Shots:
Part A of P-II (APEX) trial assessed APG777 vs PBO in 123 mod. to sev. AD pts, which met its 1EP with 71% vs 33.8% EASI reduction as well as highest absolute & PBO-adjusted EASI-75 (66.9% vs 24.6%); results were consistent across disease severity, & EASI-75 at Wk. 16 reached 83.3% & 89.5% in…
Shots:
BioAtla has shared ongoing P-I dose-escalation trial data on BA3182 for treatment-refractory metastatic adenocarcinoma at ESMO 2025
As of June 20, 2025, 39 pts received BA3182 (QW) in the range of 0.0026 to 0.6mg with either 0, 1, or 2 priming doses, 4–7 days before treatment; 17 received IV doses (0.0026–0.032mg) & 22 received SC doses…
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PulseSight Therapeutics has dosed first pts in the P-I (PST-611-CT1) trial to assess safety & tolerability of PST-611 in humans
The P-I single ascending dose study will evaluate safety & determine maximum tolerated dose of PST-611 for P-IIa trial in 6–12 pts with dry age-related macular degeneration/geographic atrophy pts, with preliminary results expected in…
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Novartis has reported topline P-III (GCAptAIN) trial results on Cosentyx to treat adults with newly diagnosed or relapsing giant cell arteritis (GCA)
The P-III (GCAptAIN) trial assessed efficacy & safety of Cosentyx (300 or 150mg) vs PBO, both in combination with a glucocorticoid taper regimen, in GCA pts across 27 countries
In the trial,…
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Seegene has launched the STAgora platform for infectious disease analysis, with a formal launch planned at ADLM 2025to seek business partnerships & highlight STAgora's integration with Cureca PCR system
STAgora, when integrated with Seegene’s syndromic quantitative PCR tech, provides advanced visibility into single & multi-pathogen infections to allow clinicians to make faster, more informed…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, and Biosimilar. Check out our full report below:
Neurocrine Reports Data From KINECT-HD Study Evaluating INGREZZA in Huntington’s Disease (HD)
Read More: Neurocrine
UCB Reports the P-III Data of Fenfluramine in CDKL5 Deficiency Disorder (CDD) Patients
Read More: UCB …
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The EC has approved Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regions
Approval was based on the P-III (NIAGARA) trial (n=1063) in MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery …
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MatOrtho has reported the European CE Mark approval of ReCerf for hip resurfacing arthroplasty, allowing wider availability in UK, EU & markets accepting CE mark approval
ReCerf was previously approved by Australia’s TGA in Nov 2024 & was used in over 1,600 pts since 2018, with highly positive patient-reported outcomes & a low 6yr. revision…
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The EC has approved Vevzuo & Evfraxy, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) following the CHMP positive opinion in Apr 2025
Approval was based on the comprehensive clinical data, which showed comparable PK, safety, efficacy & immunogenicity of Vevzuo & Evfraxy to the reference product
Vevzuo prevents SREs in adults with bone-involved malignancies…
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The global P-I/II/III (CLIMB-121 & 111) trials assessed Casgevy in sev. SCD & TDT pts (12–35 yrs), with 2yr. post-infusion follow-up, after which pts entered the ongoing 15yr. CLIMB-131 trial, with SCD pts followed for >5.5yrs & TDT for >6yrs.
In SCD, 43/45 pts were VOC-free for ≥12mos., with mean VOC-free duration of 35mos.…

