SEC Form 10-Q filed by Applied Therapeutics Inc.
$APLT
Biotechnology: Pharmaceutical Preparations
Health Care
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| 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 |
8-K - Applied Therapeutics, Inc. (0001697532) (Filer)
8-K - Applied Therapeutics, Inc. (0001697532) (Filer)
SCHEDULE 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)
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
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
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
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
4 - Applied Therapeutics, Inc. (0001697532) (Issuer)
4 - Applied Therapeutics, Inc. (0001697532) (Issuer)
3 - Applied Therapeutics, Inc. (0001697532) (Issuer)
SC 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)
SC 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)
SC 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)
4 - Applied Therapeutics Inc. (0001697532) (Issuer)