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Telix gets FDA acceptance for resubmitted brain imaging NDA
The U.S. FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara), a radiolabeled glioma imaging agent intended to characterize progressive or recurrent glioma in adults and...
Gilead exercises Kymera option for KT-200 CDK2 molecular glue degrader
Gilead Sciences exercised its option to exclusively license KT-200, a preclinical oral CDK2 molecular glue degrader program developed by Kymera Therapeutics. Under the licensing agreement,...
Roche and C4 Therapeutics expand targeted protein degradation with DAC collaboration
Roche signed a new collaboration with C4 Therapeutics to develop degrader-antibody conjugates (DACs), combining Roche ADC delivery experience with C4’s targeted protein degradation payload...
Realta adds $40M to fund Series A for hypoxic ischemic encephalopathy treatment
Realta Life Sciences raised an additional $40 million in the final tranche of its Series A, bringing total funding to more than $150 million as the company advances its treatment for hypoxic...
Mezagitamab posts Phase 2 signal for platelet-disorder patients in breakthrough trial readout
A Phase 2 trial of mezagitamab in immune thrombocytopenia (ITP) reported that the investigational antibody substantially increased platelet counts, marking a near-term clinical proof point for a...
Oricell and other updates collide with booming CAR-T capital and pipeline urgency
Multiple reports from Oricell’s financing rounds and related pre-IPO updates highlight how solid-tumor CAR-T developers are locking in runway to reach pivotal trial readouts. Investors are funding...
C4 and Roche, plus Gilead, underline Big Pharma’s degrader momentum
Fresh licensing and collaboration announcements are reinforcing degrader momentum at Big Pharma. Gilead’s decision to exclusively license Kymera’s KT-200 CDK2 molecular glue degrader adds another...
IPO and capital-raising rebound continues with biopharma financings
Biopharma financing activity is showing a clear rebound in early 2026, with Q1 total financings reported at $22.82 billion—up sharply year over year despite a softer quarter relative to Q4 2025....
FDA rejection of Replimune melanoma therapy
The FDA again rejected Replimune’s oncolytic virus therapy for advanced melanoma after the company failed to resolve trial-related doubts, according to the agency’s renewed decision. Replimune...
Gilead and Kymera deepen molecular-glue degrader pipeline
Gilead exercised its option to exclusively license KT-200, a preclinical oral CDK2 molecular-glue degrader developed by Kymera Therapeutics. The move follows an earlier June 2025 option and comes...
China NMPA approval for MGI’s DNBSeq-T1+ sequencer
MGI Tech said its DNBSeq-T1+ sequencer received medical device registration from China’s NMPA, enabling deployment in the Chinese clinical market. The benchtop instrument targets applications...
Pre-IPO funding for Oricell’s solid-tumor CAR-T push
Oricell Therapeutics secured a pre-IPO venture financing worth more than $110 million to advance CAR-T programs aimed at solid tumors. The company’s lead asset, Ori-C101, is a GPC3-targeted...
Avalyn Pharma targets IPO to fund Phase 3 inhaled IPF programs
Avalyn Pharma filed to pursue an IPO to fund Phase 3 trials for inhaled respiratory therapies for idiopathic pulmonary fibrosis. The biotech’s lead program, AP01, is an inhaled formulation of...
FDA policy shift: America First PDUFA becomes reward-based
A BIOCentury report says the FDA is shifting from a punitive model to a reward-based “America First” PDUFA policy, changing incentives tied to where first-in-human trials are conducted. Under the...
Roche and C4 Teraputics expand into degrader-antibody conjugates
Roche signed a new pact with C4 Therapeutics to develop degrader-antibody conjugates (DACs), blending antibody delivery with targeted protein degradation payloads. The collaboration includes $20...
AI and multiomics push into hospital operations
Luminai raised $38 million in Series B funding to scale an AI platform that automates healthcare administrative workflows, starting with referral management. The company said it is working with...
Seeding the next wave of single-cell toxicity prediction
DeepCyte launched with $1.5 million in seed funding, positioning its single-cell metabolomics platform and AI software to predict drug toxicity and mechanisms at single-cell resolution. The...
Bioanalytical expansion: Seer to apply proteomics tech to Singapore cohort study
Seer said the PRECISE-SG100K population proteomics initiative will use its Proteograph platform to profile plasma proteomes of about 10,000 participants. The proteomics data will be combined with...
Biotech IPO plans and late-stage funding for inhaled pulmonary fibrosis assets
Avalyn Pharma has filed for an IPO to fund Phase 3 development of inhaled therapies aimed at idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis. The company’s lead candidate,...
China CAR-T financing ahead of public-market push
Oricell Therapeutics raised additional capital in a pre-IPO round as the Shanghai-based CAR-T developer accelerates plans for a public listing. The company said it has raised more than $110...