DBVT stock rose in morning trade on January 15, 2021, after receiving a response letter from the FDA on its peanut allergy drug.
Citi analyst Joel Beatty raised the firm’s price target on DBV Technologies to $8 from $4 and keeps a Buy rating on the shares following the “encouraging” regulatory update on Viaskin Peanut. The update suggests the FDA “may be OK” with the current efficacy profile of Viaskin Peanut, which is encouraging and should alleviate some investor concerns, Beatty tells investors in a research note.
With the announcement of FDA feedback based on the Complete Response Letter issued for the Biologics License Application submission for Viaskin Peanut in peanut allergic children ages four to 11 years old, DBV Technologies has a “clear developmental path” to address the remaining open items focused on patch adhesion, H.C. Wainwright analyst Andrew Fein tells investors in a research note. The analyst views modified patch execution as “low risk considering the same dosing and delivery with limited concerns on adverse events in this context.” Fein keeps a Buy rating on DBV with a $14 price target.
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the receipt of written responses from the U.S Food and Drug Administration (FDA) to questions provided in the Type A meeting request the Company submitted in October 2020. The Type A meeting request was submitted following the Company’s receipt of a Complete Response Letter (CRL) in connection with its Biologics License Application (BLA) for Viaskin™ Peanut (DBV712), an investigational, non-invasive, once-daily epicutaneous patch to treat peanut allergy in children ages 4 to 11 years.
DBV believes that the feedback received from the FDA provides a well-defined regulatory path forward. In exchanges with the FDA, DBV proposed potential resolutions to two main concerns identified by the FDA in the CRL: the impact of patch adhesion and the need for patch modifications. DBV will address details about a new human factor (HF) validation study and additional chemistry, manufacturing and controls (CMC) data in subsequent interactions with the FDA.
The FDA agreed with DBV’s position that a modified Viaskin™ Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin™ Peanut patch and the peanut protein dose of 250 µg (approximately 1/1000 one peanut) remains unchanged and performs in the same way it has performed previously.
In order to confirm the consistency of efficacy data between the existing and modified patches, FDA has requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess the modified Viaskin™ Peanut patch in the intended patient population.
DBV plans to initiate the selection of modified prototype patches in the first quarter of 2021. Additionally, DBV will submit the protocol for the safety and adhesion trial in children with peanut allergy to FDA for review and comments in the second quarter of 2021 before initiating the trial.
“We are very encouraged by the positive feedback received from the FDA, and we appreciate the clarity provided,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies. “I want to thank the DBV team for their dedication in working to address the FDA’s findings over the past few months. We intend to advance a remediation plan for Viaskin™ Peanut and work closely with FDA to review protocols and re-file our BLA as soon as possible, so that we can bring Viaskin™ Peanut, if approved, to patients suffering from peanut allergies.”
“We look forward to working with our investigators, clinical trial sites, and key stakeholders as we continue in our development of investigational Viaskin™ Peanut,” said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. “Everyone at DBV remains highly committed to the possibility of bringing this innovative treatment option to patients and families.”
Based on the guidance received from the FDA and DBV’s plans to implement such guidance, DBV continues to expect that the organization-wide cost reduction measures resulting from its previously announced global restructuring plan will extend its cash runway to the second half of 2022.
The Company will host a conference call and webcast to discuss this update on Thursday, January 14, 2021 at 5:00 PM ET (11:00 PM CET). To participate in this conference call, please dial (866) 939-3921 (US Toll-free) or (678) 302-3550 (US Toll). To access the call using an international dial-in number, please see this link:
https://www.yourconferencecenter.com/AlternateNumbers/alternatenumbers.aspx?100899&t=A&o=UAvBpvVOITNgJB. The reference number for this call is 50075790. A live webcast is available on DBV’s website, www.dbv-technologies.com, under the Investor Relations & Media section and will be archived there for 30 days.
DBV Technologies is developing Viaskin™, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, DBV’s method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV’s food allergies programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies has global headquarters in Montrouge, France and offices in Bagneux, France, and North American operations in Summit, NJ and New York, NY. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).