A new eye medicine from Regeneron Pharmaceuticals (REGN) and Bayer AG was a safe and effective way of treating vision loss from macular degeneration, a U.S. advisory panel unanimously said on Friday.
The advisers to the Food and Drug Administration also said the drug, to be marketed as Eylea, could be dosed once every two months, giving it an edge over the typical monthly dosing of its chief competitor, Lucentis, from Roche Holding .
“The data is very compelling for equivalence (with Lucentis),” said Dr. Lynn Gordon, a panel member and associate professor in the department of ophthalmology at the University of California in Los Angeles.
The FDA usually approves medicines that win advisory panel backing and is expected to rule on Eylea by Aug. 20. The panel voted 10-0 in favor of the medicine.
There were several hedge funds that were bullish about Regeneron before this decision is announced. Here are the winners:
1. Carl Icahn – Icahn Capital: Had $109 Million in REGN at the end of March.
2. Jacob Gottlieb – Visium Asset Management: Had$55 Million in REGN at the end of March.
3. Daniel Gold – QVT Financial: Had$52 Million in REGN at the end of March.
4. Arthur Cohen and Joe Healey – HealthCor: Had$9 Million in REGN at the end of March.
5. Samuel Isaly – OrbiMed Advisors: Had $4 Million in REGN at the end of March.
Regeneron gained 26.2% between April 1st and June 16th. So Carl Icahn already made $29 Million before the FDA panel’s decision.