On a quest to boost its renal diseases pipeline with two late-stage drugs, Novartis AG has announced plans to acquire precision medicines drug developer Chinook Therapeutics Inc., offering up to $3.5 billion. The move drove Chinook’s shares (NASDAQ:KDNY) up by 58.3%, or $13.99, on June 12, closing at $37.98. Read More
Promising early data continue to roll out for Intellia Therapeutics Inc.’s hereditary angioedema (HAE) candidate, NTLA-2002, with one of the earliest treated patients in the phase I study remaining attack-free for more than a year. But it was the systemic CRISPR candidate’s potential as a one-time treatment that generated the most discussion on the company’s call as investors tried to assess its potential advantage in a crowded HAE market. Read More
The lead asset of Applied Genetic Technologies Corp. has been spun into Beacon Therapeutics Ltd., which launches with $120.9 million to run a phase II/III pivotal trial of AGTC-501 in X-linked retinitis pigmentosa, and to take forward two other in-licensed preclinical programs in age-related macular degeneration and cone rod dystrophy. Read More
Patent expirations, a shrinking IPO window and reduced capital availability amidst higher interest rates are just a few of the challenges faced by the biotech industry in the post-pandemic era, although the mid- to long-term industry outlook is still favorable. The 33rd edition of Ernst & Young’s Beyond Borders report describes these obstacles and more faced by biotech, as well as advice for companies for traversing “a complex path forward.” Read More
Disc Medicine Inc.’s positive phase II data from an ongoing, open-label trial called Beacon with oral bitopertin in erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) whetted investor appetite for the results of the other mid-stage Disc experiment known as Aurora with the compound, due early next year. Read More
It didn’t take long for the filing of a second constitutional challenge to the U.S. Inflation Reduction Act’s price negotiations for prescription drugs. In the wake of a similar suit filed three days earlier by Merck & Co. Inc., the Chamber of Commerce filed a complaint June 9 in the U.S. District Court for the Southern District of Ohio. Read More
Barring truly major surprises, exagamglogene autotemcel (Exa-cel, Vertex Pharmaceuticals Inc.) is on track to become the first approved CRISPR-based gene editing therapy. It is partly in expectation of Exa-cel’s approval that the European Hematology Association (EHA) and the European Society for Bone Marrow Transplantation hosted a session on “transplantation versus gene therapy in sickle cell disease.” Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adverum, Alvotech, Ambulero, Avrobio, Daewoong, Hanall, Johnson & Johnson, Novartis, Ray, Teva, Vincere. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Anthos, Astellas, Astrazeneca, Crispr, Praxis, Sanofi, Vertex, Vor. Read More