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FDA rejection of Replimune melanoma therapy (RP-1)
The FDA again rejected Replimune’s oncolytic virus therapy RP-1 for advanced melanoma, issuing a second complete rejection tied to unresolved questions about the study results. The decision...
Oricell pre-IPO financing to advance solid-tumor CAR-Ts
Oricell Therapeutics closed a $110 million pre-IPO round to expand its global footprint and push forward its GPC3-targeted autologous CAR-T program, Ori-C101, toward registrational trials in...
Antibody platform expansion: FairJourney Bio opens cryo-EM facility in San Diego
FairJourney Bio opened a new cryo-electron microscopy structural biology facility in San Diego, expanding its U.S. capacity and integrating atomic-resolution structure work directly into its...
FDA regulatory pathway for Telix imaging agent (Pixclara/TLX101-Px)
The FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine), a radiolabeled imaging agent for characterizing progressive or recurrent glioma in both adults...
Funding: Stipple Bio emerges with $100M Series A for ADC pipeline
Stipple Bio stepped out of stealth with an oversubscribed $100 million Series A to advance its lead antibody-drug conjugate candidate, STP-100, expected to enter clinical studies in early 2027....
Biotech financings: Realta secures additional $40M for HIE therapy
Realta Life Sciences raised an additional $40 million in the final tranche of its Series A, bringing total funding to more than $150 million. The company is developing a treatment for hypoxic...
Protein degradation partnerships: Gilead and Roche deepen degrader bets
Gilead exercised its option to exclusively license Kymera Therapeutics’ KT-200, an oral CDK2 molecular glue degrader, extending a growing wave of targeted protein degradation investments. The...
Clinical updates: mezagitamab Phase 2 data in immune thrombocytopenia
A Phase 2 trial reported that mezagitamab, an investigational antibody, significantly increased platelet counts in patients with immune thrombocytopenia (ITP). The study positions mezagitamab as a...
CAR-T in autoimmune disease: durable remission case after five years
Five years after an early lupus CAR-T breakthrough case, clinicians and researchers highlighted that the patient remains in remission and continues working at the clinic where she was treated. The...
New AI+protein platform: drug discovery tools designed with diffusion models (YuelDesign suite)
University of Virginia researchers built a diffusion-model drug design suite dubbed YuelDesign, YuelPocket, and YuelBond, aimed at tailoring drug molecules to specific protein targets while...
FDA fires second CRL at Replimune’s melanoma virus therapy
The FDA has rejected Replimune Group’s oncolytic virus therapy for advanced melanoma again, issuing a second complete response letter (CRL) for RP-1 (vusolimogene oderparepvec) after the company...
Oricell books $110M pre-IPO round for GPC3 solid-tumor CAR-T
Oricell Therapeutics secured more than $110 million in a pre-IPO financing to advance its lead solid-tumor CAR-T program targeting GPC3, a protein enriched on liver cancer cells. The company said...
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....