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Top 3 Biotech Stocks With Major Catalysts Coming Up
Investors are always looking for the best opportunities in the stock market. The biotechnology sector is one of the best places for bulk yields. These companies, like investors, are also looking for; to find medical solutions where necessary. If one gets medical gold, the benefits can be phenomenal for early investors who quickly realize the potential. However, where space offers a good reward, it carries a risk. If a company does not meet the requirements to bring a treatment to market, the consequences can be cruel for the stock and thus for the investors. After the completion of clinical trials, the last hurdle for drug approval is a date with the regulators. PDUFA (Law on the Use of Prescriptions on Drug Users) – the deadline for the FDA’s review of new drugs – determines whether a treatment is suitable for a purpose or not, and a yay or no can be a major catalyst to to raise or crash shares. With this in mind, we have opened the TipRanks database to get the decline in three biotechnology stocks waiting for the upcoming PDUFA dates. All are currently rated by Buy, and Street analysts predict strong gains in the coming year. Cormedix (CRMD) We start with Cormedix, a biopharmaceutical company specializing in infectious and inflammatory diseases, whose PDUFA date is fast approaching. Cormedix’s only focus is currently Defencath, a synthetic broad-spectrum antimicrobial and antifungal agent, and on February 28, the FDA will decide whether to cut the mustard. The company developed the treatment to prevent catheter-related bloodstream infections (“CRBSIs”) in patients with end-stage renal disease who receive hemodialysis via a central venous catheter. Defencath is already on the market in Europe and other regions under the brand name Neutrolin. B. Riley analyst Andrew D’Silva, believes that the FDA’s recent actions predict that it is good for the drug. “CRMD received priority rating for the candidate, which shortened the FDA’s review period from submission from ~ 10 months to ~ 6 months, and the FDA subsequently determined that an AdCom meeting is not necessary. As a result, we are increasing the probability of success with an FDA approval of 70% to 85%, which is in line with the typical approval figures seen for candidates once an NDA / BLA has been submitted, ‘D’Silva said. Candidate phase 3 study results, in which treatment shows a statistically significant 71% decrease in CRBSI in patients undergoing hemodialysis compared to heparin, D’Dilva thinks Defencath can save the healthcare system about $ 1 billion a year. This is without first taking into account the “benefits of reduced antibiotic use, improved quality of life, reduced mortality rate or a willingness to pay (WTP) per quality-adjusted life “Silva’s calculations lead him to believe that CAMMEDIX’s TAM (total accountable market) for hemodialysis is in the region of $ 1.7 billion. Consistent with its optimistic approach, D’Silva rates CRMD as a better performer (i.e. buy), coupled with a price target of $ 25. If his dissertation plays out, a potential profit of 75% could be in the card. (To view D’Silva’s record, click here) Overall, CRMD shares are up a unanimous inch, with 4 Buys supporting the stock’s strong buy consensus rating. Shares are selling for $ 14.30, and the average price target of $ 22 indicates an upward potential of ~ 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 at different stages of progress – all focusing on disease attenuation with a significant unmet medical need. The upcoming catalyst for Kiniksa is the March 21 PDUFA date for rilonacept, for the treatment of recurrent pericarditis (RP), a painful and debilitating auto-inflammatory cardiovascular disease. The FDA granted orphan drug status and breakthrough therapy for the treatment, which showed positive results in the phase 3 study. With approximately 40,000 patients with RP in the US seeking or undergoing medical treatment, Kiniksa is focusing on bringing a treatment that not only repeats the symptoms of pericarditis, but also reduces the likelihood of future recurrences. Among the fans is David Nierengarten, an analyst at Wedbush, who believes the company has the right approach. “We believe the commercial messages are healthy and straightforward: in addition to the impressive efficiencies on the top line, it supports the most important secondary endpoints of patient-reported quality of life and reduces the deterioration medicine,” the 5-star analyst said. The analyst added: “We consider KNSA’s rational commercialization strategy for rilo to be encouraging and expect the program to be well received by cardiologists who treat an excessive number of recurrent pericarditis patients and by patients who gain rapid convincing benefits.” Based on all of the above, Nierengarten KNSA rates a better performance (ie buy), along with a price target of $ 35. This target sets the upside potential at 55%. (To see Nierengarten’s record, click here.) Other analysts share a similar enthusiasm with Nierengarten when it comes to KNSA. Since three Buy ratings have been awarded over the past three months compared to no Holds of Sells, the consensus is unanimous: the stock is a ‘strong buy’. Meanwhile, the average price target of $ 31.67 sets the potential twelve-month profit at ~ 40%. (See KNSA stock analysis on TipRanks) Aveo Pharmaceuticals (AVEO) In hopes of providing better results for patients, AVEO Pharmaceuticals promotes drugs that target oncology and other unmet medical needs. The company has various drugs being developed, but the focus is currently on the FDA’s forthcoming decision for Tivozanib, the company’s remedy for third and fourth-line treatment of advanced renal carcinoma (RCC). The drug has already been approved for the treatment of adult patients with advanced renal carcinoma (RCC) in other regions, specifically in the European Union, Norway, New Zealand and Iceland. The PDUFA date is scheduled for March 31, and following the positive data from the late-stage study, Baird analyst Michael Ulz believes a successful outcome is in the map. Tivozanib was shown to significantly increase symptom-adjusted time without symptoms or toxicity (Q-TWiST) compared with sorafenib (15.04 versus 12.78 months; p = 0.0493), which further has a differentiated tolerance profile stresses based on a quality of life measure for tivozanib, despite similar overall survival results … We still see potential for approval based on the TIVO-3 study and expect investor focus on the upcoming PDUFA date (March 31) remains, what we consider to be an important catalyst, “says Ulz. Ulz rates AVEO a buy with a price target of $ 17. The implication for investors? Upwards of 106%. (To see here, click here ) It was relatively quiet when it came to other analytics activities. In the last three months, only two analysts have issued ratings. Since they were both Buys, word on the street that AVEO is a moderate buy. , 50, ka shares climb ~ 64% higher over next twelve months (see AVEO stock analysis on TipRanks) Visit TipRanks’ best-selling stocks, a newly launched tool that recognizes all TipRanks stocks, for great ideas for biotechnology stocks at attractive valuations. Disclaimer: The opinions expressed in this article are solely those of the proposed analysts. The content is for informational purposes only. It is very important to do your own analysis before investing.