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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,…
2 days ago

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Artera Secures FDA Clearance for AI-Based Breast Cancer Risk Tool

Shots: The US FDA has granted clearance to ArteraAI Breast, a digital pathology-based risk stratification tool for early-stage HR+ /HER2- breast cancer, expanding the company’s oncology AI platform beyond prostate cancer ArteraAI Breast uses multimodal AI combining digitized histopathology images & clinical data to generate an AI-derived risk score predicting distant metastasis risk, helping clinicians…
2 days ago

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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…
3 days ago

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Alebund Pharmaceuticals Completes Patient Enrollment in P-III (RESPOND-2) Trial of AP301 for Hyperphosphatemia

Shots: Alebund has completed patient enrollment in the global P-III (RESPOND-2) trial assessing AP301 for the treatment of hyperphosphatemia across the US (n=138) & China (n=144) The RESPOND-2 trial enrolled 282 pts (planned n=264) aged ≥12yrs with chronic kidney disease on maintenance dialysis with hyperphosphatemia & incl. an 8wk. double-blind phase, a 24wk. open-label phase,…
3 days ago

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Bayer to Acquire Perfuse Therapeutics for ~$2.45B

Shots: Bayer has entered into an agreement to fully acquire Perfuse Therapeutics, incl. its asset PER-001, complementing Bayer’s pipeline & expertise in ophthalmology As per the deal, Bayer will acquire Perfuse for ~$2.45B, incl. $300M upfront payment & additional development, regulatory, & commercial milestone payments; PER-001 (intravitreal implant), a small molecule endothelin receptor antagonist, is…
3 days ago

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Caris Launches Caris MI Clarity for AI-Powered Breast Cancer Recurrence Risk Assessment

Shots: Caris has launched Caris MI Clarity, an AI-driven prognostic test for postmenopausal pts with HR+/HER2-, node-negative early-stage breast cancer, designed to assess both early (0–5yrs.) & late (5–15yrs.) distant recurrence risk from a single test at diagnosis The test leverages Caris’ multimodal dataset, computational pathology & AI-driven ML to analyze digitized H&E slides and…
3 days ago

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Multi4 Medical Receives CE Mark Approval for Multi4 System to Perform Outpatient Bladder Cancer Treatment

Shots: Multi4 Medical received CE mark approval for the Multi4 System, an all-in-one bladder cancer treatment platform enabling treatment during the same outpatient visit without operating room use, anesthesia, or hospitalization The Multi4 instrument integrates local anesthesia delivery, tumor resection, automatic tissue extraction for pathology, & cauterization into a single endoscopic device, allowing awake pts…
3 days ago

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Arrowhead Pharmaceuticals Licenses ARO-PNPLA3 to Madrigal Pharmaceuticals in a ~$1B Deal

Shots: Arrowhead has granted Madrigal an exclusive global license to ARO-PNPLA3, a RNAi therapeutic designed to reduce liver expression of PNPLA3 as a potential treatment of metabolic dysfunction-associated steatohepatitis As per the deal, Arrowhead will receive $25M upfront & ~$975M in development, regulatory, & sales milestones, with tiered royalties ranging from high-single digits to the…
3 days ago

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Sensei Biotherapeutics Reports First Patient Dosing in P-Ib/II Trial of PIKTOR in HR+/HER2- Advanced Breast Cancer

Shots: Sensei Biotherapeutics has dosed the first patient in P-Ib/II (FTH-PIK-101) trial assessing PIKTOR (serabelisib & sapanisertib) + fulvestrant &/or other anticancer therapies in pts with HR+/HER2- advanced or metastatic breast cancer  PIKTOR was evaluated in the P-Ib study in heavily pretreated advanced breast, endometrial, & ovarian cancers, where PIKTOR + paclitaxel achieved a 47%…
4 days ago

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Ortho Development Launches Trivicta Cementless Hip Stem for Primary Hip Arthroplasty

Shots: Ortho Development has reported the full US commercial launch of the Trivicta Hip Stem, a cementless triple-taper femoral component for primary total hip arthroplasty, following a controlled market introduction Trivicta system features a 35μm hydroxyapatite coating over sintered titanium beads to support early osteointegration, alongside standard & extended offset options, progressive neck lengths, &…
4 days ago

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