Sanofi Reports P-IIa (HS-OBTAIN) Trial Data of Brivekimig for Hidradenitis Suppurativa

Shots: Sanofi has reported the P-IIa (HS-OBTAIN) trial data assessing brivekimig (150mg, SC, Q2W) vs PBO in pts with mod. to sev. hidradenitis suppurativa, incl. biologic-naïve pts for 16 wks., followed by a 12wk. open-label period & an 8wk. safety follow-up At 16wks., brivekimig achieved higher HiSCR50 median response rates of 67% vs 37%, with 54%…

ByRidhi RastogiSeptember 17, 2025

NEWS

Areteia Therapeutics Reports P-III (EXHALE-4) Trial Data of Dexpramipexole to Treat Eosinophilic Asthma

Shots: Areteia Therapeutics has reported P-III (EXHALE-4) trial data assessing dexpramipexole (75 or 150mg, PO, BID) vs PBO as an add-on therapy to treat pts (n=600; ≥12yrs.) with inadequately controlled moderate-to-severe asthma & blood AEC ≥300 cells/μL Trial showed that 150mg improved lung function over Wks. 20 & 24 (1EP), as measured by pre-BD FEV1…

ByRidhi RastogiSeptember 17, 2025

NEWS

Novo Nordisk Reveals P-III (REDEFINE 1) Trial Data of Cagrilintide for Weight Loss in Obese/Overweight

Shots: Novo Nordisk has reported a sub-analysis of P-III (REDEFINE 1) trial assessing cagrilintide monotx. (2.4mg) with lifestyle intervention vs PBO in 3,417 obese/overweight pts with ≥1 obesity-related comorbidities, & without type 2 diabetes Trial showed 11.8% superior weight loss vs 2.3% after 68wks., while 31.6% lost ≥15% of body weight vs 4.7%. However, weight…

ByRidhi RastogiSeptember 16, 2025

NEWS

Akeso Reports First Patient Dosing in P-II (COMPASSION-36) Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma (HCC)

Shots: Akeso has dosed its first patient with cadonilimab + lenvatinib in P-II (COMPASSION-36/AK104-225) trial against lenvatinib for the treatment of advanced HCC in pts previously treated with Tecentriq & Avastin; study is ongoing in the US, EU & China Cadonilimab has also shown superior efficacy in combination regimens, incl. 100% DCR with FOLFOX-HAIC in resectable multinodular HCC…

ByRidhi RastogiSeptember 15, 2025

NEWS

MAIA Biotechnology Reports P-II (THIO-101) Trial Data of Ateganosine Regimen for Advanced NSCLC

Shots: MAIA Biotechnology has reported P-II (THIO-101) trial data assessing ateganosine followed by Libtayo (cemiplimab) in pts with advanced NSCLC who progressed after ≥2 SoC therapy regimens As of Jun 30, 2025, ateganosine (180mg) showed mPFS of 5.6 vs 2.5mos. & mOS of 17.8mos., plus 2 pts completed 33 cycles across pts of all treatment lines,…

ByRidhi RastogiSeptember 15, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 08, 2025 – Sep 12, 2025)  

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, and DigiHealth. Check out our full report below:   AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC Read More: AstraZeneca Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for 1L…

ByRidhi RastogiSeptember 12, 2025

NEWS

Nanjing Leads Biolabs Reports First Patient Enrolment in P-Ib/II Trial of Opatisumab for Advanced Melanoma

Shots: Nanjing Leads Biolabs has enrolled the first patient in P-Ib/II trial assessing opatisumab as monotx. & in combination with toripalimab, for the treatment of 1L advanced melanoma in China Additionally, Opatisumab is being evaluated as monotx. in a registrational study for EP-NEC that completed enrolment in Aug 2025, & is also under investigation in multiple P-II trials…

ByRidhi RastogiSeptember 12, 2025

NEWS

Merck Reports P-III (STRIDE-13) Trial of Capvaxive for Active Immunization Against Pneumococcal Disease

Shots: Merck has reported P-III (STRIDE-13) trial evaluating Capvaxive (21-valent pneumococcal conjugate vaccine) vs PPSV23 in pts (n=882; 2 to <18yrs.) with prior pediatric pneumococcal vaccination & chronic conditions increasing pneumococcal disease risk Trial showed that Capvaxive induced immune responses to all 21 serotypes per opsonophagocytic activity (OPA) geometric mean titers (2EP), plus was noninferior…

ByRidhi RastogiSeptember 11, 2025

NEWS

Regeneron Reports Follow-Up Data from P-III (EMPOWER-Lung 3) Trial of Libtayo (Cemiplimab) to Treat NSCLC

Shots: The P-III (EMPOWER-Lung 3) trial assessed Libtayo (350mg, Q3W for 108wks.; n=312) vs PBO (n=154), both with Pt-based CT (Q3W ×4 cycles), in 466 adults with LA/M NSCLC harboring no EGFR, ALK, or ROS1 alteration At mFU of 60.9mos., trial showed a 34% reduction in death risk (mOS: 21.1 vs 12.9mos.; 5yr. survival probability:…

ByRidhi RastogiSeptember 11, 2025

NEWS

ImmunityBio Reveals P-II (QUILT-3.055) Trial Findings of Anktiva in CPI-Resistant NSCLC

Shots: ImmunityBio has reported P-II (QUILT-3.055) trial data assessing Anktiva (nogapendekin alfa inbakicept-pmln) + checkpoint inhibitor immunotherapy (CPI) in CPI-resistant advanced NSCLC Among 86 pts (51% 2L, 49% 3L+), mOS was 14.3mos. (23 alive at Dec 2025); 69/86 achieving ALC ≥1,200 had mOS of 15.8 vs 11.5mos. in non-achievers, while baseline ALC ≥1,200 & mean…

ByRidhi RastogiSeptember 9, 2025

Sanofi Reports P-IIa (HS-OBTAIN) Trial Data of Brivekimig for Hidradenitis Suppurativa

Areteia Therapeutics Reports P-III (EXHALE-4) Trial Data of Dexpramipexole to Treat Eosinophilic Asthma

Novo Nordisk Reveals P-III (REDEFINE 1) Trial Data of Cagrilintide for Weight Loss in Obese/Overweight

Akeso Reports First Patient Dosing in P-II (COMPASSION-36) Trial of Cadonilimab for PD-1 Treatment-Resistant Hepatocellular Carcinoma (HCC)

MAIA Biotechnology Reports P-II (THIO-101) Trial Data of Ateganosine Regimen for Advanced NSCLC

PharmaShots Weekly Snapshots (Sep 08, 2025 – Sep 12, 2025)

Nanjing Leads Biolabs Reports First Patient Enrolment in P-Ib/II Trial of Opatisumab for Advanced Melanoma

Merck Reports P-III (STRIDE-13) Trial of Capvaxive for Active Immunization Against Pneumococcal Disease

Regeneron Reports Follow-Up Data from P-III (EMPOWER-Lung 3) Trial of Libtayo (Cemiplimab) to Treat NSCLC

ImmunityBio Reveals P-II (QUILT-3.055) Trial Findings of Anktiva in CPI-Resistant NSCLC

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