Month: March 2024

Verrica Pharmaceuticals Announced the FDA Granted YCANTHTM New Chemical Entity Status and Orange Book Listing

We are currently working to bring into the upcoming ProhostBiotech Letter some small clinical and commercial innovating firms that are challenging the Top-Tier firms that are currently generating billions of dollars in selling revenues.  These firms are developers of products for treating  type 2 diabetes, obesity and NASH diseases, in addition to clinical stage firms that are challenging the current developers of gene editing diseases …

Italfarmaco Received FDA Approval for Duvyzat™ for the Treatment of Duchenne Muscular Dystrophy

Italfarmaco in the NEWS  From Milan, Italy: Today, Italfarmaco announced that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat) – a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD) – a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from early childhood. From Italfarmaco Paolo Bettica, MD, PhD, Chief Medical Officer …

Illumina Stock Price Will Rebound With or Without This News

Illumina in the NEWS On March 21, 2024, we learned that the EU antitrust regulators suffered a blow as an adviser to Europe's top court said that they exceeded their powers when they blocked U.S. Illumina's (ILMN) $7.1 billion bid for merging with Grail.   In 2021,  the European Commission asserted a rarely used Article 22 to assess Illumina . . . This content is for …

Selecting New Small Biotech Firms for Investment

During a discussion with colleagues about the best way to select small and new biotechnology firms for investment purposes, we started our answer by stating that selecting small and new biotechnology firms for investments is extremely challenging. As a matter of fact, the choice of firms for investment cannot be guaranteed approval of the firms’ products based on early and mid clinical trials' promising results, …

Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra for the Patients with NASH That Have Moderate to Advanced Liver Fibrosis

Madrigal Pharmaceuticals in the NEWS Yesterday, March 14, 2024 Madrigal Pharmaceuticals (MDGL) announced that the U.S. FDA has granted accelerated approval for the firm’s product Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). The Approval for this . . . This content is for …

Today’s Bad, Bear Market and Cullinan Oncology Providing 2023 Accomplishments and Financial Results

The Market Today the Stock Market is bearish and most of the biotech stocks are down until the mid-day hour (around 2:30 PM).  Most of the time, the cause of a bearish market has nothing to do with the biotech the firms' accomplishments or incomes. As we keep reminding, we are living under devastating circumstances created mostly by us not by the biotechnology sciences, which …

Arcturus Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results, Provides Corporate Update and Hosts a Conference Call

Arcturus Therapeutics Fourth Quarter and Full Year 2023 Earnings Conference Call Before listening to the Conference call, which is at 4.30 PM, we remind about Arcturus Therapeutics Holding's history, which we believe proves the firm creates novel, safe and far reaching treatments and vaccines.    Conference Call: Today, Thursday, March 7, 2024 @ 4:30 p.m. ET Domestic: 1-877-407-0784  International:1-201-689-8560 Conference ID: 13744044  Webcast Link Arcturus …

Compugen Reports Fourth Quarter and Full Year 2023 Results

Compugen in the NEWS Compugen (CGEN) offered its fourth Quarter and full year 2023 results yesterday, which we yearned to learn about for many reasons. These reasons include learning about the outcome of the Company’s  discovered targets and its created products that would treat the targeted cancers. For those who have no clue about Compugen, the following is the information needed . . . This …

BioCardia Inc Reports Positive Interim Results from Phase III CardiAMP Cell Therapy Heart Failure Trial

BioCardia Inc in the NEWS BioCardia, Inc. (BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, today announced positive interim results from the Phase III randomized controlled trial of its CardiAMP® autologous cell therapy in 110 randomized patients with advanced chronic heart failure at a mean 20-month follow-up, (CardiAMP HF). According to . . . This content is for paid subscribers. …

Akero Therapeutics Reports Statistically Significant Histological Improvements at Week 96 in Phase 2b HARMONY Study

Akero Therapeutics Akero Therapeutics (AKRO) released preliminary topline week 96 results from HARMONY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), fibrosis . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Prohost Letter #459 ~ NAFLD & NASH

Prohost Letter #459 ~ NAFLD & NASH NAFLD is Non-Alcoholic Fatty Liver Disease, and NASH is Non-Alcoholic Steatohepatitis. We will start with NAFLD.   NAFLD The Non-Alcoholic Fatty Liver Disease is caused by excessive fat building up inside the liver cells. It is obvious that what is called Non-Alcoholic fatty liver disease is not caused by alcohol. The liver disease caused by Alcohol is called …