Outlook Therapeutics (OTLK) announced that following an internal strategic review, the management team and board of directors have implemented initiatives to streamline the organization, reduce operating expenses and preserve capital, with the goal of maximizing its efforts to commercially launch Lytenava for the treatment of wet AMD in the European Union, or EU, and United Kingdom and supporting the resubmission of the biologics license application, or BLA, for ONS-5010/Lytenava to the FDA. Lytenava has an initial 10 years of market exclusivity. Separately, upon receipt of the full efficacy and safety results for the NORSE EIGHT clinical trial in the United States, which are expected in January 2025, Outlook Therapeutics plans to resubmit its BLA application for ONS-5010 in the first quarter of calendar 2025. Previously, the company announced that ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment with the FDA in the NORSE EIGHT trial. However, the preliminary data from the trial demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile for ONS-5010. Lawrence Kenyon, interim CEO and CFO commented, “In light of the current financial market conditions and the Company’s strategic focus on the commercial launch of LYTENAVA in Europe, following Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency in the UK, we conducted a strategic review with the goal of preserving capital and extending our cash runway as long as possible. As a result of this process, we identified potential efficiencies and are taking immediate cost-saving measures, including a 23% reduction in our workforce representing $1.4 million in annual savings excluding the costs of the reduction in workforce. As we look ahead, we remain steadfast in our belief in the potential of ONS-5010/LYTENAVA to meet the global needs of retina specialists, patients, and payers and are dedicated to advancing our regulatory and commercial efforts.”
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