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Sep 30, 2021
Applied Therapeutics Q3 2021 Earnings Report
Reported positive data in both the Galactosemia pediatric study and pilot SORD Deficiency study, highlighting execution across programs and expansion into additional indications with AT-007.
Key Takeaways
Applied Therapeutics announced positive data from studies in Galactosemia and SORD Deficiency, and is preparing for a commercial launch in Galactosemia in 2022 and a registrational study in SORD later in 2021.
Announced positive data in the Galactosemia pediatric study.
Reported positive data in the pilot SORD Deficiency study.
Preparing for commercial launch in Galactosemia in 2022.
Focused on launching registrational study in SORD later in 2021.
Applied Therapeutics
Applied Therapeutics
Forward Guidance
The company plans to initiate a registrational study in SORD by the end of 2021 and anticipates a commercial launch in Galactosemia in 2022.
Positive Outlook
- Plan to initiate a registrational study in SORD by the end of 2021.
- Anticipated commercial launch in Galactosemia in 2022.
- AT-007 has the potential to be the first disease-modifying therapy for SORD Deficiency.
- Data from clinical trials will support future development of product candidates.
- Likelihood of obtaining regulatory approval of product candidates.
Challenges Ahead
- Plans to develop 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 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.