The antiviral drug Remedivir received marketing approval on Thursday from the US Food and Drug Administration as a Kovid-19 treatment. for
The sale of the drug, which will market the drug under the brand name Vecleri, could help the company go through a growing competition for treatment of HIV and hepatitis.
Gilead stock (ticker: GILD) was up nearly 4% on Friday after the news, down to the $ 63 level.
Gilead Chief Medical Officer Maradad Parsi said in a release on Thursday that the company had accelerated production of Vecleri and would be able to meet the global demand for the drug by next week.
Until vaccines end the Kovid epidemic, analysts expect billions of dollars in annual sales for treatments such as Veakleri and other measures that have received FDA’s Emergency Use Authority or full approval. An antibody infusion from
(REGN) was given to President Donald Trump along with Gilead’s medication during his Kovid hospitalization. Regenon and his rival
(Only) seeking emergency authorization for their antibody treatment.
SVB Leerink analyst Geoffrey Porges has high expectations for Veklury’s revenue and has cited the product as a major reason for its outperform rating on Gilead stock – which he thinks could reach $ 88. National governments can stock the drug against future outbreaks.
In Raymond James, Steven Seedhouse has cooled towards stocks with a market performance rating. But he acknowledges in Thursday’s note that FDA approval is “a very good case” [Gilead]. “
Full approval sets the precedent for Vecleri Kovid vaccines, following a first emergency use authority, as the first Kovid measure to cross the finish line. If current clinical trials produce good results, then the preferred vaccines
(MRNA) will get emergency authorization quickly. A panel of vaccine experts convened by the FDA on Thursday expressed concern that the widespread use of a vaccine under such temporary authorization may make it harder to continue the placebo-controlled trials required for full approval and safety monitoring.
Yesterday’s approval for Veklury fulfills Gilead’s many post-marketing needs. It should conclude the study of the drug in children and pregnant women, check for any viral resistance, and study the effects of Vecleri on the heart, liver, and kidneys. At Thursday’s FDA hearing, agency officials said they would fight hard to require vaccine developers to continue double-blind, placebo-controlled trials, even after any emergency use authorities.
Write Bill Alpert at [email protected]