Below is a Seeking Alpha article breaking down the issues surrounding RPRX. Who knows if anything surprisingly positive will come out Monday. Chart looks primed for a run, but I took my gains and I'm happy. I'll keep watch after December.
But CLDN is the the next suppressed stock primed for a run, IMO. Many shares traded in the 1.40-1.60 range. Many shares shorted. This will make its way back up again. I expect $3 in December. Several suppressed bio techs, one by one, have come back around. I was right with RPRX, and I think CLDN has much more promise than the former. Just a matter of time. Not if, but when.
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Is It All Over For Repros Therapeutics?
Nov. 23, 2015 6:57 PM • RPRX
Summary
FDA cancellation of the Advisory Committee meeting citing last minute concerns has dealt a huge blow to the stock.
Cancellation was attributed to questions that arose late in the review regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data.
Secondary hypogonadism definition and patient selection may be the bigger issue that some analysts are concerned about.
Repros Therapeutics (NASDAQ:RPRX) and its investors received a major blow when FDA cancelled the advisory committee meeting scheduled for November 3, 2015 to decide the approval of Androxal (enclomiphene) for secondary hypogonadism. RPRX has had to cross many hurdles with FDA over the years with respect to Androxal. Some analysts appear to have already written the obituary for Androxal .
FDA Advisory committee was scheduled to discuss new drug application for androxal (enclomiphene citrate 12.5 mg and 25 mg capsules for the proposed treatment of secondary hypogonadism in fertile men (men with more than 15 million sperm/milliliter (ml)), younger than 60 years of age with a Body Mass Index (BMI) over 25. The two studies ZA304 and ZA 305 had shown positive results in Phase III clinical trials when compared head to head with AndroGel (topical testosterone gel) and placebo with high statistical significance. There were no significant safety issues in trials. Out of the two deaths in the trial one was due to a traffic accident and the other due to a stroke which couldn't be attributed to Androxal. Androxal is an oral selective estrogen receptor modulator (SERM) for the treatment of secondary hypogonadism in overweight men. Unlike testosterone supplementation it doesn't cause lowering of sperm count while restoring normal testosterone levels. Recent FDA cardiovascular safety concerns regarding testosterone therapy and the prevalence of secondary hypogonadism had given investors reason for great enthusiasm. It is believed to be an over $1 billion a year drug if approved. Institutional ownership was at 58.91% as of September 30,2015.
FDA's eleventh hour cancellation of the Advisory Committee has generated a lot of anger, disappointment and speculation. Androxal had a PDUFA date of November 30, 2015. Cancellation was attributed to questions that arose late in the review regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data (whether Androxal truly met the primary endpoint in phase III trials). RPRX CEO Podolski defended the Repros-chosen lab, saying that it was CLIA-certified and a reliable conductor of the necessary assays. The pessimism stemming from FDA's decision however involves more than just the concern for bioanalytical method validation. The secondary hypogonadism definition and patient selection may be the bigger issue that some analysts are concerned about.
Male hypogonadism is a condition in which the body does not produce enough of the testosterone hormone. Primary hypogonadism is a condition that originates from primary testicular failure. Secondary hypogonadism indicates a problem in the hypothalamus or the pituitary gland - parts of the brain that signals the testicles to produce testosterone. It has many causes like Kallaman syndrome, pituitary disorders, inflammatory disorders,HIV/AIDS, Medications, obesity and stress induced to list a few. The trials were done with overweight patients in the age group 18 to 60years. Men were screened with two morning Total Testosterone measurements to identify individuals for the intent-to-treat population (ITT) by virtue of having a serum TT of <300 ng/dL (<10.4 nmol/L) and a low or inappropriately normal LH level (<9.4 IU/L). The baseline characteristics of ZA-304 and ZA-305 trials were highly and statistically consistent within studies and between studies for age, body mass index , sperm concentrations and serum TT. The conundrum however is whether these patients were screened for any of the specific causes of secondary hypogonadism mentioned above other than weight. In other words was the hypogonadism due to the patients being overweight or did some of them have other conditions too. If some of them did or didn't have other conditions then how would those variables skew the results. To cite an example would a patient with a BMI of 32 with sarcoidosis and hypogonadism experience the same benefit as a patient with BMI 32 without sarcoidosis on Androxal? Did RPRX ignore other causes and get too focused on obesity? A slide from an old presentation, "It's really Obesity" seems to suggest that it may be the case. If FDA is concerned about selection bias and whether true randomization was achieved then RPRX is in trouble because further studies/analysis may be needed. Logic would dictate that it would be blatantly unfair on the part of FDA to come up with this sort of objection at the last moment. History with respect to FDA though would suggest otherwise.
RPRX's financial health is not great. The company had cash and cash equivalents of approximately $26.2 million as of September 30, 2015 as compared to $46.6 million as of December 31, 2014. Approximately $20.5 million and $22.9 million was used in operating activities during the nine month periods ended September 30, 2015 and 2014, respectively. The other product in RPRX pipeline Proellex for symptomatic uterine bleeding in women with fibroids has just completed randomization for phase 2b trials and results are expected in the second quarter of 2016 per a recent press release. Proellex has already had problems with FDA in the past when FDA had put a clinical hold on the trial before lifting it in 2010. Bottom line is that investors should not consider getting in at this level. It is best to wait for FDA concerns to be better defined and what FDA expects RPRX to do to address those concerns.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
