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AnaptysBio Announces Third Quarter 2020 Financial Results and Provides Pipeline Updates
Positive topline data from GALLOP Phase 2 clinical trial of imsidolimab in moderate to severe Generalized Pustular Psoriasis (GPP) announced in October 2020
About this update from Anaptysbio, Inc.
[{"type":"text","content":"Positive topline data from GALLOP Phase 2 clinical trial of imsidolimab in moderate to severe Generalized Pustular Psoriasis (GPP) announced in October 2020 FDA end-of-Phase 2 meeting anticipated in Q4 2020 to outline registration path of imsidolimab for the treatment of GPP, in accordance with the orphan drug designation obtained in July 2020 POPLAR Phase 2 clinical trial of imsidolimab monotherapy in palmoplantar pustulosis (PPP) fully enrolled and topline data anticipated in Q1 2021 Expansion of imsidolimab program into two new clinical indications, EGFRi-mediated skin toxicities and ichthyosis, with Phase 2 trials to be initiated in Q4 2020 US BLA approval for dostarlimab, our PD-1 antagonist antibody partnered with GlaxoSmithKline (GSK), anticipated for endometrial cancer in Q4 2020, resulting in payment of $20 million of the $75 million in FDA BLA and EMA MAA regulatory milestone payments anticipated in upcoming 18 months Amended strategic immuno-oncology collaboration with GlaxoSmithKline to increase dostarlimab royalties, add ZejulaTM royalty effective January 2021 and receive additional $60 million cash in Q4 2020 SAN DIEGO, Nov. 04, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today reported operating results for the third quarter ended September 30, 2020 and provided pipeline updates.\n “We are excited with the recent interim results from our GALLOP trial and look forward to engaging with regulatory authorities to progress imsidolimab into registration trials for the treatment of GPP,” said Hamza Suria, president and chief executive officer of AnaptysBio. “Under our amended immuno-oncology collaboration with GSK, we look forward to the anticipated first FDA approval of dostarlimab and its advancement for patients suffering with various oncological disorders.” Imsidolimab (Anti-IL-36 Receptor) Program In July, we announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for imsidolimab, our proprietary anti-interleukin-36 receptor (IL-36R) antibody, for the treatment of patients with GPP. Treatment of GPP by imsidolimab is being evaluated in the GALLOP Phase 2 trial. Patient...