More than seven years after DBV Technologies made its initial bid for approval of its Viaskin Peanut allergy patch, and several setbacks later, new data suggest the company's additional labours may have been worthwhile.
The drugmaker's shares jumped more than 60% during after-hours trading Tuesday when it reported that the pivotal Phase III VITESSE trial of Viaskin Peanut met its primary endpoint. On the back of the study's success, DBV plans to submit a biologics licensing application (BLA) for the patch to the FDA in the first half of 2026. Viaskin Peanut holds breakthrough therapy designation from the FDA, and DBV expects its submission "may be eligible for priority review."
The readout also triggered welcome financial news for the company, which had inked a financing in March worth up to $306.9 million. While $125.5 million was immediately available to DBV, the remaining $181.4 million could only be drawn down based on the satisfaction of specified conditions. Now that VITESSE has hit its primary endpoint, the exercise period of some of the warrants will accelerate.
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