Repros Therapeutics Inc. (NASDAQ:RPRX)
Repros Therapeutics Inc. (NASDAQ:RPRX) rebound from this year’s lows of $0.26 a share continued in Friday’s trading session, as its shares gained 3.11% to end the week at $0.5336. However, the stock is still down for year-to-date after losing more than 50% in market value since January.
FDA Clinical Hold Debacle
Investor confidence in Repros Therapeutics Inc. (NASDAQ:RPRX) took a hit in June after the U.S. Food and Drug Administration (FDA) instituted a clinical hold on the company’s Proellex program for the treatment of uterine fibroids. According to the agency, Repros Therapeutics Inc. (NASDAQ:RPRX) will have to conduct a much larger clinical study if the FDA is to lift the partial clinical hold. A point of concern to investors is that the additional requirements could end up being expensive and time-consuming.
This is not the first time that the biopharmaceutical company has found itself at odds with the FDA with regards to the development of Proellex. In 2009, the FDA placed the program under clinical hold, but later allowed it to continue under partial clinical hold with low oral dosage.
Repros Therapeutics Inc. (NASDAQ:RPRX) is also evaluating Proellex in its Phase IIb study for uterine fibroids by vaginal delivery. The company says it plans to increase its focus on this study given that it does not have clinical hold issues.
“Clinical work done to date suggests that vaginal delivery of telapristone acetate has the potential to yield good efficacy with significantly lower systemic blood levels. Furthermore, we intend to leverage drug delivery technology that could offer to dose less frequently than once per day,” said CEO, Larry Dilaha.
Q2 Net Loss
The Texas-based biopharmaceutical company reported a net loss of (-$2.2) million or (-$0.08) a share for the three months ended June 30, 2017, compared to a net loss of (-$4.3) million a year ago. The decline was primarily due to a decrease in clinical development expenses related to Proellex and enclomiphene product candidates.
Repros Therapeutics Inc. (NASDAQ:RPRX)’s net loss for the first six months of the year stood at (-$8.1) million or (-$0.30) a share, compared to a net loss of (-$9.1) million for the corresponding period last year.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.