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 Rastogi2 days ago

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Mirum and Incyte Report FDA Approval of Atebrioz (Zilurgisertib) for Fibrodysplasia Ossificans Progressiva

Shots: The US FDA has approved Atebrioz (100mg, PO, QD) tablets to reduce the volume of total new heterotopic ossification (HO) in pts (≥12yrs.) with FOP, & issued a Rare Pediatric Disease PRV to Incyte. MAA is under EMA’s review Approval was based on Cohort 1 of the P-II (PROGRESS) study, where at Wk. 24,…

ByRidhi RastogiSeptember 28, 2026

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Elevar Therapeutics Secures the US FDA Approval for Lyrfigtu (Lirafugratinib) to Treat Cholangiocarcinoma

Shots: The US FDA has approved Lyrfigtu for the 2L treatment of cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement; US availability is expected by Q4’26 In the P-I/II (ReFocus) trial, Lyrfigtu showed a cORR of 46%, an mDoR of 11.8mos., & 12mos. PFS rate of 49.2% (mPFS: 11.3mos.), with a predictable and manageable safety…

ByRidhi RastogiSeptember 24, 2026

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Genentech Reports Topline P-II (CT-388-104) Trial Data on Enicepatide in T2D and Overweight or Obesity

Shots: Genentech has reported topline P-II (CT-388-104) trial data assessing enicepatide (CT-388; QW, SC) vs PBO in 447 adults living with type 2 diabetes and overweight or obesity for 48wks. Enicepatide met both 1EPs, with dose-dependent reductions in blood glucose & body weight at 48wks. At 24 mg, HbA1c fell 2.65% from 8.1% baseline, while…

ByRidhi RastogiSeptember 23, 2026

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Roche Reports EC Approval of Susvimo to Treat nAMD

Shots: The EC has approved Susvimo (ranibizumab 100mg/mL solution for injection) for the treatment of neovascular age-related macular degeneration (nAMD), based on the 3 studies, P-III (Archway), P-II (LADDER) & open-label LTE study (Portal) Archway showed Susvimo (refilled in Q6M) maintained vision improvements equivalent to ranibizumab (QM, IVT), with Portal showing maintenance of vision up…

ByRidhi RastogiSeptember 22, 2026

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Resolution Therapeutics Reports Enrollment Completion in P-I/II (EMERALD) Trial of RTX001 in ESLD

Shots: Resolution Therapeutics has reported that the final patient has been treated in P-I/II (EMERALD) trial assessing RTX001 in patients with end-stage liver disease (ESLD) & a history of decompensated liver cirrhosis; Interim data are expected in the Q4’26 RTX001 is engineered with IL-10 & MMP-9 to enhance anti-inflammatory & anti-fibrotic effects of RMT, delivered…

ByRidhi RastogiSeptember 11, 2026

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BMS Reports Topline P-II (QUINTESSENTIAL) Trial Data on Arlo-Cel for Heavily Pretreated R/R Multiple Myeloma (MM)

Shots: The P-II (QUINTESSENTIAL) trial assessed arlocabtagene autoleucel (arlo-cel) in r/r MM pts, who were previously treated with an immunomodulatory inhibitor, a proteasome inhibitor, an anti-CD38 therapy & a BCMA-targeted therapy The trial met its 1EP, showing improvement in ORR, & its key 2EP of CRR in the above-mentioned pts who had previously received ≥4L…

ByRidhi RastogiSeptember 9, 2026

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uniQure Reports the US FDA BLA Submission for Ifezuntirgene Inilparvovec to Treat Huntington’s Disease

Shots: The US FDA has received a BLA for the accelerated approval of ifezuntirgene inilparvovec (AMT-130) for the treatment of Huntington’s disease, plus a request for Priority Review BLA was supported by the 3yr. data analysis from the P-I/II trial of AMT-130 vs a propensity score-matched external control derived from the Enroll-HD natural history database;…

ByRidhi RastogiSeptember 2, 2026

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Biohaven Licenses Kv7 Epilepsy Platform to SK Biopharmaceuticals in $795M Deal

Shots: Biohaven has granted SK Biopharmaceuticals exclusive worldwide rights to its Kv7 ion channel platform, led by opakalim (BHV-7000), a P-II/III candidate for focal epilepsy, with RISE3 topline results are expected in H2’26 Biohaven will receive upfront & milestone payments up to $795M for the Kv7 platform, incl. $400M in cash ($350M at closing &…

ByRidhi RastogiAugust 26, 2026

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GSK’s Jemperli (Dostarlimab) Secures US FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer

Shots: The US FDA has accepted the sBLA under Project Orbis & granted priority review to Jemperli in previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (PDUFA: Feb 2027), with eligibility for an earlier decision through the NPV program sBLA was based on the global P-II (AZUR-1) trial assessing Jemperli (dostarlimab) monotx. (500mg, IV, Q3W…

ByRidhi RastogiAugust 25, 2026

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

Mirum and Incyte Report FDA Approval of Atebrioz (Zilurgisertib) for Fibrodysplasia Ossificans Progressiva

Elevar Therapeutics Secures the US FDA Approval for Lyrfigtu (Lirafugratinib) to Treat Cholangiocarcinoma

Genentech Reports Topline P-II (CT-388-104) Trial Data on Enicepatide in T2D and Overweight or Obesity

Roche Reports EC Approval of Susvimo to Treat nAMD

Resolution Therapeutics Reports Enrollment Completion in P-I/II (EMERALD) Trial of RTX001 in ESLD

BMS Reports Topline P-II (QUINTESSENTIAL) Trial Data on Arlo-Cel for Heavily Pretreated R/R Multiple Myeloma (MM)

uniQure Reports the US FDA BLA Submission for Ifezuntirgene Inilparvovec to Treat Huntington’s Disease

Biohaven Licenses Kv7 Epilepsy Platform to SK Biopharmaceuticals in $795M Deal

GSK’s Jemperli (Dostarlimab) Secures US FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer

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