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Sep 30, 2023
Applied Therapeutics Q3 2023 Earnings Report
Reported third quarter 2023 financial results and provided updates on regulatory submissions and clinical trial readouts.
Key Takeaways
Applied Therapeutics reported its third quarter 2023 financial results, highlighting progress in its late-stage pipeline and upcoming regulatory and clinical milestones. Key activities include the planned regulatory filings for govorestat for Classic Galactosemia and upcoming Phase 3 trial readouts for ARISE-HF and INSPIRE trials.
Regulatory submissions for govorestat (AT-007) for the treatment of Classic Galactosemia to US FDA and EMA are on track for 4Q 2023.
Phase 3 ARISE-HF Trial of AT-001 (caficrestat) in Diabetic Cardiomyopathy is on track for data readout in 4Q 2023.
Phase 3 INSPIRE Trial of AT-007 trial in Sorbitol Dehydrogenase (SORD) Deficiency is expected to readout in 1Q 2024.
The company is developing govorestat for CNS rare metabolic diseases and AT-001 for Diabetic Cardiomyopathy.
Forward Guidance
Applied Therapeutics anticipates key regulatory and clinical inflection points later this quarter and in early 2024.
Positive Outlook
- Timing of data readouts for ARISE-HF trial
- Timing of data readouts for INSPIRE trial
- Plans to submit an NDA for approval
- Plans to submit an MAA for approval
Challenges Ahead
- Plans to develop, market and commercialize product candidates
- The initiation, timing, progress and results of current and future preclinical studies and clinical trials and research and development programs
- Ability to take advantage of expedited regulatory pathways for any of product candidates
- Estimates regarding expenses, future revenue, capital requirements and needs for additional financing
- Ability to successfully acquire or license additional product candidates on reasonable terms and advance product candidates into, and successfully complete, clinical studies
Historical Earnings Impact
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Avg. Return Before/After Earnings
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