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

NEWS

Gilead Reports Final P-III (MYR301) Trial Data of Bulevirtide for Patients Living with Chronic Hepatitis Delta Virus

Shots: Gilead has reported final P-III (MYR301) trial data assessing bulevirtide (QD) for 144wks. in 150 pts living with HDV, who were randomized to either bulevirtide (2mg, n=49 or 10mg, n=50) or no antiviral therapy arm (n=51); pts in no therapy arm were switched to 10mg after 48wks. In the trial, 36% adults (23/64) with…

ByRidhi RastogiMay 7, 2025

NEWS

Daiichi Sankyo and AstraZeneca Report Topline P-III (DESTINY-Breast11) Trial Data of Neoadjuvant Enhertu for HER2+ Early-Stage Breast Cancer

Shots: Daiichi Sankyo & AstraZeneca has reported topline P-III (DESTINY-Breast11) trial data assessing neoadj. Enhertu (5.4mg/kg) monotx. or Enhertu followed by paclitaxel, Herceptin & Perjeta (THP) vs SoC + THP in high-risk, locally advanced HER2+ early-stage breast cancer pts (n=927) Trial showed that Enhertu regimen achieved significant improvement in pCR rate (1EP), while EFS (2EP) data was…

ByRidhi RastogiMay 7, 2025

NEWS

Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya for Ulcerative Colitis (UC)

Shots: J&J has reported P-III (ASTRO) trial data assessing Tremfya SC induction (400mg at Wks. 0, 4 & 8) followed by either Tremfya 100mg SC Q8W or 200mg SC Q4W vs PBO in adults with mod. to sev. active UC; sBLA under the US FDA’s review At Wk. 24, trial showed improved clinical remission rates…

ByRidhi RastogiMay 6, 2025

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

Gilead Reports Final P-III (MYR301) Trial Data of Bulevirtide for Patients Living with Chronic Hepatitis Delta Virus

Daiichi Sankyo and AstraZeneca Report Topline P-III (DESTINY-Breast11) Trial Data of Neoadjuvant Enhertu for HER2+ Early-Stage Breast Cancer

Johnson & Johnson Reports P-III (ASTRO) Trial Data of SC Tremfya for Ulcerative Colitis (UC)

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