Repros Therapeutics Inc (RPRX) Receives a Negative FDA Letter Regarding Enclomiphene


Shares of Repros Therapeutics Inc (NASDAQ:RPRX) are getting pummeled this morning after the company received a letter from the Food and Drug Administration (FDA) regarding their drug enclomiphene.

While shares of Repros had been up significantly in the last few days as investors wagered on a positive response from the FDA, much of those gains are being given back this morning.

In the letter, the FDA stated that the design for their phase 3 studies of enclomiphene were no longer adequate and that additional Phase 3 studies are recommended.

“We are disappointed that the FDA has taken this position without the benefit of an advisory committee recommendation,” said Joseph Podolski, President and CEO of Repros. “We plan to work closely with the Agency to gain more information to determine the appropriate next steps regarding the enclomiphene application.”

The stock is down 31.11% or $0.75 after the negative news, hitting $1.65 per share. About 608,029 shares traded hands. RPRX has declined 70.19% since April 28, 2015 and is downtrending. It has underperformed by 68.56% the S&P500.

Out of 3 analysts covering Repros Therapeutics (NASDAQ:RPRX), 0 rate it “Buy”, 1 “Sell”, while 2 “Hold”. This means 0 are positive. Repros Therapeutics was the topic in 4 analyst reports since August 20, 2015 according to StockzIntelligence Inc. Ladenburg Thalmann downgraded the stock on October 30 to “Neutral” rating. Brean Capital downgraded the shares of RPRX in a report on October 30 to “Hold” rating.

The institutional sentiment decreased to 0.74 in Q2 2015. Its down 0.46, from 1.2 in 2015Q1. The ratio fall, as 23 funds sold all Repros Therapeutics Inc shares owned while 19 reduced positions. 16 funds bought stakes while 15 increased positions. They now own 14.48 million shares or 5.86% less from 15.38 million shares in 2015Q1.

Sarissa Capital Management Lp holds 1.86% of its portfolio in Repros Therapeutics Inc for 1.13 million shares. Destrier Capital Management Llc owns 329,030 shares or 0.57% of their US portfolio. Moreover, Rtw Investments Llc has 0.48% invested in the company for 229,364 shares. The New York-based General American Investors Co Inc has invested 0.35% in the stock. Baker Bros. Advisors Lp, a New York-based fund reported 1.96 million shares.

Repros Therapeutics, Inc. is a biopharmaceutical firm focused on the development of new drugs to treat hormonal and reproductive system disorders. The company has a market cap of $42.55 million. The Company’s product candidates include Androxal and Proellex. It currently has negative earnings. The Company’s primary product candidate Androxal is a single isomer of clomiphene citrate and an orally active proprietary small molecule compound, which is developed for the treatment of secondary hypogonadism in overweight men.