DAWN - Day One Biopharma falls 14% as Bank of America downgrades
2023-04-25 09:21:10 ET
Day One Biopharmaceuticals ( NASDAQ: DAWN ) lost ~14% pre-market Tuesday after Bank of America downgraded the clinical-stage biotech to Underperform from Buy, noting near-term negative catalysts for the stock.
Bank of America expects the company to release a full pivotal data readout for its lead asset, tovorafenib, at an upcoming medical event (likely ASCO) ahead of a potential filing of a new drug application in Q2 2023.
“We think there is a risk that both of these events will be negative catalysts for the stock,” the analysts wrote, slashing their price target for DAWN to $9 from $34 per share.
Day One ( DAWN ) is advancing tovorafenib, in a pivotal Phase 3 trial called FIREFLY-2/LOGGIC as a frontline therapy for patients with newly diagnosed pediatric low-grade glioma (pLGG).
In January, the company reported topline data from its ongoing, pivotal Phase 2 FIREFLY-1 trial for the candidate in patients with relapsed or progressive pLGG.
“Given recent regulatory precedence and lower expectations for the full data, we see the path to approval based on FIREFLY-1 alone as becoming less likely,” the analysts added.
Estimating a 1–2-year delay for commercialization and setting the firm’s near-term revenue forecasts for DAWN below consensus, BofA projects a difficult setup for the stock in the near term.
More on tovorafenib
- Day One begins dosing in phase 1b/2 trial of tovorafenib/pimasertib combo for solid tumors
- Day One Biopharmaceuticals: Strong Potential, Price Drop Opportunity, Some Concerns
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Day One Biopharma falls 14% as Bank of America downgrades