3 main biotechnology titles with major catalysts approaching
Investors are always looking for the best stock market opportunities. The biotech sector is one of the go-to places for outsized yields. These companies, like investors, are also looking; to find medical solutions where needed. When you strike medical gold, the rewards can be phenomenal for early investors who quickly recognized the potential. However, where space offers a nice reward, it comes with many risks. If a company does not meet the requirements to bring a treatment to market, the implications can be brutal for the stock and, therefore, for the pockets of investors. After clinical trials are complete, the last hurdle to getting a drug approved is a meeting with regulatory bodies. The Prescription Drug User Fee Act (PDUFA) sets the deadline for FDA review of new drugs – determining whether or not a treatment is right and a yes or no can act as a major catalyst to send skyrocketing actions or falling. With this in mind, we opened the TipRanks database to find out the three biotech stocks awaiting the next PDUFA dates. All are currently rated Buy, with Street analysts predicting strong gains in the coming year. Cormedix (CRMD) We’ll start with Cormedix, a biopharmaceutical company specializing in infectious and inflammatory diseases, whose PDUFA date is fast approaching. Cormedix is currently focusing only on Defencath, a synthetic broad-spectrum antimicrobial and antifungal drug, and on February 28, the FDA will decide whether to cut mustard. The company developed the treatment for catheter-related bloodstream infections (CRBSI) in end stage renal disease patients receiving hemodialysis through a central venous catheter. Defencath is already on the market in Europe and other regions under the brand name Neutrolin. B. Riley’s analyst Andrew DSilva believes the recent actions by the FDA bode well for the drug’s chances of approval. “CRMD was granted priority review for the candidate, which reduced the time to review the submission by the FDA from ~ 10 months to ~ 6 months, and the FDA subsequently determined that a meeting AdCom was not required. Therefore, we increase the likelihood of successful FDA approval from 70% to 85%, which is in line with typical approval rates seen for applicants once an NDA / BLA was submitted, “commented DSilva. Based on the results of the Phase 3 candidate study, in which the treatment showed a statistically significant 71% decrease in CRBSI in patients on hemodialysis compared to heparin, DSilva believes that Defencath could save the healthcare system about $ 1 billion per year. This without even taking into account the benefits of reducing antibiotic use, improving quality of life, reduction in mortality or willingness to pay (WTP) p ar quality-adjusted life year (QALY) gained. DSilvas’ calculations lead him to believe that Cormedix TAM (Total Addressable Market) for hemodialysis is in the order of $ 1.7 billion. Consistent with its bullish approach, DSilva attributes CRMD to outperform (i.e. buy) with a price target of $ 25. If his thesis comes to fruition, a potential gain of 75% could be in the cards. (To see DSilvas track record, click here) Overall, there is unanimous support for CRMD stocks, with 4 buys supporting the consensus Strong Buy rating. The shares are selling for $ 14.30, and the average price target of $ 22 suggests potential upside of around 54% from that level. (See CRMD Stock Analysis on TipRanks) Kiniksa Pharmaceuticals (KNSA) Next, we have Kiniksa Pharmaceuticals, and unlike Cormedix, the company has a diverse pipeline of drugs in different stages of progress – all focused on weakening drugs. diseases with significant unmet medical needs. Kiniksa’s next catalyst is the PDUFA date of March 21 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 treatment status for the treatment that showed positive results in the Phase 3 study. With approximately 40,000 RP patients in the United States seeking or undergoing treatment Medically, Kiniksas is focused on bringing a treatment to market that not only treats the symptoms of a recurrence of pericarditis, but also reduces the likelihood of future recurrence. Among the fans is Wedbush analyst David Nierengarten, who believes the company has the right approach. We think the commercial message is strong and simple: in addition to the impressive effectiveness of the high end, the main secondary parameters of the quality of life reported by the patients and the gradual reduction of the DMARDs support its use, estimated the 5 star analyst. The analyst added: Overall, we see KNSA’s rational marketing strategy for rilo as encouraging and we expect the program to be well received by cardiologists who treat a disproportionate number of patients with recurrent pericarditis. and by patients given the early onset convincing benefits. Based on all of the above, Nierengarten awards KNSA an outperformance (i.e. a buy) with a price target of $ 35. This target places the upside potential at 55%. (To view Nierengartens’ track record, click here) Other analysts share similar enthusiasm with Nierengarten when it comes to KNSA. Given that 3 buy ratings have been given in the past three months compared to no take or sell, the consensus is unanimous: the stock is a strong buy. Meanwhile, his average price target of $ 31.67 places the potential year-over-year gain at ~ 40%. (See KNSA stock market analysis on TipRanks) Aveo Pharmaceuticals (AVEO) In hopes of providing better patient outcomes, AVEO Pharmaceuticals is advancing targeted drugs for oncology and other unmet medical needs. The company has various drugs in development, but the focus is currently on the upcoming FDA decision for Tivozanib, the company’s drug for the third and fourth line treatment of advanced renal cell carcinoma (CRC). The drug is already approved to treat adult patients with advanced renal cell carcinoma (CRC) in other regions, particularly in the European Union, Norway, New Zealand and Iceland. The date for the PDUFA is set for March 31, and following positive data from the late stage study, Baird analyst Michael Ulz believes a positive result is in the cards. Tivozanib was shown to significantly increase the quality-adjusted time without symptoms or toxicity (Q-TWiST) compared to sorafenib (15.04 vs 12.78 months; p = 0.0493), highlighting a pattern of differentiated tolerability based on a measure of quality of life for tivozanib, despite similar overall survival (OS) results … We continue to see potential for approval based on the TIVO-3 study and we expect investors to remain focused on the next PDUFA date (March 31), which we see as the next key enabler, ”said Ulz. To this end, Ulz rates AVEO a purchase with a target price of $ 17. The implication for investors? 106% increase. (To view Ulz’s track record, click here) He’s been relatively calm when it comes to other analyst activity. In the past three months, only 2 analysts have issued ratings. However, since they were both buys, rumor has it that AVEO is a moderate buy. Based on an average price target of $ 13.50, stocks could climb ~ 64% more over the next twelve months (see AVEO Stock Analysis on TipRanks) biotechnology traded at attractive valuations, visit TipRanks Best Stocks to Buy, a newly launched tool that brings together all the information about TipRanks stocks. 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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