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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. Cormedix (CRMD) 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 70% to 85%, which is in line with typical approval rates seen for candidates once an NDA/BLA have been submitted," D’Silva commented. Taking onto account the candidate’s Phase 3 study results, in which the treatment showed a statistically meaningful drop of 71% in CRBSI in patients undergoing hemodialysis compared to heparin, D’Silva thinks Defencath could save the healthcare system around $1 billion a year. This is without even taking into account the “benefits related to reduced antibiotic use, improved quality of life, reduced mortality, or a willingness-to-pay (WTP) per quality-adjusted life year (QALY) gained.” D’Silva’s calculations lead him to believe Cormedix’ TAM (total addressable market) for hemodialysis is in the region of $1.7 billion. In line with his optimistic approach, D’Silva rates CRMD an Outperform (i.e. Buy) along with a $25 price target. Should his thesis play out, a potential gain of 75% could be in the cards. (To watch D’Silva’s track record, click here) Overall, CRMD shares get a unanimous thumbs up, with 4 Buys backing the stock’s Strong Buy consensus rating. Shares sell for $14.30, and the average price target of $22 suggests an upside potential of ~54% from that level. (See CRMD stock analysis on TipRanks) Kiniksa Pharmaceuticals (KNSA) Next up, we have Kiniksa Pharmaceuticals, and unlike Cormedix, the company has a varied pipeline of drugs in different stage of progress - all focusing on weakening diseases with significant unmet medical need. The upcoming catalyst for Kiniksa is the March 21 PDUFA date for rilonacept, for the treatment of recurrent pericarditis (RP), an agonizing and debilitating autoinflammatory cardiovascular disease. The FDA has granted both orphan drug and breakthrough therapy status for the treatment which showed positive topline results in the Phase 3 study. With roughly 40,000 patients with RP in the U.S. either looking for or undergoing medical treatment, Kiniksa’s focus is on bringing to market a treatment that not only addresses the symptoms of a pericarditis recurrence but also lowers the probability of future recurrences. Among the fans is Wedbush analyst David Nierengarten, who believes the company has the right approach. “We believe the commercial messaging is sound and straightforward: in addition to the impressive top-line efficacy, key secondary endpoints of patient-reported quality-of-life and tapering of background medication support its use,” the 5-star analyst opined. The analyst added, “In all, we see KNSA’s rational commercialization strategy for rilo as encouraging and expect the program to be well received by cardiologists who treat disproportionate numbers of recurrent pericarditis patients and by patients given the rapid onset of convincing benefit.” Based on all of the above, Nierengarten rates KNSA an Outperform (i.e. Buy) along with a $35 price target. This target puts the upside potential at 55%. (To watch Nierengarten’s track record, click here) Other analysts share a similar enthusiasm with Nierengarten when it comes to KNSA. As 3 Buy ratings were assigned in the last three months compared to no Holds or Sells, the consensus is unanimous: the stock is a ‘Strong Buy’. Meanwhile, its $31.67 average price target puts the potential twelve-month gain at ~40%. (See KNSA stock analysis on TipRanks) Aveo Pharmaceuticals (AVEO) Hoping to provide better outcomes for patients, AVEO Pharmaceuticals advances targeted medicines for oncology and other unmet medical needs. The company has various drugs in development, but the focus right now is on the FDA’s upcoming decision for Tivozanib, the company’s drug for the third and fourth-line treatment of advanced renal cell carcinoma (RCC). The drug is already approved to treat adult patients with advanced renal cell carcinoma (RCC) in other regions, specifically in the European Union, Norway, New Zealand and Iceland. The PDUFA date is slated for March 31 and following the positive data from the late-stage study, Baird analyst Michael Ulz believes a successful outcome is in the cards. “tivozanib was shown to significantly increase quality-adjusted time without symptoms or toxicity (Q-TWiST) compared to sorafenib (15.04 vs. 12.78 months; p=0.0493), further highlighting a differentiated tolerability profile based on a quality-of-life measure for tivozanib, despite similar overall survival (OS) outcomes... We continue to see potential for approval based on the TIVO-3 study and expect investor focus to remain on the upcoming PDUFA date (March 31), which we view as the next key catalyst," Ulz opined. To this end, Ulz rates AVEO a Buy along with a $17 price target. The implication for investors? Upside of 106%. (To watch Ulz's track record, click here) It has been relatively quiet when it comes to other analyst activity. In the last three months, only 2 analysts have issued ratings. However, as they were both Buys, the word on the Street is that AVEO is a Moderate Buy. Based on the $13.50 average price target, shares could climb ~64% higher in the next twelve months. (See AVEO stock analysis on TipRanks) To find good ideas for biotech stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
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