Shots:
The OLYMPIA long-term extension study assessed Nemluvio in 508 pts with prurigo nodularis up to 4yrs., which were enrolled from the P-II or P-III (OLYMPIA 1 & 2) trials
Interim analysis at Wk. 100 showed sustained improvement, with over 90% achieving ≥4-point itch reduction & 70% being itch-free or nearly itch-free per Peak-Pruritus Numerical…
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Processa & Intact have entered into a binding term sheet for granting Intact an exclusive option to license PCS12852 for gastroparesis & other GI motility disorders
As per the deal, Processa will receive a 3.5% equity in Intact at closing, $2.5M option fee, ~$20M in development & regulatory milestones, ~$432.5M in commercial milestones, &…
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Camurus has reported topline P-IIb (POSITANO) trial data assessing 2 dosing regimens of CAM2029 (octreotide SC depot) vs PBO in 71 pts with symptomatic polycystic liver disease (PLD), with pts continuing treatment in a 2.5yr. OLE study
Trial met its 1EP with a 4.3% relative reduction in height-adjusted liver volume at Wk. 53 for…
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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 &…
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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…

