Here's How Our Readers Picked Up 170% On Theratechnologies Inc (OTCMKTS:THERF)

Back in November last year, we published this piece, highlighting Theratechnologies Inc (OTCMKTS:THERF) as a company to keep an eye on in the small-cap biotechnology space. Our thesis was relatively simple: the company had just generated some very strong data from one of its lead development assets (which it is developing in collaboration with another company called TaiMed Biologics, Inc.) and had initiated the rolling submission of a Biologics License Application (BLA) with the FDA, targeting the approval of the drug in the US. We will get into the drug in a little more detail shortly, but for now, it suffices to say that it's targeting a population with a significant unmet need and, if approved, could be a substantial revenue driver for the two companies pushing for commercialization.At the time of our coverage, and as we highlighted this one, Theratechnologies traded for around three dollars a share. At last close, the company went for $8.10 a share – a 170% plus appreciation across the period.That's a nice take, and one we imagine many of our readers will be happy to pull off the table. However, this one really could just be getting started and might make an attractive hold for anybody with an exposure already, or an attractive buy for anybody not yet in the stock.Our thesis is rooted in the same drug but slightly altered based on developments over the last couple of months and how these developments play into certain catalysts.Before we get into the catalysts, let's quickly address the drug.It's called ibalizumab and it is targeting the HIV population. In HIV, the primary hurdle to long-term treatment is what's called multidrug-resistance (MDR). Patients take a cocktail of various antivirals that work for a while, but over time become less and less effective and, eventually, stop working altogether. There hasn’t been a fresh class of antiviral added to the pool of potential options for HIV patients for more than a decade and, as the rate of MVR increases, patients are increasingly looking for alternatives to satisfy that requirement for two or more variations on the antiviral treatments they require.With ibalizumab, Theratechnologies is trying to bring a completely new class of antiviral to market. If it succeeds, and if the FDA approves it, the company could quickly acquire a large portion of the market, which in the US, is substantial – estimates suggest that approximately 25,000 Americans with HIV-1 are currently resistant to at least one drug in three different classes of antiretroviral therapies, and up to 12,000 of these patients experience a virological failure over a period of 48 weeks of treatment, requiring their physician to modify their treatment.So, when we first looked at this one, TaiMed had initiated rolling submission. At the start of May, the two companies announced that this submission had completed and that TaiMed had requested Priority Review from the FDA.For those unfamiliar with this Priority Review term, it basically means that the FDA agrees to cut its review time down from the standard 10 months to a maximum of six months' post submission acceptance. This, then, gives us a few key catalysts to watch very near term, each of which has the potential to compound the upside momentum we've already seen in this stock and drive valuation higher over the coming quarters.The first catalyst is the agency's acceptance of the application, at which point it will set a PDUFA for the drug. We will also know at this point whether the Priority Review request has been accepted or not. If it has, the approval catalyst will come six months (at the outside) from acceptance date. Assuming the agency accepts the BLA at some point over the next few weeks (which would be pretty standard in terms of time frames based on historic acceptances), we are looking at an end-of-the-year approval date under Priority Review. Without Priority Review, PDUFA extends to the end of the first quarter next year.Theratechnologies will be commercializing this one in Europe, while TaiMed has responsibility for the US market. This means, near term at least, we shouldn't see any dilution from Theratechnologies as the company won't have to fund a US rollout on an FDA green light.Catch up with our historic coverage on this one here. We will be updating our subscribers as soon as we know more. For the latest updates on THERF, sign up below!Image courtesy of NIAID via FlickrDisclosure: We have no position in THERF and have not been compensated for this article.