(Boursier.com) — In huge volumes, GenSight collapsed 66% to 0.84 euros after the company decided to withdraw its marketing authorization application for Lumevoq in Europe before obtaining the final opinion of the CAT. This choice follows recent interactions with the Committee for Innovative Therapies Medicines (CAT) indicating that the data provided so far would not be sufficient to support a positive opinion on the MA of the product. The company will now start discussions with the EMA in order to assess what the possible options would be to register the product as soon as possible.
“We disagree with the current assessment of the CAT, and remain very confident in the clinical benefit of Lumevoq for patients with LHON, which is supported by extensive evidence from multiple clinical trials and real life,” commented Bernard Gilly, CEO and co-founder of GenSight. “The decision to withdraw our application allows us to continue to work with the EMA to agree a regulatory path forward as soon as possible.”
Following this bad news, Oddo BHF downgraded the stock to ‘underperform’ and cut its target from 7 to 1.5 euro. A decision which reflects the completion of a new phase III for Lumevoq in Europe, a postponement of the launch in Europe to 2026 (vs 2024) and in the US to 2028 (vs 2027), a probability of approval of 45% (vs 80 %), the dilution attached to a probable capital increase of 20 ME at a price of 1.5 euro and a WACC of 20% (vs 15%) in order to reflect an increased financial risk.
Bryan Garnier adjusts his model to include changes in timelines, operating expenses and additional risk, and cuts his target from 9 to 2.5 euros. This leads it to adopt a ‘neutral’ view, although visibility remains limited for the moment with the combination of a delay and financial over-indebtedness.
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