Vertex(US:VRTX)2024-08-02 00:37Financial Performance & Guidance - Q2 2024 total product revenues reached $2.65 billion[6], compared to $2.49 billion in Q2 2023[25] - The company is increasing its full year 2024 product revenue guidance to $10.65 - $10.85 billion[6, 27] - Combined non-GAAP R&D and SG&A expenses for Q2 2024 were $978 million[25] - The company closed the $5 billion purchase of Alpine Immune Sciences[6] Key Pipeline & Regulatory Milestones - Vanzacaftor triple NDA accepted with Priority Review, with a PDUFA target action date of January 2, 2025 in the U.S[5, 7] MAAs validated in EU and U.K[5, 7] - Suzetrigine NDA for moderate to severe acute pain accepted with Priority Review; PDUFA target action date of January 30, 2025[5, 8] - Phase 3 study of Suzetrigine in DPN (Diabetic Peripheral Neuropathy) is expected to begin in Q3 2024[5, 10] - Povetacicept Phase 3 trial in IgAN (IgA nephropathy) is expected to initiate in Q3 2024[5, 13] Cystic Fibrosis (CF) Program - Development of VX-522, a CFTR mRNA therapy, is underway for >5,000 CF patients who cannot benefit from CFTR modulators[5, 7] - The Multiple Ascending Dose (MAD) portion of the Phase 1/2 study for VX-522 is underway, with results expected in H1 2025[7] CASGEVY Launch & Expansion - CASGEVY has been launched in SCD/TDT (Sickle Cell Disease/Transfusion Dependent Beta Thalassemia), with increasing ATC (Authorized Treatment Center) activations and patient cell collections across all regions[5] - The company anticipates activating ~75 ATCs globally over time[22]