Shots:
Varian has reported the European CE Mark approval of Embozene microspheres for genicular artery embolisation (GAE) to treat knee osteoarthritis
Additionally, a Varian-sponsored GENESIS II trial, assessing GAE vs sham treatment for knee osteoarthritis, has completed patient enrollment in the UK
GAE aims to reduce knee pain by advancing a small catheter into the…
Shots:
Pulse Biosciences has received the US FDA IDE approval to initiate its NANOCLAMP AF study evaluating nsPFA system in ~136 pts with atrial fibrillation (AF) across 20 sites, incl. 2 outside the US
The EU feasibility study of nsPFA Cardiac Clamp began in Aug 2024 with over 40 pts across 3 sites The Netherlands,…
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ImmunityBio has reported P-II (QUILT-3.055) trial data assessing Anktiva (nogapendekin alfa inbakicept-pmln) + checkpoint inhibitor immunotherapy (CPI) in CPI-resistant advanced NSCLC
Among 86 pts (51% 2L, 49% 3L+), mOS was 14.3mos. (23 alive at Dec 2025); 69/86 achieving ALC ≥1,200 had mOS of 15.8 vs 11.5mos. in non-achievers, while baseline ALC ≥1,200 & mean…
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The P-III (ASCEND) trial evaluated rocatinlimab (150 or 300mg, Q4W/Q8W) in ~2,600 atopic dermatitis pts who completed 24wks. in ROCKET trial program & continued for 32wks. in ASCEND, which will evaluate long-term safety & efficacy up to 104wks.
Trial showed a favorable long-term safety profile (1EP) with low discontinuation rates due to AEs, consistent…
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Novartis has entered into an agreement to acquire Tourmaline Bio, incl. its asset pacibekitug, expanding its cardiovascular portfolio
As per the deal, Novartis, through its subsidiary, will acquire Tourmaline for $48/share, representing an aggregate of ~$1.4B, & will merge the subsidiary into Tourmaline upon completion, making it an indirect wholly owned unit of Novartis; closing…
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Eli Lilly has reported P-III (BRUIN CLL-313) trial data assessing Jaypirca (pirtobrutinib; 200mg, PO, QD) vs chemoimmunotherapy (bendamustine + rituximab) in 282 pts with 1L chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions
Trial met its 1EP of improved PFS per IRC, while OS was immature but showed a favorable trend &…
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ONWARD Medical has received MDR CE Mark approval for its ARC-EX system to treat people with spinal cord injury (SCI); first EU commercial sales are expected by Q4’25
Approval was backed by extensive clinical data, incl. Up-LIFT trial published in Nature Medicine, showing 90% pts improved strength or function, 87% reported better QoL, &…
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Servier has entered into a definitive agreement with Kaerus Bioscience to acquire KER-0193, a potential treatment for Fragile X syndrome (FXS)
As per the deal, Kaerus will receive a total of ~$450M incl. an upfront payment as well as development & commercial milestones
KER-0193 is a BK channel modulator, which showed improvement across syndrome-relevant…
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AstraZeneca has reported P-III (FLAURA2) trial findings on Tagrisso + Pt-based CT as a 1L treatment of pts with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC
The P-III (FLAURA2) trial assessed Tagrisso (80mg, QD, PO) + pemetrexed + cisplatin/carboplatin (Q3W for 4 cycles) followed by Tagrisso + pemetrexed maintenance (Q3W) vs…
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Hengrui Pharma & Braveheart Bio have entered into an exclusive license agreement for Hengrui’s HRS-1893 to treat cardiovascular diseases
As per the deal, Braveheart will obtain exclusive global rights (ex-China, Hong Kong, Macao & Taiwan) to develop, manufacture & commercialize HRS-1893 in exchange for $65M upfront (50% in cash + 50% in shares), ~$10M…

