October 30, 2015
By Mark Terry, BioSpace.com Breaking News Staff
The Woodlands, Texas-based Repros Therapeutics Inc. announced yesterday that the U.S. Food and Drug Administration (FDA) had canceled its Nov. 3, 2015 advisory committee to review its New Drug Application (NDA) for Androxal.
Androxal (enclomiphene) was being studied in men of reproductive age with low testosterone due to secondary hypogonadism, which is associated with obesity. It is also the most common cause of low testosterone in men.
The FDA’s Division of Bone, Reproductive and Urologic Products was scheduled to convene on Nov. 3, but there were questions regarding the bioanalytical method validation of the study. The FDA had concerns regarding how this would affect interpretation of the data, and indicates it is willing to work with Repros to address the questions.
In April, the company announced that the European Medicines Agency (EMA), that its enclomiphene citrate capsules were eligible for submission for a centralized marketing authorization application (MAA) as a New Active Substance. If successful, that would be valid in all European Union member states, as well as in the European Economic Area, which is a total of 31 countries.
On Aug. 10, the company released its second quarter financial results. It showed a net loss for the quarter of $7.8 million, or about $0.32 per share. This was compared to a net loss of $8.7 million for the same period in 2014. For the six-month period that ended June 30, 2015, the company showed a net loss of $16.3 million or $0.67 per share compared to $17.5 million or $0.76 per share for the same period in 2014.
Until recently, Repros was fairly steady. On Dec. 30, 2014, shares traded for $10.34, dropping to $7.03 per share on June 1, 2015, then back up to $8.83 on Sept. 24. Shares are currently trading, however, for $1.86 per share.
Piper Jaffray analyst Joshua Schimmer, in a research report published yesterday, repeated a “neutral” rating for Repros, but cut the price target from $9 to $2.
“Concerns regarding the lab methodology/bioanalytical validation was cited in the press release as the reason for the cancellation,” Schimmer wrote. “However, on the call it sounded clear based on the company’s preview of the FDA’s briefing documents that the concern leading to cancellation was as much around the question of the appropriate patient population to study. This has been our concern all along and the reason we remain Neutral on shares as we lack confidence in a path forward given the hypogonadism conundrum…. We await a path forward for Androxal, but it is clear from the call that the company is not expecting NT approval. We do not expect RPRX will be able to find a suitable path forward.”
Of four analysts polled by TipRanks, three gave the company a “buy” rating and one a “neutral.” The stock’s consensus target price remains at $29.25.
The company also has ongoing clinical trials of Proellex for treatment of pre-menopausal women, specifically for the treatment of uterine fibroids in women that have heavy vaginal bleeding as the results of the benign tumors. To date, the trials seem to show decreased bleeding and tumor reduction.
