DBV Technologies S.A. (DBVT) stock prices were down by 27.72% shortly after market trading commenced on October 27th, 2021. This brought the price per share down to USD$3.65 early on in the trading day.
Collaboration with FDA
October 14th, 2021 saw DBVT stock receive communication from the United States Food and Drug Administration in regard to the STAMP protocol submission, dated May 6th, 2021. The communication saw the FDA request a stepwise approach to the company’s modified Viaskin Peanut (mVP) development program. The FDA will review the data from its protein uptake release study prior to the provision of additional comments on the STAMP protocol design. The communication saw the FDA state its upcoming guidance about how to best demonstrate the protein uptake comparability of the mVP to the reference or current patch.
Working with the EMA
The company also reported the progress of the EMA review of the Viaskin Peanut Marketing Authorization Application. This progress is according to the established EMA processes and ongoing communications with the EMA. DBVT stock is taking steps to prepare its responses to the Day 180 letter, while evaluating how to most effective address the Objections. These will include the remaining Major Objection which questions the limitations of the data, as well as the clinical relevance and effect size, which was supported by a single pivotal study.
DBVT Stock’s Liquidity Position
DBVT stock reported a stellar liquidity position as of September 30th, 2021. The company reported cash and cash equivalents in the amount of USD$98.2 million, as compared to the USD$196.4 million reported as of December 31st 2020 and USD$125.5 million as of June 30th, 2021. The significant decrease in cash position over the course of the first nine months of 2021 was mostly comprised of USD$89.5 million in net cash used in operating activities. This difference was further consolidated by the effect of exchange rates.
About DBVT Stock’s Viaskin
DBVT Tech continues to allocate resources towards the development of Viaskin. Viaskin is an investigational proprietary technology platform, with a wide scope of potential applications in immunotherapy. The treatment is based on EPIT, the company’s method of delivering biologically active compounds to the immune system through intact skin.
Future Outlook for DBVT Stock
DBVT stock is keen to push for the accelerated development and commercialization of its proprietary Viaskin treatment. The company is poised to maintain its trajectory of success in a bid to usher in unprecedented growth. Current and potential investors are hopeful that management will be able to effectively leverage the resources at their disposal. This is hoped to facilitate significant and sustained increases in shareholder value over the long term.