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 …

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 …

Lexeo Therapeutics in the NEWS On July 15, 2024, Lexeo Therapeutics (LXEO) announced positive interim data of LX2006 for the treatment of Friedreich ataxia (FA) cardiomyopathy. Across both the Lexeo SUNRISE-FA Phase 1/2 clinical trial (NCT05445323) and the Weill Cornell Medicine investigator-initiated Phase 1A trial (

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 …

Illumina Inc The latest take over by Illumina, Inc. (ILMN) has been a company with advanced technology known as Fluent BioSciences, a developer of emerging and highly differentiated single-cell technology.   From Illumina Inc Informing the biotech world, Steven Barnard, chief technology officer of Illumina said, "The addition of Fluent BioSciences to Illumina will provide significant and new capabilities to . . . This content …

Advanced Micro Devices in the NEWS  Advanced Micro Devices (AMD) today announced the signing of a definitive agreement to acquire Silo AI, the largest private AI lab in Europe, in an all-cash transaction valued at approximately $665 million. The agreement represents another significant step in the company’s strategy to deliver end-to-end AI solutions based on open . . . This content is for paid subscribers. Please …

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 …

SCG Cell Therapy FDA Approval SCG Cell Therapy Pte Ltd (SCG) is a biotech company developing novel immunotherapies for infectious diseases and their associated cancers, announced that United States FDA has approved its investigational New Drug (IND) application to initiate Phase 1/2 clinical trial for SCG142 – a novel next-generation human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T) cell therapy for patients with HPV-associated solid tumors. From SCG Cell Therapy Christy Ma, Chief …

From Mitsubishi Tanabe Pharma America Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at Mitsubishi Tanabe Pharma America said, “We are excited to be at the Congress of the European Academy of Neurology (EAN) this year to showcase our  research and engage with its scientific community. The findings highlight our dedication to advancing the understanding of investigational ND0612 and our commitment to recognizing …

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 …