Outlook Therapeutics: Strengthened Case for ONS-5010 Drives Attractive Risk/Reward and Increased $10 Price Target

Ascendiant analyst Edward Woo maintained a Buy rating on Outlook Therapeutics on December 20 and set a price target of $10.00.

Edward Woo has given his Buy rating due to a combination of factors centered on Outlook Therapeutics’ lead asset, ONS-5010 (LYTENAVA), and its regulatory and commercial trajectory. He notes that despite prior FDA Complete Response Letters, the company has now resubmitted its BLA with additional efficacy data and has a new PDUFA date of December 31, 2025, implying that a U.S. approval decision is imminent. Woo views the updated clinical data from the NORSE EIGHT study as generally supportive, emphasizing the noninferiority achieved at 12 weeks versus ranibizumab, which strengthens the case for eventual approval. In his view, the current market price does not adequately reflect the likelihood of near-term regulatory success and the associated revenue potential.

In addition, Woo highlights that commercial launches of LYTENAVA in the U.K. and Germany are progressing well and could reach breakeven in 2026, providing early validation of demand in major ex-U.S. markets. He acknowledges recent adjustments to revenue and EPS forecasts but still sees substantial long-term growth prospects given the large wet AMD market and the opportunity to convert off-label bevacizumab use to an approved product. With recent capital raises extending the company’s cash runway, he believes Outlook is adequately funded to execute its plan through key inflection points. Based on his NPV analysis, he raises his 12‑month price target to $10, concluding that the risk/reward profile remains attractive and justifies a Buy rating.

Woo covers the Healthcare sector, focusing on stocks such as Lucid Diagnostics, Plus Therapeutics, and Allarity Therapeutics. According to TipRanks, Woo has an average return of -14.0% and a 29.86% success rate on recommended stocks.