AllSci News
Genentech’s Enspryng advances toward first at-home subcutaneous TED standard of care
Genentech announced that the US FDA has accepted and granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab)…
Grünenthal advances NOP agonist into efficacy testing after clear Phase I
Germany-based Grünenthal Group has reported the successful completion of a Phase I trial for its proprietary nociceptin receptor (NOP) agonist, an...
Genmab's epcoritamab beats chemotherapy in earlier relapsed DLBCL, opening chemo-free path
Denmark-based Genmab A/S (Nasdaq: GMAB) reported that the Phase III EPCORE DLBCL-4 trial met its primary endpoint, with epcoritamab (Epkinly) plus...
EU approves Enhertu as first tumor-agnostic HER2 therapy
The European Commission has approved Enhertu (trastuzumab deruxtecan) as the first tumor-agnostic HER2-directed therapy and antibody drug conjugate in the EU, extending…
FDA Fast Track clears path for Satellos’ mutation-agnostic DMD therapy ahead of Phase II readouts
Toronto-based Satellos Bioscience Inc. (Nasdaq: MSLE, TSX: MSCL) announced receipt of US FDA Fast Track Designation for SAT-3247, an oral small molecule…
Neurogene's gene therapy shows sustained milestone gains in Rett syndrome through 30 months
New York-based Neurogene (Nasdaq: NGNE) reported updated Phase I/II data for NGN-401, an AAV9 gene therapy delivering a full-length human MECP2 transgene,...
Viatris ready to seek Japan approval for Tarpeyo in IgAN after positive readout
Viatris Inc. (Nasdaq: VTRS) is targeting submission of a New Drug Application to Japan's Ministry of Health, Labour and Welfare (MHLW) for Tarpeyo/Kinpeygo...
CraniUS wins NIH support to advance NeuroPASS brain drug delivery platform toward glioblastoma trial
Baltimore-based CraniUS Therapeutics has received an initial USD 1.1 million award through the NIH Blueprint MedTech Optimizer Program, with the potential...
Evommune to focus on dermatology after MRGPRX2 antagonist stumbles in Phase IIb CSU trial
Palo Alto-based Evommune, Inc. (NYSE: EVMN) reported that its oral MRGPRX2 antagonist EVO756 failed to meet its primary endpoint in a Phase IIb trial in...
Roche supplies Tecentriq for pairing with Excalipoint’s tri-specific TCE in SCLC
China-based Excalipoint Therapeutics announced a clinical trial collaboration with Roche to evaluate EXP011 (CTM012), its lead tri-specific T-cell engager, in combination with…
Zymeworks acquires Theravance for USD 929m to secure Yupelri's USD 60m annual cash flows
Canada-based Zymeworks Inc. (Nasdaq: ZYME) has agreed to acquire Dublin-based Theravance Biopharma, Inc. (Nasdaq: TBPH) for USD 17.00 per share in cash,...
Talawar's SPAC merger secures USD 285m to advance dual-pathway atopic dermatitis bispecific
New York-based Talawar Therapeutics has announced a definitive business combination agreement with JATT II Acquisition Corp (Nasdaq: JATT), a Cayman...
Sweden's Flerie acquires Biosergen to revive clinical-stage antifungal candidate
Sweden-based Flerie AB (Nasdaq Stockholm: FLERIE) has agreed to acquire Sweden-based Biosergen AB through a statutory merger, valuing Biosergen at...
Ipsen buys Kartos to add Phase III MDM2 inhibitor for myelofibrosis
France-based Ipsen (Euronext: IPN; ADR: IPSEY) has agreed to acquire Kartos Therapeutics, a Redwood City, California-based clinical-stage company, in a...
Siren Bio advances AAV immune-gene therapy into clinical trials for recurrent glioblastoma
San Francisco-based Siren Biotechnology has received a USD 8 million CLIN2 grant from the California Institute for Regenerative Medicine (CIRM) to advance...
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