Outlook Therapeutics, Inc. (OTLK) Phase 3 Data Supports Approval - Analyst

Earlier today, Outlook Therapeutics, Inc. (NASDAQ: OTLK) announced positive clinical and highly statistically significant top-line results from its pivotal Phase 3 NORSE TWO safety and efficacy trial evaluating ONS-5010 / LYTENAVA™ (bevacizumab) - the company’s lead drug candidate for treatment of neovascular age-related mascular degeneration (wet AMD).

Top-line data from NORSE TWO showed that ONS-5010 bevacizumab met the primary and key secondary endpoint for efficacy with clinically impactful change observed for treated patients. The drug also demonstrated a strong safety profile, consistent with what had been observed in prior trials.

Brookline Capital Markets analyst Kumaraguru Raja notes that “ONS-5010 was safe and efficacious, comparable to Avastin data available in literature” and believes the data is “expected to support filing and approval.”

He expects the Biologics License Application (BLA) to be submitted in the first quarter of 2022 and if approved, models $718M in peak sales for the drug.

Brookline Capital Markets maintains a “Buy” rating on OTLK and increases its price target to $8 from $5.

OTLK shares are moving 17% higher following the announcement.

Written by Vlad Schepkov | [email protected]

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