(BFM Bourse) – The company has chosen to abandon the process to obtain marketing authorization for Lumevoq from the European Medicines Agency. GenSight plans to produce new clinical data, which could result in significant delays and additional costs.
This is the big stock market setback of this Friday or even of the week. The biopharmaceutical company GenSight Biologics, which specializes in gene therapies to treat neurodegenerative diseases of the retina and central nervous system, plunged 66.20% around 2:40 p.m.
involved a major blunder in the approval process for its lead product candidate, Lumevoq, for the treatment of Leber’s hereditary optic neuropathy (LHON). This genetic disease which mainly affects young men and which results in a sudden and rapid loss of vision without causing total blindness. GenSight had submitted in 2020 an application for the marketing of this treatment to the Agency European Medicines (EMA) and hoped, lately, to obtain a green light at the end of the year.
The ace. Following an oral presentation with the EMA’s Committee for Advanced Therapies (CAT) held on Wednesday to respond to the objections of the European regulator, GenSight has decided to withdraw its application for authorization. It turned out that the CAT judged that the data provided for the company was not sufficient to support a positive marketing opinion for Lumevoq.
An unexpected decision
“This decision allows the company to engage in discussions with the EMA on the best possible path for Lumevoq in the coming weeks, with the aim of submitting a new application addressing the remaining objections as soon as possible, in Europe and in other countries. “Other countries. The company is currently considering possible options, including the production of new clinical data, which could lead to significant delays and additional costs,” GenSight said in a statement.
“This is certainly a blow and a disappointment for the company. company so far seemed very convincing”, underlines Degroof Petercam, which placed under review its opinion on the title. Lumevoq constituted 90% of the company’s value in the design office’s valuation.
“So it is also a surprise for us, especially since these data have been published in peer-reviewed journals and have been supported by concrete evidence,” adds the financial intermediary.
“If GenSight’s decision seems the most judicious in view of the situation, it is the position of the EMA which seems to us today the most surprising in view of the interactions made so far”, abounds Invest Securities. “Indeed, the EMA had shown itself to be rather ‘supportive’ throughout the regulatory process and upstream, in particular with the granting of several deadlines due to the various manufacturing problems encountered, but above all the fact that the essential clinical data was known and it seemed that the main problem was manufacturing,” adds the financial intermediary.
Future costs
“GenSight must now identify the best way to bring its product to market, but it seems obvious to us that this will require new clinical studies, which will lead to delays and additional costs”, concludes Degroof Petercam.
For now, the company will have to find short-term financing. It estimates that it currently has sufficient working capital to meet its financial obligations until June.
“The company is currently reviewing the impact of the current situation on existing financing, and taking additional steps aimed at significantly reducing its operating cash burn in 2023, while actively discussing financings and strategic options, including M&A opportunities (mergers and acquisitions, editor’s note)”, she warns.
Julien Marion – ©2023 BFM Bourse
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