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Bayer
NEWS

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Priority Review for 1L Treatment of HER2-Mutated NSCLC

Shots: The US FDA has granted Priority Review to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic NSCLC harboring HER2 (ERBB2) TKD-activating mutations & no prior systemic therapy sNDA was supported by preliminary data from Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo…
May 19, 2026

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NEWS

BeOne Medicines Receives US FDA Accelerated Approval for Beqalzi (Sonrotoclax) to Treat R/R Mantle Cell Lymphoma

Shots: The US FDA has granted accelerated approval to BeOne's Beqalzi for the treatment of adults with r/r mantle cell lymphoma, after ≥2L of systemic therapy, incl. a BTK inhibitor; regulatory review is ongoing in the EU Approval was supported by the global P-I/II (BGB-11417-201) assessing Beqalzi in r/r MCL pts (n=125), which showed 52%…
May 14, 2026

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NEWS

The US FDA Grants IND Clearance to Harbour BioMed’s HBM7004 to Initiate P-I Trial in Advanced Solid Tumors

Shots: The US FDA has granted IND clearance to initiate the P-I trial assessing the safety, tolerability, PK, & anti-tumor activity of Harbour Biomed's HBM7004 in advanced solid tumors  Preclinical studies showed that HBM7004 induced B7H4-dependent intratumoral T-cell activation, strong anti-tumor activity, in vivo stability, & reduced systemic toxicity, while combination with a B7H4x4-1BB BsAb…
May 8, 2026

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NEWS

ALX Oncology Presents P-I/II Trial Data on Evorpacept Combination in Metastatic Breast Cancer (mBC) at ESMO Breast Cancer’26  

Shots: ALX Oncology presented data from exploratory analyses of P-Ib/II trial assessing evorpacept + Ziihera in pts with heavily pre-treated HER2+ mBC, all of whom had received prior Enhertu therapy, at ESMO Breast Cancer 2026 Exploratory analyses in 24 pts treated with evorpacept + Ziihera at dosages of 20mg/kg (n=3) or 30mg/kg (n=21), showed a…
May 8, 2026

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NEWS

Siran Bio Inks ~$1B Licensing Deal with GSK for SA030

Shots: Suzhou Siran Biotechnology has granted GSK a global exclusive license to SA030, a long-acting, siRNA oligonucleotide, for the treatment of metabolic & vascular disease (excl. mainland China, Hong Kong, Macau & Taiwan)  As per the deal, Siran Bio will receive an upfront fee & potential development, regulatory & commercial milestones payments up to $1.005B,…
May 7, 2026

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Briacell
NEWS

BriaCell Therapeutics Reports US FDA IND Clearance to Initiate P-I/II Trial of Bria-BRES+ in Breast Cancer

Shots: The US FDA has granted clearance to initiate P-I/II trial of BriaCell's Bria-BRES+ for the treatment of metastatic breast cancer At AACR, the preclinical data showed that Bria-BRES+ activated adaptive & innate immunity, incl. naïve T cells, dendritic cells, & NK cells, potentially enhancing efficacy & preventing immune escape in metastatic breast cancer…
May 6, 2026

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NEWS

Laguna Biotherapeutics Reports the US FDA IND Clearance for LGNA-100 to Treat High-Risk Pediatric Leukemias

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…
April 30, 2026

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