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Dec 31, 2019
Aldeyra Q4 2019 Earnings Report
Aldeyra reported full-year financial results and provided updates on anticipated clinical milestones.
Key Takeaways
Aldeyra Therapeutics reported a net loss of $60.8 million for the year ended December 31, 2019. The company is strategically prioritizing late-stage ocular disease programs and expects to extend its cash runway through the end of 2021.
INVIGORATE Phase 3 Trial of Reproxalap in Allergic Conjunctivitis Expected to be Completed in Second Half of 2020.
Development plans for Reproxalap in Dry Eye Disease are pending FDA feedback, expected in the second half of 2020.
GUARD Phase 3 Trial of ADX-2191 in Proliferative Vitreoretinopathy Initiated.
Strategic Prioritization of Late-Stage Ocular Pipeline Expected to Extend Company’s Cash Runway Through the End of 2021.
Forward Guidance
Aldeyra expects to complete the INVIGORATE Phase 3 clinical trial of topical ocular reproxalap in the second half of 2020. Based on the achievement of symptom endpoints in two well-controlled clinical trials, Aldeyra plans to meet with the U.S. Food and Drug Administration (FDA) prior to initiating Part 2 of the RENEW Trial, and plans to provide an update on future development in dry eye disease following FDA feedback, expected in the second half of 2020.
Positive Outlook
- INVIGORATE Phase 3 Trial of Reproxalap in Allergic Conjunctivitis Expected to be Completed in Second Half of 2020
- Based on Achievement of Symptom Endpoint in Two Clinical Trials, Subsequent Development Plans for Reproxalap in Dry Eye Disease Pending FDA Feedback, Expected in the Second Half of 2020
- GUARD Phase 3 Trial of ADX-2191 in Proliferative Vitreoretinopathy Initiated
- Strategic Prioritization of Late-Stage Ocular Pipeline Expected to Extend Company’s Cash Runway Through the End of 2021
- Top-line results are expected in the second quarter of this year for ADX-629
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