Moderna Jumps on FDA Nod for Phase 2 Coronavirus Vaccine Study

Moderna jumps after it says it has received emergency FDA approval to proceed with phase 2 trials of a Covid-19 vaccine candidate.
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Shares of biotech giant Moderna  (MRNA) - Get Report jumped as much as 10% on Thursday after it said it received emergency Food and Drug Administration approval to proceed with phase 2 clinical trials of a vaccine candidate it is working on against Covid-19.

Modern also said it was finalizing plans for a phase 3 trial as early as this summer.

In its quarterly earnings release, Moderna said the FDA had completed its review of its Investigational New Drug (IND) application for its novel coronavirus vaccine candidate, and has approved allowing it to proceed to a Phase 2 study, expected to begin shortly.

“The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2,” Moderna CEO Stephane Bancel said in a statement.

“With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first BLA approved as soon as 2021,” Bancel said.

Moderna is already known for its work in vaccines that treat and prevent other types of infectious diseases, including the flu, but also more-malignant diseases such as malaria and the ziki virus. 

Part of its current efforts also include vaccines for pediatric respiratory syncytial virus (RSV), an Epstein-Barr virus (EBV) vaccine and an antibody against the chikungunya virus.

Separately, Moderna posted a first-quarter loss of $124.2 million, or 35 cents a share, vs. a loss of $132.6 million, or 40 cents a share, in the year-earlier period. The results matched analysts’ forecasts. 

Revenue came in at $8.4 million vs. $16 million for the three months ended March 31.

Shares of Moderna were up 6.64% at $52.20 in trading on Thursday.