Gilead Sciences (GILD) has now filed for conditional marketing authorization (CMA) of its antiviral medicine remdesivir for the treatment of COVID-19 with the European Medicines Agency (EMA).
The EMA reports that it has now formally started its evaluation of remdesivir under a reduced timeline and an opinion could be issued within weeks. The speed will depend on the robustness of the data and whether further information is required, says the EMA.
Such a short timeframe will only be possible because some data have already been assessed during the first cycle of a rolling review, which started on 30 April and ended on 15 May. Following this, Gilead was invited to submit further data together with a CMA application.
Should the additional data show that the benefits of remdesivir outweigh its risks, the EMA will work with the European Commission to support fast-tracking of the decision-making process and granting of a marketing authorization by the European Commission.
Remdesivir is a viral RNA polymerase inhibitor which means that it interferes with the production of viral genetic material, preventing the virus from multiplying.
It has shown broad in vitro activity against different RNA viruses, including SARS-CoV-2 and was originally developed for the treatment of Ebola virus disease.
Although remdesivir is not yet authorized for marketing in the European Union, it is available to patients through clinical trials and compassionate use programs.
Shares in GILD have soared 18% year-to-date, but analysts have a cautious Hold consensus on the stock with 10 buys, 14 holds and 4 sells. The average analyst price target stands at $80 (4% upside potential). (See Gilead’s stock analysis on TipRanks)
Nonetheless over the last week, Leerink upgraded GILD to Buy citing the company’s recent Arcus Biosciences (RCUS) investment, and three further analysts published buy ratings on June 8. Following the news of a potential AstraZeneca (AZN) merger, RBC Capital’s Brian Abrahams reiterated his buy rating with an $88 price target.
The analyst wrote “GILD’s size and improving strategic direction under new leadership will likely create hurdles to a deal of this magnitude actually getting done” but added “most importantly, we see this news as bringing to the forefront GILD’s underappreciated core HIV business, virology expertise, and emerging oncology/immunology pipeline — all of which we believe will continue to drive steady, low-risk, long-term cash flows”.
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