Why Repros Therapeutics, Inc. Shares Soared

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of Repros Therapeutics (NASDAQ: RPRX  ) , a clinical-stage biopharmaceutical company focused on therapies to treat hormonal and reproductive system disorders, rallied as much as 23% after meeting with the Food and Drug Administration and discussing the future of its testosterone drug Androxal for secondary hypogonadism.

So what: According to Repros' press release, it expects to submit its new drug application for Androxal prior to the end of 2014. Furthermore, the company notes that "no additional safety assessments are currently planned prior to NDA submission." The press release also points out that the FDA has requested additional info regarding endpoints that Repros will use to confirm the maintenance of fertility by semen assessments in two ongoing studies, and that it'll supply these endpoints while enrollment is ongoing.

Now what: Long story short, the reason Repros is roaring higher relates to the FDA's original implication in October that it may need to run a year's worth of safety data on the highest dose of Androxal, causing it to delay its NDA filing. With the need for additional safety studies now on the backburner, and the company able to provide endpoint data to the FDA while concurrently completing enrollment in the aforementioned two studies, the timeline for Androxal's possible approval just got bumped forward. Admittedly, the testosterone drug market is flooded with competitors, but most peak sales estimates project that Androxal could bring in $400 million-$475 million annually. With Repros only valued at $420 million after today's pop (at the time of this writing), an eventual approval could still leave the company with significant upside.

Repros shares are soaring today, but they'll be hard-pressed to keep pace with this top stock in 2014
There's a huge difference between a good stock and a stock that can make you rich. The Motley Fool's chief investment officer has selected his No. 1 stock for 2014, and it's one of those stocks that could make you rich. You can find out which stock it is in the special free report "The Motley Fool's Top Stock for 2014." Just click here to access the report and find out the name of this under-the-radar company.


Read/Post Comments (0) | Recommend This Article (0)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2827375, ~/Articles/ArticleHandler.aspx, 10/21/2014 4:58:15 AM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...


Advertisement