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Yahoo
14-07-2025
- Health
- Yahoo
FDA grants Zenith's ZEN-3694 Fast Track Status
Zenith Epigenetics Announces Grant of U.S. Food and Drug Administration Fast Track Designation for ZEN-3694 in NUT Carcinoma Calgary, Alberta--(Newsfile Corp. - July 14, 2025) - Zenith Epigenetics Ltd. ("Zenith" or the "Company") is pleased to announce the designation of ZEN-3694 as a Fast Track product by the U.S. Food and Drug Administration ("FDA"). FDA officials concluded that ZEN-3694, in combination with abemaciclib, meets the criteria for Fast Track designation for the treatment of metastatic or unresectable NUT carcinoma in patients who have received at least one line of prior chemotherapy. The Company is also pursuing Orphan Drug and Breakthrough Therapy designations for ZEN-3694 in NUT carcinoma. "We are thrilled that the FDA has recognized the strong potential of ZEN-3694 in benefiting patients with NUT carcinoma, an extremely aggressive, deadly cancer, for which there are no effective or approved treatments," said Donald McCaffrey, President & CEO of Zenith Epigenetics. "Fast Track designation will accelerate ZEN-3694's clinical NUT carcinoma program by expediting its development and review, and allow us to deliver this potentially life-saving drug to patients sooner." Fast Track DesignationAccording to the FDA, Fast Track "is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need". The purpose of the Fast Track program is to speed up the development of important new drugs and get them into the hands of patients earlier than would otherwise be possible. Benefits of Fast Track designation may include: More frequent meetings with FDA on drug development planning More frequent written communication from FDA on clinical trial design and other critical points Eligibility for Accelerated Approval and Priority Review NUT CarcinomaNUT carcinoma is a highly aggressive type of cancer affecting adults and children and typically occurs in the midline area of the body including head, neck, and thoracic areas. While NUT carcinoma is a rare cancer, it is currently underdiagnosed – due to lack of awareness and testing – and the actual incidence is estimated at 10,000 cases per year. However, growing awareness among clinicians, as well as new biomarker testing methods, are improving detection. With rapidly increasing diagnoses, no approved therapies, and a median overall survival of about 6 months, there is a significant unmet need for new therapeutic options in NUT carcinoma. ZEN-3694Zenith's lead clinical candidate, ZEN-3694, is currently being evaluated in two (2) active NUT carcinoma clinical trials in combination with abemaciclib ( ID: NCT05372640) and cisplatin & etoposide ( ID: NCT05019716). ZEN-3694 is a potent, selective, orally available BET inhibitor, which is well tolerated for chronic administration and has a favorable safety profile, with more than 550 patients having received the drug. In NUT carcinoma, the NUTM1 gene is fused with a transcriptional regulator – most commonly a BET protein – and drives expression of cancer-causing genes, leading to unchecked growth of tumors. Through disrupting the activity of NUT fusion protein, ZEN-3694 has demonstrated both single-agent and combination efficacy in treating NUT carcinoma. To date, the combination of abemaciclib plus ZEN-3694 has shown superior response rate and duration of response compared to single agent BET inhibitors by inhibiting resistance to therapy. About ZenithZenith Epigenetics Ltd., a wholly owned subsidiary of Zenith Capital Corp., is a clinical stage biotechnology company focused on the discovery and development of novel therapeutics for the treatment of cancer and other disorders with significant unmet medical need. Zenith Epigenetics is developing various novel combinations of BET inhibitors with other targeted agents. Our lead compound, ZEN-3694, is in clinical development for various oncologic indications such as metastatic castration resistant prostate cancer, NUT carcinoma, ovarian cancer and RAS activated tumors. Several of these studies are sponsored by NCI under the NCI-Zenith Cooperative Research & Development Agreements (CRADA) and CRADAs between NCI and other NCI collaborators. Forward-Looking StatementThis news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. In particular, this news release includes forward looking information relating to the Company's development activities involving ZEN-3694 in NUT carcinoma, ovarian cancer, RAS activated tumors, and other tumor types, as a single agent, or in combination with chemotherapies, as well as our partnerships, agreements, and collaborations in furtherance of these development activities. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our most recent MD&A which are incorporated herein by reference and are available through SEDAR+ at The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. Zenith disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For further information, please contact:Investor Relations Phone: 587-390-7865Email: info@ To view the source version of this press release, please visit Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
30-06-2025
- Business
- Globe and Mail
Resverlogix Announces Voting Results from the 2025 Meeting of Shareholders
Calgary, Alberta--(Newsfile Corp. - June 30, 2025) - Resverlogix Corp. (TSX: RVX) ("Resverlogix", or the "Corporation") today held its Annual Meeting of Shareholders (the "Meeting") in Calgary, Alberta. During business proceedings at the Meeting, shareholders elected four (4) Board members until the next annual meeting. The voting results of shares represented at the Meeting for individual directors were as follows: Votes For Votes Withheld Percent For Percent Withheld Donald J. McCaffrey 144,544,411 5,161,746 96.55% 3.45% Kelly McNeill 144,898,132 4,808,025 96.79% 3.21% Siu Lun (Dicky) To 145,379,921 4,326,236 97.11% 2.89% Kenneth Zuerblis 145,121,418 4,584,739 96.94% 3.06% Resverlogix shareholders approved all resolutions outlined in the Notice of Meeting and Management Information Circular dated May 16, 2025 (the "Information Circular"). The Information Circular is available on SEDAR+ at and on the Resverlogix website at A webcast archive of the executive presentation portion of the Meeting will be available HERE. About Resverlogix Founded in 2001, Resverlogix is a Calgary based late-stage biotechnology company, and a world leader in epigenetics, with the goal of developing first-in-class therapies for the benefit of patients with chronic disease. Resverlogix is developing a new class of epigenetic therapies designed to regulate the expression of disease-causing genes. We aim to improve patients' lives by restoring biological functions — altered by serious illnesses such as cardiovascular disease — back to a healthier state. The Company's clinical program is focused on evaluating the lead epigenetic candidate apabetalone for the treatment of cardiovascular disease, associated comorbidities, and post COVID-19 conditions. Resverlogix has partnered with EVERSANA™, the pioneer of next generation commercial services to the global life sciences industry, to support the rapid commercialization of apabetalone for cardiovascular disease, post COVID-19 conditions, and pulmonary arterial hypertension in Canada and the United States. Resverlogix common shares trade on the Toronto Stock Exchange (TSX: RVX). Follow us on: Forward-Looking Statements: This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts", and other similar expressions. In particular, this news release includes forward-looking information related to the potential role of apabetalone in the treatment of patients with cardiovascular disease, post COVID-19 conditions, pulmonary arterial hypertension, associated comorbidities, and other chronic diseases. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our Annual Information Form and most recent MD&A which are incorporated herein by reference and are available through SEDAR+ at The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Yahoo
30-06-2025
- Business
- Yahoo
Resverlogix Announces Voting Results from the 2025 Meeting of Shareholders
Calgary, Alberta--(Newsfile Corp. - June 30, 2025) - Resverlogix Corp. (TSX: RVX) ("Resverlogix", or the "Corporation") today held its Annual Meeting of Shareholders (the "Meeting") in Calgary, Alberta. During business proceedings at the Meeting, shareholders elected four (4) Board members until the next annual meeting. The voting results of shares represented at the Meeting for individual directors were as follows:Votes For Votes Withheld Percent For Percent Withheld Donald J. McCaffrey 144,544,411 5,161,746 96.55% 3.45% Kelly McNeill 144,898,132 4,808,025 96.79% 3.21% Siu Lun (Dicky) To 145,379,921 4,326,236 97.11% 2.89% Kenneth Zuerblis 145,121,418 4,584,739 96.94% 3.06% Resverlogix shareholders approved all resolutions outlined in the Notice of Meeting and Management Information Circular dated May 16, 2025 (the "Information Circular"). The Information Circular is available on SEDAR+ at and on the Resverlogix website at A webcast archive of the executive presentation portion of the Meeting will be available HERE. About Resverlogix Founded in 2001, Resverlogix is a Calgary based late-stage biotechnology company, and a world leader in epigenetics, with the goal of developing first-in-class therapies for the benefit of patients with chronic disease. Resverlogix is developing a new class of epigenetic therapies designed to regulate the expression of disease-causing genes. We aim to improve patients' lives by restoring biological functions — altered by serious illnesses such as cardiovascular disease — back to a healthier state. The Company's clinical program is focused on evaluating the lead epigenetic candidate apabetalone for the treatment of cardiovascular disease, associated comorbidities, and post COVID-19 conditions. Resverlogix has partnered with EVERSANA™, the pioneer of next generation commercial services to the global life sciences industry, to support the rapid commercialization of apabetalone for cardiovascular disease, post COVID-19 conditions, and pulmonary arterial hypertension in Canada and the United States. Resverlogix common shares trade on the Toronto Stock Exchange (TSX: RVX). Follow us on: Twitter: @Resverlogix_RVX LinkedIn: Forward-Looking Statements: This news release may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts", and other similar expressions. In particular, this news release includes forward-looking information related to the potential role of apabetalone in the treatment of patients with cardiovascular disease, post COVID-19 conditions, pulmonary arterial hypertension, associated comorbidities, and other chronic diseases. Our actual results, events or developments could be materially different from those expressed or implied by these forward-looking statements. We can give no assurance that any of the events or expectations will occur or be realized. By their nature, forward-looking statements are subject to numerous assumptions and risk factors including those discussed in our Annual Information Form and most recent MD&A which are incorporated herein by reference and are available through SEDAR+ at The forward-looking statements contained in this news release are expressly qualified by this cautionary statement and are made as of the date hereof. The Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For further information, please contact: Investor RelationsEmail: ir@ 403-254-9252 To view the source version of this press release, please visit Erreur lors de la récupération des données Connectez-vous pour accéder à votre portefeuille Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données
