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 …

Our Most Pressing Need Our current, most pressing need is news that makes sense. Stock Market investors are waiting for comprehensive news regarding inflation in the U.S., the rest of the world's economy and the price of crude oil. Indeed, we are all waiting to hear confirmed news promising the end of Russia's invasion into Ukraine. All the news we have been hearing up til …

The Stock Market Continues to Plummet Indeed, the Stock Market continues to decline, losing investors' profits.   Each time the Market plummets it takes with it promising firms' stocks but when the biotech stocks plummet new reasons are always claimed for the decline. Today's claimed reason for the deep losses is the tension between Russia and Ukraine, which, as it happens, is not the only …

The Market Devastation and Resurrection of Good Biotech Firms Due to the market’s instability that we have been experiencing for a while now, we decided to look back at some biotech firms whose values tumbled and stocks tanked as a result of both internal and external bad circumstances and other reasons. The decision to retackle these firms is in our conviction that they will rebound …

Agenus to Withdraw BLA for Balstilimab Agenus (AGEN) announced a strategic decision to withdraw its Biologics License Application (BLA) for balstilimab, its PD-1 inhibitor. The firm stated that its decision will not change the development plans for balstilimab with regard to its combination with AGEN1181, which will . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Mirum Pharmaceuticals Inc Mirum Pharmaceuticals Inc (MIRM) is a clinical-stage biopharmaceutical company focused on the development and commercialization of a late-stage pipeline of novel therapies for debilitating liver diseases. Maralixibat, is Mirum Pharmaceuticals lead product candidate. The product is an investigational oral drug in development for the following conditions:   Alagille syndrome (ALGS) Progressive familial intrahepatic . . . This content is for paid subscribers. …

Jounce Therapeutics Jounce Therapeutics (JNCE) is a clinical-stage immunotherapy company developing therapies enabling the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker-driven approach. Jounce has ongoing multiple development stage programs while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science. Jounce Therapeutics Lead Products

Gain Therapeutics Inc in the News Gain Therapeutics, Inc. (GANX) announced today topline data from its  study conducted at the University of Maryland School of Medicine (UMSOM). The study, evaluating two lead Structurally Targeted Allosteric Regulators (STARs) compounds – GT-02287 and GT-02329 – for the treatment of Gaucher and GBA1 Parkinson’s Disease, demonstrated positive effects . . . This content is for paid subscribers. Please …

Exelixis sNDA Accepted by the US FDA for CABOMETYX® The U.S. Food and Drug Administration (FDA) accepted Exelixis (EXEL) supplemental New Drug Application (sNDA) for CABOMETYX ® (cabozantinib) as a treatment for patients 12 years and older with differentiated thyroid cancer (DTC) who have progressed following prior therapy and are radioactive iodine-refractory (if radioactive . . . This content is for paid subscribers. Please click here …

Hoth Therapeutics Hoth Therapeutics (HOTH) announced that its product, HT-003, has yielded positive results in an in vivo acne therapeutic model. The model showed that HT-003 reduces the expression of toll-like receptor 2 (TLR2

Biogen Product Adulelm Approved for Alzheimer's Disease The latest news regarding Alzheimer’s disease is that of the FDA’s approval of Biogen Inc's (BIIB) Alzheimer disease product Adulelm (aducanumab). Although the approval seemed to be great news for Biogen many analysts and researchers, in highly regarded scientific institutions and universities, called it controversial. The FDA advisory committee has voted almost . . . This content is …