InflaRX  In March 2024, InflaRx Biopharmaceutical (IFRX) announced that it will pursue two initial immuno-dermatology indications with INF904 in a single Phase 2a basket trial expected to begin by the end of 2024, with initial data anticipated in the summer of 2025.  The trial will be a multi-center, open-label study on 75 patients. We will be evaluating multiple INF904 dosing regimens over . . . …

Vera Therapeutics and Viking Therapeutics Today, October 29, the market stocks’ prices moved south, including good companies, which dropped by the stock market investors. These companies are: Vera Therapeutics (VERA) In addition to today's early bad market, VERA price decline is happening because the firm has announced a Proposed Public Offering of Class A Common Stock following the outstanding . . . This content is …

Merck Updates Merck (MRK) provided updates on two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630, stating that it discontinued Phase 3 KEYNOTE-867 trial evaluating KEYTRUDA in combination with stereotactic body radiotherapy (SBRT) for the treatment of patients with stage I or II non-small cell . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

The Impact of Bad Circumstances Since early year 2024, in every Prohost Letter we have posted, we added a memo stating that we have decided to be careful not to underestimate the bad circumstances under which the world is currently living and suffering. These bad circumstances began with the unexpected coronavirus, COVID-19, that killed millions of people around the world, including children, teenagers, women and …

BioStem Technologies Inc From Jason Matuszewski, CEO of BioStem Technologies (BSEM), who stated, “BioStem had an outstanding fourth quarter. Revenue reached $11.5 million, nearly 14 times higher than revenue of roughly $0.8 million for last year’s comparable quarter. The growth was driven by the successful commercial launch into the private office setting of AmnioWrap2, our innovative placental-derived allograft product designed to . . . This …

Illumina in the NEWS On March 21, 2024, we learned that the EU antitrust regulators suffered a blow as an adviser to Europe's top court said that they exceeded their powers when they blocked U.S. Illumina's (ILMN) $7.1 billion bid for merging with Grail.   In 2021,  the European Commission asserted a rarely used Article 22 to assess Illumina . . . This content is for …

During a discussion with colleagues about the best way to select small and new biotechnology firms for investment purposes, we started our answer by stating that selecting small and new biotechnology firms for investments is extremely challenging. As a matter of fact, the choice of firms for investment cannot be guaranteed approval of the firms’ products based on early and mid clinical trials' promising results, …

BioCardia Inc in the NEWS BioCardia, Inc. (BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, today announced positive interim results from the Phase III randomized controlled trial of its CardiAMP® autologous cell therapy in 110 randomized patients with advanced chronic heart failure at a mean 20-month follow-up, (CardiAMP HF). According to . . . This content is for paid subscribers. …

Travere Therapeutics in the NEWS Yesterday, Feb. 15, 2024,  Travere Therapeutics, Inc. (TVTX) reported its fourth quarter and full year 2023 financial results and provided a corporate update. Eric Dube, Ph.D., president and chief executive officer of Travere Therapeutics said, “With ongoing growth in demand for FILSPARI in IgAN and the initiation of the pivotal Phase 3 program of pegtibatinase in classical . . . …

Precision BioSciences Receives Pre-IND Feedback from US FDA for PBGENE-HBV as it Advances Towards Clinical Readiness Precision BioSciences (DTIL) is an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion, excision, and elimination . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

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 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 . . …

Immunovent, Altimmune & Soleno In addition to Vertex (VRTX), Crispr Therapeutics (

Eye on Reata Pharmaceuticals Recently, Reata Pharmaceuticals (RETA) announced a setback of its chronic kidney disease product known as bardoxolone. The failure of this drug occurred after Reata's product Skyclaris was FDA approved for the treatment of Friedrich's ataxia (FA) - a rare genetic disease that causes difficulty walking, loss of sensation in the legs and arms . . . This content is for paid …

The Current Interest in Ventyx Biosciences Answered 1. Ventyx Biosciences Focus  We like the fact that Ventyx Biosciences (VTYX) is not just focusing on developing innovative oral Drugs for people living with autoimmune and inflammatory disorders, but also on the firm’s discovery of differentiated drug candidates, which  address unmet medical need for oral therapies. Ventyx pipeline includes three internally . . . This content is for …

Endogena Therapeutics The US FDA designated Fast Track development program for the investigation of Endogena Therapeutics' product EA-2353 for the treatment of Retinitis Pigmentosa (RP). The Fast Track is a process designed to enable patients to benefit earlier from important new drugs that treat serious conditions. This designation enables Endogena Therapeutics to have more frequent communications with the US FDA on the development of EA-2353 …

Xenon Pharmaceuticals Xenon Pharmaceuticals (XENE) - a clinical stage biopharmaceutical company developing novel  treatments aimed at improving the lives of patients with neurological disorders. The firm is advancing its neurology pipeline to address diseases with unmet medical need. The lead focus is epilepsy. On January 6, 2023, Xenon Pharmaceuticals outlined the recent progress in its clinical programs and key milestones for 2023.   From Xenon Pharmaceuticals …

It's Time to Remind About Travere Therapeutics The time has come to remind that the U.S. FDA is reviewing Travere Therapeutics’ (TVTX) New Drug Application (NDA) under Subpart H for accelerated approval of sparsentan for IgA Nephritis (IgAN). We remind that the FDA has assigned a Prescription Drug User Fee Act (

January 5, 2023 In Today's Down Market the stocks that are outperforming are as follows: Reata Pharmaceuticals (RETA) bluebird bio Inc (BLUE) And Vertex Pharmaceuticals . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

The Stock Market in the New Year It is still too early to tell how the stock market will perform in 2023. However, on Tuesday January 3, 2023 (the first market trading day in 2023), most biotech stocks plummeted, especially, that of the most promising clinical stage small firms' stocks. Today, Wednesday January 4, 2023 ( the second trading day of the new year), the …