Ultragenyx Completes Patient Enrolment in P-III (Aspire) Trial of GTX-102 for Angelman Syndrome

Shots: Ultragenyx has completed enrolment in its P-III (Aspire) trial to assess GTX-102 (apazunersen) in Angelman syndrome pts with confirmation of full maternal UBE3A gene deletion; Aurora study in more ages & genotypes to begin in H2'25 Trial will evaluate GTX-102 (intrathecal, 8mg QM for 3mos., then up to 14mg Q4M) vs a sham treatment…

ByRidhi RastogiAugust 1, 2025

NEWS

IMUNON Reports First Patient Dosing in P-III (OVATION 3) Trial of IMNN-001 for Ovarian Cancer

Shots: IMUNON has dosed the first pts with IMNN-001 in P-III (OVATION 3) trial for the treatment of women with newly diagnosed advanced ovarian cancer Trial will evaluate IMNN-001 (100 mg/m², intraperitoneally, QW) + neoadj. & adj. CT vs CT alone in newly diagnosed stage 3C/4 ovarian cancer, incl. HRD+ pts who will receive PARP…

ByRidhi RastogiJuly 31, 2025

NEWS

AbbVie Reports Topline P-III (UP-AA) Trial Data on Rinvoq (Upadacitinib) to Treat Alopecia Areata

Shots: AbbVie has reported topline P-III (UP-AA) trial data on Rinvoq (QD) for sev. alopecia areata in adults & adolescents with a mean baseline SALT score of 83.8 Trial incl. 2 replicate studies (Study 1 & 2) in AA pts (n=1399; 12-64yrs.), where both studies' Period A, pts were randomized to Rinvoq 15mg, 30mg, or…

ByRidhi RastogiJuly 31, 2025

NEWS

Eli Lilly Reports Topline P-III (BRUIN CLL-314) Trial Results of Jaypirca (Pirtobrutinib) to Treat CLL/SLL

Shots: The P-III (BRUIN CLL-314) trial assessed Jaypirca vs Imbruvica in 650 pts with treatment-naïve or experienced (but BTK-naïve) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) Trial met its 1EP of ORR non-inferiority in both pre-treated & ITT pts, with ORR favoring Jaypirca; PFS was immature but showed favorable trend, especially in treatment-naïve pts…

ByRidhi RastogiJuly 30, 2025

NEWS

Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients

Shots: Memo Therapeutics has reported P-II (SAFE KIDNEY II) trial data assessing potravitug vs PBO for the treatment of BK polyomavirus (BKPyV) infection in kidney transplant recipients (n=95) Trial didn’t meet its 1EP of undetectable BKPyV DNAemia but showed superior viral response (≥1-log₁₀ reduction) & resolution of biopsy-proven BKPyVAN by Wk. 20, with histological improvement from…

ByRidhi RastogiJuly 28, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 21, 2025 – Jul 25, 2025)  

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health and Biosimilars. Check out our full report below: AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC Read More: AstraZeneca Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of…

ByRidhi RastogiJuly 25, 2025

NEWS

Apnimed Reports Topline P-III (LunAIRo) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

Shots: The P-III (LunAIRo) trial assessed AD109 (aroxybutynin 2.5mg/atomoxetine 75mg; n=329) vs PBO (n=331) for 12mos. in 660 adults with mild to sev. OSA across all weight classes, who are intolerant of or refuse CPAP therapy Trial met its 1EP with a 46.8% vs 6.8% decrease in AHI at 26wks., which remained significant through Wk.…

ByRidhi RastogiJuly 24, 2025

NEWS

HMNC Brain Health and Spruce Biosciences Dose First Patient in P-II (TAMARIND) Trial of Tildacerfont for Major Depressive Disorder

Shots: HMNC & Spruce has dosed the first pts with tildacerfont in P-II (TAMARIND) trial for the treatment of major depressive disorder (MDD) The P-II (TAMARIND) trial will assess tildacerfont vs PBO in 88 MDD adults across the UK for an 8wk. treatment period followed by a 4wk. follow-up period to evaluate change in Hamilton…

ByRidhi RastogiJuly 23, 2025

NEWS

Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of Ilumya (Tildrakizumab) for Active Psoriatic Arthritis

Shots: Sun Pharma has reported topline data from P-III (INSPIRE-1 & INSPIRE-2) trials assessing Ilumya (100mg) in pts with active psoriatic arthritis (PsA) INSPIRE-1 & INSPIRE-2 trials to evaluate Ilumya (Q12W) vs PBO in ~800 active PsA pts over 52wks., where INSPIRE-1 enrolled pts with prior anti-TNF exposure & INSPIRE-2 enrolled anti-TNF naïve pts Both…

ByRidhi RastogiJuly 21, 2025

NEWS

AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC

Shots: AstraZeneca has reported P-III (FLAURA2) trial findings on Tagrisso + Pt-based CT as a 1L treatment of pts with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC The P-III (FLAURA2) trial assessed Tagrisso (80mg, QD, PO) + pemetrexed + cisplatin/carboplatin (Q3W for 4 cycles) followed by Tagrisso + pemetrexed maintenance (Q3W) vs…

ByRidhi RastogiJuly 21, 2025

Ultragenyx Completes Patient Enrolment in P-III (Aspire) Trial of GTX-102 for Angelman Syndrome

IMUNON Reports First Patient Dosing in P-III (OVATION 3) Trial of IMNN-001 for Ovarian Cancer

AbbVie Reports Topline P-III (UP-AA) Trial Data on Rinvoq (Upadacitinib) to Treat Alopecia Areata

Eli Lilly Reports Topline P-III (BRUIN CLL-314) Trial Results of Jaypirca (Pirtobrutinib) to Treat CLL/SLL

Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients

PharmaShots Weekly Snapshots (Jul 21, 2025 – Jul 25, 2025)

Apnimed Reports Topline P-III (LunAIRo) Trial Data of AD109 for Obstructive Sleep Apnea (OSA)

HMNC Brain Health and Spruce Biosciences Dose First Patient in P-II (TAMARIND) Trial of Tildacerfont for Major Depressive Disorder

Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of Ilumya (Tildrakizumab) for Active Psoriatic Arthritis

AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC

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