(News Bulletin 247) – The French biotech is accelerating on the stock market after announcing positive regulatory progress for its Viaskin Peanut patch in the United States and Europe.

The former star of the biotech sector, whose capitalization was close to 2 billion euros at the time of its splendor in 2017, is experiencing an impressive upward movement this Wednesday.

The DBV Technologies share soared 45.% to 1.05 euros this Wednesday around 3:00 p.m., after announcing positive regulatory progress in the United States and Europe concerning Viaskin Peanut, a patch aimed at treating children allergic to peanuts. (with peanuts). At the day’s high, the stock gained up to 100% to 1.47 euros in the morning after this information.

This surge of fever allows it to escape the unflattering status of penny stocks, i.e. those companies whose share price moves below the symbolic euro. It must be said that at the close of Tuesday evening, the stock which was trading at 0.723 euros had erased almost all of its value since its October 2017 record at more than 85 euros…

A slight scent of hope is therefore reborn for DBV Technologies while the prospect of approval of its flagship product has continued to elude for years. This patch, which was the subject of a pilot study in 2013, has in fact been rejected several times by the Food and Drug Administration (FDA), the American health authority.

Accelerated procedure

This Wednesday, the announcements are much more positive for this product. DBV Technologies reports an accelerated approval process for Viaskin Peanut in children aged 1 to 3 years, consistent with US Food and Drug Administration (FDA) guidelines.

The FDA guidelines for accelerated approval include three qualification criteria, recalls DBV Technologies. The product must treat a serious disease, it must provide a significant advantage over available therapies, and it must demonstrate an effect on an intermediate clinical endpoint, reasonably likely to predict clinical benefit.

The FDA has confirmed that DBV Technologies has already met the first two criteria cited above. “Regarding criterion 3, the FDA provided guidance and suggestions regarding the intermediate clinical endpoint, which DBV agreed to in informal discussions with the FDA,” adds the French company.

DBV also plans to request a formal meeting with the FDA to clarify their guidelines for the accelerated approval process in 1-3 year olds.

“The company also plans to launch the COMFORT Toddlers safety study in the second quarter which would include 300 to 350 subjects to bring the safety database to nearly 600 patients (including previously obtained data). As part of the accelerated approval procedure envisaged for 1-3 year olds, DBV plans to conduct an effectiveness trial in parallel with the MA (marketing authorization) application,” explains Invest Securities.

Progress in Europe

The French biotech adds that it has received a scientific opinion from the European Medicines Agency (EMA) on an indication for children aged 1 to 7 years in Europe.

“Regarding the EMA, DBV recently obtained an encouraging opinion from a scientific committee supporting the possibility of a regulatory pathway for 1-7 year olds with the modified patch based on the results already obtained in 1- 3 years (EPITOPE) and to come for 4-7 years (VITESSE) in addition to the safety data which will be completed with the studies to be initiated in the second quarter of 2025”, specifies Invest Securities.

The company also provided an update on its cash flow situation. DBV Technolgies has a cash position of $46.4 million as of September 30, 2024 compared to $66.2 million as of June 30, 2024, representing a cash burn of $19.8 million in the interim.

DBV also specifies that it has suffered operating losses and negative cash flows since its creation, namely since 2002. As of October 21, 2024, the company asserts that its available cash and cash equivalents are not expected to be sufficient to support its operating plan for at least the next 12 months. “There is therefore significant doubt about the company’s ability to continue its activity,” admits the company, whose financial visibility is assured until the first quarter of 2025. DBV Technologies says it is seeking additional funds to continue the development of Viaskin Peanut.