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 Rastogi2 hours 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 Rastogi20 hours 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 Rastogi21 hours 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 Rastogi22 hours 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 Rastogi24 hours ago

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Teva’s Weltruza Wins FDA Approval as a Once-Monthly SC Olanzapine Injection for Schizophrenia

Shots: The US FDA has approved Weltruza (olanzapine) for extended-release injectable suspension (QM, SC long-acting injectable) for the treatment of schizophrenia in adults, with availability expected in coming wks. Trial showed that Weltruza improved schizophrenia symptoms (PANSS), illness severity (CGI-S), and personal & social functioning. It will be available in 318, 425 & 531mg doses without loading…

ByRidhi Rastogi1 day ago

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Asahi Kasei Reports FDA Approval of Hovilpri for Mucocutaneous HSV Lesions in Immunocompromised Adults

Shots: The US FDA has approved Hovilpri (pritelivir; 100mg, PO) for treating acyclovir, valacyclovir or famciclovir-refractory mucocutaneous herpes simplex virus (HSV) lesions, with or without documented resistance, in immunocompromised adults. Launch is expected by the end of 2026 Approval was supported by the Part C of P-III (PRIOH-1) trial assessing Hovilpri (400mg loading dose on…

ByRidhi Rastogi1 day ago

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Vir Biotechnology Secures the US FDA Fast Track Designation for VIR-5500 to Treat Prostate Cancer

Shots: The US FDA has granted Fast Track designation to VIR-5500 for the treatment of late-line metastatic castration-resistant prostate cancer (mCRPC) VIR-5500 is being evaluated in a P-I study across 6 dose-expansion cohorts, incl. monotx. in taxane-naïve, radioligand therapy-naïve & radioligand therapy-exposed mCRPC, & combinations with enzalutamide or docetaxel in early-line mCRPC, or darolutamide in…

ByRidhi Rastogi4 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 Rastogi4 days ago

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The US FDA Approves Genentech’s Tecentriq Combination for Stage III dMMR Colon Cancer

Shots: The US FDA has approved Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) with fluoropyrimidine & oxaliplatin for the adj. treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer Approval was based on the P-III (ATOMIC) trial in above-mentioned pts (n=712), which were randomized to either mFOLFOX6 plus Tecentriq for 12 cycles…

ByRidhi Rastogi4 days ago

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)

Teva’s Weltruza Wins FDA Approval as a Once-Monthly SC Olanzapine Injection for Schizophrenia

Asahi Kasei Reports FDA Approval of Hovilpri for Mucocutaneous HSV Lesions in Immunocompromised Adults

Vir Biotechnology Secures the US FDA Fast Track Designation for VIR-5500 to Treat Prostate Cancer

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

The US FDA Approves Genentech’s Tecentriq Combination for Stage III dMMR Colon Cancer

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