Shots:
GSK has entered into a definitive agreement to acquire RAPT Therapeutics, incl. its P-II asset ozureprubart with data expected in 2027, strengthening GSK’s inflammatory & immunology pipeline
As per the deal, GSK will acquire RAPT for $58/share, representing the aggregate equity value of $2.2B & an estimated upfront investment of $1.9B cash; closing expected…
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The US FDA has granted RMAT designation to NouvNeu001 for the treatment of Parkinson's disease
The P-I data showed marked improvements in MDS-UPDRS Part III motor scores, as low-dose pts achieved 30.6 (OFF; 52.82% improvement) & 12.9 (ON; 54.67% improvement) points at 12mos. & high-dose pts 23.3 (OFF) & 9.67 (ON) at 9mos., with…
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The Chinese NMPA has accepted the sNDA of gumokimab for the treatment of active ankylosing spondylitis (AS)
sNDA was backed by the P-III (AK111-303) trial in AS, which met all efficacy endpoints, with 1EP (ASAS20 response rate) showing consistent improvements across subgroups, along with 2EP (ASAS40 response rate) & gumokimab delivering rapid symptom relief…
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The US FDA has granted full approval to Vetmedin chewable tablets (pimobendan) & Vetmedin oral solution for the delay of onset of CHF in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD)
Approval was based on the 2 multi-site studies, with the EPIC trial showing Vetmedin delayed CHF onset or cardiac-related death…
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Data from the OLE 503 study of Caplyta & pooled results from P-III (Studies 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant, in adults with MDD presented at ANCP’26
Pooled data showed higher remission (MADRS ≤10) with treatment at 6wks. (25.5% vs 13.6%), with complete remission (MADRS ≤5) in 10.6%…
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AbbVie has reported topline P-III (EPCORE DLBCL-1) trial results assessing epcoritamab vs chemoimmunotherapy (R-GemOx or BR) in 483 adults with r/r DLBCL, who had received ≥1L of therapy (73% had received ≥2L) & were ineligible for HDT-ASCT
Trial showed improved PFS, with improvements across CRR, DoR, & time to next treatment, plus the study did not…
Shots:
AstraZeneca to acquire AbelZeta’s 50% stake in the China development & commercialization rights to C-CAR031, securing full global rights to develop, manufacture, & commercialize C-CAR031 worldwide
Under a prior agreement, AstraZeneca secured global rights to develop, manufacture, & commercialize C-CAR031 outside China, while AbelZeta remains eligible for additional development milestones & royalties tied to…
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The EC approved Aspaveli (pegcetacoplan) for pts (≥12yrs.) with C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), to be used with a RAS inhibitor unless such therapy is contraindicated or not tolerated
Approval was based on P-III (VALIANT) trial assessing Aspaveli(twice weekly) vs PBO in C3G or primary IC-MPGN pts (≥12yrs., n=124) for…
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The US FDA has granted 510(k) clearance for the EnCor EnCompass Breast Biopsy and Tissue Removal System to provide clinicians with flexibility across breast imaging modalities in the diagnosis of breast disease
The EnCor EnCompass Biopsy System streamlines breast biopsy procedures by allowing clinicians to use a single integrated system across multiple imaging platforms,…
Shots:
Ocugen has reported preliminary 12mos. data from its P-II (ArMaDa) trial (n=51) of OCU410 (AAV5-RORA) in GA secondary to dry AMD, with ~50% of pts evaluated to date
Trial showed a 46% reduction in GA lesion growth vs control (medium + high dose), with the medium dose achieving a 54% reduction; 50% pts achieved…

