Autoimmune disease

When Ionis Pharmaceuticals’ Tryngolza undersold, investors immediately looked to Arrowhead Pharmaceuticals’ executives for answers on how they will navigate a launch in the same market.
Evommune is commiting $30 million upfront for Hinova Pharmaceuticals’ oral molecular glue degrader—a low-cost bet with a high probability of success, according to analysts, after clinical failures roiled the biotech’s internal pipeline earlier this year.
With the first Phase 3 data expected for Amgen’s MariTide next year, analysts are looking for evidence that the GLP-1 candidate is tolerable. Meanwhile, the company has begun testing an autoinjector formulation.
In a mid-stage trial, the lower dose of Tiziana’s intranasal monoclonal antibody reduced microglial activation in a specific type of multiple sclerosis. But the path forward remains unclear after the higher dose failed to deliver the same benefit.
Merck stole the show at the European Society for Medical Oncology (ESMO) annual conference, with new data on its Moderna-partnered personalized cancer vaccine leaking prior to the presentation and antibody-drug conjugate sac-TMT making a splash in endometrial cancer; Bristol Myers Squibb revealed the death of a patient with multiple sclerosis in an early-stage trial of zola-cel; and pharma is on track to easily surpass last year’s deal count.
The disclosure—which came ahead of a presentation of data from the Phase 1 Breakfree-2 study at the ACTRIMS-ECTRIMS meeting—follows Bristol Myers Squibb’s late summer revelation that it had paused certain trials of zolacabtagene autoleucel.
China cracks down on some biotechnology ownership transfers—but will the new policy impact licensing deals?; Disc Medicine’s Phase 3 data sweep redeems rejected rare disease therapy, teeing up another FDA run; and the ESMO conference gets underway in Madrid this week, with much-anticipated data from Merck, and Summit Therapeutics.
Novartis will continue to study Fabhalta in other indications, with late-stage studies in two rare diseases—atypical haemolytic uraemic syndrome and generalized myasthenia gravis—expected to read out later this year and next year, respectively.
A new biotech co-founded by Paul Stoffels has formed to take on the CAR T cell assets of Galapagos almost a year after the company—now known as Lakefront Biotherapeutics—abandoned them.
Johnson & Johnson beat analyst expectations in the third quarter but left Wall Street wanting more; BMS dominated the news cycle on Monday with a Phase 3 win validating its $4.1 billion RayzeBio buy and mixed data in a late-stage pulmonary fibrosis trial; Revolution Medicines’ newly approved pancreatic cancer drug works better for patients with certain mutations; and Caribou Biosciences may be on its way out.
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