FDA Events for Oncternal Therapeutics (ONCT)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Oncternal Therapeutics (ONCT).
Over the past two years, Oncternal Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ONCT-534. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ONCT-534 - FDA Regulatory Timeline and Events
ONCT-534 is a drug developed by Oncternal Therapeutics for the following indication: Resistant prostate cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ONCT-534
- Announced Date:
- September 12, 2024
- Indication:
- Resistant prostate cancer
Announcement
Oncternal Therapeutics, Inc announced its decision to discontinue its clinical trials evaluating ONCT-534, its dual action androgen receptor inhibitor for the treatment of patients with metastatic castration resistant cancer, and ONCT-808, its ROR1-targeting autologous CAR T program for the treatment of patients with aggressive B-cell lymphoma, and to explore strategic alternatives.
AI Summary
Oncternal Therapeutics, Inc. announced it will discontinue clinical trials for two of its investigational products. The company halted studies of ONCT-534, a dual-action androgen receptor inhibitor for treating metastatic castration resistant cancer, after early Phase 1 results failed to show meaningful disease improvements. Similarly, the Phase 1 trial for ONCT-808, an autologous CAR T cell therapy targeting ROR1 for aggressive B-cell lymphoma, reported expected safety issues including a death at the highest dose. Based on these clinical outcomes and the high capital needs for further development, Oncternal plans to explore strategic alternatives to maximize shareholder value. Future options may include asset sales, licensing deals, or other business combinations, while all ongoing product development activities are discontinued and workforce reductions are planned to preserve cash resources.
Read Announcement- Drug:
- ONCT-534
- Announced Date:
- July 15, 2024
- Indication:
- Resistant prostate cancer
Announcement
Oncternal Therapeutics, Inc. announced that dosing initiated for the sixth dose cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with metastatic castration-resistant prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI).
AI Summary
Oncternal Therapeutics has begun dosing for the sixth cohort in its Phase 1/2 trial of ONCT-534, a new therapy for metastatic castration-resistant prostate cancer. This cohort is receiving 1200 mg of ONCT-534 once daily, a notable increase from the 600 mg dose previously evaluated in the study. The decision to advance to this higher dose came after the Safety Review Committee reviewed favorable safety data from the earlier cohort.
ONCT-534, a dual-action androgen receptor inhibitor, is being tested in patients who have relapsed or become resistant to approved androgen receptor pathway inhibitors. The study team expects to share preliminary safety and efficacy data, including prostate-specific antigen levels, in the third quarter of 2024. The rapid enrollment and strong patient demand underscore the potential of this treatment for patients in need of new therapy options.
Read Announcement- Drug:
- ONCT-534
- Announced Date:
- July 15, 2024
- Indication:
- Resistant prostate cancer
Announcement
Oncternal Therapeutics, Inc. announced that announced that enrollment has been completed of Phase 1/2 Study of ONCT-534
AI Summary
Oncternal Therapeutics, Inc. announced that enrollment is now complete for its Phase 1/2 study of ONCT-534, with dosing already underway in the sixth dose cohort. In this highest dose group, patients with metastatic castration-resistant prostate cancer are receiving 1200 mg of the dual-action androgen receptor inhibitor (DAARI) daily. This decision was supported by the study’s Safety Review Committee after reviewing promising data from the previous 600 mg dose group, where the drug was well tolerated without any dose-limiting toxicities. The study focuses on patients whose disease has relapsed or become resistant to existing androgen receptor pathway inhibitors. An initial update on the safety and efficacy of ONCT-534, including information on prostate-specific antigen levels, is expected in the third quarter of 2024.
Read Announcement
Oncternal Therapeutics FDA Events - Frequently Asked Questions
As of now, Oncternal Therapeutics (ONCT) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Oncternal Therapeutics (ONCT) has reported FDA regulatory activity for ONCT-534.
The most recent FDA-related event for Oncternal Therapeutics occurred on September 12, 2024, involving ONCT-534. The update was categorized as "Provided Update," with the company reporting: "Oncternal Therapeutics, Inc announced its decision to discontinue its clinical trials evaluating ONCT-534, its dual action androgen receptor inhibitor for the treatment of patients with metastatic castration resistant cancer, and ONCT-808, its ROR1-targeting autologous CAR T program for the treatment of patients with aggressive B-cell lymphoma, and to explore strategic alternatives."
Currently, Oncternal Therapeutics has one therapy (ONCT-534) targeting the following condition: Resistant prostate cancer.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ONCT) was last updated on 7/13/2025 by MarketBeat.com Staff
