation is granted to drug candidates that are being developed for the treatment of serious or life-threatening conditions and have the potential to fill unmet medical needs. The program is designed to ensure that these important new treatments can reach patients as quickly as possible. A company that receives Fast Track Designation is eligible for more frequent meetings and written interactions with the FDA to discuss the drug candidate's clinical development plan, including possible eligibility for accelerated approval and priority review.
"We are pleased to receive Fast Track Designation from the FDA for VT3989 in this patient population, which is in desperate need of new and effective therapeutic options. This designation represents another important step in our ongoing development of VT3989 and will offer key advantages as we continue on our path toward potential commercialization of this first-in-class and best-in-class therapy," said Sofie Qiao, Ph.D., president and chief executive officer of Vivace Therapeutics.
VT3989 is a novel investigational small molecule cancer therapeutic that is designed to target the Hippo pathway by inhibiting palmitoylation of members of the TEAD protein family. The compound has been evaluated in more than 200 patients to date in an ongoing, open-label Phase 1 clinical study and, to the company's knowledge, is the first and only member of the TEAD autopalmitoylation inhibitor class for which compelling clinical efficacy data have been publicly reported. In addition to the promising data to date, VT3989 has demonstrated a positive safety profile in the Phase 1 trial, which supports its best-in-class potential.
About Phase 1 study of VT3989
The Phase 1 study of VT3989 (https://clinicaltrials.gov/ct2/show/NCT04665206) is a multi-center, open label trial designed to evaluate the safety, tolerability, pharmacokinetics (PK) and biological activity of VT3989 in patients with refractory metastatic solid tumors, including refractory pleural and non-pleural malignant mesothelioma.
About Vivace Therapeutics, Inc.
Vivace Therapeutics is a small molecule drug discovery and development company focused on targeting the Hippo pathway. The company is pursuing a first-in-class approach to treat human carcinomas of high unmet medical needs. Based in San Francisco Bay Area, the company has raised $105 million to date. For more information, please visit www.vivacetherapeutics.com.
Contact information
Sofie Qiao, Ph.D.
President and CEO
info@vivacetherapeutics.com
650.666.2753
Tim Brons
Vida Strategic Partners (media)
646-319-8981
tbrons@vidasp.com
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SOURCE Vivace Therapeutics, Inc.
