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.

Rhythm Pharmaceuticals is Rebounding Rhythm Pharmaceuticals (RYTM) announced yesterday, July 20, 2022, that the French National Agency for Medicines and Health Products Safety (ANSM) and Haute Autorité de santé (HAS) have granted pre-marketing authorization AP1 (autorisation d’accès précoce - early access authorization), for IMCIVREE® (setmelanotide), an MC4R agonist, for patients with genetically-confirmed Bardet-Biedl syndrome . . . This content is for paid subscribers. Please click here …

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 …

Avista Therapeutics Avista Therapeutics’ mission is to develop innovative gene therapies for retinal diseases, including rare ophthalmic conditions that have a profound impact on patients’ quality of life. Avista leverages its computationally guided single-cell adeno-associated virus engineering (scAAVengr) platform to generate and validate a toolkit of proprietary AAV vectors that target specific cell types using minimally invasive intravitreal delivery with reduced dosages. Avista’s quantitative, in …

The clinical-stage Clene Nanomedicine Firm Reported Significantly Decreased Mortality in Amyotrophic Lateral Sclerosis (ALS) CNM-Au8® treatment resulted in a significant survival benefit (5 CNM-Au8 deaths vs 14 placebo deaths CNM-Au8 treatment was well-tolerated, with no significant safety findings  during this trial Clene Inc in the NEWS Clene Inc (CLNN), along with its subsidiaries, “Clene”, and its wholly owned . . . This content is for paid …

CytomX Therapeutics Update CytomX Therapeutics (CTMX) announced plans to focus on its emerging preclinical and early clinical pipeline and realign its capital resources to drive these efforts. Sean McCarthy, D.Phil. Chief Executive Officer and Chairman, CytomX Therapeutics, said, “With the Probody® therapeutic platform, CytomX has pioneered a new and strategic field of biologics drug discovery and development. Our leadership position will continue as we incorporate …

Vertex Pharmaceuticals and ViaCyte Inc are in the NEWS Vertex Pharmaceuticals (VRTX) entered into a definitive agreement under which it will acquire ViaCyte, a private biotechnology company focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), for $320 million in cash. From Vertex Pharmaceuticals and ViaCyte Inc Reshma Kewalramani, M . . . This content is for paid subscribers. …

Is Merck to Acquire Seagen? The Wall Street Journal reported that Merck is in advanced talks to buy Seagen in a deal that could be worth $40 billion or more. The report, cited by people familiar with the matter, said that the companies are discussing a price above $200 a share for SGEN. It is said that the acquisition will help Merck boost its products …

Insilico Medicine Insilico Medicine is a clinical stage end-to-end artificial intelligence (AI)-driven drug discovery company, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques to discover novel targets and to design novel molecular structures with desired properties. Insilico Medicine is delivering breakthrough …

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. …

CureVac N.V. Files Lawsuit Against BioNTech for Infringement  CureVac N.V. (CVAC), a company that develops therapeutics based on messenger ribonucleic acid (mRNA), has moved to assert its intellectual property rights that have been accumulated over more than two decades of pioneering work in mRNA technology. Technology that contributed to COVID-19 vaccine development. The Company acknowledged filing a lawsuit . . . This content is for …

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 …

Kite Pharma - A Gilead Company In The NEWS Gilead Sciences' (GILD) firm Kite Pharma, announced that the European Commission (EC) has approved its CAR T-cell therapy Yescarta® (axicabtagene ciloleucel) for adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. Yescarta maintained its orphan medicinal product designation in this indication. From . . . This content is for …

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 …

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 …