News from Innoviva That We Consider Positively Impacting and Extremely Important Innoviva, Inc. (INVA) (Innoviva), announced that the FDA Antmicrobial Drugs Advisory Committee (AMDAC) has unanimously voted 12-0 in favor of approval of sulbactam-durlobactam based on a favorable benefit-risk assessment for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused . . . This content is for paid subscribers. Please click here …
TG Therapeutics Positive CHMP of BRIUMVI TG Therapeutics, Inc. (TGTX), informed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of BRIUMVI™ (ublituximab-xiiy) for adults with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. BRIUMVI . . . This content is for paid subscribers. Please click here to …
Vertex Pharmaceuticals and Crispr Therapeutics Agreement Aims at Accelerating Vertex's Hypo immune Cell Therapies for Type 1 Diabetes Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics (CRSP) announced that they have entered into a new non-exclusive licensing agreement for the use of CRISPR Therapeutics’ gene editing . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Important News from Vertex Vertex Pharmaceuticals (VRTX) is a worldwide biotechnology company that invests in scientific innovation. The firm created transformative medicines for people with serious diseases. Vertex has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease. It has several ongoing clinical and research programs in CF. Beyond CF, Vertex . . . This content is …
CymaBay Therapeutics CymaBay Therapeutics (CBAY) is a clinical-stage biopharmaceutical firm focused on improving the lives of people with liver and other chronic diseases that have a high unmet medical need through a pipeline of innovative therapies. The firm is proud of its deep understanding of the underlying mechanisms of liver inflammation . . . This content is for paid subscribers. Please click here to subscribe or …
The Stock Market The volatility continues in the Bear market with investors not knowing what to do with such instability. Professional traders and robots are all puzzled. Friday, March 10, 2023 the market started the trading day by dropping 150 points and it continued to drop. Nobody knew what would happen by the end of the day, which, in this case, was the end of …
Apellis Pharmaceuticals Apellis Pharmaceuticals, Inc. (APLS) is a biopharma firm developing novel products for debilitating and life-threatening diseases. Currently, Apellis has two approved medicines targeting C3. These drugs include the first and only approved therapy for geographic atrophy, a leading cause of blindness. The firm’s pipeline has dozen clinical and pre-clinical programs convincing the firm's management . . . This content is for paid subscribers. …
Prohost's Beliefs About the Status of the Market That the market is still volatile and Bear. Investors in the biotech sector who intend to bet on clinical stage firms must restrict their choices to companies that already have proof of concept regarding safety and efficacy in some midterm and pre-term clinical trial results. Caution is still important for clinical-stage firms’ stocks that have encouraging clinical …
CytomX Therapeutics We posted several articles that brought good news from CytomX Therapeutics (CTMX), yet the stock continues to go down instead of up. A few days ago, CytomX announced the achievement of a clinical candidate milestone under its agreement with Astellas. The clinical . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
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 …
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
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