Capital One says Outlook Therapeutics to receive ‘binary’ FDA decision today

Capital One analyst Zegbeh Jallah notes that the FDA is expected to make an approval decision today on ONS-5010, which is Outlook Therapeutics’ (OTLK) ophthalmic version of Genentech’s (RHHBY) Avastin. Given this is Outlook’s sole program under development, today’s decision is “expected to be a major catalyst” and also expected to be “binary for the stock,” the analyst tells investors. The firm, which is “still unsure as to what the FDA’s decision will be,” says investors should also keep an eye on the pending EMA decision expected in early 2024 along with focusing on the FDA’s decision. Capital One has an Overweight rating and $5 price target on Outlook shares, which are up 8c, or 6% to $1.36 in afternoon trading.