Category: Today’s Highlights

Madrigal Pharmaceuticals Announces U.S. Availability of its Newly Approved Product Rezdiffra

Madrigal Pharmaceuticals in the NEWS Today, April 09, 2024, Madrigal Pharmaceuticals (MDGL) announced that its NASH MASH product Rezdiffra (resmetirom) is now available in the United States. Rezdiffra is indicated 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). Continued approval for this indication may . . …

BioStem Technologies is Releasing its Fourth Quarter 2023 Financial Results Now

BioStem Technologies to Release Fourth Quarter Results BioStem Technologies (BSEM) is hosting a conference call and webcast today, April 1, 2024 at 4:30 PM ET. The call will include a discussion of fourth quarter 2023 financial results in addition to a corporate update. To access the call dial:  USA / International Toll. + 1(646) 307-1963.  USA – Toll-Free (800) 715 9871 BioStem . . . …

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 …

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 …

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 …

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.

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.

Vertex Pharmaceuticals: EC Approves First CRISPR/Cas9 Gene-Edited Therapy, CASGEVYTM, for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

European Commission Grants Conditional Marketing to Vertex Pharmaceuticals CASGEVY Tuesday Feb 13, 2024, Vertex Pharmaceuticals (VRTX) announced that the European Commission has granted conditional marketing authorization to CASGEVY (exagamglogene autotemcel ), a CRISPR/Cas9 gene-edited therapy. CASGEVY is being approved for patients 12 years of age and older with severe sickle cell disease (SCD) characterized by recurrent vaso . . . This content is for paid …

Madrigal Pharmaceuticals Announces Publication of the Phase 3 MAESTRO-NASH Trial of Resmetirom in the New England Journal of Medicine

Madrigal Pharmaceuticals Publication in the New England Journal of Medicine Resmetirom is the first investigational medicine for NASH to achieve fibrosis improvement and NASH resolution primary endpoints in a Phase 3 trial Detailed analyses reinforce the safety profile of resmetirom Resmetirom has the potential to become the first and only medicine approved for NASH; PDUFA date is March 14, 2024 Today, February 8, 2024, Madrigal …

Vera Therapeutics to Participate in Guggenheim Healthcare Talks 6th Annual Biotechnology Conference and More

Vera Therapeutics to Participate in Guggenheim Healthcare Talks February 2, 2024, Vera Therapeutics, Inc. (VERA) announced that the Company’s management team will participate in the 6th Annual Guggenheim Biotechnology Conference, which is taking place in New York in February 7and Feb 8. Fireside Chat Details: Date: Wednesday, February 7th at 2:00 PM ET The . . . This content is for paid subscribers. Please click here …

Vertex Pharmaceuticals Announced Positive Results from its Non-Opioid Product VX-548

Vertex Pharmaceuticals Positive Results for VX-548 Today, Vertex Pharmaceuticals (VRTX) announced positive results from its Phase 3 program for the treatment of moderate-to-severe acute pain. The Phase 3 program included two randomized, double- blind, placebo-controlled, pivotal trials, one following abdominoplasty . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Vera Therapeutics Presents Positive 72-Week Data Showing eGFR Stabilization in the Phase 2b ORIGIN Clinical Trial OLE in IgA Nephropathy

Vera Therapeutics Positive Data Announcement Vera Therapeutics (VERA) announced positive 72-week data from the open label extension (OLE) period of its Phase 2b ORIGIN clinical trial of atacicept in participants with IgA nephropathy (IgAN). In aggregate, the 72-week data with atacicept are consistent with a profile of true disease modification in IgAN. From Vera . . . This content is for paid subscribers. Please click here …

Ionis Pharmaceuticals: Positive Results from Phase 3 OASIS-HAE Study of Investigational Donidalorsen for Hereditary Angioedema

Ionis Pharmaceuticals in the NEWS Ionis Pharmaceuticals (IONS) today announced positive topline results for the Phase 3 OASIS-HAE study of donidalorsen in people with hereditary angioedema (HAE). The trial met its primary endpoint of reduction in the rate of angioedema attacks in patients treated with donidalorsen (80mg) via subcutaneous injection dosed every 4 weeks) or every 8 . . . This content is for paid …

Lexaria Bioscience Unveils Extensive Planned 2024 GLP-1 Study Program

Lexaria Bioscience Extensive Program Designed to Support Commercial Discussions. January 16, 2024, Lexaria Bioscience (LEXX) announced a comprehensive planned applied research program to thoroughly evaluate DehydraTECH for the improved delivery of GLP-1 drugs, designed to support prospective commercial partnering with the global pharmaceutical companies. Lexaria Bioscience patented drug delivery technology DehydraTECHTM . . . This content is for paid subscribers. Please click here to subscribe or …