Redhill Biopharma

RedHill Biopharma awarded $8 million plus costs in summary judgment by New York Supreme Court against Kukbo Co. Ltd, dismissing Kukbo's counterclaims. Kukbo has the right to appeal.

DelveInsight's 'Crohn's Disease Pipeline Insight, 2024' report details 70+ companies developing 80+ therapies, including AstraZeneca, Immunic, Suzhou Connect Biopharmaceuticals, Pfizer, and Bristol-Myers Squibb. Key therapies like MORF 057, OTL-104, TP-317, AZD 7798, IMU 856, CBP-307, PF-06651600, Deucravacitinib, E6011, Guselkumab, Mirikizumab, Filgotinib, RHB-104, Ozanimod, and Brazikumab are expected to impact the market. The report covers clinical trials, regulatory approvals, market dynamics, and therapeutic assessments by route of administration and molecule type.

DelveInsight's report on Crohn’s Disease Market Insights, Epidemiology, and Market Forecast-2034 details the market size, emerging therapies, and key companies like Takeda Pharmaceutical, Janssen Pharmaceuticals, UCB, Biogen, AbbVie, AstraZeneca, Tillotts Pharma, Gilead Sciences, Galapagos NV, Boehringer Ingelheim, Celgene (Bristol Myers Squibb), Eli Lilly and Company, RedHill Biopharma, Arena Pharmaceuticals, Mesoblast, and others. The market size in 7MM was ~USD 9,000 million in 2023, expected to increase by 2034, with key therapies like ENTYVIO, STELARA, VELSIPITY, Zeposia, LY-3074828, RHB-104, and others expected to launch. Positive results for mirikizumab and TREMFYA were reported in 2024, and Dong-A-ST's Imuldosa received FDA approval as a biosimilar to Stelara.

RedHill Biopharma collaborates with Duke University to test opaganib as a potential treatment for phosgene inhalation injury, aiming for FDA approval under the Animal Rule pathway.

The 'Antibiotic Resistance Markets - Therapeutics by Pathogen and Therapy Type' report outlines market players addressing antimicrobial resistance, including drug manufacturers, biotech companies, and regulatory bodies. It highlights the role of diagnostics in combating AMR and identifies 6 key market opportunities. The report provides five-year market forecasts and profiles over 100 biotech companies.

BARDA selected opaganib for joint development & funding as a medical countermeasure to treat Ebola virus disease. Opaganib showed a statistically significant increase in survival in an in vivo EBOV model, advancing on the FDA Animal Rule pathway. The 10th anniversary of the West Africa Ebola epidemic highlights the urgent need for effective therapies, with EBOV proving fatal in around half of all cases. Opaganib, a novel host-directed drug, has shown mutation-resistant antiviral and anti-inflammatory activity, representing an alternative therapeutic strategy for biodefense and global health preparedness.

New U.S. patent issued for a novel coronavirus pneumonia biomarker (≤60% FiO₂) prognostic for opaganib's potential efficacy in treating COVID-19. Post-hoc data from opaganib's Phase 2/3 study showed better outcomes in patients with ≤60% FiO₂ levels, including reduced need for supplemental oxygen, intubation/mechanical ventilation, and mortality.

Tulisokibart, an anti-TL1A monoclonal antibody, outperformed placebo in inducing clinical remission at week 12 in moderate to severe ulcerative colitis, according to the ARTEMIS-UC trial. The study incorporated a predictive biomarker for response, showing significant clinical remission, endoscopic improvement, and clinical response in patients on tulisokibart compared to placebo. A phase 3 program is planned to confirm these results.