NEW YORK, NY / ACCESSWIRE / July 19, 2018 / Shares of CTI Biopharma tanked nearly 44% yesterday while shares of Crinetics Pharmaceuticals exploded 44%. The former announced an update from an FDA meeting regarding the company's investigational drug pacritinib. Per FDA feedback, the company will now have to conduct a Phase 3 trial. Crinetics Pharmaceuticals soared on its first day of trading.
RDI Initiates Coverage on:
CTI BioPharma Corp.
Crinetics Pharmaceuticals, Inc.
CTI BioPharma Corp. shares closed down 43.36% on Wednesday on a little over 5 million shares traded. The stock sank to a new low of $2.25 after the company announced the outcome of its type B meeting with the FDA related to its investigational drug pacritinib. The purpose of the meeting was to discuss the regulatory pathway for the drug. According to the Food and Drug Administration's feedback, CTI BioPharma will have to conduct a Phase 3 trial to evaluate this second-generation JAK2 inhibitor for the treatment of myelofibrosis patients suffering from thrombocytopenia or who have already been treated with ruxolitinib. The new Phase 3 study is expected to open in 2019. CEO of the company, Adam R. Craig, M.D., Ph.D., commented, "We have received the clarity we requested from the FDA on a regulatory path to possible approval in the U.S., and look forward to using all available data, including pharmacokinetic analyses, to select the optimal dose for a new Phase 3 study. The new study is expected to address the unmet medical needs of patients with myelofibrosis, particularly those with severe thrombocytopenia. We plan to request an additional meeting with the FDA, after the second interim analysis, to discuss interim data from PAC203 and the design of the new Phase 3 study."
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Crinetics Pharmaceuticals, Inc. shares were up a staggering 44% on high volume on Wednesday as the stock made its debut in the market. The biotech company priced its IPO at the top end of its $15 to $17 price range. Selling 6 million shares the company raised $102 million. Per Yahoo, the company is a clinical stage pharmaceutical company founded by a team of scientists with a track record of endocrine drug discovery and development. The company is focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. It was this past March that the Company reported initial results from a Phase 1 trial with its lead product candidate, CRN00808, an oral somatostatin agonist for the treatment of acromegaly, an orphan disease affecting more than 25,000 people in the United States. The Company is also developing other oral somatostatin agonists for hyperinsulinism and neuroendocrine tumors, as well as an oral nonpeptide ACTH antagonist for the treatment of Cushing's disease.
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