Shots:
The Chinese NMPA has approved Zai lab's Tivdak for the treatment of adults with recurrent or metastatic cervical cancer with disease progression on or after CT
Approval was backed by the global P-III (innovaTV 301) trial evaluating Tivdak vs CT alone, which met its 1EP of improved OS in the IIT population
In the…
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The US FDA has approved Pfizer's Hympavzi for the treatment of pts (≥12yrs.) with hemophilia A or B with inhibitors & in pts (6-11yrs.) with hemophilia A or B with or without inhibitors
Approval of Hympavzi (SC, QW) in pts (≥12yrs.) was supported by the P-III (BASIS) trial, showing improved key bleeding outcomes incl.…
Shots:
GSK has entered an agreement to acquire Nuvalent, accelerating its entry into lung cancer
As per the deal, GSK will acquire Nuvalent through a tender offer of $124 per share in cash, valuing the company at ~$10.6B (£8.0B); net of acquired cash, GSK’s total investment is estimated at $9.4B (£7.1B). Closing is expected in…
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J&J has entered into a definitive agreement to acquire Firefly Bio, incl. its Firelink degrader antibody conjugate (DAC) platform, expanding its oncology pipeline
As per the deal, J&J will acquire Firefly Bio for $1B in cash, with closing expected later this year
The Firelink DAC platform is a targeted protein degradation tech that selectively…
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Incyte has entered into a definitive agreement to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics, to expand its hematology portfolio into bleeding disorders
As per the deal, Incyte will acquire Vega for $1.25B upfront, with ~$750M in additional payments upon achievement of sales milestones
Acquisition will expand Incyte’s hematology portfolio with…
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Engitix & GSK have entered a strategic research collaboration & option agreement to identify & validate novel therapeutic targets that drive liver fibrosis regression using Engitix’s human extracellular matrix (ECM) platform & multi-omics datasets
As per the deal, Engitix will receive ~£44.5M (~$59.3M) upfront & near-term payments, along with ~£118M (~$157.3M) per target in…
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The US FDA has accepted BLA for AVT16, a biosimilar to Entyvio (vedolizumab) as a lyophilized vial for IV administration, to treat adults with mod. to sev. active ulcerative colitis & Crohn’s disease
BLA is supported by analytical, PK, & immunogenicity data demonstrating biosimilarity between AVT16 & the reference product, plus Alvotech has filed a…
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In TRIUMPH-1 trial & nested studies in knee osteoarthritis pain & OSA, retatrutide met all 1EPs at 80wks., with weight loss of 25.9% (9mg) & 28.3% (12mg). At 12mg, 65.3% pts achieved a BMI <30 & 33.3% reached BMI <25, while those with BMI ≥35 lost ~85 lbs through 104wks. It also reduced WOMAC…
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Nurix has entered a global collaboration with Roche to develop & commercialize bexobrutideg (PO), a BTK targeted protein degrader, which is under P-II/III trial for chronic lymphocytic leukemia
Nurix will receive $700M upfront & ~$2.3B in milestones. Development costs will be shared (40% Nurix & 60% Roche), with both co-commercializing the drug & equally…
Shots:
AstraZeneca has reported the global P-III (I CAN/ALXN1210-IgAN-320) trial assessing Ultomiris (IV) vs PBO in ~510 adults with IgAN who are at risk of disease progression
Trial showed a 46.6% reduction in 24-hr. UPCR from baseline at 34wks. vs 5.6% with PBO, as early as Wk. 10 & sustained through 34wks. The results were consistent…

