Shots:
FDA has granted priority review to BeOne's Tevimbra + Ziihera & CT for the 1L treatment of unresectable locally advanced/metastatic HER2+ gastric, GEJ, or esophageal adenocarcinoma; BeOne plans to participate in the FDA’s Project Orbis
sBLA was based on the P-III (HERIZON-GEA-01) trial, which assessed Ziihera + CT ± Tevimbra vs Herceptin + CT as…
NEWS
Shots:
The US FDA has granted IND clearance to LGNA-100, Laguna Biotherapeutics’ lead clinical candidate from the QUAIL platform, to initiate the P-I trial
The P-I single ascending dose study will assess safety, tolerability, & mechanism of LGNA-100 via IV infusion in pediatric & young adults with high-risk acute leukemias & MDS post αβ-depleted HSCT…
Shots:
Huahui Health has entered into a global exclusive option, license & collaboration agreement, granting BeOne an exclusive option for the development, manufacturing, & commercialization of HH160, a novel trispecific antibody in oncology immunotherapy
As per the deal, Huahui will receive $20M upfront, $100M upon exercising the option, & ~$1.9B in development, regulatory & sales milestones, as well as tiered…
Shots:
The US FDA has received NDA for Immunome’svaregacestat for the treatment of adults with desmoid tumors
NDA is supported by the global P-III (RINGSIDE) trial assessing varegacestat (1.2mg, QD) vs PBO until disease progression or death in 156 pts with progressing desmoid tumors; eligible pts could then enter OLE phase, which is ongoing
Trial…
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The EC has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product
Approval was based on extensive data, incl. structural & functional analytical data, PK & clinical studies, which showed similarity & interchangeability in terms of analytical, PK, efficacy, safety, & immunogenicity between Poherdy &…
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…
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:
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 …

