Halozyme Therapeutics has withdrawn its bid to acquire Evotec after Evotec declined to engage in discussions about the potential deal. The proposed acquisition was valued at approximately 2 billion euros.
Despite Halozyme's efforts to initiate talks with Evotec's leadership, multiple requests for meetings were turned down. Halozyme's CEO, Helen Torley, expressed disappointment, stating that it has become clear there is no interest from Evotec in pursuing the acquisition.
In the wake of Halozyme's withdrawal, private equity firm Triton has emerged as a potential player in the Evotec landscape. Triton recently acquired a 10% stake in the company and is reportedly exploring the possibility of a buyout.
Neurogene has reported the death of a study participant involved in a clinical trial for a gene therapy aimed at treating Rett syndrome. The patient, who received a high dose of the therapy, experienced severe complications consistent with known risks associated with gene therapies utilizing adeno-associated virus (AAV) vectors.
Following a critical condition, Neurogene disclosed that the patient succumbed to complications from a rare and life-threatening hyperinflammatory syndrome linked to high systemic exposure to AAV. Despite this tragic incident, the Food and Drug Administration (FDA) has permitted Neurogene to continue its clinical trials, albeit with a lower dosage of the gene therapy.
Argenx is expanding testing of its drug efgartigimod in various subtypes of myositis, a group of rare autoimmune diseases. The decision to expand testing follows promising efficacy and safety results from the Phase 2 portion of a Phase 2/3 study.
Efgartigimod, marketed as Vyvgart for conditions such as myasthenia gravis, presents a substantial market opportunity, with analysts estimating potential peak annual sales of at least $1 billion.
Kyowa Kirin has agreed to pay Kura Oncology $330 million upfront for the rights to an experimental oral leukemia drug currently in Phase 1 testing. The drug, known as ziftomenib, targets relapsed or treatment-resistant acute myeloid leukemia characterized by the NPM1 mutation.
Under the terms of the agreement, Kura could receive an additional $420 million contingent upon ziftomenib reaching the market. This partnership allows Kura to lead the development and sales of ziftomenib in the United States, while Kyowa Kirin will manage these responsibilities outside the U.S.
Douglas Throckmorton, the deputy center director for regulatory programs at the FDA, has announced his retirement set for January after a distinguished 27-year career at the agency's main drugs office. Throckmorton has been in his current role since 2005, overseeing a wide array of critical issues related to drug evaluation and approval processes.
His retirement raises questions about the future direction of the FDA and the leadership that will guide the agency in addressing the evolving landscape of drug development and regulation.