BioNTech Reports P-II/III Study Misses First Dual Primary Endpoint for BNT113 in HPV16-Positive Head and Neck Cancer

Shots: BioNTech reported that its P-II/III AHEAD-MERIT study did not meet the first dual 1EP of progression-free survival (PFS) for BNT113 plus pembrolizumab vs pembrolizumab alone in 1L treatment of unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) expressing PD-L1 The Independent Data Monitoring Committee recommended continuing the study to evaluate…

ByPrince Giri56 minutes ago

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BMS Reports the P-III (ACTION-1) Trial Data on RYZ101 for SSTR+ GEP-NETs

Shots: Accord BioPharma has launched Filkri, a biosimilar version of Neupogen (filgrastim), in the US following the FDA approval in Jan 2026 Filkri was approved based on data showing its similarity to Neupogen, with no clinically meaningful differences. It is available in 300mcg/0.5mL & 480mcg/0.8mL PFS presentations, with pack sizes of one or 10 PFS…

ByRidhi Rastogi23 hours ago

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Mirum Reports Topline P-III (EXPAND) Trial Data on Livmarli (Maralixibat) in Ultra-Rare Cholestatic Liver Diseases

Shots: The P-III (EXPAND) trial assessed Livmarli (285µg/kg, BID,PO) vs PBO for cholestatic pruritus in pts (≥6mos.; n=52: 6 adults & 46 pediatric) with ultra-rare cholestatic liver diseases, incl. biliary atresia (BA), achieving statistically significance across all 5 EPs In the pediatric population, Livmarli improved pruritus severity (ItchRO(Obs): −1.81 vs −0.83) & increased days with…

ByRidhi Rastogi1 day ago

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BMS Reports the P-III (ALOFT-IPF) Trial Data on Admilparant in Idiopathic Pulmonary Fibrosis

Shots: BMS has reported the topline P-III (ALOFT-IPF) trial data assessing admilparant (60 & 120mg, PO, BID) vs PBO for ≥52wks. in adults (n=~1,255; ≥40yrs.) with idiopathic pulmonary fibrosis (IPF) Trial met its 1EP at 60mg showing improvement in FVC at Wk. 52, with 120mg also slowing the decline of FVC but was not statistically…

ByRidhi Rastogi2 days ago

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AstraZeneca Reports the P-III (HICKORY) Trial Data on Efzimfotase Alfa in Hypophosphatasia

Shots: The P-III (HICKORY) trial data assessed efzimfotase alfa (ALXN1850; Q2W, SC) vs PBO in 124 pts (≥12yrs.) with HPP who have not been previously treated with Strensiq;data were presented at ASBMR 2026 At Wk. 25, ALXN1850 did not significantly improve 6MWT (1EP), achieving a LS mean difference of 17.05m, while FACIT-Fatigue showed nominally significant…

ByRidhi Rastogi2 days ago

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Merck Reports the P-IIb/III (BRUNELLO) Trial Data on Remigromig for Diabetic Macular Edema

Shots: Merck has reported the P-IIb/III (BRUNELLO) trial data assessing remigromig (MK-3000; 0.5 & 0.8mg, IVT, Q4W) vs ranibizumab (0.5mg, Q4W) in 984 adults with diabetic macular edema (DME) In the trial, both remigromig doses met the 1EP, showing non-inferiority at 1yr. BCVA gains were +9.1 & +8.7 letters with 0.5 & 0.8mg, respectively, vs…

ByRidhi Rastogi2 days ago

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Genentech Reports P-III (MEERKAT & SANDCAT) Trial Data on Vamikibart in Uveitic Macular Edema (UME)

Shots: Genentech has reported the 1yr. data from the P-III (MEERKAT & SANDCAT) trials assessing vamikibart (intravitreal; 0.25 or 1mg, Q4W) vs a sham procedure for ~16wks. in adults with UME, followed by PRN treatment through wk. 52 At 52wks., trial showed numerically greater vision gains in both trials (1EP), with sustained improvements in BCVA…

ByRidhi Rastogi2 days ago

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BMS Reports P-III (EXCALIBER-RRMM) Trial Data on Zenbexus Combination for R/R Multiple Myeloma

Shots: BMS has reported topline data from P-III (EXCALIBER-RRMM) trial, assessing Zenbexus+ daratumumab & dexamethasone (ZDd; n=400) vs daratumumab + bortezomib + dexamethasone (DVd; n=400) in 800 pts with MM, as early as first relapse At an mFU of 23mos., trial showed improvement in the dual-1EP of PFS, with mPFS of 42 vs 20mos., demonstrating…

ByRidhi Rastogi5 days ago

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Innovent Reports the P-III (RESTORE-3) Study of Sycume in Inactive Thyroid Eye Disease

Shots: Innovent has reported the P-III (RESTORE-3) trial data assessing Sycume(teprotumumab N01/IBI311) vs PBO in Chinese pts (n=116) with inactive thyroid eye disease (bilateral CAS ≤ 2 points) Trial met its 1EP at Wk. 24, showing higher proptosis response rate as compared to PBO (60.4% vs. 23.5%), plus in 2EP, Sycume showed LS Mean change…

ByRidhi Rastogi5 days ago

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argenx Reports the P-II (FB102-301) Trial Results on FB102 for Celiac Disease

Shots: argenx has reported the topline P-II (FB102-301) trial results assessing FB102 (2 IV infusions) vs PBO in 126 adults with celiac disease who were symptom free on a strict gluten-free diet for at least 12mos. The trial met its 1EP, showing improvement in the Vh:Cd ratio in pts undergoing a gluten challenge. Improvements in…

ByRidhi RastogiOctober 9, 2026

BioNTech Reports P-II/III Study Misses First Dual Primary Endpoint for BNT113 in HPV16-Positive Head and Neck Cancer

BMS Reports the P-III (ACTION-1) Trial Data on RYZ101 for SSTR+ GEP-NETs

Mirum Reports Topline P-III (EXPAND) Trial Data on Livmarli (Maralixibat) in Ultra-Rare Cholestatic Liver Diseases

BMS Reports the P-III (ALOFT-IPF) Trial Data on Admilparant in Idiopathic Pulmonary Fibrosis

AstraZeneca Reports the P-III (HICKORY) Trial Data on Efzimfotase Alfa in Hypophosphatasia

Merck Reports the P-IIb/III (BRUNELLO) Trial Data on Remigromig for Diabetic Macular Edema

Genentech Reports P-III (MEERKAT & SANDCAT) Trial Data on Vamikibart in Uveitic Macular Edema (UME)

BMS Reports P-III (EXCALIBER-RRMM) Trial Data on Zenbexus Combination for R/R Multiple Myeloma

Innovent Reports the P-III (RESTORE-3) Study of Sycume in Inactive Thyroid Eye Disease

argenx Reports the P-II (FB102-301) Trial Results on FB102 for Celiac Disease

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