Hookipa Pharma's New Drug Application Gets FDA Clearance, Shares Up 30%

(RTTNews) - Shares of Hookipa Pharma Inc. (HOOK) jumped 30% in extended session Thursday after the company announced that the Food and Drug Administration approved a Investigational New Drug Application for its immunotherapy to treat cancers.

Hookipa Pharma is a biotech company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform.

Hookipa said FDA cleared its IND Application for a Phase 1/2 clinical trial of HB-201, a TheraT-based immunotherapy, for the treatment of Human Papilloma Virus (HPV)-positive cancers.

"With the FDA's clearance of our IND application we have achieved an important milestone advancing HB-201 into clinical development," Chief Executive Joern Aldag said in the announcement.

Hookipa intends to start the Phase 1/2 clinical trial in the second half of 2019 with preliminary safety and efficacy data expected in late 2020 or early 2021. It will be Hookipa's first clinical trial in immuno-oncology.

HOOK closed Thursday's trading at $6.68, down $0.16 or 2.34%, on the Nasdaq. The stock, however, gained $2.17 or 32.49% in the after-hours trade.