Dizal Reports Enrollment Completion in P-III (WU-KONG28) Trial of Sunvozertinib for EGFRm NSCLC

Shots: Dizal has completed pts enrollment in P-III (WU-KONG28) trial of sunvozertinib as a 1L treatment of NSCLC harboring EGFR exon 20 insertion mutations (exon20ins); NDA under the US FDA’s priority review (PDUFA: Jul 7, 2025) Trial assessed sunvozertinib vs Pt-based doublet CTs in treatment-naïve NSCLC pts with EGFR exon20ins across 16 countries & regions…

ByRidhi RastogiJune 20, 2025

NEWS

Merck and Daiichi Sankyo Report First Patient Dosing with Ifinatamab DXd in P-III (IDeate-Prostate01) Trial for mCRPC

Shots: Merck & Daiichi Sankyo have dosed first pts with ifinatamab deruxtecan (I-DXd) in its P-III (IDeate-Prostate01) trial for metastatic castration-resistant prostate cancer (mCRPC), which was initiated based on positive P-I/II (IDeate-PanTumor01) trial data The P-III (IDeate-Prostate01) trial will evaluate I-DXd (12mg/kg) vs docetaxel (75mg/m²) plus corticosteroid in ~1440 mCRPC pts, who progressed during or after…

ByRidhi RastogiJune 19, 2025

NEWS

AbbVie Reports Topline P-III (TEMPLE) Trial Data on Qulipta (Atogepant) for Migraine Prevention

Shots: The P-III (TEMPLE) trial assessed Qulipta (60mg, QD) vs the highest tolerated dose of topiramate (50, 75 or 100mg; QD) over 24wks. in 545 adults with ≥4 monthly migraine days (MMD) across 73 sites in the EU, Israel & Canada, followed by a 52wk. open-label phase, where all pts received Qulipta Trial met its…

ByRidhi RastogiJune 19, 2025

NEWS

Galderma to Present OLYMPIA Extension Study Data on Nemluvio for Prurigo Nodularis at ICD 2025

Shots: The OLYMPIA long-term extension study assessed Nemluvio in 508 pts with prurigo nodularis up to 4yrs., which were enrolled from the P-II or P-III (OLYMPIA 1 & 2) trials Interim analysis at Wk. 100 showed sustained improvement, with over 90% achieving ≥4-point itch reduction & 70% being itch-free or nearly itch-free per Peak-Pruritus Numerical…

ByRidhi RastogiJune 18, 2025

NEWS

Camurus Reports Topline P-IIb (POSITANO) Trial Data on CAM2029 for Symptomatic Polycystic Liver Disease

Shots: Camurus has reported topline P-IIb (POSITANO) trial data assessing 2 dosing regimens of CAM2029 (octreotide SC depot) vs PBO in 71 pts with symptomatic polycystic liver disease (PLD), with pts continuing treatment in a 2.5yr. OLE study Trial met its 1EP with a 4.3% relative reduction in height-adjusted liver volume at Wk. 53 for…

ByRidhi RastogiJune 18, 2025

NEWS

Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma

Shots: J&J has reported P-II (RedirecTT-1) trial data on Talvey (talquetamab-tgvs) + Tecvayli (teclistamab-cqyv) in 90 heavily pretreated r/r MM pts with extramedullary disease, where 84.4% were triple-class refractory, 35.6% penta-drug refractory, 20% had prior BCMA CAR-T, & 8.9% had prior bsAb exposure Trial showed a 78.9% ORR, with 54.4% achieving CR or better, incl.…

ByRidhi RastogiJune 16, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jun 09, 2025 – Jun 13, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar & Animal Health. Check out our full report below:  Apellis Pharmaceuticals and Sobi Report P-III (VALIANT) Trial Data of Empaveli for C3 Glomerulopathy (C3G) and Primary IC-MPGN Read More: Apellis Pharmaceuticals and Sobi Daiichi Sankyo Reports First Patient…

ByRidhi RastogiJune 13, 2025

NEWS

Celldex Highlights P-II Trial Data of Barzolvolimab for Chronic Spontaneous Urticaria at EAACI Congress 2025

Shots: The P-II trial assessed barzolvolimab (Q4W: 75 or 150mg; Q8W: 300mg) vs PBO for 16wks. in 208 CSU pts unresponsive to antihistamines, followed by 36wks. of active treatment, where 75mg & PBO pts were re-randomized to 150 or 300mg; pts were then followed for 24wks. Enrolment to P-III (EMBARQ-CSU1 & EMBARQ-CSU2) trials is ongoing …

ByRidhi RastogiJune 13, 2025

NEWS

Novartis to Highlight P-IIIb Trial Data of Fabhalta for Paroxysmal Nocturnal Hemoglobinuria (PNH) at EHA 2025

Shots: Novartis has reported P-IIIb (APPULSE-PNH) trial data assessing Fabhalta (iptacopan; 200mg, BID, PO) for 24wks. in 52 PNH adults with Hb levels ≥10g/dL who switched from anti-C5 therapies (eculizumab or ravulizumab) Trial showed a 2.01 g/dL mean Hb increase, with 92.7% pts achieving ≥12g/dL & no transfusions over 24wks. It also depicted improved fatigue…

ByRidhi RastogiJune 12, 2025

NEWS

Johnson & Johnson Presents P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis at EULAR 2025

Shots: The P-IIIb (APEX) trial assessed Tremfya (Q4W or Q8W) vs PBO for 24wks. in biologic-naïve PsA pts with inadequate response to SoCs, followed by a 24wk. active treatment period then a 12wk. safety follow-up; pts could enter a 2yr. extension phase prior to the final safety follow-up Trial showed reduced joint damage progression per…

ByRidhi RastogiJune 12, 2025

Dizal Reports Enrollment Completion in P-III (WU-KONG28) Trial of Sunvozertinib for EGFRm NSCLC

Merck and Daiichi Sankyo Report First Patient Dosing with Ifinatamab DXd in P-III (IDeate-Prostate01) Trial for mCRPC

AbbVie Reports Topline P-III (TEMPLE) Trial Data on Qulipta (Atogepant) for Migraine Prevention

Galderma to Present OLYMPIA Extension Study Data on Nemluvio for Prurigo Nodularis at ICD 2025

Camurus Reports Topline P-IIb (POSITANO) Trial Data on CAM2029 for Symptomatic Polycystic Liver Disease

Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma

PharmaShots Weekly Snapshots (Jun 09, 2025 – Jun 13, 2025)

Celldex Highlights P-II Trial Data of Barzolvolimab for Chronic Spontaneous Urticaria at EAACI Congress 2025

Novartis to Highlight P-IIIb Trial Data of Fabhalta for Paroxysmal Nocturnal Hemoglobinuria (PNH) at EHA 2025

Johnson & Johnson Presents P-IIIb (APEX) Trial Findings of Tremfya for Active Psoriatic Arthritis at EULAR 2025

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