Amplia Therapeutics Limited (ASX: ATX) has announced that its Focal Adhesion Kinase (FAK) inhibitor, narmafotinib, has been granted Fast Track Designation by the United States Food and Drug Administration (FDA). This designation, aimed at expediting the development of drugs intended to address unmet medical needs in serious conditions, could provide an advantage in treating advanced […]
BriaCell Therapeutics Corp., a clinical-stage biotechnology company, saw its shares surge by more than 150% to $1.55 following the release of positive overall survival data from its Phase 2 clinical study involving Bria-IMT in combination with an immune checkpoint inhibitor. The treatment is aimed at patients with late-stage metastatic breast cancer. However, despite this recent […]
Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced disappointing results from the phase II/III SKYSCRAPER-06 study, aimed at evaluating the efficacy of tiragolumab plus Tecentriq (atezolizumab) and chemotherapy in treating non-squamous non-small cell lung cancer. The study did not meet its primary endpoints of progression-free survival (PFS) and overall survival (OS), signaling a setback in […]
Hinova Pharmaceuticals Inc. (688302.SH), a trailblazer in the biopharmaceutical industry, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Fast Track designation to its investigational drug, HP518. This drug is being developed specifically for the treatment of Androgen-receptor positive (AR+) triple-negative breast cancer (TNBC), a notably aggressive subtype of breast […]
Antengene Corporation Limited, a commercial-stage global biopharmaceutical company, has announced a significant milestone with the China National Medical Products Administration (NMPA) approving a new indication for XPOVIO (selinexor). This approval allows the use of XPOVIO as a monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), one of the most […]
Amgen (NASDAQ: AMGN) has achieved a significant milestone with the recent U.S. Food and Drug Administration (FDA) approval of BLINCYTO (blinatumomab) for the consolidation phase treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL), irrespective of measurable residual disease (MRD) status. Key Study Findings […]
Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a trailblazer in developing small molecule therapeutics for cancer, has released the final results of its Phase 1 trial combining azenosertib with gemcitabine for relapsed or refractory osteosarcoma. The study findings, presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, showcased a notable improvement in […]
Telix Pharmaceuticals Limited (ASX: TLX) has announced the successful completion of the CUPID Phase I dose escalation study of TLX592, marking a significant advancement in targeted alpha therapy (TAT) for prostate cancer. This milestone is especially noteworthy as TLX592 incorporates Telix’s proprietary RADmAb engineered antibody technology, promising a new era in cancer treatment efficacy and […]
Bristol Myers Squibb (NYSE: BMY) announced that its Phase 3 CheckMate -73L trial did not achieve its primary endpoint of progression-free survival (PFS) in patients with unresectable, locally advanced stage III non-small cell lung cancer (NSCLC). This clinical trial evaluated the efficacy of Opdivo (nivolumab) combined with concurrent chemoradiotherapy (CCRT), followed by Opdivo plus Yervoy […]
In a significant development for cancer research, Innovent Biologics, Inc. (HKEX: 01801), a leading biopharmaceutical company renowned for its innovative medicines in oncology, cardiovascular and metabolic diseases, autoimmune disorders, ophthalmology, and other major diseases, has announced the presentation of preclinical data on multiple novel bispecific antibodies and antibody-drug conjugates (ADCs) from its oncology pipeline at […]