RECORDATI

Roche acquires Poseida Therapeutics for up to $1.5B, expanding into CAR-T therapies. U.S. overdose deaths decline by 14.5% to 97,000 over 12 months. Arrowhead Pharmaceuticals licenses programs to Sarepta Therapeutics for $500M upfront and $325M in equity. Recordati and Angelini Pharma consider merger to form Europe's largest generics group. FDA approves BridgeBio's heart drug for transthyretin amyloidosis, challenging Pfizer's tafamidis. Novo Holdings expected to receive EU approval for $16.5B acquisition of Catalent Pharma Solutions. Amgen's obesity drug MariTide shows 20% weight loss in Phase II. Anavex Life Sciences submits MAA to EMA for Alzheimer's treatment. Biohaven's muscle drug fails in SMA study. embecta reports strong revenues of $1.12B, discontinues insulin patch pump. Axsome Therapeutics reports positive Phase 3 results for narcolepsy drug AXS-12. Kronos Bio to lay off 83% of workforce. PTC Therapeutics sells Rare Pediatric Disease Priority Review Voucher for $150M. EMA launches medicine shortages monitoring platform. Alector lays off 41 employees after Alzheimer's drug AL002 fails. Grifols seeks to refinance €1.4B in debt. Roche's cancer drug tiragolumab fails Phase 3 trial.

Sponsors and CROs seek optimal balance in oversight to ensure efficient clinical trials, with concerns over trust and the need for 'just right' oversight highlighted at Veeva’s forum. Effective oversight ensures patient protection, data reliability, and compliance with legislation, balancing costs and efficiency.

Sanofi reports 15.7% Q3 sales growth, driven by vaccine sales and strong business performance, raising 2024 EPS guidance. Dupixent sales up 23.8%, with full-year target confirmed at €13 billion. Pharma launches grew 67.1%, led by ALTUVIIIO, Nexviazyme, and Rezurock. Vaccines sales increased 25.5%, boosted by flu sales and Beyfortus. Opella sales rose 7.9%, supported by Qunol acquisition. R&D expenses grew 12.7%, while SG&A expenses grew 6.4%. Business EPS at €2.86, up 12.2% reported and 17.6% at CER. Four regulatory approvals and four positive phase 3 data readouts achieved. Negotiations underway to transfer a controlling stake of Opella to CD&R. 2024 business EPS guidance upgraded to low single-digit growth at CER.

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Sanofi sells global rights to Enjaymo to Recordati for $825M upfront, with potential $250M more if sales goals are met. Enjaymo, a treatment for cold agglutinin disease, adds to Recordati's rare disease portfolio, expected to generate €150M+ in 2025.

Recordati acquires worldwide rights to Sanofi's Enjaymo, the only approved treatment for cold agglutinin disease (CAD), for $825m upfront plus $250m in milestone payments. Enjaymo, a humanised monoclonal antibody, treats haemolysis in CAD patients and has generated €100m in revenue over the last 12 months, with projections for €150m in 2025.

Glucocorticoid-induced hypercoagulopathy in endogenous Cushing syndrome (CS) increases thromboembolic risk, with CS patients having an 18-fold higher risk of venous thromboembolism (VTE) compared to the general population. VTE risk is highest postoperatively, with up to 5.6% incidence. Hypercoagulopathy persists post-surgery and improves within 6 months. Relacorilant, a selective glucocorticoid receptor modulator, showed improvements in coagulation markers without undesirable effects, suggesting potential benefits for CS patients, particularly those at high VTE risk.