After many months of jockeying, the U.S. FDA has approved Ascendis Pharma A/S’ hormone replacement therapy Yorvipath (palopegteriparatide) for treating hypoparathyroidism. Ascendis said this is the first and only treatment for adults with the rare endocrine disease.
Aldeyra Therapeutics Inc. has bounced back from a complete response letter in November to produce positive phase III data for reproxalap in treating dry eye disease. The company is one of many developing treatments using diverse mechanisms of action.
The U.S. FDA has granted accelerated approval to Novartis AG’s Fabhalta (iptacopan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. The approval strengthens the company’s renal disease presence as it puts two other IgAN treatments through clinical trials.
In December 2020, Servier Pharmaceuticals LLC bought Agios Pharmaceuticals Inc.’s approved acute myeloid leukemia drug, Tibsovo (ivosidenib), and the rest of its oncology business in a deal valued at up to $2 billion. Now, the U.S. FDA has approved one of those assets, with the brand name Voranigo (vorasidenib), for treating gliomas.
Big pharma continues to invest heavily into molecular glue degraders. The latest deal has Eisai Co. Ltd. striking up a research collaboration that could bring Seed Therapeutics Inc. up to $1.5 billion in up-front and milestone payments. The two said they plan to discover, develop and commercialize MGDs for several undisclosed neurodegeneration and oncology targets.
Instil Bio Inc. plans re-energize the company by in-licensing the development and commercial rights to antibodies outside of China from Shanghai-based Immuneonco Biopharmaceuticals Inc. In return, Immuneonco is getting an undisclosed up-front payment and the chance for near-term payments of up to $50 million.
Big pharma continues to invest heavily into molecular glue degraders. The latest deal has Eisai Co. Ltd. striking up a research collaboration that could bring Seed Therapeutics Inc. up to $1.5 billion in up-front and milestone payments. The two said they plan to discover, develop and commercialize MGDs for several undisclosed neurodegeneration and oncology targets.
Bristol Myers Squibb Co. (BMS) has terminated its $1.3 billion-plus deal for Agenus Inc.’s anti-TIGIT bispecific antibody AGEN-1777 as part of a promised belt-tightening. In May 2021, BMS paid Agenus a non-refundable $200 million up-front payment in cash for the licensing, manufacturing and commercialization agreement, then a $20 million milestone payment in December 2021 and another clinical milestone payment in January 2024 for $25 million.
A T-cell therapy from Adaptimmune Therapeutics plc has received accelerated approval from the U.S. FDA to treat advanced synovial sarcoma (SS). Tecelra (afamitresgene autoleucel), a CAR T targeting MAGE-A4, is the first engineered T-cell therapy for solid tumors and the first treatment option for the indication in more than a decade.
Instil Bio Inc. plans re-energize the company by in-licensing the development and commercial rights to antibodies outside of China from Shanghai-based Immuneonco Biopharmaceuticals Inc. In return, Immuneonco is getting an undisclosed up-front payment and the chance for near-term payments of up to $50 million.
