Repros Therapeutics Inc.’s RPRX shares touched a 52-week low of $1.18 on Dec 1 with the company announcing disappointing news that the FDA has issued a complete response letter (CRL) for its lead pipeline candidate, enclomiphene. The company was looking to get enclomiphene approved for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. Shares plunged 27.4% on the news.
Taking into account recent scientific developments, the FDA mentioned in the CRL that the design of the phase III studies that were conducted on enclomiphene is no longer sufficient to show clinical benefit. Therefore, the regulatory agency has asked the company to conduct an additional phase III study or studies on the candidate in order to get it approved for the target population. Moreover, the FDA raised concerns regarding study entry criteria, titration and bioanalytical method validation of the phase III program. Repros stated that it will coordinate with the agency regarding the path forward.
Considering that Repros has no approved product in its portfolio at the moment with enclomiphene being its lead pipeline candidate, the CRL on the candidate comes as a major blow for the company. Moreover, with the FDA requiring additional studies to be conducted, there could be a significant delay before enclomiphene enters the U.S. markets. Timely approval would have allowed the company to start generating sales as early as next year.
Apricus Confirms Plans for its Secondary Hypogonadism Drug
In response to the FDA serving a CRL to Repros, Apricus Biosciences, Inc. APRI, a California-based biopharmaceutical company developing a treatment for secondary hypogonadism, confirmed its regulatory and clinical strategy for fispemifene.
Fispemifene, a selective estrogen receptor modulator, is in a phase IIb proof-of-concept study for the treatment of sexual dysfunction in men with symptomatic secondary hypogonadism.
Apricus said that the study is being conducted in tandem with the protocol addressing the FDA's suggestions regarding the target patient population, clinical benefits which are both important and relevant to the target population and using symptom-based endpoints aimed at evaluating those specific benefits in the given population.
The company plans to report data from the study in the first quarter of 2016. Positive data would allow the company to file for approval in 2016.
Currently, both Repros and Apricus are Zacks Rank #2 (Buy) stocks. A couple of favorably ranked stocks in the health care sector are Achillion Pharmaceuticals, Inc. ACHN and Anika Therapeutics Inc. ANIK. Both hold a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment