In its second big collaboration of the past six months, privately held Tentarix Biotherapeutics LP plans to discover and develop biologics for treating oncology and immunology indications with Abbvie Inc. The deal comes at a time of change at Abbvie, which is getting a new CEO, watching the marketplace erosion of bestselling Humira (adalimumab) and digesting two major acquisitions at a cost of billions.
Helping executive and investors prepare for better economic times is a strong theme in the upcoming BIO CEO 2024 conference, which runs Feb. 26 and 27 in New York. The annual conference, sponsored by the Biotechnology Innovation Organization, is designed to present a broad, unbiased view of investment opportunities. Panels of experts are set to discuss hot therapeutic areas and the key business issues facing companies and the industry.
Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group.
Based on positive phase III study data, Applied Therapeutics Inc. plans to take its CNS-penetrant aldose reductase inhibitor to the U.S. FDA to talk about an NDA for treating the rare disease sorbitol dehydrogenase (SORD) deficiency. Interim data from 12 months of treatment showed govorestat (AT-007) hit the study’s primary endpoints along with several key secondary endpoints. The double-blind, placebo-controlled registrational study of patients ages 16 to 55 is ongoing, with another 12 months of data yet to come. SORD, a hereditary axonal neuropathy created by sorbitol dehydrogenase gene mutations, affects about 3,300 people in the U.S. and about 4,000 in Europe, according to Applied Therapeutics.
The U.S. FDA has approved Eicos Sciences Inc.’s Aurlumyn (iloprost) for treating severe frostbite. The injectable vasodilator, which opens blood vessels and stops blood from clotting, is now approved for adults to reduce finger or toe amputations and is, according to the FDA, the first-ever treatment option for severe frostbite. The drug, also referred to as ES-2001, had the FDA’s priority review and orphan drug designations for treating severe frostbite.
Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group.
Autolus Therapeutics Inc. has picked up plenty of financial momentum, about $600 million worth, in its runup to a November 2024 PDUFA date for its CD19 CAR T therapy. Helping propel that momentum is Biontech SE, another CAR T therapy developer. For $50 million cash, Biontech bought the rights to use Autolus’ manufacturing and commercial infrastructure in the U.K. so it can advance its CAR T-cell BNT-211 program in the clinic.
Amgen Inc. reported its latest financial numbers but much of the conversation on the Feb. 6 conference call was about obesity. The same was true with Eli Lilly and Co. as weight loss drove the narrative.
Vertex Pharmaceuticals Inc. upped its own ante with pivotal phase III data in its strong suit, cystic fibrosis (CF). Taking on Trikafta, the company’s bestseller, Vertex’s once-daily vanzacaftor/tezacaftor/deutivacaftor (vanza) combo hit all primary and key secondary endpoints in two randomized controlled studies of those ages 12 and older.
In August 2020, Johnson & Johnson paid $6.5 billion cash to acquire Momenta Pharmaceuticals Inc. That strengthened J&J’s immune-mediated disease portfolio and grew its interest in autoantibody-driven disease therapies by bringing nipocalimab into the fold. Now the investment is paying off with top-line results of phase II and III studies that hit their primary endpoints using the fully human glycosylated monoclonal antibody targeting the human neonatal Fc receptor. The studies were in treating generalized myasthenia gravis and in Sjögren’s disease.