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 …

Prohost Letter #461 Preventing HIV Infection and Treating Primary Biliary Cholangitis Gilead Sciences Gilead Sciences’ (GILD) stock price has been paralyzed for more than three consecutive years.  The long paralysis of Gilead reminds us of Amgen Therapeutics whose stock price was paralyzed at $50 for more than 3 years. The stock rebounded and continued to outperform after we selected it in 2011 Recently, Gilead announced …

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.