NEW YORK, NY / ACCESSWIRE / July 3, 2017 / CEL-SCI was one of the biggest gainers on the NYSE last Friday as traders seemed very encouraged by how quickly the company plans to address changes that the FDA has asked for in its multikine investigator brochure. Shares of Opko health saw a slight decrease on Friday but has kept its "buy" rating from firm Ladenburg Talmann.
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Opko Health, Inc.
CEL-SCI Corporation's shares won big this past Friday, closing up the day with a gain of 19.25%. The stock even hit high of $2.47 during intra-day trading. It was announced last week that the company has received a letter from the U.S. Food and Drug Administration on its June 2nd submission of its multikine investigator brochure. The FDA has requested three additional changes need to be made and instructed on what the changes were specifically. CEL-SCI has said it plans to quickly make these changes and submit their response to the FDA as soon as possible after the Fourth of July holiday is over. Multikine is the company's very first immunotherapeutic agent being developed as a first-line treatment for advanced primary head and neck cancer. It has already been cleared by regulators in 24 countries around the globe for a study in a worldwide Phase III clinical trial in advanced primary head and neck cancer patients who have not yet been treated. The trial should be the largest clinical trial for head and neck cancer ever done.
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Opko Health, Inc.'s shares closed down a modest 0.90% this past Friday. There was no remarkable news for the diversified healthcare company on Friday, but near the end of last month, the Kidney Disease Improving Global Outcomes (KDIGO) organization updated its Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder. Opko CEO stated, "The updated KDIGO guideline highlights the unmet needs that exist in the treatment of SHPT, and we are working with physicians and other health care professionals to address these needs with Rayaldee." Rayaldee are extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. Last month firm Ladenburg Talmann Financial Services reiterated a "buy" rating on the stock and has a $19.50 price target on it. Shares close at $6.58 on Friday.
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