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Novartis bets $2B on next-gen allergy drug & Otsuka buys an anti-PTSD drug for $700M upfront

Good Morning! One small approval from the European Medical Agency, one giant leap for at-home injectable cancer therapy!

What happened: Johnson & Johnson’s Darzalex (daratumumab) has received European approval for self-administration, becoming the first injectable cancer therapy in Europe authorized for at-home use. Following a Type II label change by the EMA, patients or caregivers may administer the drug after the fifth dose with proper training and medical approval, across all ten of its indications.

Why it matters: The move is expected to reduce clinic visits and improve access, while strengthening J&J’s position in the multiple myeloma market. Analysts note it may also help offset upcoming patent challenges, with sales projected to peak at $7.6bn in 2028 before declining amid increasing competition.

Bottom line: This approval offers a more accessible way to treat cancer while lightening the burden on the healthcare systems in Europe. A double win.

— Joachim E.

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SNAPSHOT

Novartis bets $2B on next-gen allergy drug to succeed blockbuster Xolair

Nasal spray and paper napkins in a blue box on a yellow background. Medicine. Disease. Cold. Coronavirus. Covid- 19. Nasal spray,allergy. nasal secretion

Why it matters: Xolair generated $1.7B in 2025 sales but faces looming biosimilar competition in the U.S. Novartis is investing early to secure a stronger, next-generation successor and maintain dominance in allergy treatments.

Backstory: Excellergy only emerged from stealth about five months ago with $70 million in funding, though the company was founded in 2021 with seed backing from Red Tree. It has focused on a new class of therapies called effector cell response inhibitors, or ECRIs, based on discoveries from Stanford University and the University of Bern.

Zoom in: Exl-111 is designed as an “effector cell response inhibitor” (ECRI), a new drug class that goes beyond conventional anti-IgE drugs like Xolair. It removes IgE directly from immune cell receptors without activating them and so avoiding side effects. Preclinical data showed >99% removal of cell-bound IgE in basophils. Early trials began recently, with phase 3 development underway. The goal that Exl-111 is going after is faster symptom relief, deeper suppression, and more convenient dosing vs. Xolair.

Big picture: The deal reflects a broader pharma strategy of replacing aging biologics with more precise, next-gen therapies before generics erode revenue. If successful, ECRIs could redefine treatment across multiple allergic diseases, including allergic asthma, food allergies, or chronic urticaria.

What’s next: Novartis will integrate Excellergy’s program into its pipeline and push clinical development forward as biosimilar Xolair competitors are expected in the U.S. by late 2026.

SNIPPETS

What’s happening in biotech today?

🧠 PTSD push: Otsuka Pharmaceutical announced it will acquire New York–based Transcend Therapeutics for $700M upfront, with up to $525M in additional milestone payments, to gain control of TSND-201, an experimental PTSD treatment currently entering Phase 3 trials. The drug, whose active ingredient is methylone, aims to enhance neuroplasticity by targeting neurotransmitter systems without triggering hallucinogenic effects associated with similar compounds like MDMA. Otsuka views the therapy as potentially “paradigm-shifting” in psychiatry and expects the deal to close by mid-2026. The acquisition aligns with Otsuka’s strategy to expand its neuroscience portfolio beyond existing treatments such as Abilify Maintena and Rexulti.

🌬️COPD breakthrough: AstraZeneca reported that its experimental antibody tozorakimab successfully met primary endpoints in two Phase 3 trials for chronic obstructive pulmonary disease (COPD), reducing flare-ups across a broad patient population regardless of eosinophil levels or smoking history. The results surprised analysts, as similar IL-33–targeting drugs from competitors have failed in late-stage trials. Unlike existing biologics such as Dupixent and Nucala, which are limited to certain patient groups, tozorakimab may be effective in a wider population by targeting a specific form of the IL-33 protein involved in inflammation and mucus buildup. If approved, the drug could significantly expand treatment eligibility and become a major commercial product for AstraZeneca.

Promise pending: AstraZeneca’s experimental in vivo CAR-T therapy, ESO-T01, showed early promise in a small Phase 1 trial for multiple myeloma, with four of five patients responding and three achieving complete remission within 60 days, demonstrating the feasibility of generating CAR-T cells directly in the body. However, all patients experienced serious side effects, including cytokine release syndrome and infections, and one patient died due to complications potentially linked to disease progression or treatment-related factors. While the safety profile appears similar to traditional CAR-T therapies, it does not yet offer clear advantages, and questions remain about durability and differentiation from existing treatments like Carvykti.

🚀 Accelerated start: The FDA granted accelerated approval to Rocket Pharmaceuticals’ gene therapy Kresladi for treating severe leukocyte adhesion deficiency type 1 (LAD-1), a rare and life-threatening immune disorder affecting children who lack transplant options. The therapy demonstrated the ability to improve survival, reduce hospitalizations, and lower infection rates, though side effects such as anemia and low blood cell counts were observed, and longer-term data is still needed. While not expected to be a major commercial product due to the disease’s rarity, the approval marks an improved milestone for Rocket after years of setbacks, providing financial relief through a valuable priority review voucher and supporting its transition into a commercial-stage company.

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