Profile
Sector:
HealthcareIndustry:
BiotechnologyCountry:
United StatesIPO:
14 May 2019Next earnings report:
08 November 2024Last dividends:
N/ANext dividends:
N/APrice
after hours | Fri, 01 Nov 2024 23:09:17 GMTDividend
Analysts recommendations
Institutional Ownership
APLT Latest News
Applied Therapeutics (APLT) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
Here is how Applied Therapeutics Inc. (APLT) and Cardinal Health (CAH) have performed compared to their sector so far this year.
Applied Therapeutics (APLT) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.
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 galactosemia and SORD deficiency, and its PDUFA for the former arrives at the end of November. With no AdCom, approval seems the likeliest outcome. Despite financial constraints, strong patient and HCP support suggest a successful commercial launch for govorestat, making Applied stock a “Buy” with expected valuation growth.
Applied Therapeutics stock surges 69% as the FDA says that no advisory committee meeting is required to discuss the govorestat NDA for classic galactosemia.
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, 2024, remains on track for the FDA to decide whether govorestat should be approved to treat patients with galactosemia. Pre-NDA meeting with FDA expected in 2nd half of 2024 to discuss possible administrative actions of NDA filing submission of govorestat for the treatment of patients with SORD deficiency.
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 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, with a PDUFA date set for November 2024. APLT holds $146.5 million in cash, ensuring a sufficient runway to FDA approval and initial product revenues by early 2025.
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 (APLT) surges 124% in a month due to encouraging updates from two separate developmental programs for govorestat to treat different rare neurological indications.
What type of business is Applied Therapeutics?
Applied Therapeutics, Inc. is a biopharmaceutical company that develops products for the treatment of cardiovascular diseases, galactosemia, and diabetic complications. Applied Therapeutics, Inc. was founded in 2016 with headquarters in New York, New York. The portfolio of Applied Therapeutics includes three main products: AT-007 - being developed for the treatment of galactosemia, a rare and destructive pediatric metabolic disorder. AT-001 - a product with broad systemic impact and peripheral nerve permeability, being developed for the treatment of diabetic cardiomyopathy and fatal heart fibrosis. AT-003 - intended for the treatment of diabetic retinopathy or DR. DR is an ophthalmic disease that occurs in patients with diabetes, its treatment is limited to the use of expensive biologics requiring intravitreal injection.
What sector is Applied Therapeutics in?
Applied Therapeutics is in the Healthcare sector
What industry is Applied Therapeutics in?
Applied Therapeutics is in the Biotechnology industry
What country is Applied Therapeutics from?
Applied Therapeutics is headquartered in United States
When did Applied Therapeutics go public?
Applied Therapeutics initial public offering (IPO) was on 14 May 2019
What is Applied Therapeutics website?
https://www.appliedtherapeutics.com
Is Applied Therapeutics in the S&P 500?
No, Applied Therapeutics is not included in the S&P 500 index
Is Applied Therapeutics in the NASDAQ 100?
No, Applied Therapeutics is not included in the NASDAQ 100 index
Is Applied Therapeutics in the Dow Jones?
No, Applied Therapeutics is not included in the Dow Jones index
When was Applied Therapeutics the previous earnings report?
No data
When does Applied Therapeutics earnings report?
The next expected earnings date for Applied Therapeutics is 08 November 2024