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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...
Merck KGaA makes record-scale move into life-science tools with Bio-Techne acquisition
Merck KGaA agreed to buy Bio-Techne for about $11.3 billion in cash, marking its largest deal since the Sigma-Aldrich acquisition in 2015. The offer values Bio-Techne at $73 per share and...
Ionis monetizes Alexander disease franchise with Recordati ex-U.S. licensing
Recordati licensed Ionis’ Alexander disease therapeutic candidate in a deal that shifts regulatory and commercial responsibilities to the Italian company. The arrangement supports Ionis’ strategy...
Revolution’s second RAS blocker posts strong pancreatic cancer response signals and moves into Phase 3
Revolution Medicines reported high response activity for its second RAS inhibitor, zoldonrasib, in Phase 1/2 pancreatic ductal adenocarcinoma (PDAC) data focused on the KRAS G12D mutation. In...
Novartis pays Antares $105M to pursue undruggable oncology targets with small molecules
Novartis agreed to pay Antares Therapeutics $105 million upfront under a multi-year collaboration to discover small-molecule programs against cancer targets considered “undruggable.” The deal...
RQ Bio raises $115M Series A to advance long-acting flu prevention antibody program
RQ Bio raised an oversubscribed $115 million Series A to advance RQB01, a long-acting antibody therapy intended to prevent seasonal influenza in high-risk and immunocompromised populations. The...
Tempus and Angiosarcoma Awareness partner to expand rare-cancer multiomics dataset
Tempus AI partnered with Angiosarcoma Awareness to advance rare cancer research using the company’s computational resources and multiomic datasets. The collaboration incorporates roughly 600...
Natera integrates Prospera dd-cfDNA into Phase 3 kidney transplant rejection trial
Natera and Eledon Pharmaceuticals partnered to use Natera’s Prospera donor-derived cell-free DNA (dd-cfDNA) test as an exclusive longitudinal monitoring assay in Eledon’s Phase III kidney...
Sangamo enters Chapter 11, with Lilly and Astellas lined up to acquire key platforms and rare-disease programs
Sangamo Therapeutics filed for Chapter 11 bankruptcy protection and agreed to asset-sale agreements that would transfer major technology platforms and a subset of programs. In the filings, Eli...
FDA IND clearance enables Ascletis obesity peptide program to move toward clinic
Ascletis Pharma received FDA IND clearance for ASC-35, a once-monthly subcutaneous GLP-1/GIP dual peptide agonist targeting obesity. The clearance advances the candidate toward clinical evaluation...
Regulatory approval and label expansion for lipid-lowering therapy
Ionis Pharmaceuticals said the FDA approved a label expansion for Tryngolza (formerly known in development as an antisense drug targeting triglycerides), widening its use in patients with severely...