Shots:
Quince Therapeutics has completed enrolment in its P-III (NEAT) trial to assess eDSP (6 infusions once every 21–30 days) vs PBO in Ataxia-Telangiectasia pts (n=105), incl. 83 pts (6-9yrs.) in primary analysis population & 22 pts aged ≥10yrs.
Trial will assess change from baseline to the last efficacy visit using RmICARS as the 1EP; pts…
Shots:
AstraZeneca has reported P-III (CARES) trial findings assessing anselamimab (QW for 4wks. then Q2W till completion) + SoC vs PBO + SoC in pts (N=406) with stage IIIa (n=281) & stage IIIb (n=125) light chain (AL) amyloidosis
Trial did not meet its 1EP of time to all-cause mortality & frequency of CV hospitalisations. However,…
Shots:
Merck has initiated P-III (EXPrESSIVE-11) trial to evaluate MK-8527 (QM) vs FTC/TDF for HIV PrEP in ~4,390 individuals at higher risk across 16 countries (enrolment from Aug 2025), & will begin the P-III (EXPrESSIVE-10) trial in ~4,580 women (16-30yrs.) in sub-Saharan Africa, with enrolment starting in the next few mos.
Decision to initiate P-III…
Shots:
Takeda has reported data from 2 P-III (FirstLight & RadiantLight) trials assessing oveporexton over 12wks. in NT1 pts, where FirstLight randomized 168 pts in 3 arms (high dose, low dose & PBO), while RadiantLight randomized 105 pts in 2 arms (high dose & PBO)
Both studies showed improvements across all doses at Wk. 12…
Shots:
AstraZeneca has reported P-III (BaxHTN) trial findings on baxdrostat in pts with uncontrolled hypertension on two antihypertensives & those with resistant hypertension on ≥3 drugs, incl. a diuretic
The P-III (BaxHTN) trial evaluated baxdrostat (1 or 2mg) vs PBO on top of SoCs in 796 pts over 12wks. At Wk. 24, 300 pts on…
Shots:
LEO Pharma has reported 16wk. interim data from P-IIIb (ADHAND) trial assessing Adbry monotx. (tralokinumab; 300mg, Q2W) vs PBO for 16wks. in adults with mod. to sev. atopic dermatitis on hands eligible for systemic therapy, followed by a 16wk. open-label phase, where all pts received Adbry
Trial met its 1EP, with higher proportion of…
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…
Shots:
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,…
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 …

