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Top related persons:
Andrew Kelly - 1 William Blair - 1 Tim Lugo - 1 Stacey Saiontz - 1 anaphylaxis - 1 James Tarbox - 1 Christy Santhosh - 1 Sriparna Roy - 1
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U.S Bengaluru White Oak , Maryland anaphylaxis
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Thomson - 2 Food and Drug Administration - 1 FDA - 1 REUTERS - 1 ARS Pharmaceuticals - 1 U.S . Food - 1 Pharma - 1 Regulators - 1

Search resuls for: "Tim Lugo"


4 mentions found


☆ Nasal spray alternative to EpiPen suffers setback as FDA seeks fresh study
  + stars: | 2023-09-20 | by ( Sriparna Roy Jahnavi Nidumolu | Sriparna Roy | Jahnavi Nidumolu | ) www.reuters.com   time to read: +2 min
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. The rejection and request for additional testing sharply contrasts the backing from the U.S. Food and Drug Administration's (FDA) independent experts for the spray, neffy, in May. EpiPen-maker Viatris (VTRS.O) had in June petitioned the FDA to require that ARS conduct more trials that closely mimic real-world conditions. It did not test neffy in anaphylaxis, a severe, life-threatening allergic reaction, due to ethical concerns. ARS expects to re-submit its application in the first half of 2024, with an FDA decision likely in the second half.
Persons: Andrew Kelly, William Blair, Tim Lugo, Stacey Saiontz, anaphylaxis, James Tarbox, Christy Santhosh, Sriparna Roy, Jahnavi, Varun Organizations: Food and Drug Administration, FDA, REUTERS, ARS Pharmaceuticals, U.S . Food, Pharma, Regulators, ARS, Texas Tech University Health Sciences Center, Thomson Locations: White Oak , Maryland, U.S, anaphylaxis, Bengaluru
☆ Sarepta slumps as concerns emerge around upcoming gene therapy data
  + stars: | 2023-06-23 | by ( ) www.reuters.com   time to read: +2 min
June 23 (Reuters) - Sarepta Therapeutics shares (SRPT.O) slumped 11% on Friday as some analysts voiced concerns that upcoming confirmatory trial data for its gene therapy to treat Duchenne muscular dystrophy (DMD) may not be enough to secure approval for expanded use. The U.S. health regulator had on Thursday granted Sarepta's Elevidys therapy accelerated approval to treat DMD patients aged between 4 and 5 years who can walk, contrary to the company's application for all patients who can walk. Sarepta's gene therapy is the first of its kind for DMD, an inherited progressive muscle-wasting disorder that almost always affects young boys. Elevidys, a one-time treatment, is expected to change the way that DMD patients are treated as current therapies require regular use. William Blair's Tim Lugo called the treatment "transformational for Duchenne's patients" and "a significant opportunity for Sarepta".
Persons: Sarepta's, Gavin Clark, Gartner, William Blair's Tim Lugo, Leroy Leo, Khushi, Devika Organizations: Sarepta Therapeutics, Food and Drug, BioMarin Pharmaceuticals, Thomson Locations: U.S, Bengaluru
☆ Sarepta surges after FDA panel backs Duchenne gene therapy
  + stars: | 2023-05-15 | by ( ) www.reuters.com   time to read: +2 min
May 15 (Reuters) - Shares of Sarepta Therapeutics (SRPT.O) soared 29% premarket on Monday as a backing by the U.S. health regulator's advisers increased the certainty of an accelerated approval for the company's gene therapy for a muscle-wasting genetic disorder. Eight of the 14 advisers to the Food and Drug Administration late Friday voted that the company had enough data to support an accelerated approval for its gene therapy for Duchenne muscular dystrophy (DMD). The vote came after FDA staff had earlier last week voiced concerns that the data from the company's mid-stage trial lacked "unambiguous evidence" about benefits from the therapy. TD Cowen analyst Ritu Baral expects an approval for the therapy, especially considering the FDA leadership's interest in promoting biomarker-based accelerated approvals for gene therapies. The FDA, often follows the advice of its expert advisers but is not obligated to do so, is slated to make a decision on accelerated approval by May 29.
☆ FDA reviewers raise doubts over data on Sarepta's gene therapy
  + stars: | 2023-05-10 | by ( Leroy Leo | ) www.reuters.com   time to read: +2 min
May 10 (Reuters) - The U.S. Food and Drug Administration's staff reviewers raised concerns over limited data on Sarepta Therapeutics Inc's (SRPT.O) gene therapy for a muscle-wasting disorder, ahead of a meeting of the agency's advisers on Friday. The agency's staff on Wednesday highlighted several issues with the data and said that existing studies did not provide "unambigious evidence" that the gene therapy will benefit patients with Duchenne muscular dystrophy. The FDA also highlighted that DMD, a rare disorder that mainly affects young boys, is an urgent unmet medical need. The advisory committee's vote on Friday and an eventual decision by the FDA is seen as a test of the agency's accelerated approval pathway for gene therapies. Sarepta has three drugs available for the disease for people with different types of genetic mutations but they have to be given as weekly intravenous infusion, while the experimental gene therapy is a one-time treatment.
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