(AOF) – GenSight Biologics (+60.78% to 0.66 euros) sees its stock skyrocket in high volumes after announcing that its production partner in the United States has successfully produced a batch of Drug Substance ( DS) for Lumevoq its gene therapy for the treatment of Leber’s hereditary optic neuropathy (LHON), compliant with Good Manufacturing Practice (GMP) standards. The biotech specialist in gene therapies specifies that this batch could be available in the first quarter of 2024 for a resumption of the early access program and the launch of a new clinical trial.
“With this achievement, we confirm that our robust manufacturing process can be implemented at the highest quality level required by the authorities,” commented Bernard Gilly, Co-founder and Managing Director of GenSight Biologics. “Lumevoq is expected to be available again to patients and doctors in early 2024. This success also clarifies our timeline for Lumevoq, which is great news for LHON patients blinded by the disease.”
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Biotechs put to the test
These companies are suffering from a much less favorable economic cycle, which is reflected in particular by a drop in venture capital financing of start-ups. These companies are therefore obliged to carry out layoff plans. Added to this is a much more restrictive regulatory framework. First, in the United States, measures linked to the Inflation Reduction Act (IRA) could have a strong impact on the margins of stakeholders. Indeed, from 2026, the federal Medicare program will be able to renegotiate the price of drugs marketed for nine years (chemical) or 13 years (biological), with discounts that could range from 35 to 60% for biotechs. Likewise, in Europe, with the new drug regulations presented in Brussels in April, the duration of patent protection will be reduced if the innovative treatment is not marketed in all member countries within two years.