Moderna (MRNA) has announced that the FDA has completed its review of the company’s Investigational New Drug (IND) application for its novel coronavirus vaccine candidate (mRNA-1273).
The FDA will now allow the vaccine to proceed to a Phase 2 study, which is expected to begin shortly, Moderna revealed. Shares are surging 15% in Thursday’s pre-market trading, with the stock already recording a whopping 150% year-to-date gain.
Looking further ahead, the company is also finalizing the protocol for the Phase 3 study of mRNA-1273, which is expected to begin in early summer of 2020.
“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. 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 (biologics license application) approved as soon as 2021” says Stéphane Bancel, Moderna’s CEO.
Moderna notes that it was awarded up to $483 million funding from BARDA for accelerated development of mRNA-1273, and has also entered into a strategic collaboration with Lonza Ltd. to manufacture up to one billion doses of mRNA-1273 per year.
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.
For instance the company also announced positive interim results from its Phase 1 Zika vaccine candidate (mRNA-1893) study.
Although analysts have a Strong Buy consensus on Moderna stock, its recent rally means that the $46 average analyst price target now indicates 6% downside potential from current levels. (See MRNA stock analysis on TipRanks).
“We note our model currently ascribes modest long-term sales projections for mRNA-1273 given limited visibility on commercial prospects for the program in the long term” comments Chardan Capital analyst Geulah Livshits. She has a buy rating on the stock and $52 price target, adding “We do believe there is a possibility of governments selecting mRNA-1273 for stockpiling in 2021-22.”
Japan Plans To Approve Gilead’s Remdesivir Today- Report
Sarepta Reports Earnings Miss; But Key SRP-9001 Data Still On Track
Global Blood Therapeutics Reports Q1 Beat, Impressive Oxbryta Sales