DBV Technologies S.A. - DBVT STOCK NEWS

DBV Technologies has outlined its regulatory path for the Viaskin Peanut 250 μg patch, targeting toddlers aged 1-3 years with peanut allergies, after receiving feedback from the FDA. The FDA confirmed that the Phase 3 EPITOPE study achieved its primary endpoint without requiring an additional efficacy study. However, a new safety study is mandated to augment existing data, aiming for a database of around 600 patients. As of March 31, 2023, the company reported cash equivalents of $192.3 million, a decrease from $209.2 million at year-end 2022. DBV is committed to developing treatment options for young children with peanut allergies, and it plans to submit a proposed protocol for the safety study to the FDA by the end of Q2 2023.

DBV Technologies, a clinical-stage biopharmaceutical company, held its 2023 Ordinary and Extraordinary General Meeting on April 12, 2023, chaired by Michel de Rosen. Shareholders approved all resolutions proposed by the Board of Directors. These resolutions reflect the company's ongoing commitment to advancing its innovative Viaskin™ platform, which focuses on epicutaneous immunotherapy for food allergies. DBV Technologies is actively conducting clinical trials for Viaskin Peanut, aimed at improving the treatment landscape for food allergic patients. The company operates globally from Montrouge, France, and Basking Ridge, NJ, with shares traded on Euronext Paris (DBV) and Nasdaq (DBVT).

DBV Technologies will hold its Ordinary and Extraordinary General Meeting on April 12, 2023, at 10:00 a.m. CET in Montrouge, France. The meeting's agenda and draft resolutions were published in the French legal bulletin on March 8 and March 24, 2023. Shareholders can access preparatory documents via the Company's website and can request to receive these documents by post or electronically until April 7, 2023. The General Meeting will be webcast live, with a replay available for two years. DBV Technologies is focused on developing the Viaskin™ platform for immunotherapy targeting food allergies, with ongoing clinical trials for Viaskin Peanut.

DBV Technologies has announced that it does not hold cash deposits or securities at Silicon Valley Bank. This update is crucial for investors, as it mitigates potential concerns about liquidity related to the recent turmoil affecting the bank. The company is focused on developing Viaskin, an innovative platform for treating food allergies through epicutaneous immunotherapy. DBV Technologies is currently conducting clinical trials for Viaskin Peanut, aimed at children with peanut allergies. The company is based in Montrouge, France, and its shares are listed on Euronext Paris (DBV) and Nasdaq (DBVT).

DBV Technologies announced the screening of the first patient in the VITESSE Phase 3 clinical trial aimed at evaluating the modified Viaskin Peanut patch for peanut-allergic children aged 4 to 7 years. The trial, conducted at approximately 80 sites across the US, Canada, Australia, and Europe, will enroll 600 subjects, randomizing them 2:1 between active and placebo groups. The primary endpoint assesses treatment responders at Month 12.

Positive interactions with the FDA have supported the trial's protocol, paving the way for a potential Biologics License Application. Screening is expected to conclude in the first half of 2024, with topline results anticipated in early 2025.