Repros Therapeutics (RPRX) Continues To Slide On FDA Response


Repros Therapeutics Inc (NASDAQ: RPRX)

Repros Therapeutics is seeing a continuation of bad news in the market after a Complete Response letter from the United States Food and Drug Administration with regard to a recent New Drug Application. Today, we’ll take a look at the response provided, how the market is reacting to the news, and what we can expect to see from RPRX moving forward. So, let’s get right to it.

RPRX Gets Unwanted News From The FDA

Repros Therapeutics recently announced that it had received a Complete Response Letter from the FDA with regard to its NDA of enclomiphene. Enclomiphene was designed for the treatment of secondary hypoganadism in overweight men. The goal of the drug was to restore normal testicular function. Unfortunately, the FDA responded to the company stating that enclomiphene cannot be approved in its present form. In the letter, the FDA stated that new developments in the medical field show that the design of enclomiphene Phase 3 studies are no longer adequate to demonstrate clinical benefit. As a result, RPRX will be required to conduct a new Phase 3 study which will support approval. In the new study, RPRX will be required to change the bioanalytical method validation, titration, and entry criteria. In a response to the FDA’s letter, Joseph Podolski, President and CEO of Repros Therapeutics had the following to say:

We are disappointed that the FDA has taken this position without the benefit of an advisory committee recommendation… We plan to work closely with the Agency to gain more information to determin the appropriate next steps regarding the enclomiphene application.”

How The Market Reacted To The News

As we’ve come to expect any time we see negative news with regard to a publicly traded company, RPRX is having a rough time in the market. After vast declines yesterday, and a decline of 1.14% so far today, the stock is currently (10:01) trading at $1.72 per share.

What We Can Expect To See Moving Forward

Based on the recommendation from the FDA, I’m expecting to see a new Phase 3 study conducted. In the mean time, I’m not expecting to see much by way of positive activity surrounding the stock. Unfortunately, when the FDA declines an application we tend to see downtrends for quite some time.

RPRX Analysis

Out of 3 analysts covering Repros Therapeutics (NASDAQ:RPRX), 0 rate it “Buy”, 1 “Sell”, and 2 “Hold”. This means none 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 a “Neutral” rating. Brean Capital downgraded the shares of RPRX in a report on October 30 to a “Hold” rating.

The institutional sentiment decreased to 0.74 in Q2 2015. Its down 0.46, from 1.2 in 2015 Q1. The ratio dived, 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 2015 Q1.

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. 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 $41.10 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.

What Do You Think?

Where do you think RPRX is headed moving forward, let us know your opinion in the comments below!

[Image Courtesy of Wikipedia]


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