AllSci News
uniQure raises USD 150m after positive FDA signal on Huntington's disease therapy
Lexington, Massachusetts-based uniQure N.V. (Nasdaq: QURE) announced a proposed underwritten public offering of ordinary shares and pre-funded warrants...
Lilly closes USD 7.8 billion Centessa deal, enters sleep-wake disorder market with OX2R pipeline
The High Court of Justice of England and Wales has sanctioned the scheme of arrangement implementing Eli Lilly's acquisition of Centessa Pharmaceuticals plc...
Pierre Fabre’s Braftovi becomes first targeted therapy approved for BRAF-mutant colorectal cancer in Europe
France-based Laboratoires Pierre Fabre has received European Commission approval for Braftovi (encorafenib) in combination with cetuximab and FOLFOX (fluorouracil, leucovorin, and oxaliplatin)…
Sanofi wins EU approval for Cenrifki in non-relapsing SPMS despite FDA rejection
The European Commission has approved Cenrifki (tolebrutinib) for adults with secondary progressive multiple sclerosis (SPMS) without relapses in the last two years,…
Orion secures EU orphan designation for Hippo pathway-targeted ODM-212 in mesothelioma
Finland-based Orion Oyj (Helsinki: ORNBV) announced receipt of orphan designation from the European Commission for ODM-212 in malignant mesothelioma, based on a…
AbbVie expands Skyrizi into pediatric psoriasis with new weight-based formulation
The European Commission has approved Skyrizi (risankizumab) for children and adolescents aged six years and older with moderate to severe plaque psoriasis…
Novartis advances FAP theranostic platform with first-in-human imaging agent trial across six solid tumors
Novartis has initiated a first-in-human Phase I trial of [68Ga]Ga-DFC413 (JFI447), a gallium-68-labeled radioligand designed to image fibroblast activation...
China approves first CAR-T therapy for a solid tumor with CARsgen’s Satri-cel
China’s NMPA has approved Satri-cel (satricabtagene autoleucel) for Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least…
Tecelra converts to full US FDA approval, extends use to patients aged 12 and older
Louisville, Kentucky-based US WorldMeds has received full US FDA approval for Tecelra (afamitresgene autoleucel), the TCR-T cell therapy originally developed by Adaptimmune…
Cancer Cell publication provides biological rationale for sac-TMT's Phase III push into first-line EGFR-mutant NSCLC
Translational research published in Cancer Cell this week offers a mechanistic rationale for one of the most strategically significant combination studies...
Exelixis reports split Phase III outcome for zanzalintinib ahead of FDA review
Exelixis, Inc. (Nasdaq: EXEL) reported that the final analysis of its second dual primary endpoint in the Phase III STELLAR-303 trial did not reach...
Bionyra launches with USD 165m to challenge TL1A incumbents in inflammatory disease
France-based Bionyra Pharma, a clinical-stage biopharmaceutical company developing mono and multispecific antibodies for immune-mediated inflammatory...
Nura Bio's USD 73.8m Series B validates SARM1 inhibition strategy in ALS
South San Francisco-based Nura Bio, Inc., a clinical-stage biopharmaceutical company developing neuroprotective small molecule therapies, has completed a...
MoonLake reports best-in-class one-year HS data for sonelokimab
Switzerland-based MoonLake Immunotherapeutics (Nasdaq: MLTX) reported Week 52 data from its Phase III VELA-1 and VELA-2 trials showing that 67.2% of adults...
101 Therapeutics bypasses peer review to seek emergency evaluation of Ebola therapy candidate
Israel and New Jersey-based 101 Therapeutics Ltd. has released Phase II/III clinical data for 101-PGC-005, a macrophage-targeted dexamethasone prodrug,...
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