Applied Therapeutics, Inc.

Equities

APLT

US03828A1016

Biotechnology & Medical Research

Market Closed - Nasdaq Other stock markets 04:00:00 2024-04-26 pm EDT			5-day change	1st Jan Change
4.28 ^USD	+1.18%		-2.28%	+27.76%

Apr. 15	Applied Therapeutics, Inc. Announces Management Changes	CI
Mar. 28	Applied Therapeutics Shares Slip 13% After FDA Extends Drug Review	DJ

US FDA extends review of Applied Therapeutics' genetic disease drug

March 28, 2024 at 04:42 pm EDT

March 28 (Reuters) - The U.S. Food and Drug Administration has extended its review of Applied Therapeutics' experimental drug to treat galactosemia, a rare genetic metabolic disease, the company said on Thursday.

The health regulator will now give its decision by Nov. 28, 2024, compared with its previous action date of Aug. 28. (Reporting by Mariam Sunny in Bengaluru; Editing by Krishna Chandra Eluri)

Latest news about Applied Therapeutics, Inc.

Applied Therapeutics, Inc. Announces Management Changes	Apr. 15	CI
Applied Therapeutics Shares Slip 13% After FDA Extends Drug Review	Mar. 28	DJ
FDA Extends Review Period for Applied Therapeutics Genetic Disease Treatment	Mar. 28	DJ
Applied Therapeutics Gets NDA Review Period Extension for Galactosemia Treatment -- Shares Fall After Hours	Mar. 28	MT
US FDA extends review of Applied Therapeutics' genetic disease drug	Mar. 28	RE
Applied Therapeutics, Inc. Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia	Mar. 28	CI
RBC Initiates Applied Therapeutics at Outperform, Speculative Risk With $12 Price Target, Sees Lead Drug Govorestat 'Well-Positioned for Success'	Mar. 26	MT
UBS Adjusts Applied Therapeutics Price Target to $13 From $12, Maintains Buy Rating	Mar. 15	MT
UBS Adjusts Applied Therapeutics Price Target to $12 From $4, Maintains Buy Rating	Mar. 06	MT
Applied Therapeutics, Inc. Reports Earnings Results for the Full Year Ended December 31, 2023	Mar. 06	CI
Earnings Flash (APLT) APPLIED THERAPEUTICS Reports Q4 Revenue $10M	Mar. 06	MT
Applied Therapeutics, Inc. announced that it has received $99.997998 million in funding from a group of investors	Feb. 29	CI
Applied Therapeutics' NDA for Govorestat Accepted by FDA; Launches $100 Million Private Placement; Shares Jump	Feb. 28	MT
Applied Therapeutics Shares Surge on FDA Review, $100 Million Funding Round	Feb. 28	DJ
Leerink Partners Initiates Applied Therapeutics at Outperform Rating $12 Price Target	Feb. 22	MT
Sector Update: Health Care Stocks Higher Late Afternoon	Feb. 16	MT
Sector Update: Health Care	Feb. 16	MT
Applied Therapeutics Says Phase 3 Trial of Govorestat Meets Interim Primary Goal; Shares Rise	Feb. 16	MT
Transcript : Applied Therapeutics, Inc. - Special Call	Feb. 15
Applied Therapeutics, Inc. Announces Positive Interim 12-Month Results from the Ongoing Phase 3 Inspire Trial	Feb. 15	CI
Applied Therapeutics, Inc. Announces Positive Results from 12-Month Interim Analysis of Govorestat (At-007) in the Ongoing Inspire Phase 3 Trial in Sorbitol Dehydrogenase Deficiency	Feb. 15	CI
Wall Street ends topsy-turvy day marginally up	Jan. 05	RE
Top MIdday Decliners	Jan. 05	MT
S&P 500, Nasdaq climb as fresh data boosts rate-cut bets again	Jan. 05	RE
Global markets live: Walt Disney, Qiagen, Mobileye, Apple, CVS Health...	Jan. 05

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Company Profile

Applied Therapeutics, Inc. is a clinical-stage biopharmaceutical company. It is focused on developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. The Companyâs lead drug candidate, govorestat, is a novel central nervous system penetrant Aldose Reductase Inhibitor (ARI) for the treatment of central nervous system (CNS) rare metabolic diseases, including Galactosemia, Sorbitol Dehydrogenase (SORD) Deficiency, and PMM2-CDG. The Company is also developing AT-001, a novel potent ARI, for the treatment of Diabetic Cardiomyopathy (DbCM) a fatal fibrosis of the heart. It has completed a Phase I/II clinical trial evaluating AT-001 in approximately 120 patients with type 2 diabetes, in which no drug-related adverse effects or tolerability issues were observed. The preclinical pipeline also includes AT-003, an ARI designed to cross through the back of the eye when dosed orally, for the treatment of Diabetic retinopathy.

Sector

Biotechnology & Medical Research

Calendar

2024-05-08 - Q1 2024 Earnings Release (Projected)

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Ratings for Applied Therapeutics, Inc.

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ESG Refinitiv

C-

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Analysts' Consensus

Sell

Buy

Mean consensus

BUY

Number of Analysts

Last Close Price

4.28 USD

Average target price

11.6 USD

Spread / Average Target

+171.03%

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Company calendar

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