International Top Pharmaceutical Companies News Weekly — March 18, 2024 to March 24, 2024

• AstraZeneca: On March 21, 2024, results from the Phase III FLAURA2 trial demonstrated that AstraZeneca’s Tagrisso (osimertinib) in combination with chemotherapy provided clinically meaningful benefits in patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) following disease progression. With two years of follow-up, the Tagrisso-plus-chemotherapy regimen also showed a favorable trend toward improved overall survival (OS). These results were presented at the 2024 European Lung Cancer Congress (ELCC) held in Prague, Czech Republic. Previously, at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC), primary endpoint data showed statistically significant and clinically meaningful improvement in progression-free survival (PFS) with Tagrisso plus chemotherapy. In February 2024, the U.S. FDA granted approval in the United States for Tagrisso plus chemotherapy following priority review based on these results. At 41% data maturity, the interim OS analysis showed a favorable trend in the Tagrisso-plus-chemotherapy arm (hazard ratio [HR] 0.75; 95% confidence interval [CI] 0.57–0.97), with consistent results across pre-specified subgroups—including sex, race, EGFR mutation type, age at diagnosis, smoking history, performance status, and baseline central nervous system (CNS) metastasis status. In this interim analysis, the OS data did not reach statistical significance and will continue to be evaluated as a key secondary endpoint in the final analysis. The pre-specified post-progression time to first subsequent therapy (TFST) endpoint showed sustained benefit (Tagrisso plus chemotherapy: 30.7 months vs. Tagrisso alone: 25.4 months; HR 0.73; 95% CI 0.56–0.94); time to second progression (PFS2) (Tagrisso plus chemotherapy: 30.6 months vs. Tagrisso alone: 27.8 months; HR 0.70; 95% CI 0.52–0.93); and time to second subsequent therapy (TSST) (Tagrisso plus chemotherapy: not reached vs. Tagrisso alone: 33.2 months; HR 0.69; 95% CI 0.51–0.93). Additional safety analyses from the FLAURA2 trial were also presented at the ELCC. Results indicated that the frequency and severity of adverse events were highest during initial chemotherapy administration alongside Tagrisso and decreased over time during the maintenance phase. Patient-reported outcomes (PROs) from the FLAURA2 trial were also presented at the ELCC. Results showed a trend toward improved health-related quality of life (HRQoL), along with trends toward symptom improvement following Tagrisso plus chemotherapy—including dyspnea (shortness of breath or difficulty breathing), chest pain, and cough. Any decline in HRQoL following Tagrisso plus chemotherapy was neither clinically meaningful nor persistent, resolving after completion of chemotherapy.

International Top Pharmaceutical Companies Weekly Updates: Regulatory Approvals, Licensing & Partnerships, M&A, Clinical Developments, and Financial Results — March 2, 2026 to March 8, 2026

• Vertex Pharmaceuticals: On March 5, Vertex Pharmaceuticals released Phase IV clinical trial data for JOURNAVX (suzetrigine), a prescription non-opioid pain signal inhibitor for the treatment of moderate-to-severe acute pain in adults. The data indicate that the drug effectively controls pain and enables patients to recover without opioid use following various orthopedic surgeries. Specifically, 90.9% of patients required no opioids for up to 14 days following treatment completion—suggesting JOURNAVX holds promise as a non-opioid therapeutic option for moderate-to-severe acute pain. JOURNAVX is an oral, non-opioid, highly selective pain signal inhibitor with greater selectivity for NaV1.8 than for other NaV channels. NaV1.8 is a voltage-gated sodium channel selectively expressed only in peripheral neurons involved in pain perception (i.e., nociceptors), where it transmits pain signals. Because JOURNAVX blocks pain signals exclusively in the periphery—not in the brain—it effectively alleviates pain while avoiding limitations associated with certain current therapies, including the addiction risk linked to opioid use. • Biogen: On March 4, Stoke Therapeutics, Inc. and Biogen announced publication of zorevunersen study data in The New England Journal of Medicine. The publication encompasses results from two completed Phase 1/2a clinical trials and an ongoing open-label extension trial—the first demonstration of the drug’s potential to modify disease course in patients with Dravet syndrome. During treatment with zorevunersen added to standard antiepileptic drugs (AEDs), seizures were significantly and durably reduced, and improvements were observed across multiple cognitive and behavioral measures—beginning in the Phase 1/2a treatment period and persisting throughout an additional three years of therapy in the extension trial. These effects persisted on top of standard AED therapy. Over the subsequent three-year treatment period, patients demonstrated continuous improvements in communication ability, motor skills, social functioning, activities of daily living, and quality of life. Zorevunersen is an investigational antisense oligonucleotide designed to treat the root cause of Dravet syndrome by increasing production of functional NaV1.1 protein in brain cells from the affected (wild-type) SCN1A gene copy. This highly specific mechanism of action aims to reduce seizure frequency beyond what is achievable with AEDs alone and to improve neurodevelopment, cognition, and behavior. Stoke and Biogen have entered a strategic collaboration to jointly develop and commercialize zorevunersen for Dravet syndrome. Stoke retains exclusive rights to zorevunersen in the United States, Canada, and Mexico; Biogen holds commercialization rights for all other global regions. Financial Performance and Dividend Distribution: • Novartis: On March 6, Novartis announced that its shareholders’ meeting approved an increase in the dividend to CHF 3.70 per share. The 2025 dividend will be paid on March 12, 2026.

Mativ Holdings Declares $0.10 Dividend

5 days ago

Mativ Holdings announced a quarterly dividend of $0.10 per share, yielding 3.42% forward. The payment is scheduled for December 18 to shareholders of record on November 27.

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