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The P-III (OASIS-4) study evaluated elinzanetant (120mg, PO, QD) vs PBO for 52wks. to treat mod. to sev. VMS associated with endocrine therapy for treatment or prevention of HR+ breast cancer, with an optional 2yr. extension; regulatory filings are ongoing in the US, EU & other regions
Trial showed reduced VMS frequency (1EP), with…
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The P-III (DeLLphi-304) trial evaluated Imdelltra (tarlatamab-dlle) vs SoC CT (topotecan globally excl. Japan; lurbinectedin in the US, Canada, Australia, Singapore, Korea; amrubicin in Japan) in SCLC pts (n=509) who progressed on or after 1L of Pt-based CT
Trial met its 1EP of superior OS & 2EPs of improved PFS & PROs for dyspnea…
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Regeneron has entered into an in-licensing agreement with Hansoh for exclusive global clinical development & commercialization rights of HS-20094, excl. Mainland China, Hong Kong & Macau
As per the deal, Hansoh will receive $80M upfront & ~$1.93B in development, regulatory & sales milestones, with low double digits royalties on sales in Regeneron-licensed areas
HS-20094…
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The US FDA has approved mNEXSPIKE (mRNA-1283) for active immunization against COVID-19 in individuals (≥12yrs.) with ≥1 underlying risk factor as defined by Centers for Disease Control and Prevention; regulatory review is ongoing in other regions
Approval was based on P-III (NextCOVE) trial assessing mNEXSPIKE (10 or 50μg) vs Spikevax (mRNA-1273) in ~11,400 subjects…
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BMS & BioNTech will co-develop & co-commercialize BioNTech’s BNT327 alone & in combination to treat solid tumors; BMS to hold MA globally excl. the US, UK, China, Turkey, & EU, where BioNTech will be the holder
As per the deal, BioNTech will receive $1.5B upfront, $2B in non-contingent annual payments through 2028 & ~$7.6B…
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Novartis has reported interim P-III (PSMAddition) trial data assessing Pluvicto + SoC (ARPI + ADT) vs SoC in PSMA+ mHSPC adults, with pts switching to Pluvicto upon confirmation of radiographic progression & per physician's discretion
Trial met its 1EP of improved rPFS, with favorable OS trend (2EP) observed; data to be shared in future…
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Sandoz has launched Wyost & Jubbonti, interchangeable biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) in the US
Jubbonti (60mg/1mL) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer & women on adjuvant aromatase…
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The US FDA has accepted NDA of linerixibat for the treatment of cholestatic pruritus in PBC pts (PDUFA: Mar 24, 2026)
NDA is supported by P-III (GLISTEN) trial assessing linerixibat (n=119) vs PBO (n=119) to treat 238 PBC pts with cholestatic pruritus; pts could switch to linerixibat in Part B of the trial
Trial…
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AstraZeneca has shared P-III (MATTERHORN) trial data assessing perioperative Imfinzi + FLOT (n=474) vs PBO + FLOT (n=474) in 948 pts with stage II-IVA G/GEJ cancers at ASCO 2025
Pts received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles before surgery followed by Imfinzi (2 cycles with FLOT CT + 10…
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Sanofi to acquire Blueprint Medicines, expanding its rare immunological disease portfolio
As per the deal, Blueprint shareholders will receive $129/share in cash (~$9.1B equity value) & one non-tradeable CVR of $2 & $4 per share upon achievement of development & regulatory milestones, respectively, for BLU-808, totaling the deal value up to $9.5B on a…

