NEW YORK, NY / ACCESSWIRE / April 18, 2017 / The volatile Biotech Industry has continued to be home to some of the largest gainers on the market in 2017. President Trump's pledge for a faster FDA approval process has already paid dividends for the industry as the FDA has already approved 13 new drugs in 2017, compared to just 22 new drug approvals in 2016. The iShares NASDAQ Biotechnology Index ETF and SPDR S&P Biotech ETF have posted gains of 9.5 percent and 16.25 percent, respectively, year-to-date.
RDI Initiates Coverage on:
Cleveland BioLabs, Inc.
Infinity Pharmaceuticals Inc.
Cleveland BioLabs' shares soared 194.48 percent to close at $4.80 a share on Monday. The stock traded between $2.03 and $4.88 on volume of 39.03 million shares traded. On Monday, the company announced that the FDA has given its consent for the initiation of an in vivo biocomparability study of two formulations of entolimod. Entolimod is being developed as a treatment for acute radiation syndrome. Shares of Cleveland BioLabs have gained approximately 238.03 percent year-to-date.
"We are excited to have received agreement from the FDA to commence the in vivo biocomparability study," continued Yakov Kogan, PhD, MBA, Chief Executive Officer. "Following completion of the in vivo study and discussion of the submitted study results with the FDA, we expect the agency to resume the review of our pre-EUA dossier."
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Infinity Pharmaceuticals' shares spiked 19.02 percent to close at $2.19 a share on Monday. The stock traded between $1.85 and $2.20 on volume of 3.40 million shares traded. Infinity's IPI-549 is an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma. Earlier this month, the company presented updated Phase 1 clinical data for IPI-549 at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington, D.C. Shares of Infinity Pharmaceuticals have gained approximately 62.22 percent year-to-date.
"Our preclinical research demonstrates that IPI-549 could offer a unique approach within immuno-oncology by reprogramming macrophages from a pro-tumor to an anti-tumor phenotype, thereby activating anti-tumor T cells," commented Jeffery Kutok, M.D., Ph.D., Chief Scientific Officer at Infinity. "These data reported today are promising and represent a significant de-risking for our clinical program. We look forward to completing the dose-escalation modules of this study, and in the second half of 2017, we expect to initiate the expansion modules where we will continue to evaluate safety and also assess the activity of IPI-549 alone and in combination with Opdivo."
Access RDI's Infinity Pharmaceuticals Research Report at:
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