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mRNA in autoimmune targeting: Novartis-Abogen deal reshapes next wave
Novartis has signed an exclusive worldwide licensing deal with Abogen Biosciences for its lead mRNA-encoded CD19xCD3 T-cell engager, ABO2203, in a transaction valued at $575 million upfront with...
Regulatory update: FDA opens clinical trial modernization office
The FDA opened a new clinical trial modernization office within the agency’s Center for Drug Evaluation and Research (CDER), signaling a push to speed and streamline how trials are designed and...
Geographic atrophy retreat: Aviceda winds down after Phase 2 failure
Aviceda Therapeutics is winding down after a Phase 2 setback for an eye program intended to move into Phase 3. A source familiar with the decision said the company is now in the process of closing...
Clinical development funding: AnaCardio raises to advance oral heart failure therapy
AnaCardio secured a €62.5 million ($70.5 million) Series B round to fund Phase IIb development of AC01, an oral calcium-sensitizing contractile agent for chronic advanced heart failure with...
Oncology efficacy signal: Immix interim NXC-201 readout drives capital market action
Immix Biopharma moved immediately after an interim clinical readout for NXC-201, reporting an 89% complete response rate among 45 patients with light-chain (AL) amyloidosis in its BCMA-targeted...
Clinical failure in cancer immunotherapy: IDO1 inhibitor plus melanoma vaccine misses target
A clinical trial targeting tumor immunosuppression by combining an IDO1 inhibitor with a therapeutic melanoma vaccine failed to increase tumor-fighting T-cell responses, according to results...
Regulatory and trial evidence for precision oncology: MRI-based sarcoma response prediction
MRI Habitat Imaging appears to predict soft tissue sarcoma treatment response weeks earlier than standard scans, according to a report describing the approach’s performance in guiding clinical...
AI + diagnostics and companion diagnostics: CellCarta and Imagene expand NSCLC CDx workflow partnership
CellCarta and Imagene AI expanded their partnership to support AI-powered biomarker and companion diagnostic (CDx) programs across the full development pathway, from analytical validation to...
Clinical infrastructure and oncology operations: trial-recruitment ‘momentum’ after referral
A new industry analysis argues that boosting patient referrals alone is not solving clinical trial recruitment slowdowns, because patients often stall after the referral before they reach...
Rare disease genomics and gene editing: Intellia’s lonvoguran ziclumeran gets BLA approval
The FDA approved Intellia Therapeutics’ biologics license application for lonvoguran ziclumeran (lonvo-z), an in vivo CRISPR-based one-dose genome editing therapy for hereditary angioedema (HAE)....
Large pharma expands China-fueled immunology pipeline
Sanofi and Regeneron expanded their long-running immunology alliance, moving four next-generation antibody programs into the shared portfolio and targeting pivotal testing in 2029. The update...
Novartis licenses Abogen’s mRNA T-cell engager for autoimmune reset
Novartis agreed to an exclusive worldwide license of Abogen Biosciences’ lead mRNA-encoded CD19xCD3 T-cell engager, ABO2203, in a deal worth $575 million upfront with potential milestones totaling...
Aviceda shuts down after geographic atrophy Phase 2 failure
Aviceda Therapeutics is winding down after a Phase 2 setback in its geographic atrophy program. A source familiar with the decision said the company had planned to advance the eye drug toward a...
NIH grantmaking hits multi-year low as award counts fall
Grant Witness analysis and NIH data indicate the agency issued 60,924 grant awards by September 24 of fiscal year 2026—its lowest total in six fiscal years at the same point in the calendar. The...
FDA expands longevity agenda in updated FARS framework
FDA Chief Scientist Steven Kozlowski said the agency plans to include aging and longevity among topics highlighted in an updated Focus Areas of Regulatory Science (FARS) report. Kozlowski...
FDA opens clinical trial modernization office in CDER
The FDA opened a new clinical trial modernization office within the agency’s Center for Drug Evaluation and Research (CDER), reflecting a formal push to accelerate how trials are designed and...
Corporate financing: AnaCardio raises to advance oral heart failure drug into Phase 2b
AnaCardio raised €62.5 million (about $70.5 million) in a Series B round to fully fund AC01’s advancement through Phase 2b development. The oral calcium-sensitizing contractile agent targets...
Biotech investing: Immix presses forward after NXC-201 interim readout and launches offering
Immix Biopharma announced a $125 million offering shortly after reporting an interim readout from its Phase II NEXICART-2 trial. The company said BCMA-targeted CAR-T therapy NXC-201 achieved an...
Clinical milestone: Lonvoguran ziclumeran clears Phase 3 and wins HAE BLA approval
The FDA approved lonvoguran ziclumeran (lonvo-z), an in vivo CRISPR treatment for hereditary angioedema (HAE), after the therapy cleared Phase III and received BLA approval in September. The...
Regulatory focus: Pfizer’s Litfulo pivots toward vitiligo market authorization
Pfizer presented Phase 3 results for Litfulo (ritlecitinib) in vitiligo, reporting significant improvements in skin pigment measures across two pivotal studies. The company’s daily pill, if...