Last month Repros Therapeutics ($RPRX) hoisted a red flag for investors, saying that investigators had spotted an odd bulge in its late-stage study for their lead drug Androxal, being studied for the treatment of secondary hypogonadism. Leery that a large number of patients had been enrolled in one site, with blinded data demonstrating a high response rate, the company opted to shift gears, moving patients from a second late-stage study into the first Androxal trial and extending the timeline for wrapping the Phase III.
But today the Texas-based biotech reversed gears again, saying that regulators at the FDA indicated they would be satisfied if they analyzed the first batch of Phase III data twice, with and without the patients from the outlier, with a final readout expected in the third quarter. A second study will also be allowed to recruit additional patients, reassuring analysts that the company will have plenty of data on hand to explain any aberrations that might arise from the site in question. And the special protocol assessment it won remains intact.
That news triggered a rapid spike in the company's share price, which zoomed up 40%.
"Being allowed to enroll (new) patients in the second study, should help them mitigate the risk associated with the quality of the data," Keay Nakae, a senior research analyst with Ascendiant Capital Markets, tells Reuters.
- here's the press release
- read the Reuters report