Mymetics Corp (MYMX)

[Work Harder]

Two of the leaders responsible for regulatory and product development at DBV Technologies are set to leave the company this month.

Both men were central to the development of Viaskin Peanut and its submission to FDA

Viaskin Peanut has hit bumps in the road on its path to market, from its inability to hit the primary endpoint in phase 3 through to DBV’s need to pull the original filing after the FDA identified gaps in the manufacturing and quality control sections. Three of the people involved in those events, Ruban, Martin and former CMO Lucia Septién-Velez, have left DBV this year.

DBV is yet to replace any of the departing executives, although it did hire ex-Alexion Pharmaceuticals EVP Julie O’Neill to direct “all product development, manufacturing, supply chain, quality assurance and end-to-end process optimization” at the start of the year. O’Neill will take on Martin’s primary responsibilities.

Given the mess DBV made of the original filing, the overhaul of the regulatory leadership could be seen as a positive. But it leaves DBV without the experience of several people who were central to the development of Viaskin Peanut and with unfilled gaps in its leadership team.

DBV needs the new-look team to nail the filing this time around. With DBV planning to refile for FDA approval months before its money runs out in the fourth quarter, there is little margin for error, particularly as the earlier setbacks have diminished its ability to raise more cash.

Shares in DBV have risen by more than 60% since the stock cratered following the filing withdrawal late last year but remain well down on the heights they scaled before the clinical and regulatory setbacks.

https://www.fiercebiotech.com/biotech/dbv-loses-regulatory-r-d-execs-ahead-peanut-drug-refile

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