Company Update (NASDAQ:ADXS): Advaxis, Inc. Receives Orphan Drug Designation in the European Union for Axalimogene Filolisbac

Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to axalimogene filolisbac for the treatment of anal cancer.

“We’re pleased to announce Advaxis’ second EMA Orphan Drug Designation within four weeks, which strengthens our pipeline and confirms the potential that Lm Technology™ immunotherapies may offer to patients with high unmet medical needs,” said Daniel J. O’Connor, CEO of Advaxis. “Our clinical program in anal cancer is building momentum as a result of this designation, the encouraging preliminary data in patients with anal cancer, as well as the honor of receiving the Farrah Fawcett Foundation’s ‘Medical Visionary Angel Award’ for our commitment to innovative research in anal cancer and HPV-related cancers. Receiving Orphan Drug Designation moves us one step closer to our goal of bringing a valuable new treatment to patients as quickly as possible.”

Orphan Drug Designation in the European Union (EU) is granted to drugs or biologics that treat a life-threatening or chronically debilitating rare disease affecting fewer than five in 10,000 individuals in the EU. Products receiving orphan drug designation are eligible to receive market exclusivity for a period of up to ten years, as well as development incentives such as regulatory and protocol assistance and scientific advice. (Original Source)

Shares of Advaxis Inc closed last Friday at $9.58, down $0.69 or -6.72%. ADXS has a 1-year high of $30.13 and a 1-year low of $3.64. The stock’s 50-day moving average is $12.09 and its 200-day moving average is $15.67.

On the ratings front, Advaxis has been the subject of a number of recent research reports. In a report issued on October 5, H.C. Wainwright analyst Swayampakula Ramakanth reiterated a Buy rating on ADXS, with a price target of $30, which represents a potential upside of 213.2% from where the stock is currently trading. Separately, on September 14, FBR’s Vernon Bernardino maintained a Buy rating on the stock .

According to, 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 -21.8% and -25.3% respectively. Ramakanth has a success rate of 15.8% and is ranked #3580 out of 3618 analysts, while Bernardino has a success rate of 16.7% and is ranked #3605.

Advaxis Inc is a clinical development stage biotechnology company. The company is engaged in developing safe & effective immunotherapies for cancer & infectious diseases.


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