Four Drug Stocks Facing FDA Approval Decisions in July

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.

Amarin shares have already doubled in value this year, boosted by strong AMR101 clinical data and improved patent protection that should give the drug sufficient market exclusivity if approved on July 26. If AMR101 is approved, however, watch investor focus shift quickly to speculation about the sale of the company to Big Pharma. Very few Amarin shareholders will be happy if the company announces plans to launch AMR101 on its own.

Also on July 26, Horizon Pharmaceuticals ( HZNP) will also receive FDA's approval decision for a proprietary, time-release formulation of the steroid prednisone for the treatment of rheumatoid arthritis. The same drug under the brand name Lodotra is already approved in Europe.

Lastly, Onyx Pharmaceuticals ( ONXX) is all but assured FDA approval of its multiple myeloma drug Kyprolis on Friday, July 27 following last month's overwhelmingly positive advisory panel vote.

Onyx share are up more than 50% since the FDA panel voted unanimously to recommend the approval of Kyprolis for patients with advanced multiple myeloma that no longer responds to current treatment.

--Written by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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