Myasthenia Gravis

BioNxt Solutions Inc. is advancing its cladribine oral thin film (ODF) program, showing over 40% improved bioavailability in preclinical studies. This progress supports initiating clinical trials for Multiple Sclerosis (MS) and expanding to Myasthenia Gravis (MG), leveraging a capital-efficient strategy with an established API. The ODF platform aims to enhance patient adherence and simplify administration for chronic neurological and autoimmune conditions, targeting substantial and growing markets.

Zai Lab announced that VYVGART, NUZYRA and ZEJULA have been renewed on China’s 2025 NRDL, expanding access for generalized myasthenia gravis, community‑acquired pneumonia/ABSSSI, and maintenance therapy in platinum‑sensitive ovarian cancer. The renewals underscore clinical value, lower patient costs, and position Zai Lab for growth in immunology, infectious disease and oncology, with projected multi‑year revenue uplift and an 18‑22% CAGR through 2028.

Argenx will present over 40 abstracts at the 2025 AANEM/MGFA meeting, highlighting data on VYVGART (IV and SC) and empasiprubart. Key presentations include ADAPT SERON results showing VYVGART’s efficacy in AChR antibody-negative gMG, interim ADAPT Jr data in juvenile gMG, and Phase 2/3 empasiprubart programs for CIDP and MMN (EMVIGORATE, EMNERGIZE, EMPASSION). Real-world evidence and long-term data will also be presented, reinforcing VYVGART’s sustained benefit. The conference will address concerns of allergic risks and infection management.

Kyverna Therapeutics will present interim Phase 2 KYSA-6 trial results for KYV-101 in myasthenia gravis at the AANEM meeting in October 2025. Data from six patients with up to 9 months follow-up will be shared. KYV-101, a CD19 CAR T-cell therapy, aims for durable remission after a single dose. The study has been upgraded to a registrational Phase 2/3 trial, with Phase 3 initiation planned by year-end 2025. The presentation by Dr. Srikanth Muppidi will be on October 29th.

Dianthus Therapeutics (DNTH) will report topline results from its Phase 2 MaGic trial of claseprubart (DNTH103) in generalized Myasthenia Gravis (gMG) on September 8, 2025, at 8:00 a.m. EDT. The clinical-stage biotech company, focused on antibody complement therapeutics for autoimmune diseases, will host a conference call and webcast with a Q&A session. Investors can access the webcast via the company’s investor relations website, with a replay available afterward. Claseprubart targets the classical complement pathway, potentially offering a targeted gMG treatment.

Argenx’s VYVGART® demonstrated statistically significant improvements in AChR-Ab seronegative generalized myasthenia gravis (gMG) patients in the ADAPT SERON phase 3 study (p=0.0068). This is the first global Phase 3 study showing benefits across MuSK+, LRP4+, and triple seronegative subtypes. Argenx plans to submit an sBLA to the FDA by the end of 2025 to expand VYVGART’s label. The drug maintained its consistent safety profile. The results position VYVGART as a potential foundational therapy for a broader gMG population.