What is the Lawsuit About?
Applied Therapeutics is a clinical-stage biopharmaceutical company specializing in the development of novel drug candidates against validated molecular targets in rare diseases. The Company's lead drug candidate, govorestat, is a central nervous system penetrant Aldose Reductase Inhibitor for the treatment of CNS rare metabolic diseases, including Galactosemia.
During the relevant period, the Company stated that its New Drug Applications submitted to regulators for govorestat were“supported by rapid and sustained reduction in galactitol, which resulted in a meaningful benefit on clinical outcomes across pediatric patients, alongside a favorable safety profile.” Applied Therapeutics also assured investors that its tests were“performed properly” and that the Company“felt good about the quality of the data,” stating that it“took really extensive steps” and“actually videotaped” and had“master trainers” review all of the performances of the 10-meter walk-run test-the primary endpoint of the Company's Phase III INSPIRE study for govorestat.
The Stock Declines as the Truth is Revealed
On November 27, 2024, Applied Therapeutics issued a press release stating that the FDA issued a Complete Response Letter for the NDA for govorestat. The Complete Response Letter stated that the FDA completed its review of the application and determined that it was unable to approve the NDA due to“deficiencies in the clinical application.”
This news caused the price of Applied Therapeutics stock to fall more than 80% over the course of multiple trading days, from a closing price of $10.21 per share on November 26, 2024 to a closing price of $1.75 per share on December 2, 2024.
Then, on December 2, 2024, Applied Therapeutics revealed that it received a warning letter from the FDA relating to its govorestat study discussing“issues related to electronic data capture” and“a dosing error in the dose-escalation phase of the study resulting in slightly lower levels than targeted in a limited number of patients[.]”
This news caused the price of Applied Therapeutics stock to fall more than 26% over the course of multiple trading days, from a closing price of $1.75 per share on December 2, 2024 to a closing price of $1.29 per share on December 5, 2024.
Click here for more information: .
What Can You Do?
If you invested in Applied Therapeutics you may have legal options and are encouraged to submit your information to the firm.
All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses.
Submit your information by visiting:
Or contact:
Ross Shikowitz
...
212-789-3619
Why Bleichmar Fonti & Auld LLP?
Bleichmar Fonti & Auld LLP is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs' Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.'s Board of Directors (pending court approval), as well as $420 million from Teva Pharmaceutical Ind. Ltd.
For more information about BFA and its attorneys, please visit .
Attorney advertising. Past results do not guarantee future outcomes.
MENAFN01012025004107003653ID1109046768
GlobeNewsWire - Nasdaq
Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.
Tags
Label
Comments
No comment
Category
Date
1/1/2025
Most popular stories
Poland Assumes EU Council Presidency With Focus On Security...
Poland Assumes EU Council Presidency With Focus On Security...
When Will Rigetti And These Two Stock Rally End?...
When Will Rigetti And These Two Stock Rally End?...
Dubai: Is It Time To Shift From Gold To Diamonds? Changing Jewellery T...
Dubai: Is It Time To Shift From Gold To Diamonds? Changing Jewellery T...
Dubai: Gold Prices Jump In Early Trade On New Year, Set To Stay High I...
Dubai: Gold Prices Jump In Early Trade On New Year, Set To Stay High I...
'Bruce Lee Of Afghanistan' Dreams Visting Hong Kong, Performing In Mov...
'Bruce Lee Of Afghanistan' Dreams Visting Hong Kong, Performing In Mov...
M&M 11Th Most Valuable Automobile Manufacturer In World: Anand Mahindr...
M&M 11Th Most Valuable Automobile Manufacturer In World: Anand Mahindr...
Market Research
Market Research
Manuka Honey Market Report 2024, Industry Growth, Size, Share, Top Compan...
Modular Kitchen Market 2024, Industry Growth, Share, Size, Key Players An...
Acrylamide Production Cost Analysis Report: A Comprehensive Assessment Of...
Fish Sauce Market 2024, Industry Trends, Growth, Demand And Analysis Repo...
Australia Foreign Exchange Market Size, Growth, Industry Demand And Forec...
Cold Pressed Oil Market Trends 2024, Leading Companies Share, Size And Fo...
Pasta Sauce Market 2024, Industry Growth, Share, Size, Key Players Analys...
News 
Market Data 
Discover 
lol
AI
