Nektar in the NEWS The FDA's Anesthetic and Analgesic Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) unanimously voted no regarding the approval of Nektar Pharmaceuticals’ (NKTR) New Drug Application (NDA) for its opioid product oxycodegol (formerly NKTR-181). In a short

XBiotech XBiotech (XBIT), headquartered in Austin, Texas, develops innovative proprietary manufacturing technology that reduces the cost and complexity of biological drug production. XBiotech is dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies. The firm is currently advancing a pipeline of therapies by harnessing naturally occurring antibodies from patients with immunity to certain diseases. Indeed, XBiotech is utilizing natural human immunity . . . This content …

Moderna's mRNA Vaccine Today could be one of the important early days as Moderna (MRNA) succeeded in cementing proof of concept for the validity of its messenger RNA (mRNA) as a vaccine. Moderna announced yesterday positive seven-month interim safety and immunogenicity data after the third and final vaccination in the Phase 1 study of its investigational cytomegalovirus (CMV . . . This content is for …

Coming Soon at Prohost Biotech We have stories to tell about our picked stocks which we believe could deepen the Prohost Biotech readers’ understanding of our strategy regarding the evaluation of the biotech companies. Our strategy has made it possible for us to fairly evaluate both the development-stage firms and the revenues- and incomes-generating firms in the biotech sector.     Most of our stories will …

More from the Prohost Portfolio with Our Observations Gilead (GILD) has cash and new products reaching the market, and its agreement with Galapagos will soon bring another drug approval. We will tackle Gilead’s news and all the firms in the Prohost Portfolio with more details in the upcoming Year in . . . This content is for paid subscribers. Please click here to subscribe or here to …

Regenxbio Results from RGX-121 for MPSII Regenxbio (RGNX) announced interim data from Phase I/II trial of RGX-121 for Mucopolysaccharidosis Type II (MPS II). RGX-121 is designed to deliver the gene that encodes iduronate-2-sulfatase (I2S) enzyme directly to the central nervous system (CNS) using the AAV9 vector. About Mucopolysaccharidosis Type . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

From Amarin Amarin (AMRN) announced the U.S. FDA has approved a new indication and label expansion for Vascepa® (icosapent ethyl) capsules. According to Amarin’s press release, with this label expansion approval, Vascepa has become . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Ionis Pharmaceuticals Ionis Pharmaceuticals (IONS) announces a private placement of $507.5 million principal amount of 0.125% convertible senior notes due 2024. To read this news go to the original  content to download multimedia by clicking here.  During the announcement of 2019 third-quarter financial results the conference call started citing the firm's improved revenues and income. Revenues have increased by more than 50% to nearly $630 million and …

Nektar Therapeutics Presents NKTR-255 at ASH Nektar Therapeutics’ (NKTR) IL-15 agonist investigational candidate NKTR-255 presentations at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition have been promising. Positive data presented from Fred Hutchinson Cancer Research Center preclinical studies conducted in collaboration with researchers from the Dana-Farber Cancer Institute and more. NKTR-255 is currently . . . This content is for paid subscribers. …

Firstly, Forty-Seven and IVERIC bio  We remind that the two condemned stocks Forty-Seven (FTSV) and  IVERIC bio (

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 …

PTC Therapeutics Risdiplam Results for SMA PTC Therapeutics (PTCT) has positive results from part 2 of the SUNFISH trial evaluating the safety and efficacy of the product risdiplam. The results demonstrate that the trial has met its primary endpoint of change from baseline after 1 year of treatment with risdiplam compared to placebo. The change was measured by the Motor . . . This content …

Reata Pharmaceuticals CARDINAL Study Met Primary and Key Secondary Endpoints Reata Pharmaceuticals (RETA) announced that the Phase 3 portion of the CARDINAL study of bardoxolone methyl (bardoxolone) in patients with chronic kidney disease (CKD) caused by Alport syndrome met its primary and key secondary endpoints.   This news is surely music in the ears of families with members . . . This content is for paid …

Exelixis and Ipsen Received Approval from Health Canada for CABOMETYX® From Exelixis (EXEL) we learned that its partner, Ipsen Biopharmaceuticals Canada, has received approval from Health Canada of CABOMETYX® (cabozantinib) tablets for the treatment of hepatocellular . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Exelixis and Daiichi Sankyo Partner to Prevent and Treat Diabetic Nephropathy Exelixis (EXEL) and Daiichi Sankyo (

Karyopharm Therapeutics Third Quarter Financial Results Generated Revenues For the first time since its establishment Karyopharm Therapeutics (KPTI) financial results report revenues from a strong launch of its first approved product. Indeed, the firm’s third-quarter 2019 financial results are the first quarter in which Karyopharm generated revenues. In early July the U.S. FDA granted the company’s product Xpovio® (selinexor . . . This content is for …

IVERIC bio Stock Outperforms IVERIC bio (ISEE) has good news its stock is responding to. A randomized, controlled Phase 2b clinical trial data seem to confirm that the IVERIC bio product Zimura® (avacincaptad pegol), a complement factor C5 inhibitor, has met its prespecified primary endpoint in reducing the rate of geographic atrophy (GA) growth in . . . This content is for paid subscribers. Please …

Seattle Genetics Announced Positive Results for HER2CLIMB Trial Seattle Genetics (SGEN) announced positive topline results from the HER2CLIMB trial evaluating tucatinib in HER2-positive breast cancer.  The trial compared tucatinib in combination with trastuzumab and capecitabine to trastuzumab and capecitabine

Bayer Decision to Advance IONIS-FXI-LRx for Clotting Disorders On October 9, 2019 Ionis Pharmaceuticals (IONS) announced it had been notified by its partner Bayer (

RegenxBio Rebounding RegenxBio (RGNX) has the viral vectors which could safely deliver genes into the cells. The firm has improved the adeno-associated viruses making them safe and effective gene delivery vehicles. One of the three currently approved gene therapy products, Zolgensma® for pediatric spinal muscular atrophy (SMA), marketed by Novartis, used RegenxBio’s adeno-associated . . . This content is for paid subscribers. Please click here to …