Category: Today’s Highlights

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 …

CymaBay Therapeutics: New Published Data Demonstrates Correlation Between Itch Cytokine Interleukin-31 Reduction and Pruritis Improvement

CymaBay Therapeutics in the NEWS CymaBay Therapeutics (CBAY) today announced the first published findings demonstrating the impact of seladelpar on serum interleukin-31 (IL-31) levels and its correlation with pruritus improvement in people with primary biliary cholangitis (PBC). Seladelpar is a first-in-class oral, selective PPARδ agonist being investigated for the treatment of patients with primary . . . This content is for paid subscribers. Please click here …

Vertex Stock Soars Pre-Market Announcing Positive Results from Phase 2 Study of VX-548 for the Treatment of Painful Diabetic Peripheral Neuropathy

Vertex Pharmaceuticals in the NEWS Today, December 13, 2023, Vertex  Pharmaceuticals (VRTX) announced positive results from its Phase 2 dose-ranging study of the selective NaV1.8 inhibitor VX-548 in people with painful diabetic peripheral neuropathy (DPN). Treatment with all . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Roche Announces Positive Phase III Results for Inavolisib Combination in Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation

Roche in the NEWS From Basel, today, December 5, 2023 - Roche (RHHBY) announced positive results from the Phase III INAVO120 study of the investigational therapy, inavolisib, in combination with palbociclib (Ibrance®) and fulvestrant as a potential first-line treatment option for people with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast . . . This content is for paid subscribers. Please click here to …

AbbVie Inc to Acquire ImmunoGen

AbbVie Inc Acquisition of Immunogen in the News AbbVie Inc. (ABBV) and ImmunoGen (IMGN) today announced a definitive agreement under which AbbVie will acquire . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Immunovant Inc: Positive IMVT-1402 Results that Would Confirm Best-in-Class Potential in Treating Autoimmune Diseases

Immunovant Inc in the NEWS Immunovant, Inc. (IMVT) announced initial data from 600 mg MAD cohort of a Phase 1 clinical trial of its product IMVT-1402 in healthy adults. The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMVT . . . This content is for paid subscribers. Please click here to subscribe …

Anavex Announced US Patent Office Granted a Patent No. 11,813.242 Entitled A273 a Therapeutic for Insomnia, Anxiety and Agitation

Anavex Life Sciences Granted US Patent Anavex Life Sciences (AVXL) – a development-stage biopharmaceutical company announced that the United States Patent and Trademark Office (USPTO) granted U.S. Patent No. 11,813,242 entitled “A273 as a therapeutic for insomnia, anxiety, and agitation.  This patent expands Anavex’s existing patent coverage of ANAVEX®273 (blarcamesine), including U.S. Patent No. 11 . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Vertex Pharmaceuticals and CRISPR Therapeutics Announce Authorization of the First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY

Vertex Pharmaceuticals and CRISPR Therapeutics Announce Authorization of CASGEVY Conditional Approval for Both Sickle Cell Disease and Transfusion Dependent Beta Thalassemia Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics (CRSP) today announced that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) granted them conditional marketing authorization for CASGEVYTM (exagamglogene autotemcel ), a CRISPR/Cas9 gene . . . This content is for paid subscribers. Please …