Why This FDA Clearance Is a Big Deal For Sorrento Therapeutics

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By Chris Lange Published
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Why This FDA Clearance Is a Big Deal For Sorrento Therapeutics

© courtesy of the U.S. Food and Drug Administration

Sorrento Therapeutics, Inc. (NASDAQ: SRNE) stock jumped on Monday after the company announced that the U.S. Food and Drug Administration (FDA) had cleared its Phase 2 study in hospitalized patients with moderate to severe COVID-19.

The study will be focused on the safety and efficacy of once-weekly injections of STI-5656 (abivertinib maleate) in hospitalized COVID-19 patients who have a high risk for rapid clinical deterioration and acute respiratory distress syndrome (ARDS).

Back in May, Sorrento announced that it had entered into a binding term sheet for an exclusive license to ACEA Therapeutics’ Abivertinib across all indications for all territories outside of China. The parties have since entered into an exclusive license agreement.

Essentially, abivertinib works to inhibit pro-inflamatory cytokine production. These cytokines are associated with cytokine release syndrome (CRS) or cytokine storm and COVID-19 disease progression with poor outcomes in patients with ARDS.

Because abivertinib targets multiple cytokines simultaneously, Sorrento expects that the effects of Abivertinib will be incremental to the initial published findings by others and that the clinical benefits will be more pronounced given the broader range of anti-cytokine activity.

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So far, abivertinib has been studied in over 600 patients worldwide in various oncologic indications, including one registration trial in non-small cell lung cancer.

Most treatment-related adverse events observed were grade 1 or 2. Other common treatment-related adverse included anemia, neutropenia and thrombocytopenia, each of which are generally considered typical with long-term use of tyrosine kinase inhibitors. No unexpected adverse effects were reported.

Sorrento stock was last seen up about 17% at $8.13, with a 52-week range of $1.39 to $10.00. The consensus analyst price target is $23.00.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.

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