Applied Therapeutics Stock Price, News & Analysis

Applied Therapeutics (Nasdaq: APLT) provided a regulatory update on govorestat for the treatment of Classic Galactosemia. The company completed its late-cycle review meeting with the FDA, which no longer intends to hold an Advisory Committee meeting. The FDA's review of the New Drug Application (NDA) continues as planned, with the PDUFA target action date set for November 28, 2024.

The FDA communicated that the Priority Review of the NDA is proceeding as scheduled, with alignment on post-marketing requirements expected in October 2024. Applied Therapeutics expressed satisfaction with the ongoing collaborative dialogue with the FDA and remains committed to bringing the first potential treatment to Classic Galactosemia patients.

Applied Therapeutics (Nasdaq: APLT), a clinical-stage biopharmaceutical company, has announced its participation in two upcoming investor conferences. The company will take part in:

• The Baird 2024 Global Healthcare Conference with a fireside chat on September 10, 2024, at 3:45 p.m. ET in New York, NY
• The 2024 Cantor Global Healthcare Conference with a presentation on September 18, 2024, at 10:20 a.m. ET in New York, NY

Live webcasts for both events will be available on the company's website under the Investor Relations section. Replays will be archived for 90 days following each event. Applied Therapeutics focuses on developing novel drug candidates for indications with high unmet medical needs.

Applied Therapeutics (Nasdaq: APLT) reported Q2 2024 financial results and provided updates on its drug candidate govorestat. Key highlights include:

1. FDA PDUFA target action date for govorestat in Classic Galactosemia: November 28, 2024
2. EMA decision expected in early Q1 2025
3. FDA Advisory Committee meeting tentatively scheduled for October 9, 2024
4. Planned NDA submission for govorestat in SORD Deficiency: early Q1 2025
5. Q2 2024 financials: $122.2 million cash and equivalents, $2.9 million net income ($0.02 per basic share)
6. Cash runway expected into 2026, potentially extended by Priority Review Voucher sale

Applied Therapeutics (Nasdaq: APLT) has been added to the Russell 3000® Index, effective after the U.S. market closed on June 28, 2024. This inclusion is part of the 2024 annual reconstitution of Russell indexes, which track the performance of the largest 3,000 U.S. stocks. This milestone highlights Applied Therapeutics' progress as a publicly traded company focused on developing novel drug candidates for diseases with high unmet medical needs.

CEO Shoshana Shendelman emphasized the significance of this addition, noting upcoming regulatory updates for their drug candidates, govorestat, for Classic Galactosemia and SORD Deficiency. The Russell 3000® Index is a key component of the global Russell indexes, used by investment managers and institutional investors to benchmark over $10 trillion in assets.

Applied Therapeutics, Inc. reported financial results for the first quarter of 2024, highlighting significant regulatory progress regarding the potential approval of govorestat for Classic Galactosemia in the US and EU. The Company also discussed a potential NDA submission for SORD Deficiency. Dale Hooks was appointed as Chief Commercial Officer, and full results from the Phase 3 ARISE-HF Study of AT-001 in Diabetic Cardiomyopathy were presented. Financially, the Company ended the quarter with $146.5 million in cash and cash equivalents, with a net loss of $83.9 million. The Company expects its cash to fund operations into 2026.

Applied Therapeutics, Inc. (Nasdaq: APLT) will participate in a fireside chat at the 2024 RBC Capital Markets Global Healthcare Conference on May 14, 2024. The company is a clinical-stage biopharmaceutical developing drug candidates for unmet medical needs.