Stoke Therapeutics and Biogen Report First Patient Dosing in P-III (EMPEROR) Trial of Zorevunersen for Dravet Syndrome

Shots: Stoke Therapeutics & Biogen have dosed their first patient with zorevunersen in global P-III (EMPEROR) trial for the treatment of Dravet syndrome; Trial has initiated in the US, UK, & Japan, with an EU study planned Trial will assess zorevunersen (70mg on Day 1 & Wk. 8, then 45mg at Wks. 24 & 40) vs sham…

ByRidhi RastogiAugust 12, 2025

NEWS

Novartis Reports Topline P-III (NEPTUNUS-1 & 2) Trials Finding on Ianalumab to Treat Active Sjögren’s Disease

Shots: Novartis has reported topline P-III (NEPTUNUS-1 & 2) trial data assessing ianalumab (VAY736) in adults with active Sjögren's disease NEPTUNUS-1 assessed ianalumab (300mg, QM) vs PBO in 275 Sjögren's disease pts for 52wks. while NEPTUNUS-2 evaluated ianalumab (300mg; QM or Q3M) vs PBO for up to 52wks. in 504 pts; pts could then either…

ByRidhi RastogiAugust 11, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Aug 04, 2025 – Aug 08, 2025) 

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, Biotech, M&A and Biosimilars. Check out our full report below:  Roche Reports P-III (Portal) Trial Data on Susvimo for Neovascular Age-Related Macular Degeneration (nAMD) Read More: Roche Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma Read…

ByRidhi RastogiAugust 8, 2025

NEWS

Genmab Reports P-III (EPCORE FL-1) Trial Data on Epcoritamab for R/R Follicular Lymphoma

Shots: Genmab has reported P-III (EPCORE FL-1) trial data assessing epcoritamab (SC) + rituximab & lenalidomide (R2) vs R2 alone for the treatment of adult patients with r/r follicular lymphoma The trial met dual primary endpoints with improved ORR and PFS, reducing risk of progression or death by 79%; interim data will be submitted to…

ByRidhi RastogiAugust 8, 2025

NEWS

Flare Therapeutics Reports First Patient Dosing in P-Ib Trial of FX-909 for Urothelial Cancer

Shots: Flare Therapeutics has dosed its first patient with FX-909 in P-Ib trial for the treatment of locally-advanced or metastatic urothelial cancer The P-Ib trial will assess FX-909 (30 & 50mg; QD) in 40 pts, incl. a biomarker-defined population, building on clinical PoC achieved in P-Ia, with P-Ia data to be presented in 2025. Efficacy…

ByRidhi RastogiAugust 7, 2025

NEWS

Fapon Biopharma Reports First Patient Enrolment in P-I Trial of FP008 for Solid Tumors

Shots: Fapon Biopharma has enrolled the first patient in China for its P-I trial of FP008 for advanced solid tumors, conducted at Zhejiang Cancer Hospital. The patient completed the DLT observation with a favorable safety profile. The trial focuses on evaluating FP008's safety and tolerability FP008 demonstrated favorable safety and PK in monkey studies and…

ByDipanshu DixitAugust 7, 2025

NEWS

Marea Therapeutics Reports First Patient Dosing in P-IIb (TYDAL-TIMI 78) Trial of MAR001 for Atherosclerotic Cardiovascular Disease

Shots: Marea Therapeutics has dosed its first patient with MAR001 in P-IIb (TYDAL-TIMI 78) trial for adults at increased risk of atherosclerotic cardiovascular disease (ASCVD) Trial will evaluate MAR001 (300, 450, 900mg; Q4W) vs PBO in ~216 adults with elevated triglycerides & remnant cholesterol at high ASCVD risk, with the 1EP assessing % change from…

ByRidhi RastogiAugust 7, 2025

NEWS

Vertex Reports the P-II Study of VX‑993 in Acute Pain After Bunionectomy

Shots: Vertex announced topline results from its P‑II study of selective NaV1.8 inhibitor VX‑993 in 367 pts with acute pain post-bunionectomy; VX‑993 did not achieve a statistically significant improvement in SPID48 vs placebo VX‑993 was safe and well tolerated at all doses, with AEs mostly mild/moderate; no SAEs related to VX‑993 and no discontinuations due…

ByPrince GiriAugust 7, 2025

NEWS

UroGen Pharma Reports P-III (ENVISION) Trial Data on Zusduri to Treat LG-IR-NMIBC

Shots: UroGen Pharma has reported P-III (ENVISION) trial data of Zusduri (mitomycin; QW, intravesical) as a chemoablative therapy for adults (n=240) with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) Trial showed a 24mos. DoR of 72.2% (Kaplan-Meier) in pts with CR at 3mos., with a mFU of 23.7mos. after 3mos. CR; the mDoR was…

ByRidhi RastogiAugust 6, 2025

NEWS

Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma

Shots: Ethris has dosed the first pts in a P-IIa trial of ETH47 for asthma symptom reduction after rhinovirus challenge, building on P-I trial data, which showed strong respiratory tract activity, local IFNλ induction, antiviral gene activation, & no systemic exposure The P-IIa trial will evaluate ETH47 vs PBO in ~50 adults with asthma who…

ByRidhi RastogiAugust 5, 2025

Stoke Therapeutics and Biogen Report First Patient Dosing in P-III (EMPEROR) Trial of Zorevunersen for Dravet Syndrome

Novartis Reports Topline P-III (NEPTUNUS-1 & 2) Trials Finding on Ianalumab to Treat Active Sjögren’s Disease

PharmaShots Weekly Snapshots (Aug 04, 2025 – Aug 08, 2025)

Genmab Reports P-III (EPCORE FL-1) Trial Data on Epcoritamab for R/R Follicular Lymphoma

Flare Therapeutics Reports First Patient Dosing in P-Ib Trial of FX-909 for Urothelial Cancer

Fapon Biopharma Reports First Patient Enrolment in P-I Trial of FP008 for Solid Tumors

Marea Therapeutics Reports First Patient Dosing in P-IIb (TYDAL-TIMI 78) Trial of MAR001 for Atherosclerotic Cardiovascular Disease

Vertex Reports the P-II Study of VX‑993 in Acute Pain After Bunionectomy

UroGen Pharma Reports P-III (ENVISION) Trial Data on Zusduri to Treat LG-IR-NMIBC

Ethris Reports First Patient Dosing in P-IIa Trial of ETH47 for Asthma

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