argenx

Halozyme proposes to acquire Evotec for €11.00 per share, creating a leading global pharma services company with capabilities in drug discovery, biologic manufacturing, and drug delivery technologies, diversifying and scaling Halozyme's revenue and EBITDA into the next decade. The all-cash transaction would be funded by cash on hand and new debt, with expected net leverage less than 2x two years post-close.

Bullous pemphigoid (BP) affects elderly patients, often misdiagnosed, with no approved therapies in the US. Current treatments include off-label corticosteroids and immunomodulators. The BP pipeline includes advanced Phase III therapies like AstraZeneca’s Fasenra, Sanofi/Regeneron’s Dupixent, and Akari Therapeutics’ nomacopan. Unmet needs and market opportunities are significant due to lack of approved therapies and diagnostic biomarkers.

Semaglutide shows promise in treating osteoarthritis, potentially paving the way for FDA approval. Ozempic and Wegovy, both semaglutide-based drugs, are now listed as available by the FDA, potentially impacting compounding pharmacies. CRISPR gene editing continues to advance with notable researchers like Alexis Komor and Patrick Hsu. AstraZeneca's top executive in China is under investigation. A small study indicates TMS may slow Alzheimer's progression.

Complement inhibitors market is growing due to the complement system's role in rare and chronic diseases. Over 40 companies are developing 50+ pipeline inhibitors, including Gefurulimab, ANX005, DNTH103, and others. Recent milestones include Q32 Bio presenting ADX-097 data at ASN Kidney Week 2024 and ReAlta Life Sciences dosing the first patient in a Phase II study of RLS-0071.

Iptacopan (Fabhalta) showed a clinically meaningful reduction in proteinuria and confirmed clinical benefit of alternative pathway inhibition in IgA nephropathy, with a 38.3% lower UPCR than placebo by month 9. The study also found significant decreases in complement pathway biomarkers, supporting selective alternative pathway inhibition.

A subgroup analysis of the phase 3 ADHERE trial showed efgartigimod PH20 SC efficacy in CIDP patients previously treated with corticosteroids, IVIg/SCIg, or off-treatment, with 77.8%, 58.8%, and 72.3% achieving clinical improvement, respectively. The therapy was well-tolerated and FDA-approved in June 2024.

Halozyme Therapeutics announces argenx has nominated four new targets for ENHANZE® drug delivery tech, bringing the total to six, including FcRn. argenx to pay Halozyme $30 million upfront and potential future milestone payments up to $85 million per target.

Amgen's Phase 3 results for rocatinlimab in atopic dermatitis and Uplizna in myasthenia gravis were met with skepticism by analysts, who noted rocatinlimab's underwhelming efficacy and safety concerns, while Uplizna's potential as a second-line treatment was seen as sizable but not a threat to market leaders.

FDA approves Roche's OCREVUS ZUNOVO™ with Halozyme's ENHANZE® for RMS and PPMS, offering a 10-minute subcutaneous injection.

Roche received FDA approval for OCREVUS ZUNOVO™, a subcutaneous injection using Halozyme's ENHANZE® technology for RMS and PPMS, offering a 10-minute, twice-a-year treatment.