Shots:
The US FDA has granted BDD to Airiver Pulmonary Drug Coated Balloon (DCB) to treat central airway stenosis
Additionally, the first patient has been enrolled & treated in a trial evaluating the Airiver DCB vs SoC bare balloon dilation in ~200 pts with central airway stenosis; positive results could support a future FDA regulatory…
NEWS
Shots:
Teva & Blackstone Life Sciences have entered a four-year strategic funding agreement to support the continued clinical development of duvakitug
As per the deal, Blackstone will provide $400M to Teva over four years to fund duvakitug development, while Blackstone will receive potential milestone payment subject to FDA approval, & additional commercial milestones, as well…
Shots:
The P-II (COMPASSION-03/AK104-201) trial assessed cadonilimab in pts with recurrent or metastatic CC who have failed prior Pt-based CT, showing mOS of 17.5mos. in pts regardless of PD-L1 expression, with18 & 24mos. OS rates of 47.8% & 40.9%, respectively
Updated data with 26.5mos. mFU showed that among 99 efficacy-evaluable pts achieving CR, mOS & PFS…
Shots:
Sino Biopharm via its subsidiary Chia Tai Tianqing has entered into an exclusive license agreement with a fully owned subsidiary of Sanofi for rovadicitinib
As per the deal, Sanofi will obtain exclusive global license to develop, manufacture & commercialize rovadicitinib in exchange for $135M upfront & ~$1.395B in development, regulatory & sales milestones, as…
Shots:
Antengene has granted UCB a global exclusive license to develop, manufacture, & commercialize ATG-201 for B-cell–related autoimmune diseases, plus access to Antengene’s associated manufacturing tech supporting the therapy
As per the deal, Antengene will receive $80M in upfront & near-term milestones & ~$1.1B in development & commercial milestones, as well as net sales-based tiered…
Shots:
Genevant & Arbutus reached a global settlement with Moderna to resolve all US & international disputes over the alleged unauthorized use of their LNP delivery technology in the COVID-19 vaccines, incl. Spikevax
As part of the settlement, Moderna will pay $950M upfront to Genevant & Arbutus in Jul 2026 & ~$1.3B more pending…
Shots:
Lynk has reported topline P-III trial data assessing zemprocitinib (12 or 24mg) vs PBO in 356 pts with mod. to sev. atopic dermatitis
At Wk. 16, zemprocitinib (12 & 24mg) met both co-1EPs, showing superiority vs PBO in EASI-75 (+38.1% & +46.4%) & vIGA-AD 0/1 (+30.3% & +31%), & significantly improved WI-NRS4 itch response…
Shots:
The Chinese NMPA has approved Jaypirca (pirtobrutinib) for the treatment of adults with r/r CLL/SLL after ≥1L of systemic therapy incl. a BTK inhibitor
Approval was based on the P-III (BRUIN CLL‑321) study assessing Jaypirca monotx. (200mg, PO, QD) vs investigator’s choice of IdelaR or BR in 238 previously treated pts with r/r CLL/SLL
Trial…
Shots:
Merck & Eisai has reported the P-III (LITESPARK-011) trial data assessing Welireg (belzutifan; 120mg, PO, QD) + Lenvima (lenvatinib; 20mg, PO, QD) vs cabozantinib in 747Â pts with advanced RCC whose disease progressed on or after anti-PD-1/ PD-L1 therapy
At mFU of 29mos., trial met its 1EP of improved PFS by 30% (mPFS: 14.8 vs…
Shots:
Gyre has entered into an agreement to acquire Cullgen in an all-stock transaction valued at ~$300M, making it a wholly owned subsidiary upon deal completion in Q2’26
Following the acquisition’s close, the combined company will operate as a fully integrated biopharma organization with US & China capabilities across discovery, manufacturing, & commercialization, addressing inflammatory…

