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Akeso’s ivonescimab beats Keytruda on overall survival in China as Summit Therapeutics’ global wager gains another proof point
Akeso's HARMONi-2 trial reported median overall survival of 30.8 months for ivonescimab against 22.6 months for pembrolizumab, strengthening the scientific case while leaving global validation in Summit Therapeutics' territories as the crucial commercial test.
Telix wins Pixclara approval as first U.S. FET-PET agent opens brain cancer market
Telix has secured FDA approval for Pixclara, the first U.S.-approved FET-PET imaging drug for glioma, converting a 2025 Complete Response Letter into a new brain-cancer diagnostics franchise.
Can Nanoscope make severe retinitis pigmentosa treatable without knowing the mutation?
The FDA has accepted Nanoscope Therapeutics’ BLA for MOGENRY, a one-time optogenetic therapy designed to restore useful vision in severe retinitis pigmentosa regardless of the patient’s underlying mutation.
Roche gets January FDA date for Enspryng after cutting MOGAD relapse risk 68%
Roche has secured FDA Priority Review for Enspryng in MOGAD after Phase 3 data showed a 68% reduction in relapse risk, with a U.S. decision due by January 10, 2027.
ABEC to open Wilson biopharma manufacturing facility in North Carolina
ABEC is opening its Wilson, North Carolina manufacturing facility four years after announcing an initial $11 million investment, adding U.S. capacity for bioprocess equipment and consumables used across biologics and vaccine production.
Nanoscope moves mutation-agnostic MOGENRY gene therapy into FDA review
The FDA has accepted Nanoscope Therapeutics’ MOGENRY BLA for severe-vision-loss retinitis pigmentosa, moving a one-time optogenetic treatment toward potential approval without requiring mutation-specific genetic targeting.
TACTI-004 investigation gives Immutep a possible explanation as efti prepares for 2027 restart
Immutep finds efti manufacturing differences after TACTI-004 and refocuses development on head and neck cancer and soft tissue sarcoma.
Superluminal lands $60m Series B to take genetic obesity drug into human trials
Superluminal Medicines has secured an oversubscribed $60 million Series B to move a selective small-molecule MC4R agonist into Phase 1, entering an obesity niche where Rhythm Pharmaceuticals already generates more than $70 million a quarter.
Tarsus completes Alkeus acquisition as Phase 3 retina strategy takes shape
Tarsus Pharmaceuticals has completed its acquisition of Alkeus Pharmaceuticals, paying $450 million upfront for a Phase 3 Stargardt disease program that could expand a fast-growing eye-care business beyond XDEMVY.
IDEAYA and Servier start Phase III adjuvant uveal melanoma study
IDEAYA and Servier have dosed the first patient in the 450-person OptimUM-11 Phase III study, extending darovasertib plus crizotinib into primary uveal melanoma before the combination’s metastatic indication has completed regulatory review.