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Pfizer's latest DMD data release supports the start of Phase 3 trials, but should not inspire investors that it is a winner in the space. CAMBRIDGE, Mass., June 26, 2020 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the Company has completed the submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for casimersen (SRP-4045). Shares of Nio Inc. shot up 8.8% into record territory in premarket trading Tuesday, after the China-based electric car maker reported a second-quarter loss that was about half what was expected as revenue more than doubled, and provided an upbeat deliveries outlook for the current quarter. About 8% of the children who have DMD have the gene mutation that Vyondys 53 treats.The “Vyondys 53 approval removes a major overhang for the stock as concerns surrounding the future SRPT’s commercial products such as Exondys 51 being pulled from the market and cash flows required to support SRPT’s growing gene therapy platforms have now been lifted,” SVP Leerink’s Joseph Schwartz wrote on Dec. 12. All rights reserved. Casimersen works in a similar fashion to Sarepta's first drug for DMD, Exondys 51, which was … Deliveries reached a quarterly record of 10,331 vehicles, and the company expects a further increase to 11,000 to 11,500 vehicles in the third quarter. (When you consider that the advisory committee meeting on this was back in April, you get the idea). Elizabeth Regan / Industry Dive
Sarepta's Vyondys 53 Receives FDA Approval for DMD, Stock Up The free newsletter covering the top industry headlinesTopics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more.The free newsletter covering the top industry headlinesTopics covered: Pharma, biotech, FDA, gene therapy, clinical trials, drug pricing and much more. "Beyond the strong order growth, we are proud to reach a milestone quarter with respect to the key financial metrics of the company, highlighted with the historically high vehicle gross margin of 9.7%, lowest-ever operating losses and more importantly, a positive cash flow from operations for the first time in our history," said Founder and Chief Executive William Bin Li. Aug 12, 2020 The FDA’s attitude toward Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) therapies is nothing short of dramatic. In just four months, the agency shocked industry watchers twice, first with a rejection and now a reversal for the biotech’s Exondys 51 follow-on.While the FDA didn’t elaborate on the sudden change of course, Sarepta said it had Controversy erupted in 2016 when Sarepta’s Exondys 51 won an FDA thumbs-up based on dystrophin data without showing actual clinical benefits such as improvement on disease progression. Citi Group analyst Joel Beatty said it was now more likely that Sarepta would be able to win approval for Duchenne treatment casimersen and gene therapies it is developing.
The FDA granted accelerated approval to Sarepta Therapeutics Vyondys 53 (golodirsen), a Duchenne muscular dystrophy drug it turned down just four months ago for safety reasons. (Reuters) - Shares of Sarepta Therapeutics Inc soared 32% on Friday after U.S. regulators shocked Wall Street by reversing their rejection of its muscle-wasting disorder therapy less than four months ago, to allow the drug’s immediate launch.
Novavax will have billions of doses of COVID-19 vaccine capacity next year and could single-handedly meet U.S. demand, executives said.Enclose phrases in quotes. The FDA approval remained contingent on the results of a post-approval trial expected to conclude by 2024, for which Sarepta is enrolling patients. Sep 14 – Sep 16, 2020 Jefferies analyst Michael Yee said the change of heart could have implications for a review of Biogen Inc’s Alzheimer’s drug, aducanumab. Sarepta Therapeutics shocked the market with news of a quicker-than-expected approval by the Food and Drug Administration for the company’s Duchenne Muscular Dystrophy … Total revenue rose 146.5% to RMB3.72 billion ($535.4 million), to beat the FactSet consensus of RMB3.51 billion.
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