Merck Reports P-III (KEYNOTE-B96/ENGOT-ov65) Trial Findings on Keytruda for Platinum-Resistant Ovarian Cancer

Shots: Merck has reported ongoing P-III (KEYNOTE-B96/ENGOT-ov65) trial findings on Keytruda for the treatment of Pt-resistant recurrent ovarian cancer Trial assessed Keytruda (400mg, IV, Q6W for ~2yrs.) with CT ± Avastin vs PBO + CT ± Avastin in pts (n=643) Trial met its 1EP of improved PFS in overall population & 2EP of OS in pts…

ByRidhi RastogiMay 15, 2025

NEWS

Herantis Pharma Reports First Patient Dosing in P-Ib Trial of HER-096 for Parkinson’s Disease

Shots: Herantis has dosed first pts with HER-096, a synthetic peptidomimetic in final arm of its P-Ib trial for Parkinson’s disease The P-Ib trial consists of 2 parts, with the 1st assessing the safety & PK properties of 300mg HER-096 (SC) & Part 2 evaluating HER-096 vs PBO in 2 Arms along with selected biomarkers…

ByRidhi RastogiMay 14, 2025

NEWS

Cytokinetics Reports P-III (MAPLE-HCM) Trial Data of Aficamten for Obstructive Hypertrophic Cardiomyopathy

Shots: Cytokinetics has reported P-III (MAPLE-HCM) trial data assessing aficamten vs SoC metoprolol in pts (n=175) with symptomatic obstructive hypertrophic cardiomyopathy (HCM); regulatory review is ongoing in the US FDA (PDUFA: Dec 26, 2025) & EMA, with its NDA also under NMPA's priority review The trial met its 1EP, showing superior improvement in peak oxygen…

ByRidhi RastogiMay 14, 2025

NEWS

Genentech Reports P-III (APHINITY) Trial Data of Perjeta Regimen for Early-Stage Breast Cancer

Shots: Genentech has reported 10yr. P-III (APHINITY) trial data assessing Perjeta + Herceptin & CT vs Herceptin + CT vs PBO as an adj. therapy in 4804 pts with operable HER2+ early-stage breast cancer After 10yrs, trial depicted improved OS, with 91.6% pts alive vs 89.8% on Herceptin + CT & PBO, with sustained invasive…

ByRidhi RastogiMay 13, 2025

NEWS

Novo Nordisk Reports P-III (REAL8) Basket Trial Data of Sogroya for Children with Growth Disorders

Shots: The P-III (REAL8) basket trial assessed Sogroya (0.24mg/kg, QW or 0.05 mg/kg, QD) in pre-pubertal children with NS, TS, or ISS; SGA-born children were randomized to Sogroya 0.24mg/kg QW or QD dosing (0.035 or 0.067mg/kg) Trial met its 1EP, showing QW dosing was non-inferior to GH therapy (QD) at Wk. 52, with superior HV…

ByRidhi RastogiMay 12, 2025

NEWS

AstraZeneca Reports P-III (POTOMAC) Trial Findings of Imfinzi Regimen for High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Shots: AstraZeneca has reported P-III (POTOMAC) trial findings assessing Imfinzi in 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi + BCG induction & maintenance, Imfinzi + BCG induction-only, or SoC BCG therapy Imfinzi + BCG induction & maintenance therapy showed improved disease-free survival (DFS; 1EP) vs SoC BCG, while Imfinzi + BCG induction-only did…

ByRidhi RastogiMay 12, 2025

NEWS

Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis

Shots: J&J has reported P-III (ICONIC-TOTAL) trial data assessing icotrokinra (QD, PO; n=208) vs PBO (n=103) in 311 PsO pts (≥12yrs.) with ≥1% body surface area & at least mod. plaque PsO at high-impact sites At Wk. 16, trial met its 1EP, with 57% vs 6% achieving IGA 0/1 & ≥2-grade improvement while in scalp…

ByRidhi RastogiMay 12, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (May 05, 2025 – May 09, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, Biosimilar & Animal Health. Check out our full report below: Recursion Presents Preliminary P-Ib/II (TUPELO) Trial Data of REC-4881 for Familial Adenomatous Polyposis (FAP) at DDW 2025 Read More: Recursion Chengdu Origen and Vanotech Report the First Patient Dosing in P-I (VAN-2401)…

ByRidhi RastogiMay 9, 2025

NEWS

Cognition Therapeutics Reports Topline P-II (MAGNIFY) Trial Data of Zervimesine for Geographic Atrophy (GA)

Shots: Cognition has reported topline P-II (MAGNIFY/COG2201) trial data assessing zervimesine (200mg, QD, PO) vs PBO in adults with GA secondary to dry AMD; trial concluded after enrolling ~100 of 246 planned subjects In the trial, nearly 2/3 pts completed 12mos. & 1/3 completed 18mos. of dosing, showing a 28.6% slower GA progression & ~12%,…

ByRidhi RastogiMay 9, 2025

NEWS

GSK Reports the P-III (GLISTEN) Study Results of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

Shots: GSK has reported P-III (GLISTEN) trial data assessing linerixibat (n=119) vs PBO (n=119) to treat PBC pts (N=238) with cholestatic pruritus; pts could switch to linerixibat in Part B of the trial Trial met its 1EP, showing significantly reduced itch per WI-NRS scale in PBC pts, as assessed by monthly itch score, over 24wks.…

ByRidhi RastogiMay 8, 2025

Merck Reports P-III (KEYNOTE-B96/ENGOT-ov65) Trial Findings on Keytruda for Platinum-Resistant Ovarian Cancer

Herantis Pharma Reports First Patient Dosing in P-Ib Trial of HER-096 for Parkinson’s Disease

Cytokinetics Reports P-III (MAPLE-HCM) Trial Data of Aficamten for Obstructive Hypertrophic Cardiomyopathy

Genentech Reports P-III (APHINITY) Trial Data of Perjeta Regimen for Early-Stage Breast Cancer

Novo Nordisk Reports P-III (REAL8) Basket Trial Data of Sogroya for Children with Growth Disorders

AstraZeneca Reports P-III (POTOMAC) Trial Findings of Imfinzi Regimen for High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis

PharmaShots Weekly Snapshots (May 05, 2025 – May 09, 2025)

Cognition Therapeutics Reports Topline P-II (MAGNIFY) Trial Data of Zervimesine for Geographic Atrophy (GA)

GSK Reports the P-III (GLISTEN) Study Results of Linerixibat for Primary Biliary Cholangitis (PBC) Patients with Cholestatic Pruritus

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