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Oncology—Phase 3 CLDN18.2 ADC filing/priority review in China
Innovent Biologics disclosed that its Claudin18.2 antibody-drug conjugate arcotatug tavatecan (IBI-343, TAK-921) met a primary endpoint in an international Phase 3 study (G-Hope-001) for advanced...
Nephrology—Finerenone expands CKD evidence into non-diabetic disease
Finerenone’s clinical footprint expanded after the Phase III FIND-CKD trial reported benefits in non-diabetic chronic kidney disease. Investigators found that the non-steroidal mineralocorticoid...
ADC / Corporate—Innovent-Takeda deal momentum continues after Phase 3 win
Innovent, fresh from a major licensing arrangement with Takeda, reported a Phase 3 win for its Claudin18.2-directed ADC arcotatug tavatecan (IBI-343, TAK-921) in advanced gastric cancer. The...
ADC / Funding—Ona Therapeutics raises to push differentiated ADCs into human trials
Ona Therapeutics closed an oversubscribed Series B financing totaling $86.6 million to advance two antibody-drug conjugates targeting treatment-resistant cancers. The money primarily supports...
Diagnostics / Regulatory—FDA breakthrough designation for invasive mold cfDNA panel
Zepto Life Technology received FDA breakthrough device designation for its FungiFlex Mold Panel, a plasma-based assay designed to detect invasive mold infections via circulating cell-free DNA. The...
Neuro / Investment—Deep science venture builds brain-entry medicine capability
Deep Science Ventures and Medicine Discovery Catapult launched a partnership aimed at overcoming one of the field’s central bottlenecks—delivering medicines across the blood-brain barrier. The...
Cell therapy operations—Cellares automates TScan’s TCR-T manufacturing for AML/MDS
Cellares and TScan Therapeutics agreed to evaluate automated manufacturing for TSC-101, TScan’s TCR-T therapy candidate intended for patients with AML and MDS undergoing allogeneic hematopoietic...
Capital markets—Fulcrum layoffs and runway extension signals sector pressure
Fulcrum Therapeutics reduced its workforce, letting go 48 of 57 full-time employees following disclosures in an SEC filing. The company’s restructuring comes as it attempts to preserve runway...
Oncology / Financing—Parabilis preps IPO to fund desmoid tumor Phase 3 development
Parabilis Medicines is preparing for a planned IPO seeking to raise more than $400 million to fund phase 3 development of its desmoid tumor drug prospect. The filing process is aimed at providing...
Oncology M&A and platform expansion
Servier moved to deepen its neurology strategy by acquiring Edgewise’s sevasemten and signaling continued M&A buildout across therapeutic franchises. The deal underscores how large pharma is using...
AI-enabled R&D partnerships
Alnylam agreed a multi-year, potentially $2 billion AI collaboration with Inceptive Nucleics to accelerate discovery of RNA interference therapies. The agreement includes $30 million upfront and...
Nephrology therapeutics and kidney risk data
A pair of kidney-focused developments pushed mineralocorticoid and drug-safety questions to the forefront. In the largest non-diabetic chronic kidney disease trial, Phase III FIND-CKD reported...
ADC pipeline acceleration and deal flow
On the ADC front, Innovent’s CLDN18.2-targeted arcotatug tavatecan (IBI-343) cleared another milestone after interim Phase III results in G-Hope-001, with the company submitting an NDA to China’s...
Immuno-oncology mechanisms and targeted degradation
Researchers at the MRC Laboratory of Molecular Biology in Cambridge identified how TRIM21 can drive antibody-directed xenophagy, detailing genes involved in an intracellular degradation pathway...
Blood-based diagnostics and tumor monitoring
Abbott and Mayo Clinic validated a tampon-based endometrial cancer test that uses PCR detection of DNA methylation markers from self-collected vaginal fluid. The platform is designed as a less...
Regulatory and FDA policy pressure on review programs
The FDA’s Commissioner’s National Priority Voucher program faced heightened scrutiny as patient groups, drug companies, and academic organizations urged the agency to pause and restart the voucher...
Oncology trial risk and full-approval challenges
ADC Therapeutics’ Lotis-5 confirmatory study continued to reverberate after safety signals complicated the company’s path to full DLBCL approval. Data showed no overall survival benefit and a...
Funding and commercialization push for cell therapies
CereVasc raised $85 million to advance its minimally invasive eShunt system targeting hydrocephalus without traditional brain shunt surgery. The company said it is preparing to complete a pivotal...
Biopharma platform financing for next-generation oncology ADCs
Ona Therapeutics closed an oversubscribed $86.6 million Series B to push two antibody-drug conjugates into human testing, including ONA-255 for breast cancer and ONA-389 for colorectal cancer. The...
Renal therapeutics: BTK inhibitor licensing
Travere Therapeutics moved to expand its rare-disease kidney pipeline, signing a global licensing deal with Everest Medicines for civorebrutinib, a covalent reversible BTK inhibitor. The...