FDA Grants Fast Track Designation to HLD-0915 in Prostate Cancer

The FDA grants FTD to HLD-0915 to mCRPC: © stock.adobe.com.

The U.S. Food and Drug Administration (FDA) has granted fast track designation to the drug HLD-0915 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

The development was announced in a news release issued by clinical-stage biotechnology company Halda Therapeutics, the company behind HLD-0915 and a novel class of therapies known as RIPTAC Therapeutics.

“We are pleased HLD-0915 has been granted fast track designation by FDA for patients with metastatic castration-resistant prostate cancer,” Christian Schade, president and CEO of Halda Therapeutics, said in the news release. “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.”

Fast track, as explained by the FDA on its website, is a process designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need, with the goal of getting important new drugs to patients earlier.

FDA Fast Track Designation Marks Milestone for HLD-0915 in Advanced Prostate Cancer

Halda Therapeutics is enrolling patients in its first-in-human phase 1/2 clinical trial evaluating the safety and tolerability of HLD-0916 for the treatment of metastatic castration-resistant prostate cancer. Notably, the goal of the open-label, multi-center trial is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of the investigational treatment.

The trial is currently enrolling patients and will have an eventual estimated enrollment of 33 patients, according to its listing on clinicaltrials.gov. The trial is being conducted in Denver, Colorado; Sarasota, Florida; Grand Rapids, Michigan; Nashville, Tennessee; and Austin, Texas, according to the listing. It is estimated to be completed in March 2027, the listing states.

It was announced earlier this year that the first patient had been dosed in the trial, as previously reported by CURE.

The trial consists of two phases, with phase 1 intended to determine the maximum tolerated dose and/or recommended dose for expansion of the drug as a stand-alone therapy, and phase 2 will further evaluate the effectiveness and safety of the drug.

Patients enrolled in the trial must have metastatic castration-resistant prostate cancer that has progressed after prior systemic therapies, according to the listing.

Halda Therapeutics, in its news release, described HLD-0915 as a bifunctional small-molecule therapy designed to selectively target prostate cancer cells by linking androgen receptors (a tumor-specific targeting protein) with an effector protein essential for cell function.

Understanding Metastatic Castration-Resistant Prostate Cancer and Patient Prognosis

Metastatic cancer describes when the disease has spread from where it originated to other parts of the body. Castration-resistant prostate cancer, as explained by the National Cancer Institute, is prostate cancer that keeps growing even when the amount of testosterone in the patient’s body is reduced to very low levels.

Metastatic prostate cancer can take an average of two to three years to become castration-resistant, but that timeframe can vary depending on the features of the disease, Dr. Bilal Siddiqui explained in an article posted to The University of Texas MD Anerson Cancer Center’s website.

Currently, Siddiqui serves as an assistant professor in the Department of Genitourinary Medical Oncology in the Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center, located in Houston.

Moreover, once metastatic prostate cancer becomes castration-resistant disease, Siddiqui explained, patients’ average survival time is estimated to be two to three years.

References

1. “Halda Therapeutics Receives FDA Fast Track Designation for HLD-0915 for the Treatment of Metastatic Castration-Resistant Prostate Cancer,” news release, Aug. 14, 2025; https://www.globenewswire.com/news-release/2025/08/14/3133392/0/en/Halda-Therapeutics-Receives-FDA-Fast-Track-Designation-for-HLD-0915-for-the-Treatment-of-Metastatic-Castration-Resistant-Prostate-Cancer.html
2. “Fast Track,” FDA, https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
3. “A Study of HLD-0915 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC);” https://clinicaltrials.gov/study/NCT06800313?term=NCT06800313
4. “Castrate-resistant prostate cancer,” National Cancer Institute; https://www.cancer.gov/publications/dictionaries/cancer-terms/def/castrate-resistant-prostate-cancer
5. “What to know about metastatic prostate cancer” by Dr. Bilal Siddiqui, The University of Texas MD Anderson Cancer Center; https://www.mdanderson.org/cancerwise/what-to-know-about-metastatic-prostate-cancer.h00-159703068.html

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