NEW YORK, NY / ACCESSWIRE / August 7, 2017 / It was a good day for pharma giants Cara Therapeutics and Spectrum Pharmaceuticals. Cara saw significant gains after the company updated investors about its CR845 candidate. Spectrum also gained on strong second quarter results and updates on several of its own candidates.
RDI Initiates Coverage on:
Cara Therapeutics, Inc.
Spectrum Pharmaceuticals, Inc.
Cara Therapeutics, Inc.'s shares closed up 22.86% on Friday with nearly 5 million shares traded. The biotech company focused on pharmaceutical product development for better pruritus and pain management reported its second quarter financial results as well as an update on its clinical stage drug development programs. For the period, the company reported loss per share of $0.29 cents for the quarter, beating the consensus estimate of loss of $0.61 by $0.32. What really may have excited traders was the company's plans for CR845, the first peripherally acting kappa opioid receptor agonist (KORA). Cara's management plans to meet with the FDA soon over a pivotal phase 3 trial for IV CR845 in uremic pruritis. The trial could start before 2017 ends. The company also plans to complete enrollment in a phase 3 trial of IV CR845 to treat acute postoperative pain in the fourth quarter.
CEO Derek Chalmers, Ph.D., D.Sc., commented, "During the quarter, we continued to make good progress with our CR845 development programs in acute postoperative pain, chronic osteoarthritis pain and chronic kidney disease-associated pruritus. Importantly, we were very pleased to receive Breakthrough Therapy designation from the FDA for I.V. CR845 for the treatment of CKD-aP in hemodialysis patients, and expect to meet with the FDA in the third quarter of 2017 to finalize our pivotal program for this indication."
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Spectrum Pharmaceuticals, Inc.'s shares closed up 22.24% on Friday with a new high of $9.09 hit during intra-day trading. Trading volume for the stock was more than four times higher than usual after announcing better than expected second quarter earnings results. The international biotech company reported a loss of 26 cents per share for the period, which was narrower than the loss of 27 cents that Wall Street was expecting. It was also better than the 35 cent loss the company reported in the year ago period. Traders were also encouraged about the company's poziotinib and rolontis candidates and over Folotyn being approved in Japan. FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma while ROLONTIS is indicated for Chemotherapy-induced neutropenia. Poziotinib is in a phase II study in the U.S. and is currently enrolling breast cancer patients that have failed multiple HER-2 directed therapies. Interim data from this study is expected by the end of the year.
CEO Rajesh C. Shrotriya, MD, commented, "During the second quarter we made significant progress in our highest priority clinical programs and achieved solid performance across our commercial business. We completed enrollment in ROLONTIS's ADVANCE registrational Phase 3 study ahead of schedule and enrollment in a second international study RECOVER is well under way in Europe and U.S. We are also very excited about the prospects of poziotinib in cancer patients with exon 20 insertion mutations and expect interim results from the Phase 2 lung cancer study before the end of the year. We are driven to bring our novel drugs to patients with unmet medical needs and look forward to multiple near-term development catalysts that could shape the Company's future." Shares of the stock have seen a gain of more than 102% this year so far.
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