NEW YORK, NY / ACCESSWIRE / June 19, 2018 / Shares of PTC Therapeutics saw big gains in Monday trading after announcing positive data with its partner Roche on their spinal muscular atrophy drug, risdiplam. Shares of Catalyst Biosciences were plummeting after announcing a worrisome update on its ongoing phase ½ trial investigating its next generation Factor IX (FIX) candidate CB 2679d/ISU304.
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PTC Therapeutics, Inc.
Catalyst Biosciences, Inc.
PTC Therapeutics, Inc. shares closed up 27.51% on about 11.7 million shares traded yesterday. The stock hit a new high of $52.95 during intra-day trading after the company and its co-developing partner Roche presented data on their spinal muscular atrophy (SMA) drug, risdiplam, at the 22nd Annual SMA Researcher Meeting. This is the highest price the stock has seen since August of 2015. It was over the weekend that PTC Therapeutics reported that after 182 days of treatment, 91 percent of babies on the drug improved more than four points on a scale that measures motor milestone developments in patients with a form of spinal muscular atrophy, or SMA. The babies demonstrated improvement that included the ability to control their heads, and to roll or sit. "While we think gene therapy is the most important competitor, given they could be on the market in 2020 and a one-time infusion, of course an oral would be a major competitor as well if the data is at least similar to" Biogen’s drug Spinraza, remarked Jefferies analyst Michael Yee. Spinraza was the first drug to be approved to treat SMA.
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Catalyst Biosciences, Inc. shares took a big tumble in Monday trading, closing the day down nearly 64%. Trading volume was tremendous compared to usual at about 7.4 million shares compared to an average of just around 180,000 shares. The clinical-stage biopharma company provided an update yesterday on its ongoing phase 1/2 trial that is investigating its next generation Factor IX (FIX) candidate CB 2679d/ISU304. The trial is being conducted by the company's collaborator ISU Abxis in South Korea. Catalyst said the data showed a presence of a neutralizing antibody in a couple of its patients in its most recently added cohort. It was in April that the trial had Cohort 6 added to it, where each patient receives a single loading dose of 75 IU/kg CB 2679d/ISU304 given intravenously. The dose will then be followed by nine daily subcutaneous doses of 150 IU/kg CB 2679d/ISU304, beginning 30 minutes after the intravenous dose. CEO of Catalyst, Nassim Usman, Ph.D., commented, "The most recent data from the ongoing Phase 1/2 trial have demonstrated clinical proof of concept for subcutaneous dosing of a potent FIX as a treatment for hemophilia B. Patients in Cohort 6 of the trial were able to maintain Factor IX levels over 30% which is at the upper end of mild hemophilia and higher than currently approved extended half-life (EHL) intravenous Factor IXs. Our next steps will be to carefully identify the cause and nature of the antibodies and provide further updates once we have the results of our analysis."
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