Author: Prohost

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.

Apellis Announces Negative CHMP Opinion on Pegcetacoplan for GA in the EU and Its Plans to Seek Re-Examination of Application

Apellis Pharmaceuticals Negative CHMP Opinion Apellis Pharmaceuticals (APLS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a negative opinion on the marketing authorization application (MAA) of intravitreal pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). This opinion was expected based . . . This content is for paid subscribers. …

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 …

Eli Lilly Gene Therapy Restores Patient Hearing

Akous Inc to Present at the Association for Research in Otolaryngology Akouos, Inc. - a wholly owned subsidiary of Eli Lilly and Company (LLY) announced positive initial clinical results from the Phase 1/2 AK-OTOF-101 study, which restored the hearing within 30 days of AK-OTOF administration in the first participant, with more than a decade history of deep . . . This content is for paid …

Sanofi to Acquire Inhibrx, Inc.

Sanofi to Acquire Inhibrx Inc Paris, January 23, 2024, Sanofi (SNY) and Inhibrx, Inc. (INBX) entered into a definitive agreement under which Sanofi agreed to acquire Inhibrx following the spin-off of non-INBRX-101 assets into New Inhibrx. INBRX-101 is a human recombinant protein that holds the promise of allowing Alpha-1 Antitrypsin Deficiency (AATD) patients to achieve normalization of serum AAT levels with less frequent (monthly vs. …

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 …

OKYO Pharma Limited: Another Ophthalmology Firm with Promising Eye Treatment

Improving eyesight is speeding towards treating devastating eye diseases from the Retina in the back of the eye to the cornea on the front surface of the eye. As we wrote in Prohost Letter #457, the current biotechnology revolution capabilities have never existed before in the history of the diagnosis and treatment of diseases. In the near past, drugs were designed to target the symptoms …

Vertex Pharmaceuticals Provides Pipeline and Business Updates in Advance of Upcoming Investor Meetings

Vertex Pharmaceuticals Updates Vertex Pharmaceuticals (VRTX) announced multiple program updates ahead of the upcoming investor meetings in January, including the 42 Annual J.P. Morgan Healthcare Conference, which took place on January 8, 2024. From Vertex Pharmaceuticals Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex said,  “2023 was marked by continued strong performance in the cystic fibrosis business and acceleration of our . . …

Cognition Therapeutics CEO Issues Letter to Shareholders

Cognition Therapeutics CEO Letter to Shareholders Cognition Therapeutics (CGTX) today announced that CEO Lisa Ricciardi has issued a Letter to Shareholders to provide an update on recent pipeline developments and a preview of the company’s strategy in 2024. The full text of the letter: A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER To my fellow shareholders, The year ahead holds great promise for Cognition Therapeutics. We …

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 …

Yes, Compugen’s Stock is Soaring, But Why?

Compugen's Soaring Stock Many recent events  led to Compugen's (CGEN) soaring stock after a huge decline in its price. In spite of the tremendous stock decline, Prohost never doubted the fact that Compugen has solid scientific fundamentals and great scientists. The firm has done a great  job utilizing its broadly applicable predictive computational discovery capabilities to identify new drug targets and biological . . . …

Cytokinetics Announces Positive Results from a Pivotal Phase 3 Clinical Trial of Aficamten

Cytokinetics We recently became enthusiastic about Cytokinetics’ (CYTK) current clinical trial results. A few days ago, Cytokinetics announced positive results from SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Why the Great Enthusiasm? The following has been behind our enthusiasm . . . This …

Sarepta Therapeutics Submits Efficacy Supplement to Expand the ELEVIDYS Label

Sarepta Therapeutics in the NEWS On 12, 22, 2023, Sarepta Therapeutics (SRPT) - a precision genetic medicine for rare diseases, announced submission of an efficacy supplement to the Biologics License Application (BLA) for ELEVIDYS (delandistrogene moxeparvovec-rokl) to expand its labeled indication as follows: “ELEVIDYS is indicated for] the treatment of Duchenne muscular dystrophy (DMD) patients with a confirmed . . . This content is for paid …
Why Arcturus Therapeutics Holdings’ Pipeline Products are Promising

Why Arcturus Therapeutics Holdings’ Pipeline Products are Promising

The information is the first of a few biotech Companies that we believe are promising in treating severe devastating  untreatable sicknesses.  Arcturus Therapeutics Holdings Based in San Diego, California, Arcturus Therapeutics Holdings (ARCT) was founded in 2013. The Company is a late-stage clinical developing novel mRNA medicines and vaccines which already  demonstrated promising results in early trials. The Company is creating . . . This content …

Anavex Life Sciences Product Blarcamesine for Alzheimer’s Disease Receives Promising News from the EMA

Anavex Life Sciences Promising News From Anavex Life Sciences  (AVXL) we learned that The Committee for Medicinal Products for Human Use (CHMP) within the European Medicines agency (EMA) agreed that oral blarcamesine for Alzheimer’s disease is eligible for submission of application for a Union Marketing Authorization in the EU under the European Medicines Agency’s centralized procedure . . . 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.