Shares in Gilead Sciences (GILD) traded down 3.4% on Monday after the company announced topline results from its Phase 3 SIMPLE trial in hospitalized patients with moderate Covid-19 pneumonia.
This open-label study evaluated 5-day and 10-day courses of the investigational antiviral remdesivir plus standard of care, versus standard of care alone. The study demonstrated that patients in the 5-day remdesivir treatment group were 65% more likely to have clinical improvement at Day 11 compared with those in the standard of care group (OR 1.65 [95% CI 1.09-2.48]; p=0.017).
The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care trended towards- but did not reach- statistical significance (OR 1.31 [95% CI 0.88-1.95]; p=0.18).
No new safety signals were identified with remdesivir across either treatment group. Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.
“These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients” said Francisco Marty of Harvard Medical School.
Following the results, Needham analyst Alan Carr reiterated his Hold rating on GILD. “Our overall interpretation from both SIMPLE trials as well as the NIH ACTT-1 trial are that 5 and 10 day regimens are roughly equivalent and that the drug is of moderate benefit to COVID-19 patients” he explained.
While the analyst acknowledges a central role for the drug in the treatment of Covid-19, he awaits clarity, on how, when, and for what price remdesivir will be distributed in the U.S. and ex-U.S. “We expect remdesivir to play a prominent role in the treatment of COVID-19 given the lack of other options” Carr says.
Remdesivir is currently approved in Japan as a treatment for patients infected with SARS-CoV-2, the virus that causes Covid-19. Outside of Japan, remdesivir is an investigational, unapproved drug. The U.S. FDA granted remdesivir an Emergency Use Authorization for hospitalized patients with severe COVID-19, but this authorization is only temporary.
Overall, the stock has a Hold analyst consensus based on 16 recent hold ratings, vs 8 buy ratings and 4 sell ratings. Meanwhile the average analyst price target stands at $79 for upside potential of 5%. Shares are currently trading up 16% year-to-date. (See GILD stock analysis on TipRanks).
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