TG Therapeutics TG Therapeutics, Inc. (TGTX) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of BRIUMVITM (ublituximab-xiiy) for the treatment of adult patients relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features . . . This content is for paid subscribers. …

Checkpoint Therapeutics Checkpoint Therapeutics (CKPT) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing open-label, multi-regional, multicohort . . . This content is for paid subscribers. Please …

BrainStorm Cell Therapeutics Inc BrainStorm Cell Therapeutics Inc (BCLI) develops innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. FDA . . . This content is …

Vertex Pharmaceuticals and Crispr Therapeutics Agreement Aims at Accelerating Vertex's Hypo immune Cell Therapies for Type 1 Diabetes Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics (CRSP) announced that they have entered into a new non-exclusive licensing agreement for the use of CRISPR Therapeutics’ gene editing . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Important News from Vertex Vertex Pharmaceuticals (VRTX) is a worldwide biotechnology company that invests in scientific innovation. The firm created transformative medicines for people with serious diseases. Vertex has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) — a rare, life-threatening genetic disease. It has several ongoing clinical and research programs in CF. Beyond CF, Vertex . . . This content is …

23andMe Aims To Raise Awareness of Lipoprotein(a), a Little-Known Genetic Risk Factor for Cardiovascular Disease March 24, 2023 (GLOBE NEWSWIRE) — In support of Lipoprotein(a) Awareness Day, 23andMe Holding Co. (ME) announced a collaboration with Novartis Pharmaceuticals Corporation (NVS) to increase awareness for Lipoprotein(a) (Lp(a)). The Information to Learn High levels of Lp(a) are associated with increased risk of heart attack, stroke and other life …

CymaBay Therapeutics CymaBay Therapeutics (CBAY) is a clinical-stage biopharmaceutical firm focused on improving the lives of people with liver and other chronic diseases that have a high unmet medical need through a pipeline of innovative therapies.   The firm is proud of its deep understanding of the underlying mechanisms of liver inflammation . . . This content is for paid subscribers. Please click here to subscribe or …

Pfizer to Acquire Seagen Pfizer (PFE) is to acquire Seagen (SGEN) for $229 per share in cash, for a total enterprise value of approximately $43 billion Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer, said, “Pfizer is deploying its financial resources to advance the battle against cancer, a leading cause of death worldwide with a significant impact on public health. Together, Pfizer and Seagen …

The Stock Market The volatility continues in the Bear market with investors not knowing what to do with such instability. Professional traders and robots are all puzzled. Friday, March 10, 2023 the market started the trading day by dropping 150 points and it continued to drop. Nobody knew what would happen by the end of the day, which, in this case, was the end of …

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 …

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 …