Get the Daily Brief
Latest Biotech News
Telix NDA acceptance for radiolabeled glioma imaging
The U.S. FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara), a radiolabeled imaging agent for characterizing progressive or recurrent glioma in both adult and pediatric...
Avalyn eyes IPO to fund inhaled IPF Phase 3
Avalyn Pharma is exploring an IPO to fund Phase III development of inhaled therapies for pulmonary fibrosis, according to an SEC filing. The company’s lead candidate, AP01, is an inhaled...
Realta raises more capital for hypoxic ischemic encephalopathy treatment
Realta Life Sciences secured an additional $40 million in the final tranche of its Series A financing, lifting total funding to more than $150 million. The company is developing a treatment for...
Emerging engineered cell therapy cybersecurity claim
A new DNA encryption approach is being reported as a way to protect engineered cells from tampering and theft by securing biological information “from within.” The work frames protection as part...
Biopharma operational tools: cryo-EM expansion for antibody discovery
FairJourney Bio opened a cryo-electron microscopy (cryo-EM) structural biology facility in San Diego, expanding the company’s U.S. presence and adding atomic-resolution structure capability...
CAR T safety strategy via receptor affinity tuning
Researchers reported a CAR T-cell optimization strategy that modulates receptor affinity to balance efficacy and safety. Instead of using a single fixed binding strength, the approach aims to...
Immunotherapy mechanism discovery in AML
A multi-institution team identified a novel immune evasion mechanism in acute myeloid leukemia centered on the glycoprotein CD43, described as a “don’t eat me” signal. The research, published in...
Telomere- and inflammation-linked neurobiology tool: MARCH2 protects from doxorubicin injury
A study in Nature Communications identified MARCH2 as a key molecular protector against chemotherapy-induced heart damage from doxorubicin. The work describes how MARCH2 stabilizes cardiac cells...
FDA rejection of Replimune melanoma therapy
The FDA rejected Replimune’s oncolytic virus therapy for advanced melanoma again, citing unresolved doubts about the study results after the company’s resubmission. The latest action extends a...
Oricell’s funding push for solid-tumor CAR-T
Oricell Therapeutics closed a pre-IPO funding round raising more than $110 million, aiming to expand its global footprint and advance a GPC3-targeted autologous CAR-T for liver cancer toward...
Mezagitamab delivers positive Phase 2 signal in ITP
In immune thrombocytopenia (ITP), a Phase 2 trial reported that mezagitamab materially increased platelet counts, providing a fresh clinical read-through for antibody-based options in a space...
Telix FDA accepts resubmitted NDA for glioma imaging agent
The FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara), a radiolabeled imaging agent for characterizing progressive or recurrent glioma across adult and pediatric...
Gilead expands Kymera licensing for CDK2 molecular glue degrader
Gilead Sciences exercised its option to exclusively license Kymera Therapeutics’ KT-200, an oral CDK2 molecular glue degrader candidate. The move follows a strategic collaboration in which Gilead...
Stipple Bio exits stealth with $100M Series A for ADC epitope selection
Stipple Bio raised a $100 million Series A after emerging from stealth, targeting improved therapeutic windows in antibody-drug conjugates (ADCs) by engineering tumor-specific binders through...
Realta raises additional $40M for hypoxic ischemic encephalopathy therapy
Realta Life Sciences secured an additional $40 million in the final tranche of its Series A funding for its hypoxic ischemic encephalopathy (HIE) treatment. The round brings Realta’s total raised...
Oricell’s pre-IPO megaround coverage (duplicate event, retained separate IDs)
Oricell’s pre-IPO fundraising continued to draw attention as the company moved closer to potential capital-market milestones while scaling its solid-tumor CAR-T platform. Separate deal coverage...
FairJourney Bio opens San Diego cryo-EM structural biology facility
FairJourney Bio opened an advanced cryo-electron microscopy (cryo-EM) structural biology facility in San Diego, expanding its U.S. footprint and integrating atomic-resolution structural biology...
Swan Genomics seed financing for nanoantenna single-molecule DNA sequencing
Swan Genomics, a startup developing optical nanoantenna-based single-molecule sequencing, raised A$8 million (about $5.8 million) in seed funding to advance proof of concept and pursue a Series A....
FDA rejection of Replimune melanoma therapy (RP-1) – regulatory setback
The FDA rejected Replimune’s oncolytic virus therapy (RP-1) for advanced melanoma for a second time, according to multiple reports tied to recent PDUFA and resubmission dates. The agency said...
Oricell pre-IPO funding to expand GPC3 CAR-T into registrational plans
Oricell Therapeutics closed a $110 million pre-IPO financing to broaden its pipeline of solid-tumor cell therapies, with a focus on its GPC3-targeted autologous CAR-T program for hepatocellular...