Exelixis

Cabometyx® (cabozantinib) showed significant reduction in disease progression or death risk in advanced pancreatic and extra-pancreatic neuroendocrine tumors (NETs) compared to placebo, according to data from the CABINET Phase III trial. The results were presented at ESMO 2024 and published in the New England Journal of Medicine. Ipsen has submitted an extension of indication Marketing Authorization to the European Medicines Agency.

Cabometyx (cabozantinib) showed significant reduction in disease progression or death risk in advanced pancreatic and extra-pancreatic neuroendocrine tumors (NETs) compared to placebo, according to final data from the CABINET Phase III trial. Ipsen has submitted an extension of indication Marketing Authorization to the European Medicines Agency. The data were presented at ESMO 2024 and published in the New England Journal of Medicine.

Final CABINET Phase III trial data showed Cabometyx significantly reduced disease progression or death risk in advanced pancreatic and extra-pancreatic neuroendocrine tumors (NETs) compared to placebo, presented at ESMO 2024 and published in NEJM. Ipsen has submitted an extension of indication Marketing Authorization to the EMA, addressing limited treatment options for advanced NETs.

CONTACT-02 trial showed Cabometyx® + atezolizumab had a positive trend in overall survival but lacked statistical significance. Ipsen will not pursue regulatory submissions for this combination outside the US and Japan. Confidence remains in Cabometyx's profile as a monotherapy and in combination with immunotherapy.

Ipsen announced final overall survival data from Phase III CONTACT-02 trial, showing a numerical but not statistically significant improvement in OS for Cabometyx® (cabozantinib) plus atezolizumab in metastatic castration-resistant prostate cancer (mCRPC). The trial met the primary endpoint of progression-free survival (PFS). Based on these results, Ipsen will not pursue regulatory submissions for this combination regimen outside the US and Japan. Ipsen remains confident in Cabometyx's profile as a monotherapy and in combination with immunotherapy.

Various researchers report financial relationships with pharmaceutical companies, including Deciphera, during and outside the conduct of the study.

Ryvu Therapeutics reported H1 2024 operating revenues of USD 12.1 million, up USD 4.2 million from H1 2023. As of September 5, 2024, Ryvu's cash position was USD 65.3 million, providing a runway through Q1 2026. The company received the final EUR 6 million tranche from the European Investment Bank and advanced its PRMT5 inhibitor RVU305 for preclinical development, targeting IND/CTA filing in H2 2025. Ryvu is progressing with RVU120 Phase II studies and expects initial data updates at ASH 2024.

Regeneron Pharmaceuticals' PE, PB, and PS ratios are low, suggesting potential undervaluation. However, its low ROE indicates lower profitability. High EBITDA and gross profit levels indicate strong financial performance, but low revenue growth may be a concern.

Various drugs and their statuses are listed, including IN-001 for anaphylaxis (Fast Track), Finereonone for heart failure (Phase 3), Tirzepatide for heart failure and obesity (Phase 3), TMB-001 for congenital ichthyosis (Phase 3), Bentracimab for ticagrelor reversal (Priority Review), Fabhalta for immunoglobulin A nephropathy (accelerated approval), RLS-0071 for acute graft-vs-host disease (Fast Track and Orphan Drug), CHIKV VLP for chikungunya (Priority Review), Diazoxide choline for Prader-Willi syndrome (Priority Review), Mirdametinib for neurofibromatosis type 1 (Priority Review), Setmelanotide for genetic obesity (Priority Review), AR882 for gout (Fast Track), SPN-830 for Parkinson disease (NDA review), BGB-16673 for chronic lymphocytic leukemia (Fast Track), Cabozantinib for neuroendocrine tumors (NDA review), Linvoseltamab for multiple myeloma (Complete Response Letter), Nivolumab plus ipilimumab for hepatocellular carcinoma (BLA review), Midomafetamine for PTSD (Complete Response Letter), and Tezepelumab-ekko for COPD (Breakthrough Therapy).