Investors are always searching out the stock market’s best opportunities. One of the go-to places for outsized returns, is the biotech sector…
These companies, like investors, are also on a quest; to find medical solutions where needed. When one strikes medical gold, the rewards can be phenomenal for early investors who were quick to recognize the potential.
However, where the space offers handsome reward, it is fraught with risk. Should a company fail to deliver the requirements to bring a treatment to market, the implications can be brutal for the stock, and therefore, to investors’ pockets.
After the completion of clinical tests, the final hurdle in getting a drug approved is a date with the regulators. PDUFA (Prescription Drug User Fee Act) dates – the deadline of the FDA’s review of new drugs – determine whether a treatment is fit for purpose or not and a yay or nay can act as a major catalyst to send shares either soaring or crashing.
With this in mind, we opened the TipRanks database to get the lowdown on three biotech stocks awaiting upcoming PDUFA dates. All are currently Buy-rated, with Street analysts predicting strong gains in the year ahead.
We’ll start off with Cormedix, a biopharma company specializing in the field of infectious and inflammatory diseases, whose PDUFA date is fast-approaching.
Cormedix’ sole focus right now is Defencath, a synthetic broad-spectrum antimicrobial and antifungal drug, and on February 28, the FDA will decide whether it cuts the mustard.
The company has been developing the treatment to thwart catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease receiving hemodialysis via a central venous catheter. Defencath is already on the market in Europe and other regions going by the brand name of Neutrolin.
B. Riley analyst Andrew D’Silva thinks the FDA’s recent actions bode well for the drug’s chances of approval.
“CRMD was granted priority review for the candidate, which reduced the FDA’s review time of the submission from ~10 months to ~6 months, and the FDA subsequently determined an AdCom meeting was not needed. As a result, we are increasing the probability of success related to an FDA approval from…
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