Analyst Douglas Tsao from H.C. Wainwright maintained a Buy rating on Outlook Therapeutics (OTLK – Research Report) and decreased the price target to $3.00 from $30.00.
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Douglas Tsao has given his Buy rating due to a combination of factors surrounding Outlook Therapeutics and its product, Lytenava. The company is on track with its Biologics License Application (BLA) resubmission for ONS-5010 in the first quarter of the calendar year 2025. Though there are uncertainties about the FDA’s recognition of the 12-week non-inferiority margin, there is cautious optimism about potential approval, influenced by past examples where drugs were approved despite missing primary endpoints initially.
Douglas Tsao also highlights the upcoming commercial launch of Lytenava in the European Union and the United Kingdom, expected in the second quarter of 2025. This launch is significant as Lytenava is the first authorized ophthalmic formulation of bevacizumab for wet AMD in these regions. The estimated high demand for anti-VEGF retina injections, many of which are currently repackaged off-label, suggests a strong market opportunity. Additionally, the strategic collaboration with Cencora to support the global launch further reinforces the Buy rating, as it is expected to facilitate rapid market adoption.