Biogen Reports P-II (CELIA) Trial Results on Diranersen in Early Alzheimer’s Disease

Shots: Biogen has reported the global P-II (CELIA) trial data assessing diranersen [60mg (Q24W), 115mg (Q24W), or 115mg (Q12W); intrathecal) vs PBO over 76wks. in 416 pts with mild cognitive impairment due to Alzheimer’s disease (AD) or mild AD dementia Although CELIA did not meet its 1EP of dose response on CDR-SB change from baseline…

ByRidhi RastogiMay 15, 2026

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Bayer Reports P-III (REVEAL) Trial Data on Iodine 124 evuzamitide to Diagnose Cardiac Amyloidosis

Shots: Bayer has reported topline P-III (REVEAL) trial data assessing PET/CT radiotracerI 124 evuzamitide (IV) vs clinical SoC diagnosis in 170 adults with suspected cardiac amyloidosis Trial met its 1EPs of sensitivity & specificity for the diagnosis of cardiac amyloidosis based on visual scan; data will be discussed with regulators, presented in future & submitted…

ByRidhi RastogiMay 7, 2026

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SynOx Therapeutics Reports Topline P-III (TANGENT) Trial Results on Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)

Shots: SynOx has reported the global P-III (TANGENT) trial data assessing emactuzumab (1000 mg Q2W × 5 doses over 8wks.) vs PBO in TGCT for 6mos., followed by 18mos. follow-up with option for open-label emactuzumab upon disease progression Trial met 1 & 2EPs with high significance, improving ORR (RECIST v1.1) & Tumor Volume Score, along…

ByRidhi RastogiApril 14, 2026

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Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-trbw) in Active Thyroid Eye Disease

Shots: Amgen has reported topline P-III results assessing Tepezza (SC, Q2W × 12) vs PBO dosed via an on-body injector in pts with mod. to sev. active Thyroid Eye Disease (TED) The trial met its 1EP, showing a 76.7% vs 19.6% proptosis response rate, with 3.17 vs 0.80 mm mean proptosis reduction (key 2EP) at 24wks.…

ByRidhi RastogiApril 7, 2026

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AstraZeneca Reports the P-III (EMERALD-3) Trial Data on Imfinzi Combination + TACE in Unresectable Hepatocellular Carcinoma

Shots: The P-III (EMERALD-3) trial assessed single priming dose of Imjudo (300mg) + Imfinzi (1500mg) followed by Imfinzi (Q4W) + transarterial chemoembolisation (TACE) ± lenvatinib vs TACE alone in 760 pts unresectable HCC eligible for embolization Imjudo + Imfinzi + Lenvatinib & TACE showed improved PFS (1EP) vs TACE alone, with OS (2EP) demonstrating a favorable trend in the…

ByRidhi RastogiApril 2, 2026

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Novocure Reports Topline P-II (PANOVA-4) Trial Data on TTFields Therapy for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Shots: Novocure reported P-II (PANOVA-4) trial data evaluating Tumor Treating Fields (TTFields) with Tecentriq & gemcitabine/nab-paclitaxel as a 1L treatment for mPDAC, with a median TTFields duration of 25.6wks. & median systemic therapy duration of 6 cycles Trial met its 1EP, showing a DCR of 74.4% in TTFields group (N=78) vs 48% with gem/nab-pac alone…

ByRidhi RastogiMarch 26, 2026

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The United Laboratories and Novo Nordisk Report P-II Trial Data on UBT251 in Chinese Patients with Type 2 Diabetes

Shots: The P-II trial assessed UBT251 (2, 4 & 6 mg, QW, SC) vs PBO & semaglutide (1mg) in 211 Chinese T2D pts, which showed HbA1c reduction of 2.16% vs 1.77% (semaglutide) & 0.66% (PBO) at 24wks. from a baseline of 8.12% Trial also showed weight loss of up to 9.8% vs 4.8% (semaglutide) &…

ByRidhi RastogiMarch 25, 2026

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Karyopharm Therapeutics Reports Topline P-III (SENTRY) Trial Data on Selinexor + Ruxolitinib for Myelofibrosis

Shots: The P-III (SENTRY) trial assessed Selinexor (60mg, QW) + ruxolitinib vs PBO + ruxolitinib in 353 pts with frontline myelofibrosis; FDA discussions on SENTRY data & its sNDA strategy is underway, with potential compendia inclusion in H2’26 As of Feb 20, 2026, trial met its first co-1EP, with 50% vs 28% achieving SVR35 at…

ByRidhi RastogiMarch 25, 2026

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Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)

Shots: Prestige has reported the topline P-III (SAMSON-II) trial results evaluating HD204, a biosimilar version of Avastin (bevacizumab), vs Avastin in 625 adults with advanced non-squamous NSCLC Trial showed an ORR of 48.7% vs 46.5% at 18wks., meeting its 1EP & showing clinical equivalence between HD204 & Avastin; 2EPs supported the primary analysis, with similar Wk.…

ByRidhi RastogiMarch 24, 2026

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Pfizer and Valneva Report Topline P-III (VALOR) Trial Data on PF-07307405 for Lyme Disease Prevention

Shots: Pfizer & Valneva have reported the P-III (VALOR) trial data in pts (≥5yrs.) at high risk of Lyme disease randomized to either PF-07307405 vs saline PBO, with one dose administered at mos. 0, 2, 5-9 followed by a fourth dose 1yr. late In pre-specified analyses, efficacy reached 73.2% at 28 days post-dose 4 &…

ByRidhi RastogiMarch 24, 2026

Biogen Reports P-II (CELIA) Trial Results on Diranersen in Early Alzheimer’s Disease

Bayer Reports P-III (REVEAL) Trial Data on Iodine 124 evuzamitide to Diagnose Cardiac Amyloidosis

SynOx Therapeutics Reports Topline P-III (TANGENT) Trial Results on Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)

Amgen Reports Topline P-III Trial Data for Tepezza (Teprotumumab-trbw) in Active Thyroid Eye Disease

AstraZeneca Reports the P-III (EMERALD-3) Trial Data on Imfinzi Combination + TACE in Unresectable Hepatocellular Carcinoma

Novocure Reports Topline P-II (PANOVA-4) Trial Data on TTFields Therapy for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

The United Laboratories and Novo Nordisk Report P-II Trial Data on UBT251 in Chinese Patients with Type 2 Diabetes

Karyopharm Therapeutics Reports Topline P-III (SENTRY) Trial Data on Selinexor + Ruxolitinib for Myelofibrosis

Prestige Biopharma Reports Topline P-III (SAMSON-II) Study Results for HD204 (Biosimilar, Avastin)

Pfizer and Valneva Report Topline P-III (VALOR) Trial Data on PF-07307405 for Lyme Disease Prevention

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