All articles by Sean Rai-Roche
Blueprint’s Ayvakit expected to take Novartis’ Rydapt crown in advanced systemic mastocytosis but off-label use in indolent unlikely
Blueprint Medicines’ Ayvakit (avapritinib) is likely to displace its competitor, Novartis’ (SIX:NOVN) Rydapt (midostaurin), in advanced systemic mastocytosis (AdSM), experts said.
Blueprint’s Phase II PIONEER trial of Ayvakit in systemic mastocytosis recruiting speedily, with few barriers to entry, sources say
Blueprint Medicines’ Phase II PIONEER trial of Ayvakit (avapritinib) in indolent systemic mastocytosis (ISM) is recruiting briskly, investigators and a source said.
LoA Update: Amgen’s Nplate in aplastic anemia soars 11 points in FDA likelihood of approval after posting strong trial results
The FDA Likelihood of Approval (LoA) for Amgen’s Nplate (romiplostim) in aplastic anaemia jumped 11 points as of 22 April, according to GlobalData’s LoA analysis.
Keros’ Phase II KER-050 to treat anaemia in myelodysplastic syndrome has potential to exceed low transfusion independence benchmark
Keros Therapeutics’ KER-050 to treat anaemia in myelodysplastic syndrome (MDS) patients needs 30% of Phase II part 2 trial participants to become transfusion independent, a secondary endpoint, to be worth investigating further in Phase III, experts said.
Omeros’ narsoplimab to replace Alexion’s Soliris as go-to stem cell-associated TMA therapy, with broad clinical utility to lead to strong market traction, say experts
Omeros’ (NASDAQ:OMER) narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathies (HSCT-TMA) will easily replace Alexion Pharmaceuticals’ (NASDAQ:ALXN) Soliris (eculizumab) as the current off-label standard of care (SOC) when approved, experts said.
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LoA Update: Pfizer’s binimetinib takes a 17-point hit to FDA approval prospects in AML due to Phase II termination
The likelihood of approval (LoA) for Pfizer’s binimetinib in acute myeloid leukaemia (AML) plummeted 17 points on 21 April, according to GlobalData’s LoA data.
Aldeyra’s reproxalap for dry eye has experts optimistic about Phase III success but FDA verdict, real-world outcomes debatable
Aldeyra Therapeutics’ Phase III dry eye disease (DED) trial for reproxalap has experts anticipating success because of strong previous results and a change in the primary endpoint.
LoA Update: Chengdu Kanghong Pharmaceuticals’ Phase III ophthalmic agent drops 7 points in AMD after trial stop
The likelihood of approval (LoA) of Chengdu Kanghong Pharmaceuticals’ (SHE:002773) Phase III conbercept in neovascular age-related macular degeneration (AMD) dropped 7 points as of 12 April, according to GlobalData’s LoA data.
LoA Update: Outlook Therapeutics’ Phase III drug sees a 7 and 10-point LoA jump in two eye disease indications after positive safety data
The likelihood of approval (LoA) of Outlook Therapeutics’ (NASDAQ:OTLK) Phase III Lytenava (bevacizumab-vikg) in diabetic macular edema (DME) rose 7 points, with its prospects in branch retinal vein occlusion (BRVO) jumping by 10 as of 6 April, according to GlobalData’s LoA data.
Outlook Therapeutics’ bevacizumab-vikg for wet AMD has experts anticipating Phase III success, but biased design likely to limit uptake
While Outlook Therapeutics’ Phase III neovascular age-related macular degeneration (AMD) trial for bevacizumab-vikg has experts expecting success, they were less optimistic about its market penetration.