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NEWS

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,…
May 6, 2026
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…
May 6, 2026
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…
May 6, 2026
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…
May 6, 2026
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…
May 6, 2026
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%…
May 5, 2026
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, &…
May 5, 2026
Guardant Health Secures the US FDA Approval for Guardant360 CDx as a Companion Diagnostic for Arvinas’ Veppanu
Shots: The US FDA has approved Guardant360 CDx as a companion diagnostic to identify pts with ESR1mutations in ER+, HER2- advanced or metastatic breast cancer who may benefit from treatment with Arvinas’ Veppanu (vepdegestrant) Approval was supported by clinical data showing that Guardant360 CDx, a non-invasive liquid biopsy test, demonstrated clinical utility in identifying ESR1 mutations to…
May 5, 2026
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