Faster FDA Approval Process Could Ignite These Biotech Stocks in 2017

NEW YORK, NY / ACCESSWIRE / February 2, 2017 /
The Biotech Industry has performed admirably in 2017, despite the negative attention drug makers have been receiving. The iShares NASDAQ Biotechnology Index ETF gained 0.85 percent to close at 280.42, up 5.67 percent year-to-date, while the SPDR S&P Biotech ETF increased 0.09 percent to close at 64.96, up 9.75 percent year-to-date. In comparison, the Dow Jones Industrial Average and the S&P 500 Index have posted gains of 0.65 percent and 1.82 percent, respectively, year-to-date. The Biotech Industry received a boost Tuesday after President Trump stated he would loosen drug regulations and push for a faster drug approval process.

“We’re also gonna be streamlining the process so that from your standpoint, when you have a drug, you can actually get it approved if it works instead of waiting for many, many years,” President Trump said. “The U.S. drug companies have produced extraordinary results for our country, but the pricing has been astronomical for our country.”

The U.S. Food and Drug Administration (FDA) approved just 22 new drugs in 2016, less than half of the 45 new drugs approved in 2015, according to Reuters. The number of drugs approved last year was the lowest number of approvals since 2010.

A Closer Look at
Today’s Trending Biotech Tickers

Alcobra Ltd.’s shares spiked 20.95 percent to close at $1.27 a share Tuesday. The stock traded between $1.08 and $1.33 on volume of 4.50 million shares traded. Alcobra is primarily focused on the development and commercialization of their proprietary drug, METADOXINE EXTENDED RELEASE (MDX), to treat cognitive disorders including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome (FXS). Analysts at Zacks Investment Research recently upgraded the company’s rating from a “hold” to a “buy” in a note to investors. Consensus of analysts has called for a “hold” rating for the company. On January 17th, Alcobra reported MDX failed to reach its primary endpoint in a recent Phase 3 clinical trial for the treatment of ADHD in adult patients.

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Infinity Pharmaceuticals’ shares surged 21.26 percent to close at $2.51 a share Wednesday. The stock traded between $2.05 and $2.55 on volume of 4.03 million shares traded. Infinity is currently developing IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma. A Phase 1 study in patients with advanced solid tumors is ongoing. On January 20th, the company presented preclinical data for IPI-549 at the Keystone Symposia Conference.

“The data presented suggest that targeting PI3K-gamma by IPI-549 within immune-suppressive myeloid cells in the tumor microenvironment could offer a unique way to both enhance the activity of checkpoint inhibition in sensitive tumors, as well as to overcome tumor resistance to checkpoint inhibition. Infinity is excited to be at the forefront of developing a potentially transformative approach within immuno-oncology, and we look forward to reporting additional data from our Phase 1 study of IPI-549 later this year,” stated Jeffery Kutok, M.D., Ph.D., vice president of biology and translational science at Infinity Pharmaceuticals and a plenary speaker at the conference.

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Today’s Research Coverage Includes:

Alcobra Ltd. (NASDAQ: ADHD)

Infinity Pharmaceuticals Inc. (NASDAQ: INFI)

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