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FDA approval expands ADC market in first-line TNBC
The FDA expanded Gilead’s Trodelvy label for first-line triple-negative breast cancer, allowing use regardless of PD-L1 status and creating a new competitive front in the TROP2 ADC market. The...
Ionis wins broader FDA label for Tryngolza
Ionis Pharmaceuticals received FDA approval that further expands Tryngolza (olezarsen) for adults with severe hypertriglyceridemia, widening the drug’s commercial address. The approval came after...
CAR T target discovery powered by human-in-the-loop AI
A study in Cell reports an AI-enabled framework for nominating CAR T antigens, with preclinical validation of a lead candidate aimed at multi-cancer potential. Researchers at the University of...
Big pharma builds new AI immune target pipeline with Immuneai
Immune profiling company Immunai entered a research collaboration with Boehringer Ingelheim worth up to $15 million to identify novel T-cell targets across oncology and autoimmune disease. Immunai...
New grant award advances mitochondrial therapy for Parkinson’s
The Michael J. Fox Foundation awarded X-tosis a $2.74 million grant to advance XTS-001 toward clinical development for Parkinson’s disease. The funding will support confirmatory studies, biomarker...
Regulatory IND move for stem-cell therapy in Parkinson’s
Unixell Biotechnology obtained FDA IND clearance for UX-DA003, its allogeneic iPSC-derived therapy for Parkinson’s disease, enabling clinical development in the U.S. The company also reported IND...
U.S. biotech financing: RQ Bio raises for long-acting flu prophylaxis
RQ Bio secured an oversubscribed $115 million Series A to advance RQB01, a long-acting antibody program aimed at preventing seasonal influenza in high-risk and immunocompromised populations. The...
Immunotherapy manufacturing: engineered feeder line boosts NK expansion
Researchers reported an engineered feeder cell line that sharply increases allogeneic NK cell production, addressing a major bottleneck in adoptive cell therapy manufacturing. Using an optimized...
Reverse merger brings Remix out of Passage Bio structure
Remix Therapeutics agreed to go public through a reverse merger with Passage Bio, with the combined company expected to trade under the Remix name and the ticker RMTX. Remix investors are slated...
M&A: Merck KGaA buys Bio-Techne to expand life-science tools and workflows
Merck KGaA agreed to acquire Bio-Techne in an approximately $11.3 billion deal, the company said, positioning the combined platform to span discovery, translational research, and commercial...
Regulatory: FDA expands Ionis antisense therapy Tryngolza for severe hypertriglyceridemia
The FDA expanded approval for Ionis Pharmaceuticals’ Tryngolza (olezarsen), allowing use in adults with severe hypertriglyceridemia and building on encouraging phase 3 results released last...
ADC competition heats up: Gilead’s Trodelvy gains first-line label in PD-(L)1-independent TNBC
Gilead Sciences’ Trodelvy won FDA approval for first-line triple-negative breast cancer (TNBC) regardless of PD-L1 status, strengthening its competitive position in the TROP2 antibody-drug...
Oncology pipeline momentum: Revolution’s zoldonrasib posts strong Phase 1/2 signals in RAS-G12D PDAC
Revolution Medicines’ second-generation RAS inhibitor zoldonrasib posted Phase 1/2 response data that suggest high activity in RAS-G12D-mutated metastatic pancreatic ductal adenocarcinoma (PDAC)....
Clinical trial integrity: Nature retracts time-of-day immunotherapy Phase 3 in NSCLC
Nature Medicine retracted a high-profile randomized Phase 3 study claiming that giving PD-1 immunochemotherapy earlier in the day improved outcomes for advanced non-small cell lung cancer. The...
Big pharma partnering with AI immune profiling: Boehringer Ingelheim pays for Immunai platform access
Immunai entered a multi-year research collaboration with Boehringer Ingelheim valued at up to $15 million through 2027, expanding how large pharma is using single-cell immune profiling paired with...
Diagnostics: Natera integrates Prospera dd-cfDNA into Phase 3 kidney transplant trial for tegoprubart
Natera and Eledon Pharmaceuticals partnered to incorporate Natera’s Prospera donor-derived cell-free DNA test into a Phase 3 kidney transplant study evaluating Eledon’s investigational anti-CD40L...
Financing: RQ Bio raises $115M Series A for long-acting single-dose influenza prevention
RQ Bio secured an oversubscribed $115 million Series A to advance its long-acting influenza prevention program, RQB01, into IND-enabling and then clinical development. The company, based in the...
Venture and emerging platform: Promega and Countable Labs launch comarketing for rare variant detection workflows
Countable Labs and Promega announced a comarketing agreement combining Promega’s automated Maxwell nucleic acid extraction workflow with Countable Labs’ single-molecule PCR for rare variant...
AI and drug discovery automation: Medra launches DARPA-linked AI Experimentalist reasoning layer
Medra introduced AI Experimentalist, a scientific reasoning layer that translates high-level research goals into end-to-end experimental workflows, as part of a new collaboration with DARPA. The...
FDA expands Trodelvy label in front-line TNBC, intensifying the TROP2 ADC race
The FDA expanded Gilead Sciences’ Trodelvy to treat front-line triple-negative breast cancer (TNBC) regardless of PD-L1 status, giving the TROP2 antibody-drug conjugate a broader positioning in...