Applied Therapeutics Stock Price, News & Analysis

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.

Applied Therapeutics (NASDAQ: APLT) has announced key leadership changes with the promotion of Dr. Evan Bailey to Chief Medical Officer (CMO) and Dottie Caplan to Executive Vice President of Patient Advocacy and Government Affairs. Dr. Bailey, previously SVP of Clinical Development, succeeds Dr. Riccardo Perfetti and will lead clinical development and medical affairs activities for govorestat in late-stage development programs. Dr. Bailey brings extensive experience from Vertex Pharmaceuticals, where he led the TRIKAFTA launch for Cystic Fibrosis. Dottie Caplan, formerly SVP of Patient Advocacy and Engagement, will expand her role to include regulatory, legislative, and public policy functions. Both appointments are strategic moves to advance Applied's rare disease treatment portfolio, particularly focusing on govorestat's development for Classic Galactosemia, CMT-SORD, and PMM2-CDG.

Applied Therapeutics (NASDAQ: APLT) presented full 12-month clinical results and new topline data from the INSPIRE Phase 2/3 trial of govorestat for treating CMT-SORD, a rare neuromuscular disease. While the primary endpoint of 10MWRT at 12 months wasn't statistically significant, the study showed significant correlation between sorbitol reduction and improvements in mobility measures. Key findings include: statistically significant improvement in CMT-Health Index, sustained sorbitol reduction through 24 months, and MRI evidence of slowed disease progression at 24 months. The drug remained generally safe and well-tolerated, with 90% of remaining patients continuing treatment in the open-label extension study. The company plans to pursue NDA submission in 2025.

Applied Therapeutics (APLT) reported Q1 2025 financial results and provided updates on its govorestat development programs. The company will present full 12-month clinical data and new topline 18-month and 24-month data from the INSPIRE Phase 3 trial for CMT-SORD Deficiency at the PNS 2025 Annual Meeting. Financial highlights include: cash position of $50.8M (down from $79.4M in Dec 2024), reduced R&D expenses of $7.8M (vs $12.2M in Q1 2024), increased G&A expenses of $17.7M (vs $9.1M), and a net loss of $21.8M ($0.15 per share). The company continues to evaluate its response to the FDA's Complete Response Letter for govorestat in Classic Galactosemia and is working to understand regulatory requirements for potential accelerated approval in CMT-SORD Deficiency.

Applied Therapeutics (NASDAQ: APLT) announced that full 12-month clinical data from the INSPIRE Phase 3 trial of govorestat (AT-007) has been accepted for a late-breaking oral presentation at the Peripheral Nerve Society (PNS) 2025 Annual Meeting in Edinburgh, Scotland. The presentation will also include new topline 18-month and 24-month data from patients before their transition to the open-label extension study.

The INSPIRE Phase 3 trial was a double-blind, placebo-controlled registrational study evaluating govorestat's effect in patients with Sorbitol Dehydrogenase (SORD) Deficiency, a subtype of Charcot-Marie-Tooth (CMT) disease. The company previously released topline results from the 12-month group-level data analysis in February 2024.

Applied Therapeutics (NASDAQ: APLT) reported its Q4 and full-year 2024 financial results, highlighting key leadership appointments and program developments. The company ended 2024 with $79.4 million in cash, up from $49.9 million in 2023.

Financial metrics show a net loss of $105.6 million ($0.76 per share) for 2024, compared to $119.8 million ($1.42 per share) in 2023. R&D expenses decreased to $48.7 million from $53.9 million, while G&A expenses increased to $56.0 million from $20.6 million.

The company is evaluating its response to the FDA's Complete Response Letter for govorestat in Classic Galactosemia treatment and continues developing the drug for SORD Deficiency. Recent appointments include John H. Johnson as Executive Chairman, Les Funtleyder as Interim CEO, Todd F. Baumgartner as Chief Regulatory Officer, and Reena Thomas Colacot as VP of Quality.