Back to top

Image: Bigstock

Repros to Meet with the FDA for Phase III Proellex Program

Read MoreHide Full Article

Repros Therapeutics Inc. (RPRX - Free Report) announced that it has requested a meeting with the FDA to discuss requirements for the phase III development of its pipeline candidate, Proellex, for the treatment of symptomatic uterine fibroids.

A look at Repros’ year-to-date share price movement shows that the stock has outperformed the Zacks classified Medical-Biomedical/Genetics industry. In fact, the stock has gained 22.3% so far this year, remarkably outperforming the 26% fall for the industry.



Coming back to the latest news, the company anticipates the meeting to take place during the first half of 2017.

Currently, Repros has completed phase II studies on both oral and vaginal delivery on Proellex. In the efficacy studies, Proellex has consistently exhibited clinically and statistically significant reduction of excessive menstrual bleeding due to the presence of uterine fibroids. The company is now proposing further development of the oral form of the candidate.

Meanwhile, Proellex is also being evaluated for the treatment of endometriosis.

Note that there is currently no FDA-approved oral drug for the long-term treatment of uterine fibroids or endometriosis. If successfully developed and commercialized, Proellex could prove to be a breakthrough treatment, catering to a huge population of women.

With no approved product in its portfolio at the moment, investor focus will remain on pipeline updates by the company. Repros’ pipeline presently comprises enclomiphene and Proellex.

Enclomiphene is currently under review in the EU for the treatment of patients with secondary hypogonadism. The company expects to receive Day 120 questions related to the application by the end of Jan 2017.

REPROS THERAPEU Price and Consensus

 

REPROS THERAPEU Price and Consensus | REPROS THERAPEU Quote

Key Picks in the Sector

Investors looking for favorably placed stocks in the health care sector may consider Heska Corp. , Sucampo Pharmaceuticals, Inc. and Cambrex Corp. . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Heska’s earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%.

Sucampo’s earnings estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $158 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.

Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%.

Zacks’ Best Private Investment Ideas

In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?

Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>


See More Zacks Research for These Tickers


Normally $25 each - click below to receive one report FREE:


Royalty Pharma PLC (RPRX) - free report >>