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Synlogic & Caldera have agreed to merge in an all-stock transaction, forming a new holding company that will operate as Caldera Therapeutics & plans to list on Nasdaq under the ticker “CALD”
Upon closing, Synlogic, Caldera, and private placement investors are expected to own ~2.3%, ~62.8%, and ~34.9% of the combined company, respectively, with…
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Nippon has exercised its exclusive US commercialization option for tadekinig alfa in Primary Monogenic IL-18-Driven Hyperinflammatory Syndrome with NLRC4 & XIAP mutations, with AB2 Bio retaining US rights to all other indications & all rights outside the US
AB2 Bio received a $6M option fee in 2025 & will now receive a $30M option…
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Health Canada has approved Yesintek Autoinjector (45 mg/0.05 mL & 90 mg/mL), a biosimilar version of Stelara (ustekinumab)
Yesintek is indicated for the treatment of mod. to sev. plaque psoriasis in pts (≥6yrs.), active psoriatic arthritis in adults, mod. to sev. active Crohn’s disease & ulcerative colitis in adults
Yesintek was previously approved as…
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J&J has entered strategic agreements & collaboration with Sail to advance its lead immune-mediated disease program & in vivo CAR-T platform, with the potential to expand the platform across additional therapeutic targets
As per the deal, Sail will receive initial payments of $785M, incl. a $465M equity investment, with additional contingent payments of ~$140M…
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AbCellera has entered into a collaboration with Vertex to research, develop, manufacture, & commercialize multispecific T-cell engagers (TCEs) for autoimmune diseases & other conditions
As per the deal, AbCellera will use its TCE platform for discovery & early development, while Vertex will fund all R&D costs and retain rights to develop & commercialize resulting…
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The EC has approved Opzelura (ruxolitinib) cream for the treatment of moderate atopic dermatitis in adults for whom topical corticosteroids (TCSs) & topical calcineurin inhibitors (TCIs) are inadequate or inappropriate
Approval was based on the P-IIIb (TRuE-AD4) study assessing Opzelura vs vehicle in 241 adults with moderate AD, which met its co-1EPs of EASI75…
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The EC has approved Rinvoq (upadacitinib; 15mg, QD) for the treatment of pts (≥12yrs.) with non-segmental vitiligo (NSV) who are candidates for systemic therapy
Approval was backed by the Viti-Up clinical program (M19-044; n=614), incl. 2 replicate trials assessing Rinvoq, where in Period A, pts were randomized to either Rinvoq or PBO for 48wks. &…
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The US FDA has granted clearance to initiate a registrational study (TEMPO-1) of CRB-701, a Nectin-4-targeted ADC, in 2L oropharyngeal squamous cell carcinoma (OPSCC), with enrolment beginning in Sep 2026
Trial (n=250) will evaluate the efficacy & safety of CRB-701 vs investigator’s choice of capecitabine, cetuximab or docetaxel, assessing ORR as the 1EP to…
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The US FDA has granted 510(k) clearance to Saber-C AVIA, a zero-profile ACDF system featuring a porous 3D-printed titanium interbody with spike & screw fixation options
Saber-C AVIA is designed to deliver the biomechanical stability of traditional plating in a lower-profile implant, featuring updated spike delivery tools, low-profile screw instruments, and a single-tray system…
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CORE Biomedicine has entered into a licensing agreement with Eisai, securing exclusive global rights to develop & commercialize multiple preclinical oncology programs
As per the deal, CORE will obtain exclusive, global rights to certain preclinical oncology programs spanning distinct targets & biological pathways, providing CORE with a broad pipeline to develop next-generation precision medicines…

