UCB Reports the P-III Data of Fenfluramine in CDKL5 Deficiency Disorder (CDD) Patients

Shots: UCB reported the P-III study (n=87; ages 1-35yrs.) of adjunctive fenfluramine vs. PBO in CDKL5 Deficiency Disorder (CDD) diagnosis and uncontrolled seizure pts. The P-III study met its 1EP (median % reduction in countable motor seizure frequency) and most key 2EPs. Fenfluramine was well tolerated with a consistent safety profile in prior DS/LGS studies UCB…

ByPrince GiriJune 30, 2025

NEWS

Neurocrine Reports Data From KINECT-HD Study Evaluating INGREZZA in Huntington’s Disease (HD)

Neurocrine reported new post-hoc patient data from the P-III KINECT-HD study (n=128; 18-75yrs.) showing significant reductions in cognitive and motor-related burden with INGREZZA (valbenazine) vs. PBO in HD chorea At maintenance (10-12wks.), INGREZZA showed greater mean score reductions across 18 cognition items and 32 of 33 motor items vs PBO. The study used the UHDRS…

ByDipanshu DixitJune 30, 2025

NEWS

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Shots: Kashiv BioSciences has reported topline results of ADL-018, its proposed biosimilar to Xolair (omalizumab) for Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) unresponsive to H1 antihistamines. The BLA and MAA filings for the product are expected with the FDA and EMA, respectively, in Q4’25 The study met its 1EPs & 2EPs, demonstrating therapeutic equivalence and…

ByDipanshu DixitJune 27, 2025

NEWS

Merck Reports the Data from P-III (HYPERION) Study of WINREVAIR (sotatercept-csrk) in Adults with Recently Diagnosed PAH

Shots : The P-III (HYPERION) study evaluating Winrevair vs PBO (both in combination with background therapy) in recently diagnosed adults (N=320, >18) with PAH (WHO Group 1) functional class (FC) II or III at intermediate or high risk of disease progression The study met its 1EP of TTCW measured by the first confirmed morbidity or…

ByPrince GiriJune 24, 2025

NEWS

Teva Reports the Data from the P-IV (PEARL) Study of Ajovy (fremanezumab) for Chronic and Episodic Migraine Prevention

S Shots: The P-IV (PEARL) study (N=1140) evaluating fremanezumab met its 1EP and 2EPs, demonstrating long-term effectiveness over two years, significantly reducing the frequency, duration, and severity of migraine attacks in both chronic and episodic migraine pts The study met 1EP of ≥50% reduction in MMD within the first 6mos. of treatment. Injection adherence remained high…

ByPrince GiriJune 23, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jun 16, 2025 – Jun 20, 2025)  

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, Animal Health & DigiHealth. Check out our full report below:   Johnson & Johnson Reports P-II (RedirecTT-1) Trial Data on Talvey + Tecvayli for R/R Multiple Myeloma Read More: J&J Camurus Reports Topline P-IIb (POSITANO) Trial Data on CAM2029 for…

ByRidhi RastogiJune 20, 2025

NEWS

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

UCB Reports the P-III Data of Fenfluramine in CDKL5 Deficiency Disorder (CDD) Patients

Neurocrine Reports Data From KINECT-HD Study Evaluating INGREZZA in Huntington’s Disease (HD)

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Merck Reports the Data from P-III (HYPERION) Study of WINREVAIR (sotatercept-csrk) in Adults with Recently Diagnosed PAH

Teva Reports the Data from the P-IV (PEARL) Study of Ajovy (fremanezumab) for Chronic and Episodic Migraine Prevention

PharmaShots Weekly Snapshots (Jun 16, 2025 – Jun 20, 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

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