CRISPR Therapeutics said CASGEVY launch momentum is building and multiple pipeline assets could generate data in the next 12 to 18 months. The company also highlighted zugo-cel progress in oncology and autoimmune disease.
Sino Biopharmaceutical won Chinese approval for a new indication for benmelstobart as maintenance therapy in unresectable stage III NSCLC after chemoradiotherapy. Phase III R-ALPS data showed significantly prolonged progression-free survival versus placebo and a manageable safety profile.
The FDA said one pivotal trial plus confirmatory evidence will become the default standard for approval of most new drugs. The shift could extend beyond rare diseases to common conditions affecting millions.
Ray Therapeutics received EMA PRIME designation for its RTx-015 optogenetic gene therapy for retinitis pigmentosa, following recent FDA RMAT status. The company also appointed Michael Murtagh as Chief Regulatory Officer to support global development.
Peptris has raised INR 70 crore ($7.7 million) in a Series A round to advance programs toward clinical readiness and expand its AI-led drug discovery pipeline over 24 months.
Oncotelic Therapeutics announced expanded international intellectual property coverage for OT-101 across neurology, oncology and CNS drug-delivery technologies. The company also highlighted biotech valuation trends tied to clinical progress and its 45% stake in GMP Bio.
Lunai Bioworks said it received U.S. Patent No. 12,369,861 for debiasing data in drug discovery predictions. The patent covers multimodal data standardization and structural bias removal before predictive modeling.
NVIDIA and Eli Lilly announced a $1 billion AI co-innovation lab as AI drug discovery expands across research, trials and manufacturing. Companies including Recursion and Tempus are using large biological and clinical datasets to speed development and support precision medicine.
The global API market is projected to grow to USD 198.39 billion by 2030 from USD 144.20 billion in 2025, at a 6.6% CAGR. Oncology, rare disease and diabetes pipelines are key growth drivers.
CRISPR Therapeutics reported a $581.6 million net loss in 2025 with revenue of just $3.5 million, while continuing to advance its gene-editing pipeline including the approved CASGEVY therapy and next-generation CAR T cell programs. The company maintains strategic partnerships and expects current funds to support operations for at least 24 months.
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