Pharmaceutical Executive Daily: FDA Approves Simtriyo

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today's Pharmaceutical Executive Daily, FDA approves Otsuka's Simtriyo as the first NDSRI treatment for ADHD, argenx agrees to acquire Forte Biosciences for approximately $2.2 billion, and an AbbVie neuroscience researcher discusses the shift from symptom management to disease modification in Parkinson's research.

FDA has approved Otsuka's Simtriyo, a once-daily extended-release capsule and the first norepinephrine, dopamine, and serotonin reuptake inhibitor approved for attention-deficit hyperactivity disorder, for adults and children as young as six. The approval was supported by four Phase III trials showing statistically significant improvements in ADHD symptoms compared with placebo, with separation from placebo evident as early as the first week of treatment. The most common side effects included decreased appetite, headache, and nausea, varying somewhat by age group. Simtriyo is expected to become available later this year following scheduling review by the Drug Enforcement Administration.

Argenx has agreed to acquire Forte Biosciences for $77 per share in cash, a deal valuing the company at approximately $2.2 billion and representing an 86 percent premium to its trading price since positive Phase Ib vitiligo data was reported earlier this month. The acquisition brings Forte's lead program, FB102, a first-in-class anti-CD122 antibody with proof-of-concept data in both vitiligo and celiac disease, into argenx's immunology pipeline. The companies say FB102 could extend to additional autoimmune conditions including alopecia areata. The deal carries no financing condition and is expected to close in the third quarter of 2026, pending majority shareholder tender and antitrust clearance.

Finally, Dr. Jan Stoehr, a neuroscience researcher at AbbVie, talks with Pharmaceutical Executive about how Parkinson's disease research is shifting from managing symptoms after they appear toward intervening earlier in the underlying protein misfolding that drives disease progression. He said multimodal biomarkers, drawn from blood, cerebrospinal fluid, imaging, and digital assessments, are giving researchers a window into disease biology years before diagnosis, which can improve clinical trial eligibility and help measure whether a therapy is engaging its intended target. Stoehr said the field's biggest challenges remain the biological complexity of neurodegenerative disease and the difficulty of measuring whether a treatment is truly altering disease trajectory rather than just easing symptoms.

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