DBV: share soars on good news from US
(CercleFinance.com) - DBV shares soared nearly 30% on the Paris stock exchange on Thursday, after announcing that it had reached agreement with the FDA on the key elements of its Phase 3 study in peanut-allergic children.
The biopharmaceutical company reports that it has reached agreement with the US health agency on the number of patients to be included, and on the methodology for collecting and analyzing patch wear time.
The study, which is placebo-controlled, aims to obtain additional data on the safety (primary endpoint) and adherence of the Viaskin Peanut patch in peanut-allergic children aged between one and three years.
In a press release, DBV says it is delighted to have received a 'clear and reasonable' regulatory path for accelerated approval of its patch.
The Phase 3 study is due to start in Q2 2025, with the aim of filing for marketing authorization in H2 2026.
In addition to this trial, two other programs involving children aged four to seven in the USA and children aged one to seven in Europe are currently underway.
DBV, which believes it has now minimized the risk associated with the regulatory path of its programs, now intends to focus on the execution of the studies with the aim of filing registration applications.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
The biopharmaceutical company reports that it has reached agreement with the US health agency on the number of patients to be included, and on the methodology for collecting and analyzing patch wear time.
The study, which is placebo-controlled, aims to obtain additional data on the safety (primary endpoint) and adherence of the Viaskin Peanut patch in peanut-allergic children aged between one and three years.
In a press release, DBV says it is delighted to have received a 'clear and reasonable' regulatory path for accelerated approval of its patch.
The Phase 3 study is due to start in Q2 2025, with the aim of filing for marketing authorization in H2 2026.
In addition to this trial, two other programs involving children aged four to seven in the USA and children aged one to seven in Europe are currently underway.
DBV, which believes it has now minimized the risk associated with the regulatory path of its programs, now intends to focus on the execution of the studies with the aim of filing registration applications.
Copyright (c) 2024 CercleFinance.com. All rights reserved.