BioSpace News Archive

Pfizer Inc. (NYSE:PFE) today announced results from the Phase 3 CROWN trial of LORBRENA® (lorlatinib, available in Europe under the brand name LORVIQUA®) versus XALKORI® (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) were published online ahead of print in the New England Journal of Medicine.

Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for OTL-200, an autologous, hematopoietic stem cell, lentiviral vector-based gene therapy in development for the treatment of metachromatic leukodystrophy (MLD). The company also has applied for Regenerative Medicine Advanced Therapy (RMAT) des

Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative therapeutics, today announced the Company has received guidance from the U.S. Food and Drug Administration (FDA) on a Phase 3 trial design for AVB-500 in platinum resistant ovarian cancer (PROC). The global, randomized, double-blind, placebo-controlled adaptive trial is designed to evaluate efficacy and tolerability of AVB-500 at a dose of 15 mg/kg in combination

Begins Enrollment in the First of Four Upcoming Late-Stage Trials in the U.S. Announces MIRA-1 Phase 2b Study Accepted for Peer-Reviewed Publication in Optometry and Vision Science

Freeline Therapeutics Holdings plc (Nasdaq: FRLN) (the “Company” or “Freeline”), a clinical-stage, fully integrated, next generation, systemic AAV-based gene therapy company with the ambition of transforming the lives of patients suffering from inherited systemic debilitating diseases, today announced that management will participate in a fireside chat at the 3rd Annual Evercore ISI Health CONx Conference on 3 December, 2020 from 08.00 – 8.20 am ET.

Swedish Orphan Biovitrum AB (publ) (SobiTM) (STO:SOBI) and Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the first patient has been dosed in the potentially registrational phase 2 MERIDIAN study of pegcetacoplan, a targeted C3 therapy, in approximately 200 adults with sporadic amyotrophic lateral sclerosis (ALS).

OpSens Inc. (“OpSens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF) today reported its results for the fourth quarter and fiscal year 2020 ended August 31, 2020 . Financial Highlights Sales of product at $29.5 million in FY 2020 compared to prior FY 2019; Delivered Q4 2020 a $2.2 million improvement in

VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”), a multi-national epigenetics company developing simple, easy to use, cost effective blood tests to help diagnose a range of cancers and other diseases, has announced that Dr. Mark Eccleston , a founding scientist and Business Development Director at Volition, will today present preli

Seres Therapeutics, Inc. (Nasdaq: MCRB) today announced that management will participate in two upcoming investor conferences: Piper Sandler 32nd Annual Virtual Healthcare Conference on December 1, 2020 where management will participate in 1x1 meetings. A fireside chat held with Seres management will be made available on the News and Events section of the Company’s website on November 23, 2020. 3

Armis Biopharma, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved the VeriFixx™ Small Bone Implant for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe. VeriFixx™ is designed to make surgical corrections of thi