Gilead Submits New Drug Application With FDA For Remdesivir

Gilead Sciences Inc. announced on Monday that it has filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for remdesivir, its investigational antiviral for the treatment of patients with COVID-19.

Gilead (GILD) said the filing is the “final tier” of the rolling NDA submission that was initiated on April 8. The antiviral, which will be sold under the brand name Veklury, is currently available in the US under an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19.

Remdesivir is a viral RNA polymerase inhibitor which means that it interferes with the production of viral genetic material, preventing the virus from multiplying.

“Since the beginning of the pandemic, Gilead has worked with urgency to establish the efficacy and safety profile of Veklury, and we now have a robust data set supporting the evaluation of use of the drug across a range of hospitalized COVID-19 patient populations,” said Gilead’s Chief Medical Officer Merdad Parsey. “Today’s filing is an important milestone as we continue to partner with the US government and healthcare authorities around the globe to address the treatment needs of patients with COVID-19.”

The application is supported by data from two randomized, open-label, multi-center Phase 3 clinical studies of remdesivir conducted by Gilead and the Phase 3 randomized, placebo-controlled study of remdesivir conducted by the National Institute of Allergy and Infectious Diseases (NIAID). These studies showed that treatment with remdesivir led to faster time to recovery compared with placebo and that a 5-day or 10-day treatment duration led to similar clinical improvement. Across both studies, remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups, with no new safety signals identified.

Remdesivir has been approved by multiple regulatory authorities around the world, including the European Union and Japan. In countries where remdesivir has not been approved, including the US, it has the status of an investigational drug, which means that its safety and efficacy have not been established.

Gilead has in recent weeks inked a number of manufacturing and supply agreements with drugmakers as the company has a target to produce more than 2 million remdesivir treatment courses by the end of this year, and several million more treatment courses in 2021.

Shares in Gilead have advanced about 5% year-to-date. The $82.93 average price target implies another 22% upside potential in the shares in the coming 12 months.

J. P. Morgan analyst Cory Kasimov reiterated a Hold rating on the stock with a $81 price target, saying that it is difficult to value GILD based on a P/E multiple given the potential lumpiness in future earnings.

“Looking ahead, we believe much of the focus / debate will be around how big and durable of a product remdesivir can be as well as other opportunities for growth (whether it be HIV/PrEP, filgo, oncology/cell therapy, or through further M&A/BD),” Kasimov said. “Until these drivers emerge, we’re most comfortable at a Neutral rating.”

The rest of the Street is cautiously optimistic on the stock with a Moderate Buy analyst consensus based on 10 Buy ratings versus 10 Hold ratings. (See Gilead stock analysis on TipRanks).