In a research report published Monday, Brean Capital analyst Jonathan Aschoff reiterated a Buy rating on Repros Therapeutics (NASDAQ:RPRX) with a $41 price target, as the company met with the FDA last Wednesday to discuss its Androxal NDA filing.
Aschoff wrote, “Most importantly, the FDA requested no new clinical trials prior to the NDA filing. Additional safety trials could always be required in the future given that CV risk is of particular interest following the recent FDA panel on TRT, but we note that among the six items the FDA wanted to discuss with Repros, CV risk was not one of them, strongly suggesting that the FDA is not concerned about Androxal’s CV risk. In addition, the FDA advised Repros to discuss the environmental assessment of Androxal with the relevant agency prior to NDA submission. Environmental assessment is mandatory in Europe and Repros has already conducted such an analysis in preparation for the Androxal MAA. Repros will promptly set up a call with the FDA where an independent contractor will present Repros’s analysis. We view the environmental assessment as a housekeeping requirement and believe it should not impact the timing for the Androxal NDA filing. Repros anticipates no additional FDA meetings and will reassess submission timelines once it has discussed the environmental assessment requirements with the FDA, but so far submission still looks likely around YE14.”
According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Jonathan Aschoff has a total average return of 12.6% and a 60.2% success rate. Aschoff has a 7.2% average return when recommending RPRX, and is ranked #181 out of 3365 analysts.