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  • Pre-Market Surge For Applied Therapeutics (APLT) After Key Regulatory News

    Pre-Market Surge For Applied Therapeutics (APLT) After Key Regulatory News

    Shares of Applied Therapeutics, Inc. (NASDAQ: APLT) are experiencing notable gains during the pre-market session today. As of the latest check, APLT stock was trading at $6.61 on the US stock charts, about 42% higher from the previous close.

    Regulatory Progress for Govorestat

    A significant update on the New Drug Application (NDA) for govorestat, a medication intended to treat Classic Galactosemia, has been released by Applied Therapeutics. The US Food and Drug Administration and the firm wrapped up a late-cycle review meeting recently (FDA). The FDA said during this meeting that it would not be necessary to have the tentatively scheduled October 9, 2024, Advisory Committee meeting.

    The FDA attested that the NDA’s Priority Review is moving along according to schedule, with post-marketing requirements expected to be finalized by October 2024. November 28, 2024, is still the anticipated action date for the Prescription Drug User Fee Act (PDUFA).

    Continued Cooperation and Prospects

    Applied Therapeutics has engaged in continuous dialogue with the FDA throughout the NDA review process and remains committed to collaborating with the agency to potentially provide the first treatment for Classic Galactosemia patients. This progressive disease urgently requires new therapeutic options, and the potential approval of govorestat represents a transformative development for affected patients and their families.

    Applied Therapeutics’ dedication to the Classic Galactosemia community is evident through strategic commercial preparations, which include developing a robust patient access program, enhancing physician awareness, and fostering strong payor engagement.

    European Market Considerations

    Applied Therapeutics has submitted a Marketing Authorization Application (MAA) for govorestat to the European Medicines Agency (EMA) in addition to the FDA evaluation. The EMA’s Committee for Medicinal Products for Human Use is presently reviewing this application, which was validated in December 2023 (CHMP).

    Applied Therapeutics (APLT) expects an early 2025 judgment from the EMA, following a three-month extension granted in April 2024. The NDA and MAA submissions are underpinned by evidence of a significant reduction in galactitol levels, which correlates with improved clinical outcomes in pediatric patients and a favorable safety profile.

  • What Caused The APLT Stock To Rise Afterhours?

    What Caused The APLT Stock To Rise Afterhours?

    Applied Therapeutics Inc. (APLT) was up 4.32% in after-hours trading at $22.70. Regular session trading saw APLT stock decreased -12.15% or $3.00. APLT stock fluctuated between $21.6162 and $25.00 during trading. It was 0.21 million shares that changed hands on the day, exceeding the firm’s daily volume for the past 50 days, which was 0.1 million shares, and exceeding its average daily volume for the year to date, which is 0.12 million.

    APLT stock has gained -38.43% in the past 12 months, and it has lost -8.42% in the past week. APLT stock has lost -2.42% over the last six months, and it has increased 18.84% over the last three months. Stocks in APLT have returned -1.14% so far this year. After falling 12% in regular sessions and becoming part of Russell index, APLT stock recovered in extended trades.

    When did APLT become part of the index?

    Biopharmaceutical company Applied Therapeutics develops novel drug candidates for indications with a high unmet medical need against validated molecular targets. APLT’s lead compound candidate AT-007 is an Aldose Reductase Inhibitor (ARI) that targets metabolic diseases of the CNS including Galactosemia, SORD Deficiency, PMM2-CDG and other rare metabolic diseases.

    At the same time, APLT is developing AT-001, a novel potent ARI, for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal form of heart fibrosis. AT-003 will allow APLT in treatment for Diabetic retinopathy to cross the back of the eye when taken internally, in addition to novel dual PI3K inhibitors for the treatment of orphan oncology indications in preclinical development.

    A recent press release from Applied Therapeutics stated that it has joined Russell Microcap Index. After the market closed on June 25, 2021, the reconstituted index took effect and APLT stock added to that. As a member of the Russell Microcap Index, APLT is automatically included in the appropriate growth and value style indices for one year. According to FTSE Russell, market capitalization rankings and style attributes determine membership in its Russell indexes.

    Applied Therapeutics (APLT) announced that the US Food and Drug Administration (FDA) granted AT-007 Fast Track status for treatment of Galactosemia, a rare metabolic disease. APLT’s AT-007 is a systemically-permeable Aldose Reductase inhibitor in development for multiple rare metabolic diseases, including Galactosemia, SORD and PMM2-CDG.

    How APLT will benefit from Fast Track status?

    The Fast Track designation will help Applied Therapeutics (APLT) develop and review drugs for serious conditions that are unmet medically, meaning that its drugs will be available to patients sooner. Fast Track designation for APLT’s clinical programs means that FDA will be able to communicate with the company early and frequently during the regulatory review process.