Applied Therapeutics, Inc. (APLT)
| Market Cap | 1.10B |
| Revenue (ttm) | -212,000 |
| Net Income (ttm) | -187.31M |
| Shares Out | 116.36M |
| EPS (ttm) | -1.43 |
| PE Ratio | n/a |
| Forward PE | n/a |
| Dividend | n/a |
| Ex-Dividend Date | n/a |
| Volume | 1,377,067 |
| Open | 8.99 |
| Previous Close | 8.93 |
| Day's Range | 8.82 - 9.86 |
| 52-Week Range | 1.79 - 10.62 |
| Beta | 2.02 |
| Analysts | Strong Buy |
| Price Target | 12.50 (+32.56%) |
| Earnings Date | Nov 7, 2024 |
About APLT
Applied Therapeutics, Inc., a clinical-stage biopharmaceutical company, engages in the development of a pipeline of novel product candidates against validated molecular targets in indications of high unmet medical need in the United States. The company’s lead product candidate is AT-007 (also called govorestat) that has completed phase 3 for the treatment of galactosemia in healthy volunteers and adults, in pediatric clinical study for the treatment of galactosemia in kids, for treating enzyme sorbitol dehydrogenase, and for the treatment of ph... [Read more]
Financial Performance
Financial StatementsAnalyst Forecast
According to 5 analysts, the average rating for APLT stock is "Strong Buy." The 12-month stock price forecast is $12.5, which is an increase of 32.56% from the latest price.
News
Applied Therapeutics: AdCom Decision Takes Govorestat Approval A Step Closer
Applied Therapeutics, Inc.'s stock surged nearly 70% yesterday after the news that the FDA will not hold an AdCom to discuss approval of AT-007 in galactosemia. AT-007 has shown clinical benefits in g...
Applied Therapeutics: FDA Stance Change For Advisory Panel Bodes Well For Review
FDA removes the need for an advisory panel to first give a recommendation review of Applied Therapeutics, Inc.'s govorestat for the treatment of patients with galactosemia. PDUFA date of November 28th...
Rare Disease-Focused Applied Therapeutics' Lead Candidate Govorestat Has Blockbuster Potential, Analyst Sees 140% Stock Upside
William Blair initiated coverage on Applied Therapeutics Inc. APLT, a late-stage development company focused on rare diseases such as galactosemia, SORD deficiency, and diabetic cardiomyopathy.
Applied Therapeutics Added to Russell 3000® Index
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 molec...
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Applied Therapeutics: A Strong Buy With AT-007 Nearing Approval For Galactosemia
Applied Therapeutics is a clinical-stage biotech focused on treating symptoms of galactosemia in the central nervous system. Govorestat (AT-007) is in late-stage regulatory approval for galactosemia, ...
Applied Therapeutics Reports First Quarter 2024 Financial Results
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 ...
Applied Therapeutics Appoints Dale Hooks as Chief Commercial Officer
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 mole...
US FDA extends review of Applied Therapeutics' genetic disease drug
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.
Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic Galactosemia
NEW YORK, March 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated mole...
Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results
NEW YORK, March 06, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates agains...
Applied Therapeutics Announces $100 Million Private Placement
Financing includes significant participation from a number of large healthcare dedicated institutional and mutual fund investors
Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemia
PDUFA target action date of August 28, 2024 MAA validated and accepted for review by EMA in December 2023 NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clini...
Applied Therapeutics: Speedy Regulatory Review Of Govorestat Might Be Possible
Positive 12-month interim results from the phase 3 INSPIRE study using govorestat for the treatment of patients with SORD deficiency achieved. Pre-NDA meeting with FDA to be sought out after to see if...
Applied Therapeutics Announces Topline Results from the ARISE-HF Phase 3 Study of AT-001 in Diabetic Cardiomyopathy
AT-001 (caficrestat) demonstrated a strong trend in stabilizing cardiac functional capacity, while the placebo group declined over 15 months
Applied Therapeutics: Multiple Inflection Points Could Generate Substantial Value
EMA validated and accepted the regulatory application of govorestat for the treatment of patients with galactosemia; the FDA has a 60-day review period to look at the application for validation and ac...
Applied Therapeutics Reports Third Quarter 2023 Financial Results
Regulatory submissions on track for govorestat (AT-007) for the treatment of Classic Galactosemia to US FDA and EMA in 4Q 2023
Applied Therapeutics to Host Diabetic Cardiomyopathy Expert Forum with Key Opinion Leaders on Tuesday, November 7
Forum to be Webcast Live Topline Phase 3 Data Readout from ARISE-HF Trial of AT-001 (caficrestat) in Diabetic Cardiomyopathy On Track for 4Q 2023 NEW YORK, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Applied Th...
Applied Therapeutics to Present Baseline Data from Phase 3 ARISE-HF Study Evaluating AT-001 at the 2023 EASD Annual Meeting
The ongoing ARISE-HF Phase 3 global clinical trial is evaluating the efficacy of AT-001 (caficrestat) on cardiac functional capacity in patients with diabetic cardiomyopathy (DbCM) Baseline data from ...
Applied Therapeutics Announces Successful Pre-NDA Meeting with the FDA and Confirms Plans to Submit NDA for Govorestat (AT-007) for Treatment of Classic Galactosemia to FDA in Q4 2023
NEW YORK, Sept. 06, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated mole...
Applied Therapeutics: Buy For Upcoming Pre-NDA Meeting (I Expect A Positive Outcome)
Applied Therapeutics is a micro-cap with low cash balance, but has major upcoming catalysts (pre-NDA meeting for galactosemia and phase 3 results in diabetic cardiomyopathy) and a huge upside potentia...
Applied Therapeutics Reports Second Quarter 2023 Financial Results
Regulatory progress for govorestat (AT-007) for the treatment of Classic Galactosemia, with potential NDA submission based on discussions with the FDA as well as EMA Marketing Authorization Applicatio...
Applied Therapeutics to Present Baseline Data on the Phase 3 ARISE-HF Study in Diabetic Cardiomyopathy at the 2023 Annual Meeting of the American Diabetes Association
NEW YORK, June 22, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molec...
Govorestat (AT-007) Receives Orphan Medicinal Product Designation from the EMA for Treatment of SORD Deficiency
NEW YORK, May 25, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecu...
Applied Therapeutics Reports First Quarter 2023 Financial Results
Demonstrated Long-term Clinical Benefit of Govorestat in ACTION-Galactosemia Kids Trial Strengthened Balance Sheet with $30 Million Private Placement of Equity Phase 3 INSPIRE Trial of Govorestat in S...