(Adds details, updates shares)
Dec 16 (Reuters) - Drug developer Advaxis Inc said
on Wednesday the U.S. Food and Drug Administration had lifted a
clinical hold on three of its experimental cancer therapies,
sending the company's shares up as much as 38 percent.
The U.S. health regulator had in October put on hold
mid-stage trials of the company's lead therapy, axalimogene
filolisbac, after a patient died.
Advaxis had then said the patient died due to progression of
cervical cancer and that the drug played no role in the death.
The FDA later placed a clinical hold on all three therapies
in the company's pipeline.
Advaxis said on Wednesday that it would resume studies on
the three therapies, which belong to a class of treatments that
spur the body's immunity system against the disease.
The company said it had agreed to implement some risk
mitigation measures, including revised study design, patient
inclusion criteria and patient surveillance measures, following
discussions with the FDA.
Advaxis is testing axalimogene filolisbac in patients with
head and neck cancer, cervical cancer and anal cancer.
The company is studying ADXS-PSA in prostate cancer patients
in combination with Merck & Co's blockbuster cancer drug
Keytruda, and ADXS-HER2 in patients whose cancer is caused by a
kind of mutation.
The company's shares, which had lost about 19 percent since
the first clinical hold in October to Tuesday's close, were up
27 percent at $10.57. They had touched a high of $11.45 earlier.
(Reporting by Vidya L Nathan in Bengaluru; Editing by Sriraj
Kalluvila)
© 2026 Thomson/Reuters. All rights reserved.