Shots:
Avata has entered into a co-development & licensing deal with Oceanus Bio for exclusive rights to AVAT-021 & AVAT-022 in Japan & Asia, excl. China & India
As per the deal, Avata will receive $95M in co-development contributions, regulatory & sales milestones, plus double-digit royalties on sales, while Oceanus will lead regulatory activities &…
Shots:
The US FDA has received NDA of gadoquatrane (0.04mmol Gd/kg body weight) for contrast-enhanced MRI of the CNS & other body regions (OBR) in adults & pediatric pts incl. term neonates; MAA was submitted to MHLW with further filings planned in coming mos.
NDA was supported by the QUANTI clinical program, which incl. 2…
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Eli Lilly has entered into a definitive agreement to acquire Verve Therapeutics to advance cardiovascular therapies
As per the deal, Lilly will acquire Verve for $10.50/share in an all-cash transaction totaling ~$1B, along with one non-tradeable CVR of $3/share tied to first pts dosing with VERVE-102 for ASCVD in P-III trial by year 10 post-closing;…
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Teva & Fosun Pharma have partnered to advance the development of TEV-56278 in immuno-oncology & accelerate global clinical data generation
As per the deal, Fosun will receive an exclusive license to develop, manufacture & commercialize TEV-56278 in mainland China, Hong Kong SAR, Macau SAR & Taiwan as well as select Southeast Asian countries, while…
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The US FDA has granted 510(k) clearance to the AVENTUS Thrombectomy System for the treatment of pulmonary embolism (PE), expanding its prior clearance for use in the peripheral vasculature
AVENTUS was evaluated in a completed pivotal IDE trial for aspiration thrombectomy with filtered blood reinfusion in intermediate-risk PE pts, which showed rapid improvement in…
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Supernus to acquire Sage Therapeutics, strengthening its neuropsychiatry product portfolio with Zurzuvae (zuranolone), & a novel CNS discovery platform
As per the deal, Sage’s shareholders will receive $8.5/share in an all-cash transaction totaling ~$561M, along with one non-tradeable CVR of $3.50/share (~$234M) tied to Zurzuvae milestones: $1 each for US sales allocable to Supernus reaching $250M (by…
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Simcere has granted NextCure exclusive global rights to develop, manufacture, & commercialize SIM0505 to treat solid tumors, excl. Greater China, where Simcere will retain its rights
As per the deal, Simcere will receive ~$745M in upfront, development, regulatory & sales milestones, along with net sales-based royalties up to double-digits outside of Greater China. NextCure…
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The US FDA has approved Andembry (garadacimab-gxii) for HAE pts (≥12yrs); commercially available before Jun 2025 end
Approval was based on P-III (VANGUARD) trial assessing Andembry (n=39) vs PBO (n=25) for 6mos., which showed 62% pts remained attack-free, with reduction in overall HAE attacks by >99% median & 89.2% mean, as well as attacks requiring…
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The EC has approved Xoanacyl (ferric citrate complex) for chronic kidney disease; UK's MAA was filed via MHRA's IRP
Approval was supported by 3 pivotal trials conducted by Akebia Therapeutics, which showed increased iron levels along with reduction in serum phosphorus in CKD pts
Averoa licensed Xoanacyl from Akebia in Dec 2022, enhancing its…
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J&J has reported P-II (RedirecTT-1) trial data on Talvey (talquetamab-tgvs) + Tecvayli (teclistamab-cqyv) in 90 heavily pretreated r/r MM pts with extramedullary disease, where 84.4% were triple-class refractory, 35.6% penta-drug refractory, 20% had prior BCMA CAR-T, & 8.9% had prior bsAb exposure
Trial showed a 78.9% ORR, with 54.4% achieving CR or better, incl.…

