Clovis Oncology Inc. called a halt late Friday to its phase II open-label monotherapy trial evaluating Rubraca (rucaparib) in recurrent metastatic bladder cancer (Atlas), based on a data monitoring committee recommendation that had reviewed the preliminary efficacy data.
Syncona Ltd. has merged two of its companies, U.K.-based Gyroscope Therapeutics Ltd., a biotech developing gene therapy for retinal diseases, and U.S.-based Orbit Biomedical Ltd., a medical device company that targets delivery of gene and cell therapies into the retina, to create a single retinal gene therapy company.
Cambridge, Mass.-based Inozyme Pharma Inc. just added $67 million to its financing with a series A2 boost led by Pivotal Bioventure Partners and Sofinnova Investments.
Three biotechs – Turning Point Therapeutics Inc., Hookipa Pharma Inc. and Trevi Therapeutics Inc. – are gearing up to join the public sector. Turning Point and Hookipa both set terms, aiming to raise $125.8 million and $100.5 million at the midpoint of their respective ranges, while Trevi filed for an IPO, aiming to raise as much as $86.25 million.
Privately held Ocugen Inc. and publicly held Histogenics Corp. have entered a definitive merger agreement to create a publicly traded, clinical-stage biopharmaceutical company using Ocugen as its name, with a focus on eye diseases.
Liquidia Technologies Inc. has announced additional positive safety and exploratory endpoint findings at the two-month timepoint in its phase III trial of LIQ-861, an inhalation dry powder formulation of treprostinil for patients with pulmonary arterial hypertension (PAH).
Entasis Therapeutics Holdings Inc. has initiated a phase III trial to evaluate ETX-2514 for treating patients in the U.S., Europe and Asia with pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii.
Dyne Therapeutics Inc., founded and seeded last year by Atlas Venture, has completed a $50 million series A along with Forbion and MPM Capital. Cambridge, Mass.-based Dyne will target therapies for patients suffering from myotonic dystrophy type 1 (DM1), a rare and inherited disorder with life-limiting complications that affects about 40,000 people in the U.S. alone.
Evoke Pharma Inc. and Intelgenx Corp. each received FDA complete response letters (CRL) regarding NDAs for products in their pipelines. Evoke's CRL for Gimoti states that the FDA cannot approve the NDA in its present form and provided recommendations to address two remaining approvability issues for an NDA resubmission.
