AstaZeneca Fasenra Approval AstraZeneca (AZN) product Fasenra (bevacizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) - a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal. The approval in the United States FDA was based on positive results from the MANDARA Phase III trial published in . …

Novartis FDA Approval Yesterday, September 17, 2024, Novartis (NVS) announced that the United States FDA has approved Kisqali®(ribociclib) in combination with an aromatase inhibitor (AI) for adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those . . . This content is for paid subscribers. Please click here …

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 …

Gilead Sciences and Genesis Therapeutics Gilead Sciences (GILD) and Genesis Therapeutics, Inc. announced today that the companies have entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets. Genesis Therapeutics is pioneering generative and predictive artificial intelligence (AI) technologies to help create therapeutics for challenging targets. This collaboration will deploy Genesis’ field-leading AI platform . . . This content …

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 …

 Jeune Aesthetics Announces Phase 1 Positive Interim Safety and Efficacy Results for KB301 On August 28, 2024,  Jeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech (KRYS) announced positive interim safety and efficacy results from both Cohorts 3 and 4 of PEARL-1, a Phase 1 study evaluating KB301, an investigational aesthetic treatment designed to deliver the COL3A1 transgene and increase type III collagen (“COL3”) levels in the …

Merck Updates Merck (MRK) provided updates on two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630, stating that it discontinued Phase 3 KEYNOTE-867 trial evaluating KEYTRUDA in combination with stereotactic body radiotherapy (SBRT) for the treatment of patients with stage I or II non-small cell . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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 …

Gilead Sciences Approval Gilead Sciences (GILD) today announced that the U.S. FDA has granted accelerated approval for Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA taken alone, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended . . . This content is …

Galderma: FDA Approval for Nemluvio® Today, August 13, 2024, Galderma (GALD.SW) announced that the U.S. FDA has approved its product Nemluvio® (nemolizumab) as a pre-filled pen for subcutaneous injection aimed at treating adults with prurigo nodularis.  Galderma exists in approximately 90 countries. It delivers an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable …

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, …

Akero Therapeutics Q2 and Business Update Akero Therapeutics (AKRO) reported second-quarter financial results for the period ending June 30, 2024,  and provided business updates. From Akero Therapeutics Andrew Cheng, president and CEO said, “The second quarter of 2024 brought important progress for EFX with the initiation of the . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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.

The Impact of Bad Circumstances Since early year 2024, in every Prohost Letter we have posted, we added a memo stating that we have decided to be careful not to underestimate the bad circumstances under which the world is currently living and suffering. These bad circumstances began with the unexpected coronavirus, COVID-19, that killed millions of people around the world, including children, teenagers, women and …

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 …