Brean Capital Sees No Surprises In 3Q14 Report For Repros Therapeutics

In a report published Tuesday, Brean Capital analyst Jonathan Aschoff reiterated a Buy rating and $41.00 price target on Repros Therapeutics (NASDAQ: RPRX).

In the report, Brean Capital noted, “Following the constructive FDA guidance meeting held last Wednesday, Repros will promptly set up a call with the FDA where an independent contractor will present Repros's environmental assessment analysis for Androxal, work already completed for the Androxal MAA, and we do not view this as an impediment. Repros will submit an NDA for Androxal after it has satisfied the environmental assessment requirements with the FDA, and we believe submission so far still looks likely around YE14.

"At last Wednesday's meeting, the FDA requested no new clinical trials prior to the NDA filing. Additional safety trials could always be required in the future, 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. Repros completed all pivotal Phase 3 trials, including ZA-304 and ZA-305 that were completed in September/October. The one-year DEXA trial ZA-303 recently showed clean safety, noting no new safety signals with long-term Androxal treatment. As for the development of Proellex, Repros intends to initiate in 4Q14 a Phase 2b trial with vaginal Proellex as well as a Phase 2 trial with oral Proellex for uterine fibrosis, and to fully enroll its Phase 2 trial with oral Proellex for endometriosis in 1H15. Repros ended 3Q14 with about $53 million in cash, far more than is needed to file the Androxal NDA. Repros reported interest income for 3Q14 of $2k and EPS of $(0.32).”

Repros Therapeutics closed on Monday at $9.22.