New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
June 10, 2014
06:32 EDTADXSAdvaxis says End-of-Phase 2 meeting with FDA has been granted to review ADXS-HPV
Advaxis announced that its request for an End-of-Phase 2 meeting with the FDA has been granted. The purpose of the EOP2 meeting with FDA is to review clinical findings to date of Advaxis's immunotherapy product candidate, ADXS-HPV, in order to assess any additional information needed prior to moving ADXS-HPV forward with the next phase of its clinical development. The meeting will establish a dialogue with FDA on ADXS-HPV during which Advaxis can obtain agency recommendations and feedback on the next steps it needs to take in investigating this important immunotherapy product candidate. Advaxis plans to prepare and provide FDA with a comprehensive package detailing its investigational invasive cervical cancer therapy, its phase 1 and 2 clinical findings, its CMC strategy and the Company's plans for a pivotal phase 3 program.
News For ADXS From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
February 3, 2016
08:11 EDTADXSAdvaxis' Axalimogene Filolisbac to be developed in Latin America with Stendhal
Advaxis announced that it has entered into a co-development and commercialization agreement with Especificos Stendhal SA de CV, for Advaxis' lead Lm Technology immunotherapy, axalimogene filolisbac, in HPV-associated cancers. Stendhal is a privately held Latin American specialty pharmaceutical company that partners with leading drug companies to deliver effective solutions for life-threatening diseases in Latin American markets. Under the terms of the Agreement, Stendhal will pay $10M toward the expenses of AIM2CERV, a planned global Phase 3 clinical trial in women with high-risk, locally advanced cervical cancer. This payment covers a significant portion of the total planned study costs. Stendhal will also work with Advaxis to complete the clinical trial of axalimogene filolisbac in Mexico, Brazil, Colombia, and other investigational sites in Latin American countries. Additionally, Stendhal will manage the regulatory approval process, promotion, commercialization and market access for axalimogene filolisbac in these markets. Advaxis and Stendhal will share profits on a pre-determined basis.

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the theflyonthewall.com disclaimer & terms of use