18:53 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

FDA lifts hold on Phase I/II of axalimogene filolisbac for SCCHN

Advaxis Inc. (NASDAQ:ADXS) said FDA lifted a clinical hold on a Phase I/II combination study that includes the company's axalimogene filolisbac (ADXS11-001). The trial is evaluating the therapy in combination with PD-L1 inhibitor Imfinzi durvalumab to...
16:24 , Jul 13, 2018 |  BC Extra  |  Clinical News

Advaxis rises after FDA lifts clinical hold

Advaxis Inc. (NASDAQ:ADXS) jumped $0.12 (10%) to $1.34 Friday after it said FDA lifted a clinical hold on a Phase I/II combination study that includes the company's axalimogene filolisbac (ADXS11-001). The trial is evaluating the therapy...
17:11 , Mar 16, 2018 |  BC Week In Review  |  Clinical News

FDA places hold on Advaxis' combo trial

Advaxis Inc. (NASDAQ:ADXS) said FDA placed a clinical hold on a Phase I/II trial of axalimogene filolisbac (ADXS11-001) in combination with PD-L1 inhibitor Imfinzi durvalumab to treat HPV-related cancers. According to the company, the hold is...
17:07 , Mar 13, 2018 |  BC Extra  |  Financial News

Clinical hold sinks Advaxis shares

Advaxis Inc. (NASDAQ:ADXS) tumbled $0.26 (12%) to $1.95 on Tuesday after the company announced late Monday that FDA had placed a clinical hold on a Phase I/II trial of axalimogene filolisbac (ADXS11-001) (see BioCentury Extra,...
23:33 , Mar 12, 2018 |  BC Extra  |  Clinical News

FDA places hold on Advaxis' combo trial

Advaxis Inc. (NASDAQ:ADXS) fell $0.49 (22%) to $1.72 in after-hours trading Monday after it said FDA placed a clinical hold on a Phase I/II trial of axalimogene filolisbac (ADXS11-001) in combination with PD-L1 inhibitor Imfinzi...
20:49 , Mar 2, 2018 |  BC Week In Review  |  Financial News

Advaxis raises $20M in follow-on

Cancer immunotherapy company Advaxis Inc. (NASDAQ:ADXS) raised $20 million on Feb. 22 through the sale of 10 million shares at $2 in a follow-on underwritten by Jefferies and Guggenheim Securities. The price is a 20% discount...
23:10 , Oct 6, 2017 |  BioCentury  |  Finance

Coasting on catalysts

While buysiders do not expect any sector-moving milestones in the wake of a catalyst-heavy third quarter, they will have at least 21 Phase III milestones and 23 PDUFA dates on their radar. But the biggest...
00:20 , Jul 8, 2017 |  BioCentury  |  Finance

A clinical quarter

Buysiders will find themselves digesting at least 23 Phase III data readouts in the next quarter, two of which could provide clarity on increasingly competitive markets in lung cancer and hemophilia. The third quarter is...
22:05 , May 31, 2017 |  BC Week In Review  |  Company News

Advaxis, BMS partner to evaluate ADXS-DUAL plus Opdivo in cervical cancer

Advaxis Inc. (NASDAQ:ADXS) will sponsor a clinical trial evaluating its ADXS-DUAL in combination with PD-1 inhibitor Opdivo nivolumab to treat metastatic cervical cancer. The trial is slated to start this year. ADXS-DUAL is the second-generation of...
20:17 , Feb 10, 2017 |  BC Week In Review  |  Clinical News

Axalimogene filolisbac: Ph III AIM2CERV started

Advaxis began the double-blind, placebo-controlled, international Phase III AIM2CERV trial to evaluate axalimogene filolisbac as adjuvant therapy following concurrent chemotherapy and radiation treatment in about 450 patients. Patients will receive an infusion of axalimogene filolisbac...