GlobalData on MSN1d
Why pharma is still far from a treatment for galactosemia
With issues in therapy delivery and a barren trial landscape, short-term chances for a commercial galactosemia treatment are ...
pharmaphorum3d
Applied Therapeutics slumps as FDA seeks more data on lead drug
Applied Therapeutics has previously said it hoped to be able to file for accelerated FDA approval based on biomarker data showing that AT-007 was able to reduce levels of galactitol, the main ...
pharmaphorum7d
Applied Tx craters as FDA rejects lead product candidate
Shares in Applied Therapeutics have lost more than 80% of their value after the FDA turned down its marketing application for lead drug govorestat as a treatment for galactosaemia. The sell-off ...
Business Wire15d
Deadline Soon: Applied Therapeutics, Inc. (APLT) Investors Who Lost Money Urged to Contact The Law Offices of Frank R. Cruz About Securities Fraud Lawsuit
What Happened? On November 27, 2024, Applied Therapeutics disclosed that it had received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the ...
WOOD-TV19d
APLT CLASS ACTION NEWS: Applied Therapeutics has been Sued for Securities Fraud - Contact BFA Law by February 18 if you Suffered Losses
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 ...
INVESTOR DEADLINE TUESDAY: Applied Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit - APLT
February 14, 2025) - The law firm of Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Applied Therapeutics, Inc. (NASDAQ: APLT) securities between January 3, 2024 and ...
Morningstar1mon
Applied Therapeutics, Inc. Sued for Securities Law Violations – Investors Should Contact Levi & Korsinsky for More Information – APLT
After market hours on December 2, 2024, Applied Therapeutics disclosed it received a “warning letter” from the FDA referring to the clinical trial issues underlying the CRL. Applied ...
Business Wire26d
Applied Therapeutics, Inc. (APLT) Investors: February 18, 2025 Filing Deadline in Securities Class Action - Contact Kessler Topaz Meltzer & Check, LLP
CONTACT KESSLER TOPAZ MELTZER & CHECK, LLP: If you suffered Applied Therapeutics losses ... that the trial data would be rejected by the FDA in the context of a New Drug Application.
ophthalmologytimes1d
Outlook Therapeutics resubmits BLA for ONS-5010 for treatment of wet AMD
Outlook Therapeutics has re-submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) ...
Morningstar13d
APLT COURT NEWS: Applied Therapeutics has been Sued for Securities Fraud; Contact BFA Law by February 18 if You Lost Money (NASDAQ:APLT)
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 ...
Mena FN12d
INVESTOR DEADLINE TOMORROW: Applied Therapeutics, Inc. Investors With Substantial Losses Have Opportunity To Lead Class Action Lawsuit - APLT
The Applied Therapeutics class action lawsuit further alleges that on November 27, 2024, defendants revealed that the FDA issued a Complete Response Letter for the NDA for govorestat which ...