Advaxis Shares Soar After FDA Lifts Clinical Hold On Cancer Drug

Shares of the late-stage immuno-oncology company Advaxis, Inc. ADXS are adding about one-fifth of their value in the wake of a positive regulatory announcement.

Advaxis shares were jumping 18 percent to $1.44 at on about four times the stock's average volume at the time of publication Friday.

What Happened

The FDA lifted the clinical hold it previously placed on the company's investigational new drug application for its axalimogene filolisbac in combination with durvalumab to treat patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer, according to Advaxis.

The IND app was submitted based on a Phase 1/2 study. The FDA imposed a clinical hold March 9 following a safety report of a patient death that occurred Feb. 27 after dosing. The death was from acute respiratory failure and came after nine months of treatment.

"New guidelines for the early detection and treatment of such rare events were agreed to with the FDA and will be implemented for this combination study," the company said.

Why It's Important

The lifting of clinical hold allows Advaxis to proceed with clinical trials that would support an NDA filing.

What's Next

Advaxis said it will enact the agreed-upon guidelines across its portfolio to ensure patient safety.

Axalimogene filolisbac has received a Fast Track designation status for treating high-risk, locally advanced cervical cancer and an orphan drug designation in three clinical indications.
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