BI Reports P-III (SYNCHRONIZE-2) Trial Data on Survodutide for Obesity/Overweight and Type 2 Diabetes at EASD 2026

Shots: P-III trial of survodutide (3.6 or 6mg, QW) in 755 pts, met both co-1EP using treatment-regimen & efficacy estimands. At Wk. 76, weight loss reached up to an average of 13.1% vs 3.1% with PBO, while up to 79.3% vs 32.7% pts achieved ≥5% weight loss (efficacy estimand) In 2EPs, trial showed reduced HbA1c…

ByRidhi RastogiOctober 1, 2026

NEWS

BMS Reports US FDA Approval of Camzyos in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The US FDA has approved Camzyos (mavacamten) for the treatment of symptomatic oHCM to improve functional capacity & symptoms in adults & pediatric pts (≥30kg) Approval was based on P-III (SCOUT-HCM) trial data assessing Camzyos (n=23) vs PBO (n=21) in 44 pts (12 to <18yrs.) with symptomatic NYHA class II-III oHCM, which met its 1EP,…

ByRidhi RastogiOctober 1, 2026

NEWS

Roche Secures US FDA Priority Review for Fenebrutinib in both Relapsing and Primary Progressive Multiple Sclerosis

Shots: The US FDA has accepted an NDA & granted priority review to fenebrutinib for RMS & PPMS based on P-III (FENhance 1 & 2) studies & the P-III (FENtrepid) trial, respectively FENhance 1 & 2 showed fenebrutinib reduced relapses and active & chronic brain lesions vs teriflunomide, lowering ARR by 51.1% & 58.5%, respectively,…

ByRidhi RastogiOctober 1, 2026

NEWS

Merck Reports the P-IIb (MK-7240-012) Trial Data on Tulisokibart in Hidradenitis Suppurativa

Shots: Merck has presented the P-IIb (MK-7240-012) study data assessing tulisokibart vs PBO in pts with moderate to severe hidradenitis suppurativa at EADV’26 Trial met its 1EP, with HiSCR50 at Wk. 16 achieved by 72% pts on high-dose tulisokibart (480mg, Q2W) & 64% on medium-dose (480mg, Q4W), representing a 37% & 29% improvement over PBO…

ByRidhi RastogiOctober 1, 2026

NEWS

Vanda Pharmaceuticals Reports the P-III Trial Results on Hetlioz in Delayed Sleep-Wake Phase Disorder

Shots: Vanda Pharmaceuticals has reported the P-III (VP-VEC-162-3502) trial data assessing Hetlioz (tasimelteon; 20mg, PO, QD; n=20) vs PBO (n=20) in 43 adults with Delayed Sleep-Wake Phase Disorder (DSWPD) Trial met its 1EP, showing Hetlioz (20mg) shifted the time of sleep onset 42.5 min. earlier vs 5.4 min. shift on PBO, plus in an exploratory…

ByRidhi RastogiSeptember 30, 2026

NEWS

Takeda Reports P-III (LATITUDE) Program Results on Zasocitinib for Plaque Psoriasis

Shots: Takeda has presented the P-III (LATITUDE) studies data assessing zasocitinib (TAK-279) in adults with mod. to sev. plaque psoriasis (PsO) at EADV’26 In P-III (LATITUDE Atlas) study, zasocitinib was superior to deucravacitinib across 1 & all key 2EPs, with complete skin clearance emerging as early as Wk. 8 & 36.5% vs 13.9% pts achieving…

ByRidhi RastogiSeptember 30, 2026

NEWS

Eli Lilly Reports P-III (TRIUMPH-2) Results on Retatrutide for Obesity and Type 2 Diabetes

Shots: TRIUMPH-2 assessed retatrutide (4, 9, or 12mg, QW) vs PBO in 1152 pts with T2D & obesity/overweight, with trial using a stepwise dose-escalation approach at Q4W. Lilly plans to file BLA in Q1’27 At 80wks., avg. body weight reductions were 12.7% (4mg), 19.1% (9mg), & 20.8% (12mg) vs 4%, plus A1C reduced by 1.4%,…

ByRidhi RastogiSeptember 30, 2026

NEWS

Kodiak Sciences Reports P-III (DAYBREAK) Trial Data on Zenkuda and Tabirafusp-ted for wAMD

Shots: Kodiak has reported the P-III (DAYBREAK) trial data assessing Zenkuda (tarcocimab tedromer) and tabirafusp-ted (KSI-501) in parallel vs aflibercept in pts with wet age-related macular degeneration (wAMD) Zenkuda met its 1EP, showing meaningful vision gains & rapid, sustained retinal drying, with 54% of pts achieving 6mos. durability at Yr. 1. tabirafusp-ted also met its vision…

ByRidhi RastogiSeptember 29, 2026

NEWS

AstraZeneca Secures US FDA Priority Review for Imfinzi + Enfortumab Vedotin for Muscle-Invasive Bladder Cancer

Shots: The US FDA has accepted sBLA and granted Priority Review to Imfinzi (durvalumab) + enfortumab vedotin (EV) for the treatment of pts with MIBC who are ineligible for or have declined cisplatin-based CT (PDUFA: Q4’26). Regulatory review is ongoing in EU & Japan sBLA was based on the P-III (VOLGA) trial, which randomized 695…

ByRidhi RastogiSeptember 28, 2026

NEWS

Eli Lilly Reports the US FDA Approval for Olumiant to Treat Severe Alopecia Areata in Pediatric Patients

Shots: The US FDA has approved Olumiant (baricitinib) for the treatment of pediatric pts (≥12yrs.) with severe alopecia areata (AA), expanding its use from treating adults with mod. to sev. active rheumatoid arthritis & sev. AA Approval was based on 36wk. data from the adolescent cohort (12 to <18yrs.) of P-III (BRAVE-AA-PEDS) study assessing Olumiant…

ByRidhi RastogiSeptember 28, 2026

BI Reports P-III (SYNCHRONIZE-2) Trial Data on Survodutide for Obesity/Overweight and Type 2 Diabetes at EASD 2026

BMS Reports US FDA Approval of Camzyos in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Roche Secures US FDA Priority Review for Fenebrutinib in both Relapsing and Primary Progressive Multiple Sclerosis

Merck Reports the P-IIb (MK-7240-012) Trial Data on Tulisokibart in Hidradenitis Suppurativa

Vanda Pharmaceuticals Reports the P-III Trial Results on Hetlioz in Delayed Sleep-Wake Phase Disorder

Takeda Reports P-III (LATITUDE) Program Results on Zasocitinib for Plaque Psoriasis

Eli Lilly Reports P-III (TRIUMPH-2) Results on Retatrutide for Obesity and Type 2 Diabetes

Kodiak Sciences Reports P-III (DAYBREAK) Trial Data on Zenkuda and Tabirafusp-ted for wAMD

AstraZeneca Secures US FDA Priority Review for Imfinzi + Enfortumab Vedotin for Muscle-Invasive Bladder Cancer

Eli Lilly Reports the US FDA Approval for Olumiant to Treat Severe Alopecia Areata in Pediatric Patients

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