Biotech Stocks Facing FDA Decision In September

(RTTNews) - The performance of Biotech stocks thus far this month is nothing to write home about, if we were to look at it from the standpoint of the movement of the NYSE Arca Biotechnology Index. So far this month, the index is down nearly 3 percent. For the same period, the S&P 500 is up 0.31 percent but the tech-heavy Nasdaq Composite is 1.36 percent higher.

Despite the lackluster showing by biotech stocks, August did have its fair share of FDA decisions. Therefore, a peek at what transpired on the FDA front in August and a preview of what September holds in store for us look pertinent.

Favorable verdicts slightly outweighed the unfavorable ones as there were three positive regulatory announcements and 2 rejections by the FDA this month.

Pet therapeutics company Aratana Therapeutics Inc. (PETX), bigger brethren Merck (MRK) and specialty pharmaceutical company Egalet Corp. (EGLT) are the ones that received glad tidings while Portola Pharmaceuticals Inc. (PTLA) and Amgen Inc. (AMGN) were in for a disappointment.

Aratana's Nocita, a local post-operative analgesia for dogs, and Merck's Keytruda in the expanded indication of recurrent or metastatic head and neck squamous cell carcinoma were greenlighted by the FDA while Egalet won FDA panel backing for its abuse-deterrent opioid Arymo ER. The unlucky two, which were rejected by the FDA, are Portola's antidote drug AndexXa and Amgen's secondary hyperparathyroidism drug Parsabiv.

As is widely known, some drugs pass the FDA muster easily, while some struggle through the arcane process of regulatory approval. However, despite the regulatory setbacks, some companies exude a steely determination to bring their drugs to the market.

In the coming month, two companies, which were given thumbs down twice for their investigational drugs, are facing the FDA for a third time, and two companies are seeking regulatory approval for label expansion of their drugs.

Click on to know more about the biotech companies awaiting FDA rulings in September.