Merck KGaA to Present P-III (MANEUVER) Trial Data of Pimicotinib for Tenosynovial Giant Cell Tumor at ASCO 2025

Shots: Part 1 of P-III (MANEUVER) trial assessed pimicotinib (n=63) vs PBO (n=31) for 24wks. in 94 TGCT pts who required systemic therapy & had no prior anti-CSF-1/CSF-1R treatment; trial also incl. an open-label Part 2 (data expected in mid-2025) & an OLE phase (Part 3) Trial met its 1EP of improved ORR (54.0% vs…

ByRidhi RastogiMay 28, 2025

NEWS

Genentech Reports P-III (STARGLO) Trial Data on Columvi for R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: Genentech has reported 2yr. P-III (STARGLO) trial data assessing Columvi + GemOx vs Rituxan + GemOx in previously treated ASCT-ineligible r/r DLBCL pts At 24.7mos. mFU, trial showed a 40% improvement in OS (mOS: not reached vs 13.5mos.), a 59% reduction in risk of progression or death, & CRs in 58.5% vs 25.3% pts;…

ByRidhi RastogiMay 26, 2025

NEWS

Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC)

Shots: Gilead has reported topline P-III (ASCENT-03) trial data (n=~540) assessing Trodelvy vs CT in 1L pts with locally advanced, inoperable, or metastatic TNBC without PD-L1 expression or PD-L1+ pts who are previously treated with a PD-L1 inhibitor Trial met its 1EP of improved PFS in treatment-naïve mTNBC pts ineligible for PD-1/PD-L1 inhibitors; OS (2EP) data…

ByRidhi RastogiMay 26, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (May 19, 2025 – May 23, 2025)  

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, DigiHealth & Animal Health. Check out our full report below:   Apnimed Reports Topline P-III (SynAIRgy) Trial Data of AD109 for Obstructive Sleep Apnea (OSA) Read More: Apnimed Ionis Reveals Topline P-III (ESSENCE) Trial Data of Olezarsen for Moderate…

ByRidhi RastogiMay 23, 2025

NEWS

Gyre Therapeutics Releases P-III Trial Findings on Hydronidone for Chronic Hepatitis B-Associated Liver Fibrosis

Shots: Gyre Therapeutics has reported P-III trial data assessing Hydronidone (270mg, QD, PO) + entecavir (n=123) vs PBO + entecavir (n=124) in 248 Chinese pts with chronic hepatitis B-associated liver fibrosis for 52wks.; 1 untreated subject was excluded from analysis Trial met its 1EP, with 52.85% vs 29.84% achieving ≥1-stage fibrosis regression (Ishak score) & 2EP,…

ByRidhi RastogiMay 23, 2025

NEWS

Merck Reports P-II (WILLOW) Trial Data of Enpatoran for Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)

Shots: The P-II (WILLOW) basket trial assessed enpatoran (25, 50 &100mg, BID, PO) vs PBO + SoC in 2 Arms, where Arm 1 has SLE & CLE pts with active lupus rash & Arm 2 has active SLE pts. Discussions with health authorities on a global P-III program are underway Arm 1 met its 1EP,…

ByRidhi RastogiMay 22, 2025

NEWS

Ionis Reveals Topline P-III (ESSENCE) Trial Data of Olezarsen for Moderate Hypertriglyceridemia

Shots: Ionis has reported topline P-III (ESSENCE) trial data assessing olezarsen (50mg: 276 pts or 80mg: 832 pts, SC, Q4W for 12mos.) vs PBO (n= 369) in 1,478 adults with mod. hypertriglyceridemia (fasting TG ≥150mg/dL to <500mg/dL) with or at risk of ASCVD Trial met its 1EP with significant PBO-adjusted TG reductions of 61% (80mg)…

ByRidhi RastogiMay 19, 2025

NEWS

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

Shots: Apnimed has reported topline P-III (SynAIRgy) trial data assessing AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) vs PBO for 6mos. in 646 adults with mild to sev. OSA across all weight classes who are intolerant of or refuse CPAP therapy Trial met its 1EP with a mean change in AHI at 26wks. & showed improvements across exploratory…

ByRidhi RastogiMay 19, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025) 

PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025)  This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A & Animal Health. Check out our full report below:     Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis Read More: J&J AstraZeneca Reports…

ByRidhi RastogiMay 16, 2025

NEWS

Merck Reports P-III (KEYNOTE-B96/ENGOT-ov65) Trial Findings on Keytruda for Platinum-Resistant Ovarian Cancer

Shots: Merck has reported ongoing P-III (KEYNOTE-B96/ENGOT-ov65) trial findings on Keytruda for the treatment of Pt-resistant recurrent ovarian cancer Trial assessed Keytruda (400mg, IV, Q6W for ~2yrs.) with CT ± Avastin vs PBO + CT ± Avastin in pts (n=643) Trial met its 1EP of improved PFS in overall population & 2EP of OS in pts…

ByRidhi RastogiMay 15, 2025

Merck KGaA to Present P-III (MANEUVER) Trial Data of Pimicotinib for Tenosynovial Giant Cell Tumor at ASCO 2025

Genentech Reports P-III (STARGLO) Trial Data on Columvi for R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Gilead Reports Topline P-III (ASCENT-03) Trial Data of Trodelvy for Triple-Negative Breast Cancer (TNBC)

PharmaShots Weekly Snapshots (May 19, 2025 – May 23, 2025)

Gyre Therapeutics Releases P-III Trial Findings on Hydronidone for Chronic Hepatitis B-Associated Liver Fibrosis

Merck Reports P-II (WILLOW) Trial Data of Enpatoran for Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)

Ionis Reveals Topline P-III (ESSENCE) Trial Data of Olezarsen for Moderate Hypertriglyceridemia

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

PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025)

Merck Reports P-III (KEYNOTE-B96/ENGOT-ov65) Trial Findings on Keytruda for Platinum-Resistant Ovarian Cancer

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