Shots:
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%…
Shots:
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…
Shots:
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…
Shots:
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…
Shots:
Daiichi Sankyo has dosed the first patient in the P-III (TROPIONLung17) trial of Datroway for TROP2-NMR–positive LA/M nonsq. NSCLC without actionable genomic alterations previously treated with immunotherapy (IT) & Pt-based CT
Trial will evaluate Datroway (6mg/kg) vs docetaxel in above-mentioned pts (n=~400) across Asia, EU & North America, assessing PFS & OS as dual…
Shots:
The US FDA has approved Zycubo (copper histidinate) for the treatment of pediatric patients with Menkes disease
Approval was supported by clinical data showing improved OS with early Zycubo treatment vs an untreated external control, reflecting ~80% reduction in the risk of death & a mOS of 177.1 vs 17.6mos.
Zycubo is a bioavailable…
Shots:
The US FDA has accepted sBLA of ropeginterferon alfa-2b-njft for the treatment of adults with essential thrombocythemia, with a PDUFA target action date of Aug 30, 2026
sBLA is supported by the statistically significant and clinically meaningful data from the P-III (SURPASS-ET) trial as well as North American P-IIb (EXCEED-ET) trial
Ropeginterferon alfa-2b-njft received…
Zonsen PepLib Biotech Grants Novartis Global License for Radioligand Therapy Asset with $50M Upfront
Shots:
Zonsen PepLib Biotech has entered into a worldwide license agreement with Novartis for an undisclosed peptide-based radioligand therapy asset
As per the deal, Novartis will obtain exclusive worldwide rights & lead the development & commercialization activities for the undisclosed asset
In return, PepLib will receive $50M upfront, with additional development, regulatory, & sales milestone payments,…

