Repros Therapeutics Inc. (NASDAQ: RPRX) saw its shares take a loss on Wednesday after the company provided a key U.S. Food and Drug Administration (FDA) update. The company participated in the industry presentation at the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting on Tuesday, but the results was not favorable.
As we have said time and time again, FDA decisions and clinical trial updates have the potential to make or break companies in the biotech and pharmaceutical industries. 24/7 Wall St. has outlined 10 Major FDA Decisions and Catalysts Expected in December.
The panel provided the FDA with advice regarding a clinical and regulatory path to approval for products, such as enclomiphene, in subjects with obesity-related hypogonadism who wish to maintain spermatogenesis. However, the panel voted 16 to five that the achievement of testosterone improvement while maintaining evidence of spermatogenesis was not sufficient, in and of itself, to provide evidence of clinical benefit.
At the meeting, numerous panel members suggested that an additional endpoint related to symptoms should be assessed. Repros expects its ongoing diet and exercise study to provide useful information toward the development of a symptom-related assessment tool.
After completing this study and evaluating the data, Repros intends to meet with FDA to discuss the design of a definitive Phase 3 study that incorporates the advice of the committee.
Joe Podolski, president and CEO of Repros, commented:
We remain encouraged that the FDA and the Committee held the committee meeting, indicating a recognition of obesity-related hypogonadism. Further, we appreciate that there was a complete discussion on the condition and that the committee clarified a path forward.
Excluding Wednesday’s move, Repros has outperformed the broad markets, with the stock up about 57% year to date.
Shares of Repros were last seen down about 10% at $1.72 on Wednesday, with a consensus analyst price target of $5.25 and a 52-week trading range of $0.80 to $3.48.
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