Shots:
Bayer has reported topline P-III (REVEAL) trial data assessing PET/CT radiotracerI 124 evuzamitide (IV) vs clinical SoC diagnosis in 170 adults with suspected cardiac amyloidosis
Trial met its 1EPs of sensitivity & specificity for the diagnosis of cardiac amyloidosis based on visual scan; data will be discussed with regulators, presented in future & submitted…
NEWS
Shots:
Waiv has collaborated with Daiichi Sankyo to lead digital pathology biomarker discovery for an ADC program, leveraging its end-to-end computational pathology platform
Waiv will use its platform to analyze early-phase trial data, incl. tumor microenvironment profiling across H&E & IHC slides, biomarker discovery, & outcome prediction, aimed at identifying biomarkers of treatment response
The…
Shots:
Roche has entered into a definitive merger agreement to acquire PathAI, building on their 2021 partnership, which scaled up in 2024 to incl. the development of AI-enabled companion diagnostic algorithms
As per the deal, Roche will acquire PathAI for $750M upfront & ~$300M in additional milestone payments; closing is expected in H2’26
The acquisition…
Shots:
Angelini Pharma has entered into a definitive agreement to acquire all outstanding shares of Catalyst, marking Angelini’s entry into the US market
As per the deal, Angelini will acquire Catalyst for $31.5 per share in cash, for a total equity value of ~$4.1B; closing is expected in Q3’26
The acquisition will strengthen Angelini’s Brain Health…
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,…
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…
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…
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,…
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…
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…

