Date | Price Target | Rating | Analyst |
---|---|---|---|
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 |
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
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
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
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10-Q - Applied Therapeutics, Inc. (0001697532) (Filer)
8-K - Applied Therapeutics, Inc. (0001697532) (Filer)
8-K - Applied Therapeutics, Inc. (0001697532) (Filer)
4 - Applied Therapeutics, Inc. (0001697532) (Issuer)
4 - Applied Therapeutics, Inc. (0001697532) (Issuer)
4 - Applied Therapeutics, Inc. (0001697532) (Issuer)
4 - Applied Therapeutics Inc. (0001697532) (Issuer)
RBC Capital analyst Brian Abrahams reiterates Applied Therapeutics (NASDAQ:APLT) with a Outperform and maintains $12 price target.
U.S. stock futures were mixed this morning, with the Nasdaq futures gaining around 40 points on Tuesday. Shares of CrossFirst Bankshares, Inc. (NASDAQ:CFB) fell sharply in today's pre-market trading following second-quarter results. CrossFirst Bankshares reported quarterly earnings of 37 cents per share, according to data from Benzinga Pro. CrossFirst Bankshares shares dipped 12.3% to $13.98 in the pre-market trading session. Here are some big stocks recording losses in today's pre-market trading session. Applied Therapeutics, Inc. (NASDAQ:APLT) fell 11.8% to $5.24 in pre-market trading after gaining 7% on Monday. Owens & Minor, Inc. (NYSE:OMI) dipped 10.6% to $12.35 in pr
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