Welcome to our dedicated page for Applied Therapeutics news (Ticker: APLT), a resource for investors and traders seeking the latest updates and insights on Applied Therapeutics stock.
Applied Therapeutics, Inc. (Nasdaq: APLT) is a clinical-stage biopharmaceutical company that regularly issues news about its progress in developing novel drug candidates for rare diseases. The company’s updates frequently focus on its lead drug candidate, govorestat (AT-007), a central nervous system penetrant Aldose Reductase Inhibitor (ARI) being developed for CNS rare metabolic diseases such as Classic Galactosemia, Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD), and phosphomannomutase 2 congenital disorder of glycosylation (PMM2-CDG).
On this APLT news page, readers can find company press releases covering clinical trial milestones, including detailed data from the INSPIRE Phase 2/3 and registrational Phase 3 trial of govorestat in CMT-SORD, investigator-initiated studies in PMM2-CDG, and regulatory interactions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These items often describe safety findings, sorbitol reduction, functional and patient-reported outcomes, and plans for potential New Drug Application (NDA) strategies.
News items also report on regulatory designations for govorestat, such as Orphan Drug, Orphan Medicinal Product, Rare Pediatric Disease, and Fast Track designations, as well as corporate developments like leadership appointments, workforce changes, cost-containment measures, and business development activities. Examples include the out-licensing of AT-001 for diabetic cardiomyopathy and partnership arrangements related to the company’s pipeline.
Another key category of APLT news involves strategic and capital markets events. Applied Therapeutics has announced a strategic review process, at-the-market equity offering agreements, Nasdaq listing and bid price notices, and, most notably, an Agreement and Plan of Merger with Cycle Group Holdings Limited. Updates related to the planned tender offer, contingent value rights (CVR) structure, and expected acquisition timeline are central topics for investors following APLT.
By reviewing the Applied Therapeutics news feed, investors and observers can track how the company describes its clinical, regulatory, financial, and strategic developments over time, and how these developments relate to the evolution of APLT stock and the proposed acquisition by Cycle.
Cycle Pharmaceuticals completed the acquisition of NASDAQ-listed Applied Therapeutics (APLT) on February 3, 2026.
The deal adds Applied’s lead clinical-stage candidate govorestat, an investigational CNS-penetrant Aldose Reductase Inhibitor targeting Classic Galactosemia, CMT-SORD and PMM2-CDG, rare metabolic diseases with no FDA-approved treatments. The transaction was funded from Cycle’s cash on hand.
Applied Therapeutics (Nasdaq: APLT) urged stockholders to tender shares after Cycle Group’s Purchaser extended its tender offer expiration to one minute after 11:59 p.m. ET on January 29, 2026.
The Offer is $0.088 cash per share plus one non-tradeable contingent value right. The Board unanimously recommends tendering, citing lack of better alternatives, an $8.5 million promissory note from Cycle at 24% interest that becomes due if the merger is terminated, and risks of liquidation or share-price decline if the Offer fails.
Applied Therapeutics (Nasdaq: APLT) agreed to be acquired by Cycle Group Holdings for $0.088 per share cash plus one non-transferrable contingent value right (CVR). The CVR can pay up to $0.10 for FDA approval in a galactosemia indication, $0.10 for FDA approval in CMT-SORD, and $0.20 upon first worldwide net sales ≥ $200M in any four-quarter period; CVR holders also share in a capped Closing Cash Payment tied to Applied cash above $500,000 (capped at $1.5M).
The tender offer is expected to close in Q1 2026; the merger has no financing condition. Applied received an unsecured promissory note enabling up to $8.5M in loans to fund working capital.
Applied Therapeutics (Nasdaq: APLT) announced that its Board has initiated a process to explore strategic alternatives including mergers, acquisitions, partnerships, licensing or other transactions to maximize shareholder value.
The Company said it reduced its workforce by approximately 46% and is implementing other cost‑containment and cash conservation measures to preserve runway. The Board completed a Type C meeting with the FDA on govorestat for CMT‑SORD in Q3 2025 and expects to request an additional Type C to discuss a potential Phase 3 design. The Company also accepted FDA written feedback on govorestat data for Classic Galactosemia and is evaluating next steps. No timetable or assurance of a transaction was provided.
Applied Therapeutics (Nasdaq: APLT) reported third quarter 2025 results and regulatory/clinical updates on Nov 13, 2025. Key corporate items include receipt of Type C meeting minutes from the FDA on govorestat for CMT-SORD, a scheduled FDA meeting in 4Q 2025 to review govorestat for classic galactosemia, and publication/presentation of single‑patient PMM2‑CDG data in JIMD and at ASHG.
Financial highlights: cash and cash equivalents $11.9M at Sept 30, 2025 (down from $79.4M at Dec 31, 2024), R&D $9.6M and G&A $8.2M for Q3 2025, and net loss $19.0M ($0.13/share) for Q3 2025. Board leadership transition: Executive Chairman John Johnson resigned in Nov 2025 for personal reasons.
Applied Therapeutics (NASDAQ:APLT) has completed a meeting with the FDA regarding the potential New Drug Application (NDA) for govorestat, targeting the treatment of Charcot-Marie-Tooth Sorbitol Dehydrogenase (CMT-SORD) Deficiency.
The company is currently awaiting official meeting minutes from the FDA to determine the next steps. No definitive path forward has been established yet regarding the potential submission strategy for regulatory approval, including under the accelerated approval pathway.
Applied Therapeutics (NASDAQ:APLT) reported Q2 2025 financial results and significant progress across its rare disease pipeline. The company's lead program, govorestat for CMT-SORD treatment, advances with an upcoming FDA meeting in Q3 2025 to discuss potential NDA submission. The company presented promising 24-month clinical data showing slowed disease progression and launched a sponsored Sorbitol Assay program for patient identification.
Financial highlights include cash position of $30.4M as of June 30, 2025, down from $79.4M in December 2024. Q2 2025 resulted in a net loss of $21.3M ($0.15 per share). The company secured an out-licensing agreement with Biossil for AT-001 and strengthened its leadership team with key promotions.