BOSTON (TheStreet) -- Four FDA drug approval decisions in July -- headlined by another weight-loss drug and a prescription fish oil pill with blockbuster potential -- will keep biotech investors busy in what is normally one of the sector's slower months.
Vivus (VVUS) is expected to learn the fate of its weight-loss pill Qnexa on Tues. July 17. Recall, FDA was supposed to rule on Qnexa in April but delayed the decision by three months in order to review a risk management plan ensuring safer use of the drug.
Shares of Vivus are up 24% since the company announced the Qnexa regulatory delay in early April, largely because investors interpreted it as a vote of confidence in the drug's eventual approval.
Seventy-seven percent of contestants in TheStreet's Summer FDA Drug Approval Contest predict Qnexa's full approval on July 17 against 19% predicting the drug's rejection. [Another 5% believe FDA will delay its decision again.] The positive sentiment towards Vivus in the contest is much higher than it was for Arena Pharmaceuticals (ARNA) and its weight-loss drug Belviq. [FDA approved Belviq, of course.]Qnexa helped patients lose more weight than Belviq (comparing across different phase III trials) but Qnexa also causes more side effects. While Qnexa is widely expected to receive FDA approval on July 17, what remains a mystery still is how regulators will restrict the drug's use in order to mitigate side effects and risks, most notably the potential for birth defects in babies born to women who take Qnexa while pregnant. Investors also wait to see how quickly Vivus can launch Qnexa after approval. With Arena and its marketing partner Eisai stuck in neutral and unable to launch Belviq until early next year, Vivus could become the first new weight-loss drug to become available for obese Americans despite being approved second. Amarin (AMRN) probably has the most highly anticipated date with FDA on Thursday July 26, as regulators decide on the approval of the company's prescription fish-oil pill AMR101 for the treatment of patients with very high levels of triglycerides. As with Qnexa, investor expectations for AMR101 are ultra-bullish: 76% of contestants in TheStreet's drug-approval contest forecast full approval versus just 5% predicting rejection. Another 19% believe FDA will delay its decision. Confidence in AMR101's approval is bolstered by strongly positive results from the phase III "MARINE" trial and the decision by FDA not to bring the drug in front an outside advisory panel.
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