Category: Today’s Highlights

Rocket Pharmaceuticals Announced FDA Approval of KRESLADI™ for Pediatric Patients with Severe Leukocyte Adhesion Deficiency-I

Rocket Pharmaceuticals in the NEWS March 27, 2026, Rocket Pharmaceuticals (RCKT) announced that the U.S. FDA has granted accelerated approval for KRESLADI™ (marnetegragene autotemcel), an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of pediatric patients with severe leukocyte adhesion deficiency-I (LAD-I) due to biallelic variants in ITGB2 without an . . . This content is for paid subscribers. Please click here to subscribe or here to log …

Oryon Cell Therapies Reports Phase 1b/2a Data Showing Sustained Motor Improvements in People with Parkinson’s Disease

Oryon Cell Therapies Oryon Cell Therapies (Oryon) - a clinical-stage biotechnology company focused on developing autologous neuron replacement medicines for Parkinson’s disease and other neurodegenerative disorders, today announced new clinical and neuroimaging data from an ongoing Phase 1b/2a study evaluating its autologous dopaminergic neuron replacement therapy for Parkinson’s disease. The study is being conducted in collaboration with expertise across Mass General Brigham led by the …

Novartis Agrees to Acquire a Pan-Mutant-Selective PI3Kα Inhibitor, Strengthening Its Breast Cancer Pipeline

Novartis in the NEWS Basel, March 20, 2026 – Novartis (NVS) today announced that it has entered into an agreement with Synnovation Therapeutics, LLC to acquire SNV4818, a pan-mutant‑selective PI3Kα inhibitor, exploring a next-generation approach for the treatment of patients with HR+/HER2- breast cancer and potentially other solid tumor indications. SNV4818 SNV4818 is an oral drug currently . . . This content is for paid …

FDA Approval of Johnson & Johnson ICOTYDE™ Ushers in New Era for First-Line Systemic Treatment of Plaque Psoriasis with a Targeted Oral Peptide

Johnson & Johnson in the NEWS March 18, 2026, Johnson & Johnson (JNJ) announced today that the FDA has approved ICOTYDE™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates . . . This content is for paid subscribers. Please click here …

Pfizer Announces Positive Topline Phase 2 Results for Next-Generation CDK4 Inhibitor, Atirmociclib, in Second-Line Metastatic Breast Cancer

Pfizer in the NEWS  NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE) yesterday announced positive topline results from the randomized Phase 2 FOURLIGHT-1 study evaluating atirmociclib in combination with fulvestrant, versus fulvestrant or everolimus plus exemestane, in people with hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer . . . This content is for paid subscribers. Please click here to subscribe …

Structure Therapeutics Reports Positive Topline Data from Phase 2 ACCESS II Trial with Once-Daily Oral Small Molecule GLP-1 Receptor Agonist, Aleniglipron

Structure Therapeutics in the NEWS SAN FRANCISCO, March 16, 2026 (GLOBE NEWSWIRE) - Structure Therapeutics Inc. (GPCR), today announced positive topline data from the ACCESS clinical program of aleniglipron for the treatment of people living with obesity and/or overweight with at least one weight related co-morbidity. In the Phase 2 ACCESS II study, aleniglipron achieved clinically meaningful . . . This content is for paid …
Vertex Pharmaceuticals Announces Positive Week 36 Interim Analysis Results for Primary and All Secondary Endpoints in the RAINIER Phase 3 Trial of Povetacicept in Adults with IgA Nephropathy

Vertex Pharmaceuticals Announces Positive Week 36 Interim Analysis Results for Primary and All Secondary Endpoints in the RAINIER Phase 3 Trial of Povetacicept in Adults with IgA Nephropathy

Vertex Pharmaceuticals in the NEWS March 9, 2026, Vertex Pharmaceuticals (VRTX) today announced positive data from a pre-specified Week 36 interim analysis of the ongoing Phase 3 RAINIER trial of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, in immunoglobulin A nephropathy (IgAN). The trial . . . This content is …

Intellia Therapeutics Announces FDA Lift of Clinical Hold on MAGNITUDE Phase 3 Clinical Trial in ATTR-CM

Intellia Therapeutics March 02, 2026 -- Intellia Therapeutics, Inc. (NTLA), announced that the U.S. FDA has removed the clinical hold on the Investigational New Drug application (IND) for the MAGNITUDE Phase 3 clinical trial of nexiguran ziclumeran (nex-z) for patients with transthyretin amyloidosis with cardiomyopathy. From Intellia Therapeutics Intellia President and Chief Executive Officer John Leonard, M . . . This content is for paid …

Intellia Therapeutics Announces Q4 and Full-Year 2025 Financial Results and Business Updates

Intellia Therapeutics in the NEWS February 26, 2026, Intellia Therapeutics, Inc. (NTLA), reported business updates and financial results for the fourth quarter and year ended December 31, 2025. From Intellia Therapeutics Intellia President and Chief Executive Officer John Leonard, M.D, said, “2025 was a time of accomplishment and resiliency for Intellia . . . This content is for paid subscribers. Please click here to subscribe or here to log …

Novo Nordisk Announces Significant Reduction in US List Price for Wegovy®, Ozempic® and Rybelsus®, Building on Continued Efforts to Expand Access

Novo Nordisk in the NEWS February 24, 2026 – Novo Nordisk (NVO) announced that, effective January 1, 2027, the company will lower the list price, or wholesale acquisition cost (WAC), of Wegovy® (semaglutide) injection 2.4 mg and tablets 25 mg, Ozempic® (semaglutide) injection 0.5 mg, 1 mg, and . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Merck Evolves Human Health Operating Structure to Support Portfolio Execution

Merck - Human Health Business RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (MRK) - known as MSD outside of the United States and Canada, today highlighted steps to evolve the structure of its Human Health organization to ensure strong commercial execution of launches across diverse therapeutic areas, positioning the company for continued commercial success. As part of this evolution, Merck is organizing its . . . This content …

Intellia Therapeutics and Immunovant Inc Positive Press Releases

Intellia Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) CAMBRIDGE, Mass., February 06, 2026 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NTLA) - a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, announced that on February 1, 2026, it awarded inducement grants to six new employees under Intellia’s 2024 Inducement Plan as a material inducement . . . This content is for …

Intellia Therapeutics Announces FDA Lift of Clinical Hold on MAGNITUDE-2 Phase 3 Clinical Trial in ATTRv-PN

Intellia Therapeutics News January 27, 2026, Intellia Therapeutics, Inc. (NTLA), today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug application (IND) for the MAGNITUDE-2 Phase 3 clinical trial of nexiguran ziclumeran (nex-z) for patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv . . . This content is for paid subscribers. Please click here to subscribe …

BioCryst Pharmaceuticals Completes Acquisition of Astria Therapeutics, Expanding Leadership in Hereditary Angioedema

BioCryst Pharmaceuticals Acquires Astria Pharmaceuticals Today, January 23, 2026, BioCryst Pharmaceuticals, Inc. (BCRX) announced it completed acquisition of Astria Therapeutics, Inc., initially announced on October 14, 2025. The transaction strengthens its position as a leader in hereditary angioedema (HAE) and enhances the company’s long-term growth trajectory. BioCryst adds navenibart BioCryst, a late-stage, long . . . This content is for paid subscribers. Please click here to …

Two Companies: 1. FDA Extended Review for Eli Lilly’s Oral Obesity Drug, Orforglipron. 2. Wall Street is Bullish on Spyre Therapeutics

Eli Lilly   The FDA extended its review for Eli Lilly (LLY) oral obesity drug, orforglipron, pushing the target decision date to April 10, 2026, from earlier expectations of late March, despite it receiving a Commissioner's National Priority Voucher for faster . . . This content is for paid subscribers. Please click here to subscribe or here to log in.