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Merck
NEWS

Merck Reveals P-III (CORALreef HeFH) Trial Data on Enlicitide Decanoate for Heterozygous Familial Hypercholesterolemia (HeFH)

Shots: Merck has highlighted P-III (CORALreef HeFH) trial data assessing enlicitide decanoate (20mg, PO, QD) vs PBO in 303 adults with HeFH at AHA’25 Trial showed significant LDL-C reductions (1EP), along with decreases in non-HDL-C (53%), ApoB (49.1%), & Lp(a) (27.5%) at Wk. 24 in HeFH pts on stable background lipid-lowering therapy. High adherence (97%) &…
November 10, 2025

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NEWS

Johnson & Johnson Reports the US FDA’s Approval of Caplyta (Lumateperone) for Major Depressive Disorder

Shots: The US FDA has approved Caplyta as an adjunctive therapy with antidepressants for treating adults with major depressive disorder (MDD). An sNDA for schizophrenia relapse prevention is also submitted Approval was based on 2 P-III (Study 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant in MDD pts Trial…
November 7, 2025

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Novo-Nordisk
NEWS

Novo Nordisk Reveals P-III (REDEFINE 1) Trial Data on CagriSema for Cardiovascular Risk Factors

Shots: The post hoc analysis of P-III (REDEFINE 1) trial assessed CagriSema (cagrilintide 2.4mg & semaglutide 2.4mg) vs PBO & individual components effects on CV risk factors in 3,417 obese/overweight pts with ≥1 obesity-related comorbidities, & without T2D Trial showed CagriSema reduced systolic BP by -10.9 mmHg over 68wks. (vs -8.8 with semaglutide, & -2.1 with PBO),…
November 7, 2025

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Johnson& Johnson
NEWS

Johnson & Johnson’s Darzalex Faspro Secures the US FDA’s Approval for High-Risk Smouldering Multiple Myeloma (SMM)

Shots: FDA has approved Darzalex Faspro (daratumumab & hyaluronidase-fihj) for high‑risk SMM based on the P-III (AQUILA) study assessing Darzalex Faspro alone vs active monitoring in adults, which met its 1EP of improved PFS by 51%, with 63.1% vs 40.7% pts progression-free at a mFU of 65.2mos. Trial also showed an improved ORR (63.4% vs…
November 7, 2025

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NEWS

Neurona Therapeutics’ NRTX-1001 Secures the EMA’s Priority Medicines (PRIME) Designation for Drug-Resistant Focal Epilepsy

Shots: The EMA has granted PRIME designation to NRTX-1001 for adults with drug-resistant focal epilepsy, based on preclinical & emerging clinical data NRTX-1001 is also being evaluated in 2 ongoing P-I/II trials for drug-resistant unilateral & bilateral mesial temporal lobe epilepsy (MTLE), with P-III (EPIC) trial planned to begin in H2’25 for drug-resistant MTLE The…
November 6, 2025

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NEWS

Merck Signs an R&D Funding Deal with Blackstone Life Sciences for Sacituzumab Tirumotecan (sac-TMT)

Shots: Merck Enters into Research and Development Funding Agreement with Blackstone Life Sciences to support development of sac-TMT, currently in 15 global P-III trials across multiple cancers, including breast, endometrial, and lung As per the deal, Blackstone will provide Merck $700M to help fund sac-TMT development through 2026. In return, Blackstone is eligible for low-to-mid…
November 5, 2025

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