reports
Applied Therapeutics Reports Fourth Quarter and Year-end 2024 Financia...
Applied Therapeutics Reports Fourth Quarter and Year-end 2024 Financial Results - Appointed John H. Johnson as Executive Chairman; Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer; and Reena Thomas Colacot as Vice President and Head of Quality NEW YORK, April 14, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the fourth quarter and full yea...
Applied Therapeutics Files Form 12b-25 with the Securities and Exchang...
Applied Therapeutics Files Form 12b-25 with the Securities and Exchange Commission NEW YORK, March 31, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that it has filed a Form 12b-25, Notification of Late Filing, with the U.S. Securities and Exchange Commission (“SEC”) related to the Company’s Annual Report on Form 10-K for the fiscal year 2024 (the “Form 10-K”). Form 12b...
Applied Therapeutics Appoints Todd F. Baumgartner, MD, MPH as Chief Re...
Applied Therapeutics Appoints Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer Dr. Baumgartner will advance Applied’s preparation for upcoming regulatory interactions NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced the appointment of Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer. Dr. Baumgartner will serve as part of the Company’s executive leadership team and will be responsible for leading Applied’s global regulatory s...
- Jonathan Moreland
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Applied Therapeutics Appoints Reena Thomas Colacot as Vice President a...
Applied Therapeutics Appoints Reena Thomas Colacot as Vice President and Head of Quality Ms. Colacot brings over 25 years of quality leadership experience across the biopharmaceutical and medical device industries NEW YORK, Jan. 21, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced the appointment of Reena Thomas Colacot as Vice President and Head of Quality. Ms. Colacot joins Applied with over 25 years of quality leadership experience across the biopharmaceuti...
Applied Therapeutics Appoints John H. Johnson as Executive Chairman
Applied Therapeutics Appoints John H. Johnson as Executive Chairman Shoshana Shendelman Steps Down as CEO; Les Funtleyder Appointed Interim Chief Executive Officer Announces Business Updates NEW YORK, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced the following leadership changes, effective immediately: John H. Johnson, a recognized leader in the pharmaceutical and biotechnology industry, has been named Executive Chairman;Dr. Shoshana S...
Molecular Templates Announces Notice of Delisting and Failure to Satis...
Molecular Templates Announces Notice of Delisting and Failure to Satisfy Continued Listing Rules AUSTIN, Texas, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM” or the “Company”), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, known as engineered toxin bodies, to create novel therapies with potent and differentiated mechanisms of action for cancer, was notified on December 16, 2024 by the Listing Qualifications Department (the “Staff”) of The Nasda...
Molecular Templates Announces Receipt of Expected Notification of Defi...
Molecular Templates Announces Receipt of Expected Notification of Deficiency from Nasdaq Related to Delayed filing of Quarterly Report on Form 10-Q and Failure to Meet Bid Price Requirements AUSTIN, Texas, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Molecular Templates, Inc. (Nasdaq: MTEM, “Molecular Templates,” or “MTEM” or the “Company”), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, known as engineered toxin bodies, to create novel therapies with potent and differentiated mechanisms of action for cancer, announc...
Applied Therapeutics Receives Complete Response Letter from U.S. FDA R...
Applied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug Application for Govorestat for Classic Galactosemia NEW YORK, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of Classic Gal...
Applied Therapeutics Reports Third Quarter 2024 Financial Results
Applied Therapeutics Reports Third Quarter 2024 Financial Results - NDA and MAA for govorestat for treatment of Classic Galactosemia under FDA Priority Review and EMA review; PDUFA target action date of November 28, 2024, and EMA decision expected in Q1 2025 - NDA submission for govorestat for the treatment of SORD Deficiency under Accelerated Approval expected in early Q1 2025 NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates again...
Applied Therapeutics to Present at the 2024 UBS Global Healthcare Conf...
Applied Therapeutics to Present at the 2024 UBS Global Healthcare Conference NEW YORK, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that it will present at the 2024 UBS Global Healthcare Conference on Tuesday, November 12, 2024, at 7:15 a.m. PT in Rancho Palos Verdes, California. A live webcast for this event will be accessible on the Events page under the Investor Relations...
Applied Therapeutics Provides Regulatory Update on Govorestat for the ...
Applied Therapeutics Provides Regulatory Update on Govorestat for the Treatment of Classic Galactosemia - Company completed Late-Cycle review meeting with FDA - FDA no longer intends to hold Advisory Committee meeting - FDA Review of NDA continues to proceed as planned with PDUFA target action date of November 28, 2024 NEW YORK, Sept. 18, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announc...
Applied Therapeutics to Participate in Upcoming Investor Conferences
Applied Therapeutics to Participate in Upcoming Investor Conferences NEW YORK, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the company will participate in the following upcoming investor conferences: Baird 2024 Global Healthcare Conference: Fireside chat on Tuesday, September 10, 2024, at 3:45 p.m. ET in New York, NY2024 Cantor Global Healthcare Conference: Presentati...
- Jonathan Moreland
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Molecular Templates, Inc. Reports Second Quarter 2024 Financial Result...
Molecular Templates, Inc. Reports Second Quarter 2024 Financial Results and Corporate Update Monotherapy activity of long duration in patients who have progressed on checkpoint therapy via a novel immuno-oncology mechanism of action with PD-L1 ETB (MT-6402) programEarly indication of monotherapy activity in CTLA-4 ETB (MT-8421) program through T-reg depletion; no drug-related adverse events > grade 2Novel mechanism of action targeting CD38+ immune cells of B-cell, T-cell, and monocytic lineage representing enhanced potency in I&I without the need for conditioning therapy AUSTIN, Texas, Aug...
- Jonathan Moreland
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Applied Therapeutics Reports Second Quarter 2024 Financial Results
Applied Therapeutics Reports Second Quarter 2024 Financial Results NDA and MAA for govorestat for treatment of Classic Galactosemia under FDA Priority Review and EMA review; PDUFA target action date of November 28, 2024, and EMA decision expected in early Q1 2025FDA Genetic Metabolic Diseases Advisory Committee (GeMDAC) Meeting to discuss NDA for govorestat for the treatment of Classic Galactosemia tentatively scheduled for October 9, 2024Company aligned with the Neurology I Division on plans to submit an NDA under Accelerated Approval for govorestat for the treatment of SORD Deficiency; ...
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