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This week's news in the biopharmaceutical field is quite dense, with FDA approvals, mergers and acquisitions, and clinical data all coming in. I noticed several highlights worth paying attention to.
First, let's talk about the actions on the FDA side. Eton Pharma just received approval for DESMODA, an oral solution of desmopressin acetate approved for the treatment of central diabetes insipidus. This is the first FDA-approved desmopressin oral solution, designed to support precise dosing without worrying about tablet splitting or cold chain issues. Eton estimates that over 13,000 patients in the U.S. are affected, including 3,000 to 4,000 pediatric patients. The company expects peak annual sales of DESMODA to reach $30 million to $50 million. This is Eton's ninth commercial product, and it seems their layout in the rare disease field is becoming increasingly comprehensive.
Allurion Technologies also received approval; their Allurion gastric balloon system obtained FDA pre-market approval. This smart capsule can be placed during a short office visit, inflates in the stomach for about four months to increase satiety, and then naturally passes out. It offers a non-surgical option for patients with BMI between 30 and 40, serving as an intermediate route between medication and bariatric surgery.
However, there have been setbacks. MacroGenics' LINNET trial was partially halted by the FDA. Their Lorigerlimab encountered safety issues in gynecologic cancer studies—four patients experienced grade 4 thrombocytopenia, myocarditis, neutropenia, and septic shock. The company said it will continue working with the FDA to resolve these issues.
In major deals, Gilead acquired Arcellx at $115 per share plus a $5 per share contingent value right, totaling $7.8 billion. This deal strengthens Gilead's position in the cell therapy field, with Kite Pharma and Arcellx already having a collaboration to develop anti-CD19 CAR-T.
There are also many points of interest in clinical data. MoonLake's Sonelokimab performed well in axial spondyloarthritis trials, with 81% of patients achieving ASAS40 response at week 12. Novo Nordisk's UBT251 in a Chinese phase 2 trial showed a 19.7% weight loss rate, much better than the 2% with placebo. However, their CagriSema and Lilly's Zepbound comparison trials were less ideal, with 23% versus 25.5%, missing the primary endpoint.
Palvella's QTORIN met primary endpoints in microcystic lymphatic malformation trials, and Argenx's VYVGART performed well in myasthenia gravis trials. These are niche indications, but once successful, they offer unique market opportunities.