Reat Pharmaceuticals Merger with Biogen Reata Pharmaceuticals announced that at a special meeting held today, preliminary results indicate that the stockholders of the firm have voted to approve the Company’s previously announced acquisition (the “Merger”) by Biogen (BIIB). Around 99.65% of the votes cast by the Company’s Class A common stockholders and Class B common stockholders, voting as . . . This content is for …
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 …
Intellia Therapeutics Intellia Therapeutics (NTLA) announced that the U.S. FDA has cleared the company’s Investigational New Drug (IND) application for NTLA-2002. About NTLA-2002 Based on Nobel Prize-winning CRISPR/Cas9 technology, NTLA-2002 is the first single-dose investigational treatment. NTLA-2002 is Intellia wholly owned investiga- tional CRISPR therapeutic candidate designed to inactivate the kallikrein B1 . . . This content is for paid subscribers. Please click here to subscribe or here to …
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 …
Prohost Letter #453 Gilead Sciences Still Way UNDERVALUED Finally, many analysts who happened to downgrade Gilead Science’s (GILD) stock for years are upgrading it. Demonstrating time and time again its scientific genius in saving millions of people from deadly diseases, Gilead has, at long last, convinced the bearish analysts to turn bullish . . . This content is for paid subscribers. Please click here to subscribe …
Reata Pharmaceuticals Announcements The FDA decision not to hold an Advisory Committee Meeting to discuss Reata Pharmaceuticals product Omaveloxolone for the treatment of Friedreich’s ataxia hints to good news about the approval of this product approval on February 2023. The NDA for Omaveloxolone for Friedreich’s ataxia is under review. A PDUFA Date is decided upon on February 28, 2023. Recently, Reata Pharmaceuticals (
Reata Pharmaceuticals Announcement Regarding the NDA for Omaveloxolone for Friedreich’s Ataxia Reata Pharmaceuticals (RETA) announced that the U.S. Food and Drug Administration (FDA) does not plan to hold an advisory committee meeting in connection with its review of the Company’s New Drug Application (NDA) for omaveloxolone for the treatment of patients with Friedreich’s ataxia. From Reata Pharmaceuticals CEO Warren Huff, Reata’s Chief Executive Officer, said, …
Reata Pharmaceuticals in the NEWS Reata Pharmaceuticals (RETA) on August 8, 2022, after the U.S. financial markets closed, received a communication from the U.S. Food and Drug Administration (FDA) informing us that they have extended the review timeline for the New Drug Application (NDA) for omaveloxolone for the treatment of Friedreich’s ataxia by three . . . This content is for paid subscribers. Please click here …
Prohost Comprehensive Letter #451 Shorting Biotech Firms with Solid Fundamentals Unfair shorting of promising stocks seems to have become the norm during the harsh circumstances that not only the United States but several other countries have been living under for more than two years. The bad circumstances in the United States seem to be motivating unfair short-sellers to take advantage of bad news and cause …
Reata Pharmaceuticals Completed Rolling NDA Submission for Omaveloxolone for Friedreich’s Ataxia Reata Pharmaceuticals (RETA) announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. FDA for omaveloxolone’s treatment of Friedreich’s ataxia (FA). The NDA is supported by the efficacy and safety data from the MOXIe Part 1, Part 2 and MOXIe Extension studies. The FDA has granted Fast Track …
Reata Pharmaceuticals Business Operations and Clinical Development Updates Reata Pharmaceuticals (RETA) – a clinical-stage biopharmaceutical company announced financial results for the quarter ended September 30, 2021, and provided an update on the Company’s business operations and clinical development programs. Recent Highlights Bardoxolone in Patients with Chronic Kidney Disease (CKD) Caused by Alport Syndrome The New Drug Application (NDA
Reata Pharmaceuticals MAA Submission for Bardoxolone Methyl Reata Pharmaceuticals (RETA) announced the submission of a Marketing Authorization Application (MAA) for bardoxolone methyl to the European Medicines Agency (EMA) for chronic kidney disease (CKD) caused by Alport syndrome. The MAA submission is based on the efficacy and safety data from the CARDINAL Phase 3 clinical trial. This . . . This content is for paid subscribers. …
Reata Pharmaceuticals Announcements Reata Pharmaceuticals (RETA) announced that the abstracts highlighting clinical data for bardoxolone methyl (“bardoxolone”) and disease education data on Alport syndrome will be presented at the American Society of Nephrology Kidney Week 2021 being held virtually from November 4 – 7, 2021. The abstracts for the oral and poster presentations are listed below and are available on the conference website at https://www.asn-online.org/education/kidneyweek/. Oral …
Reata Pharmaceuticals to Submit Omaveloxolone for NDA in Early 2022 In a press release following the completion of pre-NDA meeting with the FDA, Reata Pharmaceuticals (RETA) stated that the purpose of the pre-NDA meeting was to discuss the content of Reata’s planned NDA submission. The firm plans to submit the NDA . . . This content is for paid subscribers. Please click here to subscribe or here to …
The Comprehensive Prohost Letter Issues The Comprehensive Prohost Letter Issues will constitute a chain of 7 issues. Today’s issue will include the following: Pinpointing and selecting the biotech firms that demonstrate readiness to treat untreatable, devastating diseases. Presenting an important antibody cocktail for the treatment of COVID-19. Stating our position regarding the Alzheimer’s disease firm Cassava Sciences. Pinpointing Prohost’s . . . This content is …
Travere Therapeutics Sparsentan for IgAN Positive Results Phase 3 PROTECT Study of Travere Therapeutics (TVTX) product sparsentan for the treatment of IgA nephropathy (IgAN) demonstrated positive topline interim results. The PROTECT Study met its pre-specified interim primary efficacy endpoint with statistical significance, demonstrating a greater than a threefold reduction of proteinuria from baseline after 36 weeks of treatment . . . This content is for paid …
Reata Pharmaceuticals Two Stories Omaveloxolone in Patients with Friedreich’s Ataxia Several communications between Reata Pharmaceuticals (RETA) and the FDA have taken place in the past regarding omaveloxolone for Friedreich’s Ataxia (FA) without reaching clear results that could satisfy either the Firm or the FDA. However, recent communication by the FDA seems to have finally satisfied both. Following . . . This content is for paid …
Reata Pharmaceuticals Good News Reata Pharmaceuticals (RETA) announced it received a communication from the Division of Neurology Products of the U.S. FDA stating, that after a preliminary review of briefing materials for an upcoming Type C meeting, a pre-NDA meeting is the most appropriate format for a discussion of the development program for omaveloxolone in Friedreich’s ataxia The Division suggested that the Company withdraw the …
Prohost Portfolio PLUS #2 Re-Working Some Evaluated Biotechnology Firms Exelixis: 2020 and 2021 Wondering why Exelixis’ (EXEL) stock has looked paralyzed for more than two years? To know better about Exelixis the entrepreneur and Exelixis the creative scientific institution, we decided to go to the recorded Exelixis history, financial results and scientific . . . This content is for paid subscribers. Please click here to subscribe …
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