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What is Bio Technology?

Seasoned investors know that the biotechnology sector in inherently risky business. A drug approval can send shares soaring while skepticism on a pipeline drug from the FDA can cause shares to crash. Many analysts believe Isis Pharmaceuticals, Inc. (ISIS) is an attractive investment because it has an extensive clinical pipeline containing more than 25 drugs.

A strong pipeline is promising for investors due to the increased probability of a single drug obtaining FDA approval. Isis’ robust pipeline is a primary reason why Jim Cramer sees major upside potential in the stock. Cramer is confident that the company’s significant growth highlights its accomplishments and should not be a source of apprehension for investors.

Isis shares were approximately $14 in 2013 and increased over 300% to a high of $59 by the beginning of 2014. Shares slid in the first half of 2014 after Isis reported a quarterly net loss of $24.3 million, compared to a loss of $2.6 million in the same quarter a year prior. However, since then shares of Isis Pharmaceuticals have been consistently rising, hitting a new 52-week high of nearly $78 in mid-March.

Investors have an additional reason to be optimistic about Isis Pharmaceuticals when the company provided a positive news update on June 22. Isis Pharmaceuticals provided an update with new data from ISIS-SMNrx; a treatment for spinal muscular atrophy (SMA). The new data provided by Isis’ study confirms that children treated with ISIS-SMNrx experience an increase in muscle function and motor skills. The safety profile remained consistent with repeated doses of the drug and the worst side effects were only reported as mild or moderate.

SMA is one of the leading causes of infant mortality and affects approximately 30, 000 to 35, 000 people in the United States, Europe, and Japan. SMNrx is currently in Phase 3 testing and received Orphan Drug Designation with Fast Track Status by the FDA since there are currently no approved treatments for SMA. It is being developed in partnership with Biogen (BIIB), using Isis’ expertise in antisense drug technology and Biogen’s experience in developing neurological therapies.

In light of the positive news on SMNrx, Chad Messer of Needham reiterated a Buy rating on the stock and raised his price target from $88 to $91. Messer was impressed with the study and does not think that investors “fully appreciate” the significance of the study. He explains, “Specifically, investors may be confused about how sick Spinal Muscular Atrophy (SMA) patients are. The sickest Type I SMA infants have a life expectancy of 10.5 mo vs 16.7 mo (and counting) in an ongoing Phase II trial.” The analyst is confident that the drug will gain FDA approval as it “already exceeds what is necessary for approval in a deadly pediatric orphan indication.”

Alethia Young of Deutsche Bank did not think the recent data was as groundbreaking as Messer, but she nevertheless reiterated a Buy rating on the stock with a $78 price target. She calls the update “incremental but trending in the right direction, ” but notes the promising progress. Young even entertains the idea of early approval due because the drug treats a population with “such high unmet need.”

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