Category: Impacting News

What We Are Looking for in a Bear Market

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: A Biopharmaceutical Firm That We Like

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. …

Evaluating Regenxbio Clinical Performance of RGX-314 Using the Navxpress™ Manufacturing Platform Process

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: Why Does Good News from This Firm Cause Its Stock to Move South Instead of North?

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 Launched FDA Approved Product  BRIUMVI™ for Patients with Relapsing Forms of MS

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 …

Why Investors Have Enthusiasm for CureVac N.V.

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 …

A Note To Our Followers

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 Announces 3Q 2022 Financial Results and an Update on Clinical Development Programs

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: New Effort to Treat Alzheimer’s Disease Granted FDA Fast Track Designation

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.

Travere Therapeutics: Treating IgA Nephropathy and Focal Segmental Glomerulosclerosis

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 Announces FDA Approval of RELYVRIO™ for of ALS Leading to a Weird Stock Market Reception

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 …

Fate Therapeutics: Improving on Cellular Therapies

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.

Important Data Will Be Presented by Regenxbio on August 30th

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. …

The FDA Advisory Committee Will Soon Review the NDA of Amylyx Pharmaceuticals’ Product AMX0035 for ALS  

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: A Promising Acquisition. See Also: Genmab and BioNTech: A Promising Expansion

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 to File a BLA Using the Accelerated Approval Pathway for RGX-121 for the Hunter Syndrome

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 …

Bristol-Myers Squibb Combination Improving the Treatment of Metastatic Melanoma; AbbVie Improving the Treatment of Crohn’s Disease

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 …