Shots:
Teva has entered into a definitive agreement to acquire Emalex Biosciences, incl. its lead asset, ecopipam, expanding its neuroscience pipeline & accelerating Teva’s pivot to growth strategy
As per the deal, Teva will acquire Emalex for $700M upfront, & ~$200M in commercial milestones, plus royalties on global net sales of ecopipam, subject to regulatory approval; closing is expected in Q3’26…
Shots:
The Chinese NMPA has accepted NDA & granted priority review to HUTCHMED's sovleplenib for the treatment of adults with warm antibody autoimmune hemolytic anemia (wAIHA) who had an inadequate response to ≥1 previous glucocorticoid treatment
NDA was supported by the Chinese P-II/III (ESLIM-02) assessing sovleplenib vs PBO in adults with primary or secondary wAIHA who had…
Shots:
InnoCare has dosed the first patient with orelabrutinib in the P-III trial for the treatment of systemic lupus erythematosus (SLE), assessing its efficacy & safety against PBO, with the SRI-4 response rate at Wk. 52 as the 1EP
Orelabrutinib was assessed in the P-IIb trial, which met its 1EP, where orelabrutinib (75mg, QD) showed…
Shots:
Kestrel has entered into a strategic agreement with AbbVie, structured as a warrant deal, granting AbbVie an exclusive option to acquire Kestrel upon achievement of key development milestones
As per the deal, AbbVie will fund development of KST-6051, with an exclusive option to acquire Kestrel based on development & regulatory milestone completion, representing the…
Shots:
Profluent has entered into a multi-program strategic research collaboration with Eli Lilly to develop & commercialize custom site-specific recombinases to address diseases with unmet needs
As per the deal, Profluent will use its AI models to design & optimize site-specific recombinases for multiple genomic targets, while Lilly will gain exclusive rights to selected assets…
Shots:
CareDx has entered into a definitive agreement to acquire Naveris, extending CareDx’s Precision Medicine Testing Services strategy into specialty oncology
As per the deal, CareDx will acquire Naveris for $160M upfront & up to $100M in revenue milestones; closing is expected in Q3’26
Naveris’ liquid biopsy platform uses TTMV DNA to detect viral DNA…
Shots:
The US FDA has accepted NDA & granted priority review as well as BTD to GSK's bepirovirsen for the treatment of adults with chronic hepatitis B (CHB)
NDA & designation were supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline…
Shots:
The US FDA has approved AstraZeneca's Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) for the maintenance treatment of asthma in pts (≥12yrs.); regulatory review is ongoing in the EU, Japan & China
Approval was based on the P-III (LOGOS & KALOS) trials evaluating Breztri Aerosphere vs PT009, Symbicort, and PT009 + Symbicort in ~4,300…
Shots:
BI has reported P-III (SYNCHRONIZE-1) trial assessing survodutide (BI 456906; 3.6 or 6mg, QW) vs PBO in 725 adults living with obesity or overweight, without type 2 diabetes
Trial met co-1EP, with ~85.1% achieving ≥5% weight loss vs 38.8%, & 16.6% sustained mean loss vs 3.2% after 76wks. (efficacy estimand), mainly driven by fat…
Shots:
The US FDA has granted 510(k) clearance to Knee+ NexSight, its AR-based total knee arthroplasty solution
Knee+ NexSight projects a virtual display with voice control during knee arthroplasty, without the need of robot, console, or disposables, while delivering robotic-level accuracy with less invasive tools, reduced blood loss, & seamless workflow integration
Knee+ NexSight supports…

