Shots:
Chiesi Group has entered into a definitive agreement to acquire KalVista Pharmaceuticals, expanding Chiesi's rare immunology portfolio
As per the deal, Chiesi will acquire KalVista for $27/share, representing the total deal value of ~$1.9B, with the transaction expected to close in Q3’26 & remaining shares acquired later via a second-step merger
Upon completion, Chiesi…
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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…
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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…
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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:
The EC has approved Tuyory, a biosimilar version of RoActemra (Tocilizumab) across the EEA countries
Tuyory (tocilizumab) inhibits IL-6 signaling and is indicated for rheumatoid arthritis, juvenile idiopathic arthritis (including polyarthritis), giant cell arteritis, cytokine release syndrome, and COVID-19. It is available in both IV and SC forms, with dosing and presentations matching the reference product
Tuyory was co-developed by Gedeon Richter and Mochida Pharmaceutical …
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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…
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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…
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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…
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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…

