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 |
SC 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)
SC 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)
SC 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)
SC 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)
SC 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)
SC 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)
SC 13G - Applied Therapeutics, Inc. (0001697532) (Subject)
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SC 13G - Applied Therapeutics Inc. (0001697532) (Subject)
SC 13D/A - Applied Therapeutics Inc. (0001697532) (Subject)
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
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
4 - Applied Therapeutics Inc. (0001697532) (Issuer)
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
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 section of the Applied Therapeutics website at www.appliedtherapeutics.com. A replay of the webcast will be archived on the Company's website for 90 days following the event. Abou
- 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 announced an update on the ongoing New Drug Application (NDA) review of govorestat for the treatment of Classic Galactosemia. The Company recently completed its late-cycle review meeting with the United States Food
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: Presentation on Wednesday, September 18, 2024, at 10:20 a.m. ET in New York, NY. Live webcasts for the events will be accessible on the Events page under the Investor Relations secti
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; Expect to submit an NDA in early Q1 2025 NEW YORK, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT) (the "Company"), a clinical-stage biopha
NEW YORK, July 01, 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 was added to the Russell 3000® Index, effective after the U.S. market closed on June 28, 2024, as part of the 2024 Russell indexes annual reconstitution. "The addition of Applied to the Russell 3000® index underscores the progress we have made as a publicly traded company with a core mission of addressing diseases with no treatment options," said Shoshana Shendelman, PhD, Founder and CEO of Applied Therape
Govorestat NDA for Classic Galactosemia under Priority Review, PDUFA target action date of November 28, 2024 Govorestat MAA under review by EMA; Day 120 3-month clock-stop extension granted; decision expected in early Q1 2025Company discussing potential NDA submission under Accelerated Approval for govorestat for treatment of SORD Deficiency with Neurology I Division of FDA NEW YORK, May 09, 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 first qu
NEW YORK, May 07, 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 participate in a fireside chat at the 2024 RBC Capital Markets Global Healthcare Conference on Tuesday, May 14, 2024 at 4:35 p.m. ET in New York, New York. A live webcast for this event will be accessible on the Events page under the Investor Relations section of the Applied Therapeutics website at www.appliedtherapeutics.com. A replay of the webcast will be archived on the Company's website for 90 days followi
8-K - Applied Therapeutics, Inc. (0001697532) (Filer)
8-K - Applied Therapeutics, Inc. (0001697532) (Filer)
SCHEDULE 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)
8-K - Applied Therapeutics, Inc. (0001697532) (Filer)
8-K - Applied Therapeutics, Inc. (0001697532) (Filer)
10-Q - Applied Therapeutics, Inc. (0001697532) (Filer)
8-K - Applied Therapeutics, Inc. (0001697532) (Filer)
SCHEDULE 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)
10-Q - Applied Therapeutics, Inc. (0001697532) (Filer)
8-K - Applied Therapeutics, Inc. (0001697532) (Filer)
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
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4 - Applied Therapeutics, Inc. (0001697532) (Issuer)
4 - Applied Therapeutics, Inc. (0001697532) (Issuer)
4 - Applied Therapeutics, Inc. (0001697532) (Issuer)
4 - Applied Therapeutics, Inc. (0001697532) (Issuer)