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Multiple myeloma – Zenbexus gets FDA accelerated approval
Bristol Myers Squibb won accelerated approval in the US for Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj, plus dexamethasone, to treat adults with advanced multiple...
Multiple myeloma – Zenbexus approval explained as CELMoDs milestone
Bristol Myers’ Zenbexus approval was framed by investors and analysts as a “milestone” outcome for CELMoDs, the company’s new myeloma drug class acquired from Celgene. The FDA’s accelerated...
Myeloma – Biogen felzartamab receives first global approval in China
Biogen’s monoclonal antibody felzartamab received its first global approval in China for multiple myeloma. The therapy is authorized for second-line use for patients treated alongside lenalidomide...
Regulatory and reimbursement – ICER says Baxfendy not cost-effective
The Institute for Clinical and Economic Review (ICER) said AstraZeneca’s newly approved hypertension drug Baxfendy does not meet its cost-effectiveness bar at the company’s reported price. ICER’s...
Clinical development – Capricor seeks FDA review after adcomm setback
Capricor Therapeutics announced plans to amend its Duchenne muscular dystrophy (DMD) therapy filing after an FDA advisory committee setback. The company said it will ask the FDA to review...
Biotech funding – Boulevard emerges from stealth with $65m for autoimmune antibodies
Boulevard Bio ended stealth with about $65 million in launch financing from Deerfield Management to build an antibody pipeline focused on B cell-driven autoimmune disease. The company is advancing...
Gene therapy dealmaking – PTC wins $211m bid for Sangamo Fabry program
PTC Therapeutics won a $211 million bankruptcy auction for Sangamo’s Fabry gene therapy candidate, ST-920 (isaralgagene civaparvovec). Under the winning terms, Sangamo will receive $111 million...
Regulatory submissions – OraSure withdraws FDA filing for CT/NG molecular test
OraSure Technologies withdrew its US FDA submission for its InteliQuick CT/NG point-of-care molecular test following discussions with the agency, removing the planned 510(k) and CLIA waiver...
Funding and scale-up – Silence upsized $175m public offering for siRNA divesiran
Silence Therapeutics priced an upsized public offering expected to raise about $175 million as it advances its short interfering RNA (siRNA) pipeline. The financing was increased from an earlier...
Company funding – Aligned Marketplace raises $20m for primary care matching
Aligned Marketplace secured a $20 million Series A led by Venrock to expand its platform for matching self-insured employers with primary care clinics. The company said total funding to date is...
FDA multiple myeloma approval for new CELMoD class
The FDA granted accelerated approval to Bristol Myers Squibb’s iberdomide (Zenbexus), an oral CELMoD regimen for adults with relapsed or refractory multiple myeloma after at least one prior line...
Duchenne therapy: Capricor seeks FDA review after advisory setback
Capricor Therapeutics said it will ask the FDA to review additional data after a negative vote from an advisory committee regarding its Duchenne muscular dystrophy cell therapy. The company framed...
Gene therapy dealmaking: PTC wins Sangamo Fabry program in bankruptcy auction
PTC Therapeutics won a competitive bankruptcy auction for Sangamo Therapeutics’ Fabry disease gene therapy program, securing the ST-920 (isaralgagene civaparvovec) asset after beating bids from...
Oncology trials: Taiho and Cullinan advance zipalertinib after early unblinding
Taiho Oncology and Cullinan Therapeutics said their Phase 3 trial of zipalertinib, a next-generation EGFR inhibitor, was stopped early at a planned interim analysis in front-line lung cancer with...
Oligonucleotide therapeutics: Silence upsizes public offering after Phase 2 ‘best-case’ signal
Silence Therapeutics priced an upsized public offering to raise about $175 million, targeting short interfering RNA (siRNA) programs including divesiran. The financing arrived after the company...
Antibody startup launch: Boulevard Bio debuts with $65M and quarterly-dosing plan
Boulevard Bio emerged from stealth with about $65 million in launch financing from Deerfield Management to build a multi-specific antibody platform focused on B cell–driven autoimmune disease. The...
Big data and financing: Illumina locks in $1B credit facility and $300M note offering
Illumina secured a $1 billion credit facility with Bank of America and simultaneously filed for an underwriting agreement to issue $300 million of 4.950% notes due 2029. The new revolving/term...
Proteomics platform setback: Quantum-Si delays Proteus launch and cuts jobs
Quantum-Si said it is laying off about 20% of its workforce as it pushes back the launch of its Proteus protein sequencing system to the second quarter of 2027. The proteomics company previously...
Resource allocation in schizophrenia drug programs: MapLight dims preclinical work to advance lead asset
MapLight Therapeutics said it is pausing preclinical and discovery efforts and reallocating resources to advance its lead candidate, ML-007C-MA, for schizophrenia and Alzheimer’s disease...
Liquid biopsy screening coverage: Freenome coverage initiated ahead of colorectal test launch
Leerink initiated coverage of Freenome with an Outperform rating and an $18 price target, citing the company’s progress in liquid biopsy cancer screening. The analyst pointed to Freenome’s...