Earnings summaries and quarterly performance for Applied Therapeutics.
Executive leadership at Applied Therapeutics.
Board of directors at Applied Therapeutics.
Research analysts covering Applied Therapeutics.
Recent press releases and 8-K filings for APLT.
Applied Therapeutics to be Acquired by Cycle Pharmaceuticals
APLT
M&A
Takeover Bid
Debt Issuance
- Cycle Group Holdings Limited will acquire Applied Therapeutics, Inc. for $0.088 per share in cash plus one non-transferrable contingent value right (CVR).
- The CVR entitles holders to potential additional payments upon FDA approval for galactosemia and CMT-SORD indications, and if worldwide net sales of any product covered by the CVR exceed $200 million in any four-quarter fiscal period prior to the tenth anniversary of closing.
- CVR holders will also receive their pro rata share of Applied's cash exceeding $500,000, capped at $1.5 million, at closing.
- The transaction, unanimously approved by Applied's Board of Directors, is expected to close in the first quarter of 2026.
- Applied Therapeutics has issued a Promissory Note to Cycle for up to $8.5 million to fund working capital, as the company would otherwise be unable to continue operations for more than a limited number of days.
Dec 12, 2025, 2:37 AM
Applied Therapeutics to be Acquired by Cycle Group Holdings Limited
APLT
M&A
Takeover Bid
- Cycle Group Holdings Limited has entered into a definitive agreement to acquire Applied Therapeutics, Inc..
- Under the merger agreement, shareholders will receive $0.088 per share in cash plus one non-transferrable contingent value right (CVR).
- The CVR offers potential additional payments, including up to $0.10 for FDA approval of a galactosemia indication, up to $0.10 for FDA approval of a CMT-SORD indication, and up to $0.20 upon achieving $200 million in worldwide net sales.
- The transaction is expected to close in the first quarter of 2026.
- Applied Therapeutics has also issued a Promissory Note to Cycle, enabling it to receive loans aggregating up to $8.5 million for working capital needs.
Dec 11, 2025, 10:25 PM
Applied Therapeutics, Inc. announces strategic review and 46% workforce reduction
APLT
M&A
Layoffs
- Applied Therapeutics, Inc. has initiated a comprehensive review of strategic alternatives aimed at maximizing shareholder value, which may include mergers, acquisitions, partnerships, joint ventures, licensing arrangements, or other strategic transactions.
- In connection with this strategic evaluation, the company is implementing a workforce reduction of approximately 46%, alongside other cost-containment and cash conservation measures. This reduction is expected to be substantially completed by the end of the quarter ending December 31, 2025.
- The company provided regulatory updates on its lead drug candidate, govorestat, noting the completion of a Type C meeting with the FDA for Charcot-Marie-Tooth Sorbitol Dehydrogenase (CMT-SORD) in Q3 2025 and the receipt of written feedback from the FDA for Classic Galactosemia, with plans for further discussions regarding potential Phase 3 trial designs.
Nov 20, 2025, 1:04 PM
Applied Therapeutics Reports Q3 2025 Financial Results and Board Leadership Transition
APLT
Earnings
Board Change
- Applied Therapeutics, Inc. reported a net loss of $19.0 million, or $0.13 per basic and diluted common share, for the third quarter ended September 30, 2025, compared to a net loss of $68.6 million, or $0.48 per share, for the same period in 2024.
- Cash and cash equivalents totaled $11.9 million as of September 30, 2025, a decrease from $79.4 million at December 31, 2024.
- The company received official meeting minutes from the FDA regarding govorestat for CMT-SORD and intends to submit a request for an additional Type C meeting to further discuss a potential Phase 3 trial design.
- A meeting is scheduled with the FDA in the fourth quarter of 2025 to discuss govorestat for Classic Galactosemia, following a Complete Response Letter and warning letter issued in November 2024.
- John H. Johnson resigned as Executive Chairman of the Board and as a director, effective November 9, 2025.
Nov 13, 2025, 12:11 PM
Applied Therapeutics Reports Third Quarter 2025 Financial Results and Regulatory Updates
APLT
Earnings
Board Change
- Applied Therapeutics reported a net loss of $19.0 million, or $0.13 per basic and diluted common share, for the third quarter ended September 30, 2025, compared to a net loss of $68.6 million, or $0.48 per share, for the same period in 2024.
- Cash and cash equivalents decreased to $11.9 million as of September 30, 2025, from $79.4 million at December 31, 2024.
- The company received Type C meeting minutes from the FDA regarding govorestat for CMT-SORD and plans to request an additional Type C meeting to further discuss a potential Phase 3 trial design.
- A meeting with the FDA is scheduled for Q4 2025 to discuss the regulatory path forward for govorestat for Classic Galactosemia, following a Complete Response Letter and warning letter issued in November 2024.
Nov 13, 2025, 12:00 PM
Applied Therapeutics Provides Update on Govorestat FDA Meeting
APLT
Product Launch
New Projects/Investments
- Applied Therapeutics, Inc. (APLT) completed a meeting with the U.S. Food and Drug Administration (FDA) in the third quarter of 2025 to discuss the potential New Drug Application (NDA) submission for govorestat for the treatment of Charcot-Marie-Tooth Sorbitol Dehydrogenase (SORD) Deficiency (CMT-SORD).
- The company is awaiting official meeting minutes from the FDA to determine the next steps regarding a potential submission strategy for regulatory approval.
- At this time, a definitive path forward, including under the accelerated approval pathway, has not yet been determined.
- Govorestat has received Orphan Drug Designation from the FDA for CMT-SORD, a rare disease affecting approximately 3,300 patients in the U.S. and 4,000 patients in the EU.
Sep 29, 2025, 11:00 AM
ABLi Therapeutics to Present Final Risvodetinib Trial Results
APLT
New Projects/Investments
- ABLi Therapeutics will present final results from its 201 Trial evaluating risvodetinib in untreated Parkinson's disease (PD) as a "Clinical Breakthrough Lecture" on October 8, 2025, at the International Congress of Parkinson's Disease and Movement Disorders.
- The 201 Trial, which involved 126 participants, was the first long-term dosing trial of risvodetinib as a monotherapy in untreated PD, and the presentation will cover primary, secondary, and exploratory endpoint analysis, including the effect on underlying PD pathology.
- Risvodetinib is described as a disease-modifying therapy designed to halt disease progression and reverse functional loss in Parkinson's disease, with intellectual property protection extending beyond 2036.
- It was recently the first monotherapy shown to improve patient quality of life and reduce underlying synuclein aggregate pathology in a randomized, placebo-controlled clinical trial.
Sep 15, 2025, 12:28 PM
Applied Therapeutics Establishes $75 Million At-The-Market Offering
APLT
- Applied Therapeutics, Inc. entered into a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co. on August 29, 2025.
- This agreement allows the company to offer and sell up to $75,000,000 in common stock through "at the market" offerings.
- Cantor Fitzgerald & Co. will receive a commission of 3.0% of the aggregate gross proceeds from any shares sold.
- Concurrently, the company terminated its previous sales agreement with Leerink Partners LLC, effective August 29, 2025.
- Under the terminated Leerink Partners Sales Agreement, from August 11, 2023, to August 29, 2025, Applied Therapeutics, Inc. sold 20,615,976 shares for net proceeds of approximately $49.3 million.
Aug 29, 2025, 8:08 PM
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