Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead immunotherapy candidate, axalimogene filolisbac (AXAL), as a Fast Track product for adjuvant therapy for high-risk locally advanced cervical cancer patients. The investigation of AXAL in this under-served population will be conducted in accordance with the Special Protocol Assessment (SPA) recently granted by the FDA.
“This Fast Track designation for AXAL comes on the heels of the SPA agreement and underscores the collaborative efforts of Advaxis and the FDA in expediting a medically significant clinical program. This designation brings us one step closer to achieving our goal with the AIM2CERV trial, which aims to extend disease free survival for this serious and life-threatening condition and prevent disease recurrence,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis.
In 2014, AXAL was granted FDA Orphan Drug designation for the treatment of invasive cervical cancer.
AXAL is a targeted immunotherapy which attacks human papillomavirus (HPV)-associated cancers by altering a live strain of Listeria monocytogenes (Lm) bacteria to generate cancer fighting T cells directed against the specific cancer antigen and neutralizing factors that protect the tumor microenvironment from immunologic attack and contribute to tumor growth.
The FDA established the Fast Track Drug Development Program under the FDA Modernization Act of 1997. The program is designed to facilitate the development and expedite the review of therapies intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The advantages of Fast Track designation include actions to help expedite development, including opportunities for frequent interactions with the FDA to discuss all aspects of development to support approval, eligibility for priority review at the time of Biologics License Application (BLA) submission and early review of portions of the application before submitting a complete application. (Original Source)
Shares of Advaxis are up nearly 8% to $8.19 in pre-market trading. ADXS has a 1-year high of $22.20 and a 1-year low of $5.21. The stock’s 50-day moving average is $8.40 and its 200-day moving average is $8.00.
On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on July 6, FBR analyst Vernon Bernardino reiterated a Buy rating on ADXS. Separately, on June 29, H.C. Wainwright’s Swayampakula Ramakanth reiterated a Buy rating on the stock and has a price target of $23.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Swayampakula Ramakanth have a total average return of -21.9% and -17.5% respectively. Bernardino has a success rate of 25.7% and is ranked #3985 out of 4073 analysts, while Ramakanth has a success rate of 25.2% and is ranked #3963.
Overall, 4 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $21.00 which is 177.4% above where the stock closed yesterday.
Advaxis, Inc. is a clinical-stage biotechnology company, which intends to develop immunotherapies for cancer and infectious diseases. The company’s platform technology is designed to generate a comprehensive immune response by serving as its own adjuvant, directing antigen presentation, increasing tumor infiltrating killer T-cells, and decreasing Tregs/MDSCs in the tumor.