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 . . …
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 …
Dear Subscribers, This is what we learned this morning: FTX: we learned about the arrest of Sam Bankman Fried and about the firm’s hearing today. We heard from several sources that FTX has been a house of cards built on deception. It forced us to ask how many of these house of cards are stock market investors tempted to buy; watching stocks of small bad …
Searching for Biotech Firms The search is for firms biotech firms that have reached clinical stage with novel products that had some earlier, encouraging test results, whose technologies and lead products must have demonstrated improvement over current treatments of devastating diseases, including cancers and genetic-derived diseases. Recently, we became interested in a firm called Acumen’s Pharmaceuticals (
Rhythm Pharmaceuticals Rhythm Pharmaceuticals (RYTM): After soaring, based on great scientific and drug performance in treating genetic obesity, the selloff of the stock has occurred today after the firm’s announcement and pricing of its public offering of 4.8M shares of its common stock at $26 a share. Akero Therapeutics Akero Therapeutics (
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 …
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 …
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 …
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 …
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