TG Therapeutics  TG Therapeutics (TGTX) is a commercial stage, biopharmaceutical company developing and commercializing novel treatments for B-cell diseases. The firm’s research pipeline has several investigational medicines. TG Therapeutics has been granted U.S. FDA approval of its product BRIUMVI™ (ublituximab-xiiy), for adult patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome . . . This content is for paid subscribers. Please click here to …

Jazz Pharmaceuticals and Zymeworks Inc Announce Results of Zanidatamab Jazz Pharmaceuticals (JAZZ) and Zymeworks Inc. (ZYME)

Ionis Pharmaceuticals and Royalty Pharma Ionis Pharmaceuticals (IONS) and Royalty Pharma plc (RPRX) announced that Royalty Pharma has . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

CureVac N.V. in the News CureVac N.V. (CVAC) announced that after more than 10 years as a member of the CureVac management board and three years as CEO, Dr. Franz Haas will step down as CEO, effective March 31, 2023. Joining CureVac from Sanofi, on April 1, 2023, is Dr. Alexander Zehnder. CureVac is a biopharmaceutical firm developing a new class . . . This …

Dear Friends and Followers, We confirm our optimism towards the future biotech firms that we selected for investment, including the clinical stage small biotech companies, which also includes biotech stocks that you have never heard about from us.  We  inform you that we have Prohost Letters that will present the selected firms that we believe are promising. One of these Letters, we hope, will be …

Reata Pharmaceuticals Announcements The FDA decision not to hold an Advisory Committee Meeting to discuss Reata Pharmaceuticals product Omaveloxolone for the treatment of Friedreich’s ataxia hints to good news about the approval of this product approval on  February 2023.   The NDA for Omaveloxolone for Friedreich’s ataxia is under review. A PDUFA Date is decided upon on February 28, 2023. Recently, Reata Pharmaceuticals (

Acumen Pharmaceuticals Product ACU193 On October 23, 2022, Acumen Pharmaceuticals (ABOS) announced that the first clinical-stage monoclonal antibody ACU193 - an anti-amyloid beta oligomer antibody, which selectively targets toxic soluble amyloid beta oligomers (AβOs), has been granted  FDA Fast Track designation for the treatment of early Alzheimer . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

IgA Nephropathy  Searching for companies focused on treating severe diseases that have yet to find approved drugs is one of Prohost Biotech's tasks.  Recently we wrote about firms that have, in their pipelines, products that aim at treating NASH and ALS.  Now, we are currently interested in finding firms that have products that can successfully treat IgA nephropathy, among other diseases that have yet to …

Amylyx Pharmaceuticals in the NEWS Amylyx Pharmaceuticals (AMLX) announced that the U.S. FDA has approved RELYVRIO™ (sodium phenylbutyrate and taurursodiol) for the treatment of adults with amyotrophic lateral sclerosis (ALS). The product, RELYVRIO, (previously known as AMX0035 in the U.S.) has significantly slowed the loss of physical function in people living with ALS in a randomized, placebo-controlled . . . This content is for paid …

TG Therapeutics Results Published in NEJM TG Therapeutics (TGTX) results from the ULTIMATE I & II Phase 3 trials evaluating the firm’s investigational monoclonal antibody product ublituximab in patients with relapsing forms of multiple sclerosis (RMS) were

Fate Therapeutics: Developing Next Generation Cellular Therapies Fate Therapeutics (FATE) is a clinical-stage biopharmaceutical company developing first-in-class improved cellular immunotherapies for cancer. Fate Therapeutics uses its proprietary induced pluripotent stem cell (iPSC) product platform in clinical development and manufacture of universal off-the-shelf cell products. The . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Regenxbio to Present Important Data  Regenxbio (RGNX) will present important material at the Society for the Study of Inborn Errors of Metabolism Annual Symposium, taking place in Germany from August 30 through September 2, 2022. The presentations are meant to highlight new data from the Phase I/II/III CAMPSIITE™ trial of RGX-121, an investigational one-time AAV Therapeutic . . . This content is for paid subscribers. …

On September 7th the FDA Will Review Amylyx Pharmaceuticals NDA for ALS Treatment Amylyx Pharmaceuticals (AMLX) announced that the U.S. FDA Peripheral and Central Nervous System Advisory Committee (PCNSDAC) will reconvene to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol known also as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS

Gilead Sciences to Acquire MiroBio At $405 Million Gilead Sciences (GILD) and MiroBio - a privately held U.K based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, announced that they entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in . . . This content is for paid subscribers. Please click here to subscribe …

Regenxbio in the NEWS  Regenxbio (RGNX) announced, on August 3, 2022, its intention to file a Biologics License Application (BLA) in 2024 using the FDA's accelerated approval pathway for RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome.   The Company has also announced that a pivotal program for RGX-121 is . . . This content is for paid …

Offsetting the Biotech Firms' Good News There is no doubt that good news is filling the media about outperformances of both development-stage small biotech firms and revenues-generating firms. This good news has been offset by inflation, hiked interest rates, that aimed at bringing down the inflation, the continued presence of COVID-19 and an unwarranted European  war, which has only demonstrated the terrible impact on the …

Seagen, Astellas Pharma & Merck Collaboration Seagen (SGEN) and Astellas Pharma (ALPMY) have entered a clinical collaboration . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Incyte Announces FDA Approval of Opzelura Cream for Vitiligo Incyte (INCY) announced today, July 19, 2022, that the United States Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in 12 years old patients and older. Opzelura is the first and only FDA-approved treatment for . . . This content is for paid subscribers. Please click here …

Vertex Pharmaceuticals VX-880 for Type 1 Diabetes Vertex Pharmaceuticals (VRTX) announced that the FDA has lifted the clinical hold placed on the Phase 1/2 clinical trial of VX-880. VX-880 is an investigational allogeneic stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemia . . . This content is for paid subscribers. …

Celldex Therapeutics Interim Trial Data for Barzolvolimab Interim data from Celldex Therapeutics (CLDX) Phase 1b clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines demonstrate meaningful symptom improvements. The results showed that multiple doses of barzolvolimab resulted in dose-dependent decreases in itch and hives, as measured through the urticaria activity score over . . . This content …