Gilead Sciences Jumps Higher After FDA Gives Coronavirus Treatment 'Orphan Drug' Status

The FDA's Orphan Drug status gives Gilead's remdesivir, a nascent coronavirus treatment, incentives for faster clinical trials and years of exclusivity.
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Gilead Sciences  (GILD) - Get Report shares jumped higher Tuesday after the U.S. Food & Drug Administration gave its nascent cornavirus treatment special status that could allow it to come to market faster than through a typical approval process.

Gilead's developing coronavirus treatment, remdesivir, was designated as an 'orphan drug' by the FDA late Monday, a label that provides specials status for drugs that combat rare diseases. The treatment, which was first designed to combat the Ebola virus, had been used on so-called compassionate grounds in Europe and the United States until the company had to limit access late last week due to an "exponential increase" in requests.

"This has flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic," the company said in a statement.

"To streamline the emergency access process, Gilead is currently in the process of transitioning from individual compassionate use requests to expanded access programs," Gilead added. "This approach will both accelerate access to remdesivir for severely ill patients and enable the collection of data from all participating patients." 

Gilead shares were marked 2.6% higher in early trading Tuesday to change hands at $74.58 each, a move that would extend the stock's two-month gain to around 20% 

Last month, Gilead said that around 1,000 patients suffering from both moderate and severe coronavirus symptoms were given varying doses of remdesivir as part of a Phase 3 study after the World Health Organization said the drug may be the "only one drug right now that we think may have real efficacy" in treating the rapidly-spreading disease.

Gilead said it expects results from those trials as early as next month, and has vowed to increase supplies "as early as possible" in the near term.

In early February, U.S. doctors treating the first domestic case of the disease used the treatment, which has not yet been approved by any medical authority, on compassionate grounds only to see the patient's pneumonia-like symptoms subsequently improve, according to a New England Journal of Medicine report.