Johnson & Johnson

Autolus Therapeutics' obe-cel, an autologous CAR-T cell therapy for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia, awaits FDA approval on November 16, 2024. The therapy targets CD-19 and has shown a 78% ORR in the FELIX study, with potential peak revenues of ~$300m. Despite a 25% share price drop, Autolus holds $700m in cash and has partnerships with BioNTech, Moderna, and Bristol Myers Squibb, positioning it for future growth.

Johnson & Johnson (J&J) has submitted nipocalimab, an FcRn blocker, for FDA approval for generalized myasthenia gravis, with potential to treat up to 10 disease indications, including rheumatoid arthritis.

Lykos Therapeutics CEO Amy Emerson to step down after FDA rejection of MDMA therapy aid approval. Michael Mullette appointed interim CEO. Company plans to cut 75% of workforce and resubmit MDMA approval application.

Evernorth Health Services will offer a private-label biosimilar of Stelara (ustekinumab) starting in early 2025, with a price over 80% lower than Stelara's list price. The biosimilar will be available for $0 out of pocket for eligible patients through Accredo, potentially saving individual patients around $4,000 per year. Evernorth has already seen strong interest in its private-label Humira biosimilar, with over 25% of eligible Accredo patients using it.

Pharmaceutical industry faces significant challenges with over 14,000 layoffs in 2024 due to deteriorating financial performance, rising costs, and regulatory pressures. Companies like Pfizer and Takeda are cutting costs and closing R&D facilities, prioritizing short-term financial health over long-term innovation. The U.S. Inflation Reduction Act is expected to further strain the industry by reducing revenue streams starting in 2026, adding to the impact of inflation, supply chain disruptions, and patent expirations. These financial pressures force companies to streamline operations and reduce expenditures, potentially leading to slower innovation and reduced capacity to bring new therapies to market.

Johnson & Johnson submitted a BLA to the FDA for nipocalimab, an investigational therapy for generalized myasthenia gravis (gMG), based on data from the Phase III Vivacity-MG3 trial. Nipocalimab, an FcRn blocker, showed sustained disease control in gMG patients over 24 weeks, marking the longest controlled safety and efficacy assessment in this patient group.

Patients with myasthenia gravis in Europe often wait over a year for diagnosis, which correlates with worse clinical profiles including higher MGFA class III disease, fatigue, anxiety, and depression. The study emphasizes the need for early and accurate diagnosis and treatment strategies.

Johnson & Johnson submitted a BLA to the FDA for nipocalimab, an FcRn blocker for gMG, supported by phase III Vivacity-MG3 study data showing sustained disease control. Nipocalimab faces competition from Argenx’s and UCB’s FcRn blockers. J&J is also testing nipocalimab in other conditions, holding a Zacks Rank #4.

Johnson & Johnson submits a Biologics License Application to the FDA seeking the first approval of nipocalimab globally for treating generalized myasthenia gravis (gMG). The application included data from the Phase 3 Vivacity-MG3 study showing superior outcomes for antibody positive participants who received nipocalimab plus standard of care compared to placebo plus standard of care. Nipocalimab is the first-and-only FcRn blocker to demonstrate sustained disease control in gMG.

Johnson & Johnson seeks FDA approval for nipocalimab, a drug targeting generalized myasthenia gravis by reducing harmful antibodies. Proven effective in a Phase 3 study, it aims to set a new standard in treating autoantibody-driven diseases, with potential applications in rheumatoid arthritis and other conditions.