Author: Prohost

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.

Verrica Pharmaceuticals Reports Fourth Quarter and Full-Year 2023 Financial Results

Verrica Pharmaceuticals   Verrica Pharmaceuticals (VRCA) is a dermatology therapeutics company developing medications for skin diseases.  Today Verrica announced financial results for the fourth quarter and year ended December 31, 2023. Ted White, Verrica Pharmaceuticals' President and Chief Executive Officer said, “We continued to make considerable progress with the launch of YCANTHTM during our first full quarter of commercial operations. With a growing confidence . …

Krystal Biotech Announced Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

Krystal Biotech Today, February 26, 2024, Krystal Biotech (KRYS) firm announces its full year financial results and business updates.  Read this press release to learn about the company. New England Journal of Medicine publication of the use of B-VEC eyedrop formulation. Reached alignment with FDA to enable approval of B-VEC eyedrop formulation . . . This content is for paid subscribers. Please click here to subscribe …

Vertex Receives CHMP Positive Opinion for KALYDECO® for the Treatment of Infants with Cystic Fibrosis Ages 1 Month and Older

Vertex Pharmaceuticals in the NEWS Vertex Pharmaceuticals (VRTX) announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label expansion of KALYDECO ® (ivacaftor) for the treatment of infants with cystic fibrosis (CF) ages 1 month to less than 4 months old who have one of the . . . This content is for …

CRISPR Therapeutics Financial Results for Fourth Quarter and Full Year Ended December 31, 2023 Plus All You Need To Know About this Firm’s Capabilities   

CRISPR Therapeutics Since its inception over a decade ago, CRISPR Therapeutics (CRSP) has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents . . …

Ionis Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Ionis Pharmaceuticals  For three decades, Ionis Pharmaceuticals (IONS) invented medicines to treat serious diseases. Currently, Ionis has five marketed products and a wealthy pipeline in neurology, cardiology, and other areas of high patient need. Ionis is a pioneer in RNA-targeted therapeutics. It continues to drive innovation . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Travere Therapeutics Fourth Quarter and Full Year 2023 Financial Results

Travere Therapeutics in the NEWS Yesterday, Feb. 15, 2024,  Travere Therapeutics, Inc. (TVTX) reported its fourth quarter and full year 2023 financial results and provided a corporate update. Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics said, “With ongoing growth in demand for FILSPARI in IgAN and the initiation of the pivotal Phase 3 program of pegtibatinase in classical . . . …

Could Precision Biosciences Gene Editing Firm Become the Only Company to Cure the Life-Threatening HBV Resistant Infection 

Precision BioSciences Receives Pre-IND Feedback from US FDA for PBGENE-HBV as it Advances Towards Clinical Readiness Precision BioSciences (DTIL) is an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion, excision, and elimination . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

CRISPR Therapeutics to Present at the Citi 2024 Virtual Oncology Leadership Summit. See Also: CRISPR Therapeutics Advanced Steps

CRISPR Therapeutics Announcement Today, Feb. 15, 2024, CRISPR Therapeutics announced that members of its senior management team will present at the Citi 2024 Virtual Oncology Leadership Summit on Wednesday, Feb 21, 2024, at 1:00 p.m. ET. A live webcast of the fireside chat will be available on Events & Presentations page in the Investors section of the Company's website. A replay of the webcast will …

Two Pieces of News from CRISPR Therapeutics Today

Crispr Therapeutics First NEWS As we learned from Vertex Pharmaceuticals (VRTX) in an earlier, posted press release about the European approval, Crispr Therapeutics (CRSP) has also announced the same breakthrough . . . This content is for paid subscribers. Please click here to subscribe or here to log in.