This section highlights FDA-related milestones and regulatory updates for drugs developed by Foghorn Therapeutics (FHTX).
Over the past two years, Foghorn Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
FHD-286 and FHD-909. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
FHD-286 (mUM) - FDA Regulatory Timeline and Events
FHD-286 (mUM) is a drug developed by Foghorn Therapeutics for the following indication: Metastatic Uveal Melanoma (mUM).
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:
- FHD-286 (mUM)
- Announced Date:
- December 16, 2024
- Indication:
- Metastatic Uveal Melanoma (mUM)
Announcement
Foghorn® Therapeutics announced today that it has made the decision to discontinue the independent development of FHD-286 in combination with decitabine in patients with relapsed and/or refractory acute myeloid leukemia (AML).
AI Summary
Foghorn® Therapeutics announced that it will discontinue the independent development of FHD-286 combined with decitabine for treating patients with relapsed or refractory acute myeloid leukemia (AML). Although the Phase 1 trial showed some clinical responses based on standard response criteria, the overall response rate did not meet the company’s threshold to move forward on its own. Foghorn is now considering strategic partnerships and investigator sponsored trials (ISTs) to further explore FHD-286.
In addition, the company will focus its investment on its proprietary pipeline and its collaboration with Lilly, notably on the clinical-stage selective SMARCA2 (BRM) inhibitor FHD-909. With a cash balance of $267.4 million as of September 30, 2024, Foghorn has sufficient funds to support its operations until 2027, while it continues to explore new opportunities in oncology.
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FHD-909 - FDA Regulatory Timeline and Events
FHD-909 is a drug developed by Foghorn Therapeutics for the following indication: A BRM (SMARCA2) selective inhibitor.
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:
- FHD-909
- Announced Date:
- April 28, 2025
- Indication:
- A BRM (SMARCA2) selective inhibitor
Announcement
Foghorn® Therapeutics announced new preclinical data for potential first-in-class medicines, including FHD-909, a SMARCA2 (BRM) selective inhibitor, and the Selective CBP degrader program at the 2025 American Association for Cancer Research (AACR) Annual Meeting.
AI Summary
Foghorn Therapeutics announced promising new preclinical data at the 2025 AACR Annual Meeting. The company is focusing on FHD-909, a first-in-class, orally available SMARCA2 (BRM) selective inhibitor currently in a Phase 1 trial for patients with SMARCA4-mutated cancers, primarily targeting non-small cell lung cancer (NSCLC). Early results show that FHD-909, when used in combination with pembrolizumab, KRAS inhibitors, and standard chemotherapy, exhibits strong synergistic anti-tumor effects, encouraging further clinical exploration.
In addition, the Selective CBP degrader program has demonstrated potential in preclinical studies, particularly in ER+ breast cancer models. These data suggest that the new combination strategies could offer effective treatment options for patients with hard-to-treat cancers. Foghorn Therapeutics is committed to advancing these innovative approaches as part of its mission to develop novel medicines for serious diseases.
Read Announcement- Drug:
- FHD-909
- Announced Date:
- March 25, 2025
- Indication:
- A BRM (SMARCA2) selective inhibitor
Announcement
Foghorn® Therapeutics Inc. announced that new preclinical combination data for FHD-909, a potential first-in-class selective SMARCA2 inhibitor will be presented as an oral presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting being held April 25-30, 2025, in Chicago, Illinois.
AI Summary
Foghorn® Therapeutics Inc. announced that new preclinical combination data for FHD-909 (LY4050784), a potential first-in-class selective SMARCA2 inhibitor, will be featured at the 2025 American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois, from April 25-30, 2025. The oral presentation will discuss how FHD-909 demonstrates synergistic activity when combined with chemotherapy, pembrolizumab, and KRAS inhibitors in SMARCA4 mutant cancers, with non-small cell lung cancer as a primary focus. The company’s data highlights promising combination strategies that could enhance anti-tumor effects, and early indicators suggest that enrollment and dose escalation in the ongoing Phase 1 trial are progressing well. This event is part of Foghorn’s continued efforts to advance innovative therapies targeting challenging genomic alterations, aiming to offer new treatment options for patients with difficult-to-treat cancers.
Read Announcement- Drug:
- FHD-909
- Announced Date:
- March 6, 2025
- Indication:
- A BRM (SMARCA2) selective inhibitor
Announcement
Foghorn® Therapeutics Inc provided a business update
AI Summary
Foghorn® Therapeutics Inc. provided a business update with highlights from its 10-K filing for 2024. The company is progressing its Phase 1 trial of FHD-909, a first-in-class oral selective SMARCA2 inhibitor designed to target SMARCA4 mutated cancers, with non-small cell lung cancer (NSCLC) as the primary focus. The first patient was dosed in October 2024, and preclinical combination data with pembrolizumab and KRAS inhibitors is set to be shared at the AACR Annual Meeting in 2025.
CEO Adrian Gottschalk emphasized the strong execution of their oncology pipeline and an exciting outlook for 2025. Foghorn is also advancing programs for selective CBP, EP300, and ARID1B degradation, with further updates expected later in 2025. The company’s robust financial profile, with $243.7 million in cash and equivalents, supports a runway into 2027.
Read Announcement- Drug:
- FHD-909
- Announced Date:
- October 10, 2024
- Indication:
- A BRM (SMARCA2) selective inhibitor
Announcement
Foghorn® Therapeutics Inc announced that the first patient has been dosed with FHD-909 (LY4050784) in the Phase 1 trial for SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target patient population.
AI Summary
Foghorn® Therapeutics Inc. announced that the first patient has been dosed in the Phase 1 trial of FHD-909 (LY4050784), marking a major step in testing this first-in-class oral compound. The trial focuses on patients with SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target group. FHD-909 is designed to selectively inhibit SMARCA2 (BRM) over SMARCA4, employing a promising synthetic lethality approach to treat SMARCA4 mutations and their related solid tumors.
The open-label, multicenter trial will closely monitor the safety, tolerability, and early signs of effectiveness of FHD-909. This advancement builds on preclinical studies showing significant anti-tumor activity, supporting the potential of FHD-909 as a new therapeutic option in oncology. Foghorn is excited to continue the trial in collaboration with Lilly.
Read Announcement- Drug:
- FHD-909
- Announced Date:
- April 9, 2024
- Indication:
- A BRM (SMARCA2) selective inhibitor
Announcement
Foghorn® Therapeutics announced new preclinical data for potential first-in-class medicines including FHD-909, a BRM (SMARCA2) selective inhibitor, selective CBP degrader, and selective EP300 degrader programs at the 2024 American Association for Cancer Research (AACR) Annual Meeting. Foghorn management will hold a conference call and webcast today at 5 p.m. ET to review important pipeline updates.
AI Summary
Foghorn® Therapeutics unveiled promising preclinical data for potential first‐in‐class cancer treatments at the 2024 AACR Annual Meeting. The company highlighted FHD-909, a selective BRM (SMARCA2) inhibitor that showed good tolerability and dose-dependent anti-tumor activity in BRG1 mutated cancers, such as non-small cell lung cancer. These encouraging results support FHD-909 as a new approach for patients with BRG1-mutant tumors. In addition to FHD-909, Foghorn presented data on selective CBP and EP300 degrader programs. The CBP program demonstrated significant tumor growth inhibition without side effects common to dual CBP/EP300 inhibitors, while the EP300 program, still early in development, showed promising safety and efficacy profiles. Foghorn plans to file an IND application for FHD-909 in Q2 2024. The company will review these pipeline updates during a conference call and webcast today at 5 p.m. ET.
Read Announcement
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