Halda Therapeutics Receives FDA Fast Track Designation for HLD-0915 for the Treatment of Metastatic Castration-Resistant Prostate Cancer

NEW HAVEN, Conn., Aug. 14, 2025 (GLOBE NEWSWIRE) — Halda Therapeutics, a clinical-stage biotechnology company developing a novel class of therapies called RIPTAC™ Therapeutics, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to HLD-0915, the company’s lead development candidate, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

“We are pleased HLD-0915 has been granted Fast Track designation by FDA for patients with mCRPC,” said Christian Schade, President and CEO of Halda Therapeutics. “Fast Track designation is an important step forward as we work to advance this program through clinical development and, ultimately, to bring a novel, highly selective, oral-based treatment option to patients living with this challenging disease.”

FDA’s Fast Track designation is designed to ensure that important new treatments can reach patients as quickly as possible. A drug receiving Fast Track designation is eligible for more frequent meetings and written interactions with FDA to discuss the drug candidate’s clinical development plan, including possible eligibility for accelerated approval and priority review.

Halda is currently enrolling patients in the first-in-human, Phase 1/2 clinical trial (NCT06800313) to evaluate the safety and tolerability of HLD-0915 in the treatment of metastatic castration-resistant prostate cancer (mCRPC). The Phase 1/2 open label, multi-center clinical trial is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of orally administered, single-agent HLD-0915 in patients with mCRPC. The study includes an initial Phase 1 dose escalation to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion of HLD-0915 as a monotherapy and Phase 2 expansion cohorts to further evaluate the efficacy and safety of HLD-0915.

About HLD-0915
HLD-0915 is an innovative bifunctional small molecule therapy designed to selectively target prostate cancer tumor cells by holding together, with defined orientation and purpose, androgen receptor (a tumor-specific intracellular targeting protein) and a protein with essential function (effector protein). The ternary complex drives the formation of new, or neomorphic, protein-protein interactions, abrogating an essential function within cancer cells which results in an antitumor effect. HLD-0915 is designed to drive specific interactions between selected proteins to achieve optimal activity and pharmacology, as demonstrated in Halda’s preclinical studies. In preclinical prostate cancer models, orally delivered HLD-0915 treatment resulted in tumor shrinkage and declines in prostate-specific antigen (PSA), while delivering a favorable therapeutic index including in models of drug resistance. 

About Halda Therapeutics
Halda Therapeutics is a clinical-stage biotechnology company that has developed a proprietary RIPTAC™ (Regulated Induced Proximity Targeting Chimeras) modality that works by a novel “hold and kill” mechanism for the precision treatment of cancer and other diseases. The novel mechanism of action of RIPTAC therapeutics is uniquely designed to address cancer’s ability to evolve bypass mechanisms of resistance, a common limitation of today’s precision oncology medicines. Our lead RIPTAC programs are in clinical and pre-clinical development for major solid tumor types with additional RIPTAC therapeutic programs in our pipeline to treat additional serious diseases. Halda is led by a leadership team with deep expertise in biotechnology, drug discovery, platform innovation, and clinical development, and is located in New Haven, CT. For more information, please visit www.haldatx.com and follow us on LinkedIn.

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