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 …

Prohost Letter #444 The End of the Year Issue was delayed because our 2020 Prohost Portfolio stocks’ targets for the year failed to materialize; nobody not even the authorities were capable of predicting the pandemic, which continues to plague the world. As 2021 approached, we were unable to the End of the Year issue on time as we lacked the information required for the fair …

Reata Pharmaceuticals The Positive News  Prohost Biotech's interest in Reata Pharmaceuticals (RETA) started when we recognized and appreciated the firm’s goals and its scientific capability. Reata Pharmaceuticals' goal is discovering molecular pathways that regulate cellular metabolism, inflammation and response to stress injury; hence, treat devastating diseases that have yet to . . . This content is for paid subscribers. Please click here to subscribe or here to …

Reata Pharmaceuticals: Why its Stock Price is Down Reata Pharmaceuticals (RETA) announced that it has priced a public offering of 2,000,000 shares of its Class A common stock at a price to the public of $140.85 per share for gross proceeds of $281.7 million. Reata has granted the underwriters a 30-day option to purchase 300,000 additional . . . This content is for paid subscribers. …

Reata Pharmaceuticals We picked Reata Pharmaceuticals (RETA) for investment after confirming that the products the Company has created and is currently developing have a novel mechanism of action that enables the treatment of severe diseases that have yet to find treatments. Reata’s strategy is to build a deep understanding of the cellular response to injury in order to develop . . . This content is …

Prohost Letter 442 The Whole World Against the Blind SARS-CoV-2 Virus Investors have no doubt profited from the developers of COVID-19 vaccines which include: Moderna (MRNA), Novavax (

Prohost Letter #441 Biotechnology Companies’ Evaluations Are We Saying Goodbye to Common Sense? The SARS-CoV-2 Vaccines It is said that the difference between the SARS-CoV-2 coronavirus (COVID-19), which is causing the pandemic around the world we are currently suffering from, and other coronaviruses like SARS and/or MERS is that SARS-CoV-2 ability to replicate in the human bodies' respiratory system’s upper airways more than the others. …

Reata Pharmaceuticals Stock is Flying High Here is another example of why analysts can no longer use the same old measures to evaluate the biotechnology firms. They cannot continue to ignore the values of the firms’ technologies and very promising products. Very promising products are those that can treat diseases in patients who are condemned with a diagnosis. Today’s example is flying on the wings …

Synopsis The way many bloggers are interpreting the quarterly and yearly biotech companies’ financial results seems unfair and has proven to be. Amgen Amgen (AMGN): The stock gained over $10 yesterday and is trading now at $231. Many bloggers continue to attack the firm, mourning the loss of their protective patents on its over 30 years’ old products and ignore the record . . . …

As the Market Seems to Soar Our Eyes Are on the Following Biotech Stocks: Amgen (AMGN): A rebounding is expected following an unwarranted decline.   Gilead Sciences (GILD): A lot of good news from the firm, including the firm’s investigational product remdesivir that demonstrated positive results in beating the coronavirus infection. Read yesterday's article posted

The Market May be Plummeting But Prohost Picks are Not Biotech stocks had a strong start, but the gains disappeared in many stocks as the market demonstrated bearishness following a long-lasting rally. Currently, during the strong economic conditions, commentators attribute the reasons for the market’s upside and downside moves to China’s positive, or negative ongoing negotiations rather than to fair correction of overbought or oversold …