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Tuesday, May 12, 2020 12:36:28 PM
The fast track status designation is awarded to speed up the regulatory review of its novel coronavirus vaccine candidate (mRNA-1273).
Last week, the FDA completed its review of Moderna’s Investigational New Drug (IND) application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. The clinical stage biotech company said it is finalizing the protocol for a Phase 3 study, expected to begin in early summer of 2020.
“Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” said Tal Zaks, Chief Medical Officer at Moderna. “As we await the full set of clinical data from the NIAID-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2.”
By utilizing messenger RNA (mRNA) science, Moderna hopes to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases.
Moderna shares dropped 2.7% to $65.04 in morning U.S. trading after the stock more than tripled this year.
Five-star analyst Yasmeen Rahimi at Roth Capital raised Moderna’s price target to $68 from $41, while maintaining a Buy rating on the shares, saying that with the near-term start of a Phase 2 study for its COVID-19 vaccine, the company remains the front-runner in getting a vaccine to pivotal trials with potential approval by 2021.
Although analysts have a Strong Buy consensus rating on Moderna stock based on 9 Buys and 2 Holds, its recent rally means that the $54.30 average price target now indicates 17% downside potential from current levels.
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