Gilead Sciences (GILD) has reported that it is aware of positive data emerging from the critical National Institute of Allergy and Infectious Diseases’ (NIAID) study of remdesivir for the treatment of COVID-19.
“We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing” the company said in a press release on April 29. Trading in the stock was briefly halted, before shares surged 9% in Wednesday’s pre-market trading.
The randomized, controlled NIAID trial “has all the necessary scientific standards that are really going to help us define if this drug works or not,” Dr. Kalil, a professor at the University of Nebraska Medical Center told Reuters recently.
At the same time, Gilead also revealed positive results from the Phase 3 SIMPLE trial in severely ill COVID-19 patients.
At Day 14, 64.5% (n=129/200) of patients in the 5-day treatment group and 53.8% (n=106/197) of patients in the 10-day treatment group achieved clinical recovery.
The data showed that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course.
The 5-day treatment course should significantly expand the number of patients who could be treated with the company’s current supply of remdesivir.
“Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug” says Gilead.
“These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir.”
With shares spiking 21% year-to-date, analysts have a cautiously optimistic Moderate Buy consensus on GILD right now. Their average price target of $77 indicates marginal downside from current levels. (See Gilead stock analysis on TipRanks).
“Despite the encouraging announcement, we remind investors that Gilead has also stated its intention to make the first 1.5M vials manufactured available for free” comments Needham analyst Alan Carr.
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