Reata Pharmaceuticals ( NASDAQ: RETA ) stock rose ~15% on Tuesday after the company said in its Q3 results that it plans to submit an application to the European Medicines Agency (EMA) this year for omaveloxolone to treat Friedreich's Ataxia.
In addition, the company said it recently completed a Late-Cycle Meeting with the U.S. FDA regarding omaveloxolone, which is currently under review with an expected action date of Feb. 28, 2023. In October, the FDA had informed the company that it was not planning to hold an advisory committee meeting for the review.
Reata said in its Q3 earnings release that the FDA made no request for additional data or analyses but noted that additional data may be requested as reviews are ongoing. The FDA also confirmed that no information requests were outstanding.
The company added that the FDA said that no issues related to risk management were identified to date and the U.S. drug regulator indicated that post-marketing requirements and label review were ongoing.
With respect to post-marketing requirements and commitments, FDA added that if omaveloxolone is approved, they expect a drug-drug interaction trial with CYP3A4 modulators, a thorough QT trial, and an evaluation of pregnancy outcomes, the company noted.
Reata said that with respect to label review, during the meeting it said that the original proposed label language did not reflect the data and analyses included in the amendments to the NDA. The company has committed to submit the updated proposed label language to the NDA.
The FDA indicated that post-marketing requirements and label comments will be communicated in early 2023.
The company noted that it has advanced its commercial launch preparations in the U.S. and was building the infrastructure to support commercialization of omaveloxolone, if approved for Friedreich’s ataxia.
Friedreich's ataxia is a genetic, progressive, neurodegenerative movement disorder, which includes symptoms such as difficulty in walking, fatigue, changes in sensation, and slowed speech, among others.
Q3 results : Q3 non-GAAP net loss was -$53.9M, compared to -$46.2M in Q3 2021.
Non-GAAP R&D expenses were $36.8M, compared to $34M in Q3 2021.
The company reaffirms that its existing cash and cash equivalents and marketable debt securities will be sufficient to fund operations through the end of 2024.
For further details see:
Reata rises 15% as omaveloxolone moves ahead in FDA review process; plans EU filing