Gilead Science’s (GILD) investigational antiviral Veklury (remdesivir) has now received expanded Emergency Use Authorization (EUA) from the FDA to treat all hospitalized patients with COVID-19. Previously the treatment was only authorized for patients hospitalized with severe COVID-19.
“As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease” cheered GILD’s Merdad Parsey. The CMO added: “Today’s action by the FDA enables physicians to consider a broader range of eligible patients to potentially receive Veklury.”
According to GILD, the expanded EUA is based on results from the Phase 3 SIMPLE trial evaluating remdesivir in hospitalized patients with moderate COVID-19 pneumonia, as well as results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalized patients
The primary endpoint evaluated patients at Day 11 on a 7-point ordinal scale and found patients randomized to a 5-day course of Veklury plus standard of care were 65% more likely to have an improvement in clinical status compared with those randomized to standard of care alone (OR, 1.65; 95% confidence interval, 1.09-2.48; p=0.017).
Veklury, an investigational nucleotide analog with broad-spectrum antiviral activity, was generally well-tolerated in both the 5-day and 10-day treatment groups, the company said.
Multiple ongoing international Phase 3 clinical trials are now evaluating the safety and efficacy of Veklury for the treatment of Covid-19, in different patient populations, formulations, and in combination with other therapies.
As this is an EUA, the FDA authorization is only temporary and may be revoked. It does not take the place of the formal new drug application submission, review and approval process.
Shares in Gilead are now trading flat year-to-date, and the stock scores a cautiously optimistic Moderate Buy Street consensus. That’s with an average analyst price target of $78- indicating 20% further upside potential lies ahead.
Mizuho Securities analyst Salim Syed is bullish on GILD’s outlook, even after it announced that its rheumatoid arthritis drug, filgotinib, which was under FDA review for marketing approval, received a complete response letter (i.e. a rejection because the FDA needs more data).
He reiterated a buy rating on the stock with an $81 price target on August 19, arguing that US filgotinib revenue in 2020 not super material (i.e. not much built in for 2020). (See Gilead stock analysis on TipRanks)
“We have been of the opinion that filgotinib could be the best-in-class JAK1 inhibitor, and while this CRL leads us to moderate our filgotinib sales expectations going forward (US approval from 2020 to late 2021E), it does not dim our enthusiasm for the drug” added Oppenheimer analyst Hartaj Singh.
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