Fierce Pharma November 10, 2023
Valneva has won the race in the U.S. to gain approval of its vaccine for the chikungunya virus and the valuable award that goes along with it.
The FDA green light—which is the world’s first for the chikungunya virus—is accompanied by a priority review voucher (PRV) that can reduce the review of a drug application from six to three months. Valneva said it will sell the PRV to monetize its R&D programs.
Hours before the regulator revealed the green light on Thursday, the French company—in its quarterly earnings presentation—included a boost of between 90 million euros and 110 million euros ($96 million and $117 million) from the sale of the PRV in its 2023 revenue guidance.
Valneva beat out several...