Shots:The US FDA has accepted sNDA & granted priority review to Akeega (niraparib & abiraterone acetate tablet) + prednisone to treat adults with BRCA-mutated mHSPCsNDA was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/prednisolone + ADT vs PBO/abiraterone acetate with prednisone + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mHSPC…
Shots:Merck has reported P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W for ~2yrs.) with CT ± Avastin vs PBO + CT ± Avastin in Pt-resistant recurrent ovarian cancer pts (n=643)Trial met its 2EP of improved OS in pts with PD-L1+ tumors, building on previously reported data, which will be presented at ESMO’25;…
Shots:China’s NMPA has accepted NDA of Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had an inadequate response or are unamenable to topical corticosteroids; decision expected in 2027NDA was based on P-III (DELTA China) trial assessing Anzupgo (BID) vs vehicle in 362 Chinese pts with mod. to sev.…
Shots:Health Canada has approved Opzelura cream 1.5% for the treatment of mild to mod. AD in children (≥2yrs.), when other topical therapies are ineffective or unsuitableApproval was based on the P-III (TRuE-AD3) trial, evaluating Opzelura (BID) vs vehicle in over 300 children (≥2 to <12yrs.) with ADTrial met its 1EP with more…
Eli Lilly Reports Topline Data from P-III (ACHIEVE-2 & 5) Trials of Orforglipron for Type 2 Diabetes
Shots:The 2 P-III (ACHIEVE-2 & 5) trials assessed orforglipron (3, 12 & 36mg; QD) vs dapagliflozin (10mg; QD) in 962 adults with T2D uncontrolled on metformin, & vs PBO in 546 adults with T2D uncontrolled on titrated insulin glargine ± metformin/SGLT2i for 40wks., respectivelyACHIEVE-2 showed reduced A1C (1EP) at Wk. 40 across both…
Novartis Highlights P-III (APPLAUSE-IgAN) Trial Findings on Fabhalta (Iptacopan) for IgA Nephropathy
Shots:Novartis has reported the P-III (APPLAUSE-IgAN) trial findings assessing Fabhalta (200mg; BID; PO) vs PBO, both on top of SoC in 477 adults with IgA nephropathy (IgAN)Trial showed that Fabhalta reduced IgAN progression measured by annualized total slope of eGFR decline over 2yrs., & demonstrated favorable safety; data to be used for 2026…
Novo Nordisk Enters ~$2.1B Deal with Omeros to Advance Zaltenibart for Rare Blood & Kidney Disorders
Shots:Novo Nordisk has entered into a definitive asset purchase & license agreement with Omeros to develop zaltenibart (MASP-3 inhibitor) for rare blood & kidney disorders, while Omeros retains certain rights to other preclinical MASP-3 programs, incl. small-molecule MASP-3 inhibitors for select indicationsAs per the deal, Novo will receive exclusive global rights to develop…
Shots:The EMA has received MAA of relacorilant for the treatment of Pt-resistant ovarian cancerMAA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & showed favorable safetyRelacorilant (PO) is a GR antagonist that is…
Shots:BioCryst Pharmaceuticals has entered into a definitive agreement to acquire Astria Therapeutics, strengthening its allergic & immunology portfolioAs per the deal, Astria shareholders will receive $8.55 in cash + 0.59 BioCryst shares, valuing Astria at $13/share with an enterprise value of ~$700M (equity value: ~$920M), plus Astria shareholders will hold ~15% of pro…
Shots:Pfizer has reported P-III (HER2CLIMB-05) trial data assessing Tukysa (n=326) vs PBO (n=328), both in combination with trastuzumab & pertuzumab, as a maintenance therapy for pts with HER2+ MBC following induction therapy in the 1L settingTrial met its 1EP with a significant improvement in the investigator-assessed PFS & showed favorable safety; data to…

