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