Vanda Pharmaceuticals Initiates Thetis Study of Nereus for GLP-1–Induced Vomiting Prevention

Shots: Vanda Pharmaceuticals has initiated the Thetis study assessing Nereus (tradipitant) vs PBO for the prevention of vomiting in pts receiving GLP-1 receptor agonist therapies The Thetis study will assess the proportion of pts free from vomiting episodes as the 1EP, with Vanda expecting topline results by Q4’26 & noting that additional data may be…

ByRidhi Rastogi3 days ago

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Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC

Shots: Akeso has reported P-Ib/II study data assessing cadonilimab + anlotinib & docetaxel in pts with locally advanced or metastatic NSCLC who progressed after prior PD-(L)1 inhibitor-based therapy At mFU of 21.45mos., the trial showed 6mos. PFS rate of 55.7%, with an mPFS of 7mos. in the overall population, while in sq-NSCLC & PD-L1 TPS…

ByRidhi Rastogi5 days ago

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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 Rastogi5 days ago

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Sanofi Reports P-II Trial Results on Lunsekimig Across Multiple Immunology & Inflammatory Indications

Shots: Sanofi has reported P-IIb (AIRCULES), P-IIa (DUET) PoC & P-IIb (VELVET) data assessing lunsekimig (SC) in adults with mod. to sev. asthma, CRSwNP, & in mod. to sev. atopic dermatitis, respectively In AIRCULES, lunsekimig met 1 & 2EPs, reducing exacerbations & improving lung fuction as measured by pre-BD FEV1 vs PBO, while in DUET it met…

ByRidhi Rastogi5 days ago

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Adagene Reports P-Ib/II Trial Data on Muzastotug + Keytruda for Microsatellite Stable Colorectal Cancer (MSS CRC)

Shots: The P-Ib/II trial randomized 67 MSS CRC pts (65 evaluable) with no liver metastases to muzastotug (10mg/kg; Q3W or Q6W) or muzastotug (20mg/kg) followed by 10mg/kg (Q3W), or 20 mg/kg (Q6W), all in combination with Keytruda; P-II data expected in H1’27 As of Jan 24, 2026, pts in 10mg/kg cohorts (N=39) showed ORR of…

ByRidhi RastogiApril 6, 2026

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Revolution Medicines Initiates P-III (RASolute 303) Trial of Daraxonrasib in Pancreatic Ductal Adenocarcinoma (PDAC)

Shots: Revolution Medicines has started treatment in global P-III (RASolute 303) trial assessing daraxonrasib (PO) as monotx. & in combination with CT for the treatment of pts with previously untreated metastatic PDAC, irrespective of tumor RAS genotype The trial will assess PFS & OS as 1EP, while the key 2EPs include additional measures of antitumor…

ByRidhi RastogiApril 3, 2026

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Earendil Labs Doses First Patient with HXN-1001 in P-IIa Trial in Ulcerative Colitis

Shots: Earendil Labs has dosed the first patient with HXN-1001 in the P-IIa trial, & completed enrolment of healthy subjects in the P-I trial across Australia The P-IIa trial will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of HXN-1001 vs PBO in ulcerative colitis patients HXN-1001 is a half-life extended anti-TL1A antibody…

ByRidhi RastogiApril 3, 2026

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Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration

Shots: Merck initiates the P-IIb/III (MALBEC) trial assessing MK-8748 (Tiespectus/EYE201) for the treatment of neovascular (wet) age-related macular degeneration (NVAMD) The trial will assess the safety & efficacy of two intravitreal dose levels of MK-8748 vs aflibercept (2mg), with Q4W dosing initially for 3mos., then Q8W through Wk. 48, followed by individualized dosing intervals, with…

ByRidhi RastogiApril 3, 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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Merck Reports P-III (CORALreef AddOn) Trial Data on Enlicitide Decanoate in Hypercholesterolemia

Shots: Trial assessed enlicitide (QD, PO) vs non-statin therapies (PO) added to background statins in adults with hypercholesterolemia & ASCVD risk or history, meeting its 1EP with a 64.6% LDL-C reduction at 8wks. & reductions of 56.7% vs bempedoic acid, 36% vs ezetimibe, & 28.1% vs their combination Trial also showed 8wk. reductions in ApoB…

ByRidhi RastogiMarch 31, 2026

Vanda Pharmaceuticals Initiates Thetis Study of Nereus for GLP-1–Induced Vomiting Prevention

Akeso Reports P-Ib/II Trial Data on Cadonilimab Combination to Treat NSCLC

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

Sanofi Reports P-II Trial Results on Lunsekimig Across Multiple Immunology & Inflammatory Indications

Adagene Reports P-Ib/II Trial Data on Muzastotug + Keytruda for Microsatellite Stable Colorectal Cancer (MSS CRC)

Revolution Medicines Initiates P-III (RASolute 303) Trial of Daraxonrasib in Pancreatic Ductal Adenocarcinoma (PDAC)

Earendil Labs Doses First Patient with HXN-1001 in P-IIa Trial in Ulcerative Colitis

Merck Initiates P-IIb/III (MALBEC) Trial of MK-8748 for Neovascular Age-Related Macular Degeneration

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

Merck Reports P-III (CORALreef AddOn) Trial Data on Enlicitide Decanoate in Hypercholesterolemia

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