Repros Therapeutics (RPRX) did a complete turnaround on Friday with the announcement that a planned meeting with the FDA regarding lead drug candidate Androxal will be a “Type C” meeting rather than a “Type B” meeting. In this situation, the Type B meeting would have preceded Repros submitting a New Drug Application to the regulatory agency. FDA is essentially saying that it has insufficient data in its possession to advise Repros on the application filing – exactly why is unknown. Repros guided for a Type B meeting in September.
Repros stock was down 40% in early trading.
This latest guidance follows an FDA advisory committee meeting in mid-September to discuss testosterone replacement therapies, including the appropriate patient population in which TRT’s should be used and the risk of major adverse cardiovascular events associated with their use. Independent advisors took a dim view of the wide and aggressive use of TRT’s in older men who don’t necessarily need them, which read through negatively for Repros despite the fact that Androxal is not a traditional TRT.
Repros had expected to submit a New Drug Application for Androxal (single isomer clomiphene) in secondary hypogonadism by the end of the year. Now, investors may question whether FDA is even open to secondary hypognodism as a disease indication. The company received communication from the FDA indicating that “based on its preliminary review of the company’s briefing document, there was not sufficient clinical information provided for the meeting to be a Type B Pre-NDA meeting.” According to FDA’s industry guidance, a Type C meeting “…is any meeting other than a Type A or Type B meeting between CBER or CDER and a sponsor or applicant regarding the development and review of a product.”
Repros doesn’t know why FDA wants a Type C meeting. But, the company noted in Friday’s press release that synopses from a one-year safety study, and a drug-drug interaction study, were unavailable at the time that initial briefing documents were submitted to the FDA. Our assumption is that those documents are now in the hands of FDA.
Repros, previously Zonagen, and CEO Joe Padolski have a long and rocky track record. Credibility is an issue, and investors tend to give the company a wide berth when it comes to new unknowns. The Type C meeting, and consequently a timely NDA filing, are just that – new unknowns.
