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 …
Apellis Pharmaceuticals Apellis Pharmaceuticals, Inc. (APLS) is a biopharma firm developing novel products for debilitating and life-threatening diseases. Currently, Apellis has two approved medicines targeting C3. These drugs include the first and only approved therapy for geographic atrophy, a leading cause of blindness. The firm’s pipeline has dozen clinical and pre-clinical programs convincing the firm's management . . . This content is for paid subscribers. …
The Bear Market The volatility in the Bear stock market continues to plunge the values of biotech stocks. The Bear market is sucking investors’ capitals who bet on firms with future growth potential based on early, mid term and late clinical trial results. Travere Therapeutics Good News On February 17, 2023, before the long weekend that ended on Tuesday, Travere Therapeutics (TVTX) announced …
Prohost's Beliefs About the Status of the Market That the market is still volatile and Bear. Investors in the biotech sector who intend to bet on clinical stage firms must restrict their choices to companies that already have proof of concept regarding safety and efficacy in some midterm and pre-term clinical trial results. Caution is still important for clinical-stage firms’ stocks that have encouraging clinical …
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 …
Merck KEYTRUDA Announcement Merck (MRK) announced today that Phase 3 NRG-GY018 trial evaluating KEYTRUDA in combination with chemotherapy (carboplatin and paclitaxel) met its primary endpoint of progression-free survival (PFS) in patients with stage III-IV or recurrent endometrial carcinoma regardless of mismatch repair status. NRG-GY018 is a randomized, blinded, placebo-controlled Phase 3 trial (ClinicalTrials.gov,
CytomX Therapeutics We posted several articles that brought good news from CytomX Therapeutics (CTMX), yet the stock continues to go down instead of up. A few days ago, CytomX announced the achievement of a clinical candidate milestone under its agreement with Astellas. The clinical . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
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 (
XyloCor Therapeutics Announced Positive Results for XC001 XyloCor Therapeutics announced the completion of the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) designed to assess the safety and preliminary evidence of efficacy of lead gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina. The EXACT clinical trial met both safety and efficacy objectives. There were no safety issues related to drug product or …
TG Therapeutics TG Therapeutics (TGTX) is a commercial stage, biopharmaceutical company developing and commercializing novel treatments for B-cell diseases. The firm’s research pipeline has several investigational medicines. TG Therapeutics has been granted U.S. FDA approval of its product BRIUMVI™ (ublituximab-xiiy), for adult patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome . . . This content is for paid subscribers. Please click here to …
Shoreline Biosciences to Acquire Editas Medicine’s iNK cell franchise Editas Medicine, Inc. (EDIT), announced that it has entered into a definitive agreement with the private Shoreline Biosciences (Shoreline) to license Editas Medicine’s proprietary SLEEK (SeLection by Essential-gene Exon Knock-in) and AsCas12a gene editing technologies and acquire Editas Medicine’s preclinical . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Ionis Pharmaceuticals and Royalty Pharma Ionis Pharmaceuticals (IONS) and Royalty Pharma plc (RPRX) announced that Royalty Pharma has . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
CureVac N.V. in the News CureVac N.V. (CVAC) announced that after more than 10 years as a member of the CureVac management board and three years as CEO, Dr. Franz Haas will step down as CEO, effective March 31, 2023. Joining CureVac from Sanofi, on April 1, 2023, is Dr. Alexander Zehnder. CureVac is a biopharmaceutical firm developing a new class . . . This …
CytomX and Moderna in the NEWS On January 05, 2023, CytomX Therapeutics (CTMX) and Moderna Inc (MRNA) announced a collaboration and licensing agreement to create . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
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 …
Kala Pharmaceuticals Kala Pharmaceuticals (KALA) announced today that the U.S. FDA has accepted the investigational new drug application (IND) for its lead product candidate, KPI-012, a human Mesenchymal Stem Cell Secretome (MSC-S) for the treatment of persistent corneal epithelial defect (PCED). Kala is a . . . This content is for paid subscribers. Please click here to subscribe or here to log in.
Dear Friends and Followers, We confirm our optimism towards the future biotech firms that we selected for investment, including the clinical stage small biotech companies, which also includes biotech stocks that you have never heard about from us. We inform you that we have Prohost Letters that will present the selected firms that we believe are promising. One of these Letters, we hope, will be …
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