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Outlook Therapeutics Says FDA Clarifies Steps for ONS-5010 Study, Enters Securities Purchase Deals

Outlook Therapeutics said Tuesday it has received a written agreement with the US Food and Drug Administration under a special protocol assessment for the next steps to advance its ONS-5010.

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Outlook Therapeutics (OTLK) Receives FDA Agreement Under SPA for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172M

Outlook Therapeutics (OTLK) Receives FDA Agreement Under SPA for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172M
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Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-5010

Obtained clarity from U.S. Food and Drug Administration on next steps to advance ONS-5010NORSE EIGHT expected to commence in the first quarter of CY2024, enabling potential resubmission of the.

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Outlook Therapeutics Shares Rally Premarket on ONS-5010 Advances

By Colin Kellaher Shares of Outlook Therapeutics surged in premarket trading Tuesday after the biopharmaceutical company reported a pair of advances in its.

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Outlook Therapeutics (OTLK) Receives FDA Agreement Under SP) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-5010

Outlook Therapeutics (OTLK) Receives FDA Agreement Under SP) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-5010
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