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30.04.26 - 11:36
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Regeneron Q1 2026 net income falls 10% to $727m (PBR)
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On a non-GAAP basis, net income rose 12% to $1.04bn from $928m. GAAP diluted earnings per share (EPS) stood at $6.75 while non-GAAP diluted EPS grew 15% year-on-year
The post Regeneron Q1 2026 net income falls 10% to $727m appeared first on Pharmaceutical Business review....
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24.04.26 - 20:45
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FDA Approves First Gene Therapy To Treat Deafness (ZeroHedge)
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FDA Approves First Gene Therapy To Treat Deafness
Authored by Zachary Stieber via The Epoch Times (emphasis ours),
Federal regulators on Thursday approved the first gene therapy to restore hearing, just two months after the therapy's maker formally requested a license.
Dr. Marty Makary, the Food and Drug Administration's commissioner, in an undated file photograph. Madalina Vasiliu/The Epoch Times
The Food and Drug Administration approved the Regeneron therapy, Otarmeni, for children and adults with severe or profound hearing loss associated with OTOF gene variants.
The approval came 61 days after Regeneron filed for a biologics license, under a new effort known as the Commissioner's National Priority Voucher Program that emphasizes quickly reviewing applications for products that address unmet needs.
“Today's approval is a significant milestone in the treatment of genetic hearing loss,” Dr. Marty Makary, the FDA's commissioner, said in a statement.
“Through the national priority vo...
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