Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, today announced that the Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s immunotherapy product candidate ADXS-HER2 for patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma.
Advaxis’ investigational immunotherapies, including ADXS-HER2, are designed to capitalize on the body’s ability to recognize and attack bacterial infections. Advaxis’ core technology – Lm Technology™ – alters a live strain of Listeria monocytogenes (Lm) bacteria to generate cancer fighting T-cells directed against a 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 expedite development, including opportunities for frequent interactions with the FDA review team to discuss all aspects of development to support approval and eligibility for accelerated approval and priority review depending on clinical data at the time of Biologics License Application (BLA) submission.
“We are pleased that the FDA has granted this important designation for ADXS-HER2,” said Daniel O’Connor, Chief Executive Officer of Advaxis. “Currently, there are limited therapeutic treatment options available for this patient population, with no new treatments approved in over 20 years. ADXS-HER2 received orphan drug designation in 2015 from the FDA and EMA for the treatment of osteosarcoma. We believe that with these FDA implemented incentive programs, like Fast Track designation, patients are truly the benefactors.” (Original Source)
Shares of Advaxis closed yesterday at $8.06, down $0.63 or -7.25%. ADXS has a 1-year high of $30.13 and a 1-year low of $5.21. The stock’s 50-day moving average is $9.01 and its 200-day moving average is $9.39.
On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on April 21, H.C. Wainwright analyst Swayampakula Ramakanth reiterated a Buy rating on ADXS, with a price target of $23, which implies an upside of 185.4% from current levels. Separately, on April 18, FBR’s Vernon Bernardino reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Swayampakula Ramakanth and Vernon Bernardino have a total average return of -19.1% and -17.8% respectively. Ramakanth has a success rate of 24.7% and is ranked #3805 out of 3839 analysts, while Bernardino has a success rate of 28.1% and is ranked #3814.
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. Advaxis was founded on June 5, 1987 and is headquartered in Princeton, NJ.