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FDA approvals and removals in oncology and immunology
The FDA granted accelerated approval to Bristol Myers Squibb’s oral iberdomide (marketed as Zenbexus) for multiple myeloma that has returned or become resistant, expanding the agency’s use of...
CAR-T and next-gen cell therapies expand beyond the autologous model
Legend Biotech reported its first profitable quarter, driven by strong demand for its multiple myeloma CAR-T therapy Carvykti, while signaling intensifying competitive pressure from off-the-shelf...
Radiation oncology guideline update for pancreatic cancer
ASTRO updated its radiation therapy guidance for adult pancreatic cancer, replacing the 2019 version and publishing the revised guideline in Practical Radiation Oncology. The change is expected to...
Phase 3 readouts reshape lung cancer competition at EGFR exon 20
Taiho Oncology and Cullinan Therapeutics said their Phase 3 trial of zipalertinib plus chemotherapy cleared a registrational goal in frontline EGFR exon 20 insertion–positive lung cancer. The...
Cyber-physical security finds a path from proximity to onboard aircraft electronics
Researchers challenged a common assumption in aircraft cybersecurity by demonstrating that brief physical access to a Boeing 737’s electronics bay can be leveraged as a potential cybersecurity...
Gene therapy deals after Sangamo bankruptcy auction
PTC Therapeutics won a bankruptcy auction for Sangamo’s Fabry disease gene therapy candidate, taking the program forward with an agreement framed as a near-BLA path. The deal structure combines...
Trial results and trial design signals in rare disease and beyond
Freenome said the FDA granted Breakthrough Device Designation for its SimpleScreen lung cancer screening blood test, positioning the assay for a defined population that is not already receiving...
Clinical development financing and capital markets for RNA and antibodies
Silence Therapeutics priced an upsized public offering tied to its short interfering RNA pipeline after reporting a Phase 2 “best-case” outcome for divesiran in a rare leukemia. The financing...
Venture funding and new startups targeting autoimmune and specialty indications
Khartis emerged from stealth with a $95 million total funding haul, including a $50 million Series B, to advance an oral IGF-1R inhibitor aimed at thyroid eye disease. The company tied its TED...
Regulatory and policy framework shift: FDA user-fee reauthorization
The FDA’s next five-year Prescription Drug User Fee Act (PDUFA VIII) reauthorization includes “America First” provisions alongside faster reviews for some application types and updated ways for...
FDA approvals & regulatory actions
The FDA granted accelerated approval to Bristol Myers Squibb’s iberdomide (marketed as Zenbexus) for patients with multiple myeloma that has returned or stopped responding to treatment, expanding...
CAR-T and next-generation cellular immunotherapy
Legend Biotech reported its first profitable quarter, driven by strong demand for its CAR-T asset Carvykti, while also navigating intensifying competition from off-the-shelf bispecifics and rival...
Gene therapy: bankruptcy auction dealmaking and asset transfer
PTC Therapeutics won bankruptcy-auction rights for a Sangamo gene therapy program targeting Fabry disease, securing a $211 million bid that tees up an entry point near potential regulatory...
Oncology drug development: early clinical signals
NeOnc Technologies disclosed positive Phase 2a data for intranasal NEO100 in recurrent IDH1-mutant high-grade glioma, reporting six-month progression-free survival of 48.9% versus a pre-specified...
Oncology trials: EGFR inhibitor competitiveness in lung cancer
Taiho Oncology and Cullinan Therapeutics said their Phase 3 trial of zipalertinib plus chemotherapy in frontline EGFR exon 20 insertion–positive lung cancer met pre-planned thresholds for...
Cancer immunotherapy platforms: CAR-T strength against solid tumors
A new report described a CAR-T engineering approach aimed at improving performance against solid tumors, targeting a persistent weakness in cell therapy durability and trafficking. The coverage...
Biotech funding & corporate finance
Silence Therapeutics priced an upsized public offering intended to raise about $175 million, adding incremental capital for its short interfering RNA pipeline after divesiran reached a “best-case”...
Diagnostics & regulatory-adjacent approvals
Geneseeq received China NMPA approval for its NIFTY-grade NTRK fusion detection kit (PanTRKare assay) as a companion diagnostic, enabling patient selection for Vcare PharmaTech’s TRK inhibitor...
Immunology & platform startups
Boulevard Bio launched with $65 million in initial backing from Deerfield Management and highlighted immune-resetting antibody ambitions in autoimmune kidney disease. The company’s leadership...
Clinical trial design and guideline alignment in prostate cancer
A retrospective analysis found that active surveillance is increasingly becoming the top choice for veterans with favorable-risk prostate cancer in the US Department of Veterans Affairs system,...