September a Big Month for Drug Candidates and FDA Decisions


The process of getting a drug candidate through clinical trials to market ready is a long and arduous one, as all pharmaceutical companies can attest to. There are plenty of risks, and a single unsuccessful clinical trial can ruin a company and collapse its stock. However, if the U.S. Food and Drug Administration (FDA) ruling comes back positive, the potential for profit is enormous.

As a result this September is the month many pharmaceutical companies have been awaiting with some trepidation.

Opko Health Inc.

Opko Health Inc. is expecting a decision on its rolapitant PDUFA (Priority Review designation granted to medicines determined by the FDA to have the potential to provide substantial improvements in the treatment, prevention or diagnosis of a disease) on September 5.

The drug candidate is designed to help prevent nausea and vomiting induced by chemotherapy and in the case of a positive response by the FDA and consequent commercialization of the drug candidate, the company will receive milestone payments of up to $110 million.

As of the end of last week OpkoHealth shares were trading at $11.42 in the middle of its 12 month trading range of $8.02 to $19.20.

Tesaro Inc.

Another PDUFA response expected from the FDA on September 5 is on the New Drug Application (NDA) for oral rolapitant by Tesaro Inc. The company is in the process of preparing for the commercialization of the product at the end of the year if the FDA grants approval.

Tesaro shares are currently trading around $53-54 in the upper segment of its 52-week trading range of $23.00 to $66.95.

Xenoport Inc.

Xenoport Inc. has finalized enrollment in the Phase 2 clinical trial of XP23829, a possible treatment for moderate-to-severe chronic plaque-type psoriasis. The plans to disclose key data from the completed trial by the end of September which, depending on the results, could send the shares soaring or plummeting.

As of close of the markets on Friday, Xenoport shares were at $6.67 in the lower end of its 52-week trading range of $4.85 to $9.60.


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