AstraZeneca Imfinzi + Imjudo Updated results from the HIMALAYA Phase III trial have demonstrated that AstraZeneca (AZN) Imfinzi (durvalumab) plus Imjudo (tremelimumab) showed a sustained clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localized treatment. The results from HIMALAYA were presented at . . . …

Halozyme Therapeutics in the NEWS Halozyme Therapeutics, Inc. (HALO) announced that Roche received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) with Halozyme's ENHANZE® drug delivery technology. Tecentriq Hybreza™ can be injected subcutaneously in approximately 7 minutes compared to 30-60 minutes for standard intravenous (IV) infusion of . . . This content is for paid subscribers. Please click here to subscribe …

Johnson & Johnson FDA Approval Yesterday, September 11, 2024,  Johnson & Johnson (JNJ) announced that the FDA has approved TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) - a chronic disease of the large intestine in which the lining of the colon becomes inflamed.  About Ulcerative Colitis Ulcerative colitis is a form of inflammatory bowel . . . This …

Travere Therapeutics Approval Travere Therapeutics, Inc., (TVTX) announced that the U.S. FDA has granted full approval to FILSPARI® (sparsentan) to slow kidney function decline in adults with primary IgAN who are at risk of disease progression. In February 2023, based on the surrogate marker of proteinuria, FILSPARI was granted accelerated approval. Now, full approval has been granted based on positive long-term confirmatory results . . . This …

Regenxbio Positive Results Regenxbio (RGNX) announced positive results from the Phase I/II/III CAMPSIITE® trial of RGX-121 for patients with Mucopolysaccharidosis Type 2 (MPS II), also known as Hunter syndrome. The results were presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2024. The totality of evidence from the CAMPSIITE trial continues to . . . This content is for …

Vertex Announces CASGEVY™ Reimbursement Agreement with NHS England Vertex Pharmaceuticals (VRTX) announced a reimbursement agreement with NHS England for eligible transfusion-dependent beta-thalassemia (TDT) patients to access the CRISPR/Cas9 gene-edited therapy, CASGEVY™ (exagamglogene autotemcel).  The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) granted CASGEVY the first authorization in the world for a CRISPR-based . . . This content is for paid subscribers. Please click here …

Cytokinetics Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing, and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. The company is developing small-molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, …

Exelixis Q2 Results and Corporate Update Yesterday, Aug. 6, 2024, Exelixis, (EXEL) reported financial results for the second quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated commercial, clinical, and . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Adaptimmune Therapeutics Adaptimmune Therapeutics plc (ADAP) announced that the U.S. FDA has accelerated the approval of TECELRA® for the treatment of adults with unresectable or metastatic synovial sarcoma who received prior chemotherapy, and are  HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Anaves Life Sciences Trial Results of Blarcamesine Anavex Life Sciences (AVXL) presented comprehensive results from a Phase IIb/III study showing that blarcamesine (ANAVEX®2-73), once daily orally, significantly slowed clinical decline in people with early Alzheimer's disease (AD). The data presentation was made by Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman . . . This content is for paid subscribers. …

Viking Therapeutics Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials.  Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. The firm’s clinical programs include VK2735, a novel dual agonist of the glucagon-like …

Ionis Pharmaceuticals in the NEWS Yesterday,  July 22, 2024, Ionis Pharmaceuticals (IONS) announced positive results from the completed multiple ascending dose (MAD) portion of the Phase 1/2 open-label study of ION582 in people with Angelman . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Pliant Therapeutics Pliant Therapeutics is a late-stage biopharmaceutical company focusing on the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Pliant's lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that is in development in the lead indications for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or …

Kazia Therapeutics in the NEWS  Sydney, July 10, 2024, Kazia Therapeutics Limited (KZIA) - an oncology-focused drug development company, is pleased to announce results from GBM-AGILE, a phase II/III study that included an evaluation of paxalisib versus standard of care (SOC) for patients with the life-threatening brain cancer glioblastoma.  GBM AGILE STUDY GBM AGILE is an adaptive phase . . . This content is for …

Regeneron in the NEWS Regeneron Pharmaceuticals (REGN) and Sanofi (SNY . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Merck in the NEWS Merck Pharmaceuticals (MRK), known as Merck, Sharp & Dohme (MSD) outside the United States and Canada, and the Finnish pharmaceutical Company Orion Corporation announced that notice has been provided of the mutual exercise of an option to convert the companies’ ongoing co-development and co-commercialization agreement for the investigational product opevesostat into an exclusive global license . . . This content is …

Verona Pharma in the NEWS Yesterday, June 26, 2024, Verona Pharma plc (VRNA) announced that the US FDA has approved Ohtuvayre (ensifentrine) for maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years. The product . . . This content …

Nurix Therapeutics in the NEWS On June 16, 2024, Nurix Therapeutics (NRIX) announced the presentation of updated clinical data for NX-5948, an orally bioavailable degrader of Bruton’s tyrosine kinase (BTK), being evaluated in an ongoing Phase 1a/b clinical trial in adults with relapsed or refractory B-cell malignancies, including CLL and non-Hodgkin lymphoma (NHL

argenx in the NEWS argenx SE (ARGX) announced that the U.S. FDA has approved VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only neonatal Fc receptor (FcRn) blocker . . . This content is for paid subscribers. Please click here …

Broadcom Inc Announcements What analysts heard from the Artificial Intelligence (AI) firm Broadcom Inc is promising and exciting news about the past and excellent expectations regarding the future. The Story The Artificial Intelligence Broadcom Inc. (AVGO) reported financial results for its second quarter of fiscal year 2024 ended May 5, 2024. Broadcom provided guidance for its fiscal year 2024 and . . . This content …