Company Update (NASDAQ:AGEN): GlaxoSmithKline’s Malaria Vaccine Containing Agenus Inc’s QS-21 Stimulon® Receives Positive Opinion from European Regulators
Agenus Inc (NASDAQ:AGEN), an immunology company discovering and developing innovative treatments for cancers and other diseases, announced that GlaxoSmithKline plc (ADR) (NYSE:GSK) received a positive opinion for its Malaria vaccine candidate from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The vaccine candidate, named Mosquirix™ (RTS,S) is the first QS-21 Stimulon containing product to receive a positive regulatory decision. Agenus’ adjuvant QS-21 is designed to increase immune response to antigens in vaccines. The positive opinion signals that Mosquirix meets the necessary quality, safety and efficacy requirements according to EU standards.
“This is a significant milestone for the field of Malaria and our QS-21 Stimulon, which is an integral component of the adjuvant contained in Mosquirix, the first malaria candidate vaccine to generate positive Phase 3 data, now awaiting the World Health Organization’s recommendations and approvals by African Health authorities,” commented Garo Armen, Ph.D., Chairman and CEO of Agenus. “We look forward to seeing Mosquirix achieve the required final clearances so it can begin benefiting children at risk of contracting and dying from Malaria.”
The CHMP scientific opinion is a key step in the regulatory process toward making a vaccine against Malaria available. The positive opinion follows review by the CHMP of the candidate vaccine’s safety, efficacy and quality. Clinical data supporting the filing were mainly from a Phase 3 clinical program involving more than 16,000 infants and young children.
Following the CHMP positive opinion, two of the World Health Organization’s (WHO) independent advisory groups, the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC), will now jointly review the evidence base for the vaccine candidate and make a joint policy recommendation for how the vaccine should be used in the event that it ultimately is approved by the national regulatory authorities in the sub-Saharan African countries for which the vaccine is intended. The WHO has indicated that such a policy recommendation may be possible by end of this year. (Original Source)
Shares of Agenus closed yesterday at $8.95. AGEN has a 1-year high of $10.16 and a 1-year low of $2.56. The stock’s 50-day moving average is $8.95 and its 200-day moving average is $6.53.
On the ratings front, Agenus has been the subject of a number of recent research reports. In a report released yesterday, Maxim Group analyst Jason McCarthy maintained a Buy rating on AGEN, with a price target of $11, which implies an upside of 22.9% from current levels. Separately, on July 20, H.C. Wainwright’s Swayampakula Ramakanth reiterated a Buy rating on the stock and has a price target of $14.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason McCarthy and Swayampakula Ramakanth have a total average return of 8.0% and 21.3% respectively. McCarthy has a success rate of 53.8% and is ranked #1531 out of 3714 analysts, while Ramakanth has a success rate of 48.9% and is ranked #371.
Agenus Inc along with its subsidiaries is a biopharmaceutical company. The Company is engaged in developing and commercializing technologies to treat cancers and degenerative disorders.