Applied Therapeutics, Inc., a clinical-stage biopharmaceutical company, develops novel products to target cardiovascular disease, galactosemia, and diabetic complications. Its lead product candidate is AT-007 that has completed phase I/II for the treatment of galactosemia in healthy volunteers and adults, as well as is in pediatric clinical study for the treatment of galactosemia in kids; for treating sorbitol dehydrogenase deficiency; and for the treatment of phosphomannomutase enzyme-CDG. The company also develops AT-001 that is in phase III clinical trials for treating diabetic cardiomyopathy, as well as for the treatment of diabetic peripheral neuropathy. Its preclinical stage products include AT-003 for the treatment diabetic retinopathy; AT-104, a PI3K inhibitor for treating orphan hematological oncology T Cell Acute Lymphoblastic Leukemia. Applied Therapeutics, Inc. was incorporated in 2016 and is headquartered in New York, New York.
IPO Year: 2019
Exchange: NASDAQ
Website: appliedtherapeutics.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 12/23/2024 | Outperform → Mkt Perform | William Blair | |
| 12/2/2024 | $13.00 → $2.00 | Buy → Neutral | UBS |
| 11/29/2024 | $12.00 → $4.00 | Outperform → Sector Perform | RBC Capital Mkts |
| 7/31/2024 | Outperform | William Blair | |
| 3/26/2024 | $12.00 | Outperform | RBC Capital Mkts |
| 2/22/2024 | $12.00 | Outperform | Leerink Partners |
| 1/4/2022 | $44.00 → $7.00 | Overweight → Equal-Weight | Barclays |
| 8/27/2021 | $10.00 | Neutral → Sell | Goldman Sachs |
| 6/25/2021 | $18.00 | Neutral | Goldman |
Slowing of progression of disease observed via MRI at 24 months Improvements in outcomes and reduction in sorbitol maintained through 24 months Statistically significant correlation between absolute reduction in sorbitol and change in 10MWRT and CMT-FOM Lower Limb domain at 12 months, though the primary endpoint of 10MWRT at 12 months was not statistically significant (the measure has since been removed from the CMT-FOM clinical outcomes assessment based upon the results of the ACT-CMT study*) Statistically significant improvement in CMT-HI and statistically significant correlation between percent change in sorbitol and change in CMT-HI at 12 months Treatment with govorestat in
- Company to present full 12-month clinical data and new topline 18-month and 24-month data from INSPIRE registrational Phase 3 trial of govorestat in CMT-SORD Deficiency at the Peripheral Nerve Society 2025 Annual Meeting - Review of govorestat development programs for Classic Galactosemia and CMT-SORD Deficiency ongoing NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT) (the "Company"), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today reported financial results for the first quarter ended March 31, 2025. "We continue to focus on executing against our operational, regulatory and clinical
NEW YORK, May 09, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT) (the "Company"), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today announced that it will present full 12-month clinical results from the INSPIRE Phase 3 trial of govorestat (AT-007) in a late-breaking abstract selected for oral presentation at the Peripheral Nerve Society (PNS) 2025 Annual Meeting, being held May 17-20, 2025 in Edinburgh, Scotland. The presentation will also include new topline 18-month and 24-month data prior to the transition to the open-label extension study. The INSPIRE Phase 3 trial was a double-blind, placebo-controlle
- 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 year ended December 31, 2024. "We remain focused on preparing for potential regulatory interactions regarding govorestat in both Classic Galactosemia and Sorbitol Dehydrogenase ("SORD")
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-25 will allow the Company an automatic extension of 15 additional calendar days to file the Form 10-K for the fiscal year 2024, which is due on March 31, 2025. The Company is working dil
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 strategy. Dr. Baumgartner joins Applied as an accomplished global drug development leader with over 35 years of experience in senior regulatory, clinical development, and medical affairs roles. He has held a diverse set of leadership roles over the course of his career, notably
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 biopharmaceutical and medical device industries. In this newly created role, she will report directly to the executive leadership team and Executive Chairman, and will be responsible for overseeing all quality matters, including Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices. "We are pleased to
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 Shendelman has stepped down as Chair and CEO; andLes Funtleyder, Applied Therapeutics' Chief Financial Officer, has been named Interim Chief Executive Officer. Mr. John
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 Galactosemia. The CRL indicates that the FDA completed its review of the application and determined that it is unable to approve the NDA in its current form, citing deficiencies in the clinical application. Applied Therapeutics is reviewing the
- 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 against validated molecular targets in indications of high unmet medical need, today reported financial results for the third quarter ended September 30, 2024. "W
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William Blair downgraded Applied Therapeutics from Outperform to Mkt Perform
UBS downgraded Applied Therapeutics from Buy to Neutral and set a new price target of $2.00 from $13.00 previously
RBC Capital Mkts downgraded Applied Therapeutics from Outperform to Sector Perform and set a new price target of $4.00 from $12.00 previously
William Blair initiated coverage of Applied Therapeutics with a rating of Outperform
RBC Capital Mkts initiated coverage of Applied Therapeutics with a rating of Outperform and set a new price target of $12.00
Leerink Partners initiated coverage of Applied Therapeutics with a rating of Outperform and set a new price target of $12.00
Barclays downgraded Applied Therapeutics from Overweight to Equal-Weight and set a new price target of $7.00 from $44.00 previously
Goldman Sachs downgraded Applied Therapeutics from Neutral to Sell and set a new price target of $10.00
Goldman resumed coverage of Applied Therapeutics with a rating of Neutral and set a new price target of $18.00
4 - Applied Therapeutics Inc. (0001697532) (Issuer)
Interim primary endpoint met; Statistically significant correlation of sorbitol with the CMT-FOM clinical outcome composite (p=0.05) Sustained, statistically significant reduction in sorbitol in govorestat-treated patients vs. placebo (p<0.001) Highly statistically significant effects on the CMT Health Index (CMT-HI) patient reported outcome measure (p=0.01), with benefit of govorestat on categories of lower limb function, mobility, fatigue, pain, sensory function, and upper limb function Company plans to request a pre-NDA meeting with the neurology division of the US FDA regarding potential approval based on current data Company to host investor conference call and webcast today at 8:3
Govorestat demonstrated consistent long-term clinical outcomes benefit across a range of functional measures in the ACTION-Galactosemia Kids trial, confirming prior biomarker dataGovorestat treatment improved activities of daily living, behavior, cognition, fine motor skills, adaptive skills and tremor vs. placeboCompany plans to request a pre-NDA meeting with the FDA as soon as possible to discuss a potential NDA submission in second half of 2023; plans to submit a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in mid-2023 NEW YORK, April 24, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company
The ongoing Phase 3 INSPIRE trial is evaluating the effect of AT-007 vs. placebo in patients with SORD Deficiency on sorbitol reduction as well as clinical outcomes in approximately 50 patients age 16-55 in the US and EuropeAT-007 reduced sorbitol by a mean of 52%, or approximately 16,000 ng/ml, over a 90 day period, which was highly statistically significant vs. placebo (p<0.001)Company to host conference call to discuss results at 8:30am Eastern NEW YORK, Feb. 16, 2023 (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 medi
Substantial and significant reduction in sorbitol Company plans to initiate registrational trial by end of 2021 Company to host conference call and webcast today at 8:30 a.m. ET NEW YORK, Oct. 25, 2021 (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 reported biomarker data from a pilot trial of AT-007 in patients with SORD Deficiency. Sorbitol Dehydrogenase Deficiency (SORD Deficiency) is a rare, progressive, debilitating hereditary neuropathy that affects peripheral nerves and motor neurons. SORD De
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 strategy. Dr. Baumgartner joins Applied as an accomplished global drug development leader with over 35 years of experience in senior regulatory, clinical development, and medical affairs roles. He has held a diverse set of leadership roles over the course of his career, notably
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 biopharmaceutical and medical device industries. In this newly created role, she will report directly to the executive leadership team and Executive Chairman, and will be responsible for overseeing all quality matters, including Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices. "We are pleased to
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 Shendelman has stepped down as Chair and CEO; andLes Funtleyder, Applied Therapeutics' Chief Financial Officer, has been named Interim Chief Executive Officer. Mr. John
NEW YORK, April 15, 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 the appointment of Dale Hooks as Chief Commercial Officer, replacing Adam Hansard, effective immediately. Mr. Hooks joins Applied with over 30 years of biopharmaceutical experience in rare disease marketing and sales, holding various leadership roles. Mr. Hooks will be responsible for leading Applied's commercial preparations for the potential launch of govorestat for the treatment of Classic Galactosemia and SORD. "I am
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