DBV technologies

DBV presented at the Cantor conference data showing that 68.2% of children after three years of VIASKIN Peanut could tolerate a challenge of 12–14 peanuts without a reaction. The company has completed the pivotal studies, is in advanced talks with the FDA regarding submission of a Biologics License Application (Breakthrough Therapy designation) and expects the BLA submission in the near future. DBV has a liquidity runway of about one year and anticipates raising capital to finance commercialization while already preparing sales, reimbursement and manufacturing. It is also launching the THRIVE study to treat very young children (6–12 months) with the goal of long-term desensitization. » Mere på de.investing.com

DBV Technologies seeks to renew an at‑the‑market program (ATM) and files a shelf registration (Form S‑3ASR) to issue and sell ADSs of up to $150 million; Citizens JMP Securities is acting as placement agent. Each ADS represents five common shares; the volume includes both already-registered and newly registered ADSs and the terms remain unchanged. The company intends to use net proceeds primarily for production expansion, biologics regulatory filings for 1- to 7-year-olds, the launch of Viaskin Peanut for 4- to 7-year-olds, development of additional candidates, and general corporate purposes. After the announcement the stock fell about 3.7%. » Mere på de.investing.com

DBV Technologies reports additional data from the phase‑3 VITESSE study: about 83% of children treated with the VIASKIN patch showed an increased eliciting dose after 12 months versus 48% in the placebo group. The study met the primary endpoint with 46.6% responders in the treatment arm versus 14.8% in the placebo arm; tolerability was good, mostly mild local reactions. DBV plans to submit a Biologics License Application to the FDA in the first half of the year. » Mere på de.investing.com