NEWS

HUTCHMED Reports the P-II/III (ESLIM-02) Trial Data on Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia at EHA 2026

Shots: HUTCHMED has reported the P-III data (n=90) from P-II/III (ESLIM-02) assessing sovleplenib in in adult patients with primary or secondary wAIHA who had relapsed or were refractory to prior ≥1L of standard treatment; NDA accepted under NMPA priority review in Apr 2026 Trial met its 1EP of improved durable response rates (66% vs 15%),…

June 12, 2026

Novartis Reports P-III (RemIND) Trial Data on Remibrutinib for Chronic Inducible Urticaria (CIndU)

Shots: Novartis has reported the topline P-III (RemIND) trial data assessing remibrutinib (PO) vs PBO in adults with CIndU inadequately controlled by H1-antihistamines Trial showed higher CR rates at Wk. 12 across symptomatic dermographism (29.3% vs 14%), cold urticaria (56.3% vs 14.6%), & cholinergic urticaria (29.3% vs 15.8%), with responses emerging as early as Wk.…

June 12, 2026

Novo Nordisk Reports the MHRA Approval of Oral Wegovy for Weight Management

Shots: The MHRA has approved Wegovy pill (25mg, QD, PO) as an adjunct to lifestyle intervention for weight management in adults living with obesity or overweight, with ≥1 weight-related condition; launch is expected in select markets by H2’26 Approval was based on the P-III (OASIS 4) trial assessing oral Wegovy vs PBO over 64wks. in…

June 12, 2026

Wave Neuroscience’s MeRT System Receives the US FDA Clearance for PTSD

Shots: The US FDA has granted clearance to the Magnetic EEG-guided Resonance Therapy (MeRT) System, a personalized, biomarker-guided neuromodulation technology for Post-Traumatic Stress Disorder (PTSD) Clearance was supported by a trial conducted with investigators from Texas A&M Health Institute of Biosciences & Technology, demonstrating that MeRT significantly reduced PTSD symptom severity with clinically meaningful improvements…

June 12, 2026

Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

Shots: The Chinese NMPA has approved Akeso’s gumokimab (AK111; SC, 17 doses per year, incl. loading) to treat mod. to sev. plaque psoriasis in adults based on the P-III (AK111-301) trial & 3 supportive studies, showing rapid improvement in 2wks. Data showed short-term efficacy, with a PASI 75 response rate approaching 94.6% & PASI 100 reaching…

June 12, 2026

Takeda Reports P-III (LATITUDE Atlas) Trial Data on Zasocitinib for Plaque Psoriasis (PsO)

Shots: Takeda has reported topline P-III (LATITUDE Atlas) trial data assessing zasocitinib (TAK-279; 30mg, PO, QD) vs deucravacitinib (6mg, QD) in 606 adults with mod. to sev. PsO Trial showed that zasocitinib was superior to deucravacitinib in the 1EP, with improved PASI 100 response rates at Wk. 16, plus in all key 2EPs, incl. PASI 90…

June 12, 2026

Merck Animal Health to Acquire TARGAN

Shots: Merck Animal Health has entered into a definitive agreement to acquire TARGAN for an undisclosed purchase price; closing is expected in Q3’26 Upon closing, the acquisition will expand MAH’s poultry portfolio with WingScan, an automated chick sorting platform that uses vision tech & proprietary algorithms to identify & sort chicks by gender in real…

June 11, 2026

J&J Reports the P-II/III (ENERGY) Trial Data on Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Shots: The P-II/III (ENERGY) trial assessed 2 different dose schedules of J&J's Imaavy vs PBO in 115 adults living with wAIHA for 24wks. followed by an OLE period, where pts received Imaavy for 144wks. with a follow-up of 6wks. after the last assessment In the 30mg/kg group, Imaavy showed mean increase of 1g/dL in Hgb…

June 11, 2026

Novartis Reports the Biomarker Data from P-I/II (FORTITUDE) study of del-brax in FSHD

Shots: Novartis has reported data from the biomarker cohort of the P-I/II (FORTITUDE) study assessing delpacibart braxlosiran (2mg/kg, Q6W) vs PBO in 90 pts (16-70yrs.) with facioscapulohumeral muscular dystrophy (FSHD) Trial met its 1 & key 2EPs, showing reductions in KHDC1L (cDUX) & creatine kinase biomarker levels, which indicates potent target engagement & decrease in…

June 11, 2026

Genentech’s Tecentriq Receives the US FDA Priority Review for Stage III dMMR/MSI-H Colon Cancer

Shots: The US FDA has accepted sBLA & granted priority review to adj. Tecentriq (atezolizumab) & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) in combination with CT in stage III dMMR or MSI-H colon cancer (PDUFA: Oct 9, 2026) sBLA was based on the P-III (ATOMIC) trial assessing Tecentriq to FOLFOX6 CT in 712 pts with stage…

June 11, 2026

NEWS

HUTCHMED Reports the P-II/III (ESLIM-02) Trial Data on Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia at EHA 2026

Novartis Reports P-III (RemIND) Trial Data on Remibrutinib for Chronic Inducible Urticaria (CIndU)

Novo Nordisk Reports the MHRA Approval of Oral Wegovy for Weight Management

Wave Neuroscience’s MeRT System Receives the US FDA Clearance for PTSD

Akeso Reports the NMPA Approval of Gumokimab to Treat Plaque Psoriasis

Takeda Reports P-III (LATITUDE Atlas) Trial Data on Zasocitinib for Plaque Psoriasis (PsO)

Merck Animal Health to Acquire TARGAN

J&J Reports the P-II/III (ENERGY) Trial Data on Imaavy for Warm Autoimmune Hemolytic Anemia (wAIHA)

Novartis Reports the Biomarker Data from P-I/II (FORTITUDE) study of del-brax in FSHD

Genentech’s Tecentriq Receives the US FDA Priority Review for Stage III dMMR/MSI-H Colon Cancer

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