On September 7th the FDA Will Review Amylyx Pharmaceuticals NDA for ALS Treatment Amylyx Pharmaceuticals (AMLX) announced that the U.S. FDA Peripheral and Central Nervous System Advisory Committee (PCNSDAC) will reconvene to review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol known also as ursodoxicoltaurine]) for the treatment of amyotrophic lateral sclerosis (ALS

Gilead Sciences to Acquire MiroBio At $405 Million Gilead Sciences (GILD) and MiroBio - a privately held U.K based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, announced that they entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in . . . This content is for paid subscribers. Please click here to subscribe …

Regenxbio in the NEWS  Regenxbio (RGNX) announced, on August 3, 2022, its intention to file a Biologics License Application (BLA) in 2024 using the FDA's accelerated approval pathway for RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome.   The Company has also announced that a pivotal program for RGX-121 is . . . This content is for paid …

Offsetting the Biotech Firms' Good News There is no doubt that good news is filling the media about outperformances of both development-stage small biotech firms and revenues-generating firms. This good news has been offset by inflation, hiked interest rates, that aimed at bringing down the inflation, the continued presence of COVID-19 and an unwarranted European  war, which has only demonstrated the terrible impact on the …

Seagen, Astellas Pharma & Merck Collaboration Seagen (SGEN) and Astellas Pharma (ALPMY) have entered a clinical collaboration . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Incyte Announces FDA Approval of Opzelura Cream for Vitiligo Incyte (INCY) announced today, July 19, 2022, that the United States Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in 12 years old patients and older. Opzelura is the first and only FDA-approved treatment for . . . This content is for paid subscribers. Please click here …

Vertex Pharmaceuticals VX-880 for Type 1 Diabetes Vertex Pharmaceuticals (VRTX) announced that the FDA has lifted the clinical hold placed on the Phase 1/2 clinical trial of VX-880. VX-880 is an investigational allogeneic stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemia . . . This content is for paid subscribers. …

Celldex Therapeutics Interim Trial Data for Barzolvolimab Interim data from Celldex Therapeutics (CLDX) Phase 1b clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines demonstrate meaningful symptom improvements. The results showed that multiple doses of barzolvolimab resulted in dose-dependent decreases in itch and hives, as measured through the urticaria activity score over . . . This content …

Akero Therapeutics Financing Transactions Akero Therapeutics (AKRO) is one of the selected firms for the Prohost Portfolio. The firm is clinical-stage and develops treatments for metabolic diseases marked by high . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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 …

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.

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 (

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.

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 …

Vertex Pharmaceuticals Statistically Significant Results From Vertex VX-548 for Acute Pain Vertex Pharmaceuticals (VRTX) announced positive results from two Phase 2 proof-of-concept (POC) studies that investigated treatment with the selective NaV1.8 inhibitor VX-548 for acute pain following abdominoplasty surgery or bunionectomy surgery. Treatment with an initial dose of 100 mg followed by 50 mg . . . This content is for paid subscribers. Please click here …