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Foghorn Therapeutics Inc., founded in 2015 and headquartered in Cambridge, Massachusetts, is a biopharmaceutical company focused on discovering and developing a new class of medicines. These medicines target genetically determined dependencies within the chromatin regulatory system using Foghorn's proprietary Gene Traffic Control® Platform. This platform provides an integrated, mechanistic understanding of how various components of the chromatin regulatory system interact, allowing the identification, validation, and potential drugging of targets within the system.
The company's lead programs include FHD-286 and FHD-609. FHD-286 is a small-molecule enzymatic inhibitor of BRG1 and BRM, targeting acute myeloid leukemia (AML) and uveal melanoma. FHD-609 is a protein degrader of BRD9 aimed at treating synovial sarcoma. Additionally, Foghorn is developing preclinical and discovery programs such as selective BRM targeting non-small-cell lung cancer and selective ARID1B modulators for bladder, ovarian, and endometrial cancer.
Foghorn has established a collaboration with Merck Sharp & Dohme Corp. to discover and develop novel oncology therapeutics against a transcription factor target. The company's financial stability is reflected in its cash and equivalents of approximately $259.9 million as of September 30, 2023, which supports its robust pipeline and strategic objectives for 2024 and beyond.
Recent Achievements and Current Projects:
- Initiated a Phase 1 combination study of FHD-286 in AML with data expected in the second half of 2024.
- Progress with the selective BRM inhibitor FHD-909, with an IND planned for the second quarter of 2024, primarily targeting non-small cell lung cancer.
- Presented preclinical data showcasing selective CBP and EP300 degrader programs, demonstrating significant tumor growth inhibition without associated hematopoietic toxicity.
- Announced multiple strategic milestones, including financial updates and corporate outlooks, reflecting continued progress across various therapeutic programs.
The company remains committed to advancing its preclinical and clinical programs, supported by collaborations and financial investments, with the goal of developing novel medicines that can transform the lives of patients with serious diseases.
Foghorn Therapeutics Inc. (Nasdaq: FHTX) announced new preclinical data for its FHD-286 program during the SITC 37th Annual Meeting held from November 8-12, 2022. The data highlights the efficacy of FHD-286, a BRG1/BRM inhibitor, in combination with an anti-PD-1 antibody, showcasing improved survival benefits in preclinical models. FHD-286 is in Phase 1 trials targeting metastatic uveal melanoma and acute myelogenous leukemia, although the AML and myelodysplastic syndrome trial is currently on clinical hold. The poster presentation is scheduled for November 11, 2022.
Foghorn Therapeutics (FHTX) provided an update on its clinical trials and financial position. The Phase 1 study of FHD-286 in metastatic uveal melanoma continues to progress, with initial data anticipated in 2023. The FHD-609 program shows promise in synovial sarcoma. The company's strong balance sheet, with $373.5 million in cash as of Sept. 30, 2022, extends its financial runway into 2025. Collaboration revenues for Q3 2022 reached $6.6 million. However, a full clinical hold by the FDA on FHD-286 for AML/MDS due to safety concerns remains a notable challenge.
Foghorn Therapeutics (Nasdaq: FHTX) has elected Dr. Thomas Lynch Jr. to its Board of Directors. Dr. Lynch, president of Fred Hutchinson Cancer Center and former Chief Scientific Officer at Bristol-Myers Squibb, brings extensive scientific and clinical expertise to the role. His appointment comes as Foghorn progresses clinical trials for drug candidates FHD-609 and FHD-286. CEO Adrian Gottschalk emphasized the value of Dr. Lynch's experience in guiding the company's growth. This leadership addition could enhance Foghorn’s capabilities in drug development and strengthen its mission to address serious diseases.
Foghorn Therapeutics (FHTX) presented promising initial Phase 1 data highlighting the degradation of BRD9 in metastatic tumor biopsies of synovial sarcoma using FHD-609. This investigational drug demonstrates strong selectivity and efficacy, potentially leading to significant tumor growth inhibition. The company also introduced a new protein degrader program targeting EP300 mutations, which could benefit over 100,000 patients annually. The data reinforces Foghorn's status as a leader in protein degradation therapies, with further detailed results expected in 2023.
Foghorn Therapeutics (Nasdaq: FHTX) announced its participation in the 5th Annual Targeted Protein Degradation Summit from October 25-28, 2022, in Danvers, Massachusetts. The company will present initial pharmacodynamic data from its Phase 1 study of FHD-609, a selective degrader of BRD9 for treating synovial sarcoma and SMARCB1-loss tumors. Notable sessions include a keynote by Danette L. Daniels, Ph.D., on October 26, and a workshop on preclinical study design on October 25. Foghorn is advancing its protein degradation platform amid ongoing clinical studies.
Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical stage biotech firm, will participate in the Bank of America 2022 Precision Oncology Conference on October 3, 2022, at 12:20 p.m. ET. The company's innovative Gene Traffic Control platform aims to address gene expression issues in serious diseases, with a primary focus on oncology. A webcast of the event will be available on their website for 90 days post-event. Foghorn is developing several oncology product candidates, with two currently in clinical trials.
Foghorn Therapeutics (Nasdaq: FHTX) has announced management's participation in key investor conferences this September. The biotechnology company focuses on developing innovative treatments by correcting abnormal gene expression, particularly in oncology. The upcoming conferences include the Morgan Stanley 20th Annual Global Healthcare Conference on September 12 and the H.C. Wainwright 24th Annual Global Investment Conference on September 13. Webcasts of these events will be available on their website for 90 days post-conference.
Foghorn Therapeutics has announced the appointment of co-founder Cigall Kadoch as an Investigator for the Howard Hughes Medical Institute (HHMI), effective September 6, 2022. Following this appointment, Dr. Kadoch has resigned from her position on Foghorn’s Board of Directors but will continue as a Scientific Advisor to the Board. CEO Adrian Gottschalk praised her contributions, emphasizing her leadership in chromatin regulation research. Foghorn continues to focus on developing innovative therapies for serious diseases through its Gene Traffic Control platform.
Foghorn Therapeutics (Nasdaq: FHTX) announced a full clinical hold by the FDA on the Phase 1 study of its drug FHD-286 for acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). This decision arose from reports of additional suspected fatal differentiation syndrome cases linked to FHD-286. Meanwhile, the study for metastatic uveal melanoma is proceeding as planned, with data expected in early 2023. Foghorn remains committed to addressing FDA concerns to lift the hold promptly.
Foghorn Therapeutics (Nasdaq: FHTX) announced the election of B. Lynne Parshall to its Board as the Chair of the Audit Committee. With nearly 30 years in biotechnology and experience at Ionis Pharmaceuticals, her leadership is expected to bolster Foghorn's growth. CEO Adrian Gottschalk emphasized that her track record in therapy development will be pivotal as the company works towards its vision of a fully-integrated biotech. Parshall will play a crucial role in advancing key clinical programs, including FHD-286 and FHD-609.
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