The Great News from Amylyx Pharmaceuticals On Jun. 13, 2022, Amylyx Pharmaceuticals (AMLX) announced that Health Canada has approved ALBRIOZA (sodium phenylbutyrate and ursodoxicoltaurine), with conditions, for amyotrophic lateral sclerosis (ALS). The important thing to learn from Amylyx Pharmaceuticals' press release is that the clinical data demonstrated a . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Inflation and the Stock Market Inflation, which we were told was but a temporary passing phenomenon, has reached its maximum peak in four decades. We must not get anxious about this inflation, a well-known enemy to the economy and a catastrophe for the citizens, that has yet to be accused, by the professionals and the media, of harming the economy. We knew. Now, the stock …

Bristol-Myers Squibb Product Deucravacitinib Bristol-Myers Squibb (BMY) product deucravacitinib has demonstrated positive results from the Phase 2 PAISLEY study in comparison to placebo in patients with moderate to severe systemic lupus erythematosus (SLE). The study met the primary endpoint. Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor. The product has a unique mechanism of . . . This content is for paid …

Vertex Pharmaceuticals to Announce New Data on VX-880 Clinical Trial Vertex Pharmaceuticals (VRTX) announced three abstracts, including two oral presentations and one poster, detailing data on type 1 diabetes (T1D) and its Phase 1/2 trial of VX-880, a stem cell-derived, fully differentiated pancreatic islet cell replacement therapy. The Abstracts have been accepted for presentation during the American Diabetes Association 82nd Annual Scientific Sessions Conference held …

Regeneron Pharmaceuticals Acquisition of Checkmate Pharmaceuticals  Regeneron Pharmaceuticals (REGN) announced a successful acquisition of Checkmate Pharmaceuticals, Inc., deepening its commitment to immuno-oncology. The firm has added a new modality to the company's portfolio of potential combination-ready approaches for difficult-to-treat cancers. Checkmate's lead investigational candidate, vidutolimod, is an advanced generation CPG-4 oligodeoxynucleotide toll-like receptor 9 . . . This content is for paid subscribers. Please click here …

United Therapeutics Approval for Tyvaso DPI™ The US FDA approved United Therapeutics (UTHR) product Tyvaso DPI™ (treprostinil) inhalation powder for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (ILD) to improve exercise ability. Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the . . . This content is …

Alnylam Pharmaceuticals Alnylam Pharmaceuticals (ALNY) led the translation of RNA interference (RNAi) into a new class of innovative therapeutics, transforming the lives of people afflicted with rare and prevalent diseases with unmet needs. RNAi is a natural cellular process of gene silencing that represents  promising and rapidly advancing frontiers in biology and drug . . . This content is for paid subscribers. Please click here to …

Regeneron Pharmaceuticals and Sanofi Announce FDA Approval of Dupixent® Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the U.S. FDA has approved Dupixent (dupilumab . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Karyopharm Therapeutics  Karyopharm Therapeutics (KPTI) and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of NEXPOVIO® (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once weekly . . . This content is for paid subscribers. Please click here to subscribe or …

Vir Biotechnology  Vir Biotechnology (VIR) is a commercial-stage immunology firm focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir assembled four technology platforms that stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Vir’s current pipeline consists of product candidates targeting COVID-19, hepatitis B and hepatitis D viruses, influenza A and human immunodeficiency virus. …

Exelixis Press Release This press release covers a large part of Exelixis accomplishments, including important details about its pipeline products, especially, cabozantinib, in addition to new results from clinical trials. We advise Prohost subscribers to read this press release, so they can get a better understanding about this firm and why we believe it a great achiever.  Exelixis On May 10,  Exelixis (

Eisai and Biogen Inc: Lecanemab Eisai and Biogen Inc. (BIIB) announced that Eisai has completed the rolling submission to the U.S. FDA of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab (BAN2401). The  product is for mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence …

Exelixis CABOMETYX Approval Exelixis (EXEL) partner Ipsen received approval from the European Commission (EC) for CABOMETYX® (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), which is refractory or not eligible to radioactive iodine (RAI . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

A lot is happening while the Stock Market is tanking and is finally being considered a Bear Market. Trading in this Market as it is now is more like gambling rather than trading. We are working hard towards evaluating our picked stocks and finding the possible time they might reach our new targets.   In the meantime, Vertex's stock, which we believe is one of …

Amgen Repatha Studies Repatha is the Longest Studied PCSK9i Amgen (AMGN) announced top-line results from two Repatha® (evolocumab) open label extension (OLE) studies to the Phase 3 FOURIER cardiovascular outcomes trial. The studies were designed to assess the long-term safety and tolerability of Repatha over five years in adults with clinically evident atherosclerotic cardiovascular disease. The FOURIER-OLE (Further . . . This content is for paid …

Gilead Sciences Receives sNDA from the FDA for Remdesivir for Pediatric Patients with COVID-19 Gilead Sciences (GILD) announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury®, aka remdesivir, for the treatment of pediatric patients who are older than 28 days, weighing at least 3 kg, and . . . This content is for paid subscribers. …

Arcturus Therapeutics Holdings News Arcturus Therapeutics Holdings (ARCT) shared topline data from an ongoing Phase 1/2/3 trial evaluating ARCT-154, Arcturus’ self-amplifying mRNA vaccine candidate against COVID-19. The ongoing Phase 1/2/3 registrational study, sponsored by Arcturus’ collaborator Vinbiocare Biotechnology Joint Stock Company – a member of Vingroup Joint Stock Company, enrolled over . . . This content is for paid subscribers. Please click here to subscribe or here to log …

FDA Lifts Partial Clinical Hold on Gilead Sciences Studies of Magrolimab On April 12, 2022, Gilead Sciences (GILD) announced that the U.S. FDA lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine. The FDA removed the partial hold after reviewing the comprehensive safety data from each trial. Enrollment in the U.S. can resume . . . This …

The Clinical Stage Biotech Firms   We have reasons to believe that some clinical-stage biotechnology firms, which have yet to generate revenues, have solid scientific fundamentals, breakthrough technologies and extremely promising  products that will generate billions of dollars in future years. These solid firms’ shareholders are currently experiencing selloffs of their stocks. Short-sellers, and the followers who are encouraging the ridding of these stocks, explain …

Jazz Pharmaceuticals and Werewolf Therapeutics Agreement Jazz Pharmaceuticals (JAZZ) and Werewolf Therapeutics (HOWL)