Novartis to Acquire The Medicines Company Novartis (NVS) decided to buy The Medicines Company (MDCO) at $6.8 million. The Medicines Company’s shareholders will be getting $85 per share in cash – a 45% premium to its unaffected share price and a 57% premium to its unaffected one-week average price. The Transaction is expected to be completed in the first quarter of 2020 The Medicines Company …
Prohost Letter #437 An All Time High Market More Prohost Picks Have Reached the 2019 Targets The stock market performance has reached an all-time high with more of our picks reaching or nearing the Prohost 2019 price targets. There are stories to tell about some devastated stocks which many believed were dead and buried but were surprisingly resurrected, and their stocks are going up. Another …
Alnylam Granted FDA Early Approval of GIVLAARI™ for AHP Alnylam’s (ALNY) stock outperformed as its subcutaneous injection GIVLAARI™ (givosiran) has been granted FDA early approval. GIVLAARI™ is created and developed for the treatment of adults with acute hepatic porphyria (AHP). AHP is a family of ultra-rare, genetic diseases characterized by debilitating, life-threatening attacks and, for some patients, chronic manifestations that demeans patients’ daily functioning and …
Vertex Pharmaceuticals and CRISPR Therapeutics Rallied Today Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics (CRSP) announced positive, interim data from the first two patients with severe hemoglobinopathies treated with the investigational CRISPR/Cas9 gene-editing therapy CTX001 in ongoing Phase 1/2 clinical trials. A patient with transfusion-dependent beta-thalassemia (TDT) received CTX001 in the first quarter of 2019. Data for this patient reflect nine months of safety and efficacy follow-up. …
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.
FDA Approval for Celgene and Acceleron Drug REBLOZYL® The U.S. Food and Drug Administration (FDA) has approved Celgene’s (CELG) and Acceleron Pharma’s (XLRN) drug REBLOZYL® (luspatercept-aamt) for anemia only in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. REBLOZYL® is the first and only FDA-approved erythroid maturation agent, representing a new class of therapy that works by regulating late-stage red blood cell maturation …
The Week in Review #47 What A Week For Biotechnology Synopsis In this “Week in Review” there is no complicated scientific and clinical information, leaving the details to the articles that we usually post on the Prohost website. Most of the Prohost picked firms’ Q3 financial results have beaten expectations. Three firms have reached the Prohost 2019 targets, and more firms have outperformed, with some …
Halozyme Therapeutics is Focusing on ENHANZE® Technology Halozyme Therapeutics (HALO) decides to focus on its ENHANZE® drug delivery technology, halt the development activities for PEGPH20 and close its oncology operations. These decisions were made after the failure of HALO-301 Phase 3 clinical study evaluating PEGPH20 as a first-line therapy for patients with metastatic pancreas cancer to reach the primary endpoint of overall survival. The PEGPH20 failure …
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 …
Compugen FDA Approval for COM902 Compugen Announces FDA Clearance of IND Application for COM902 Phase 1 clinical study in patients with advanced malignancies expected to begin in early 2020 Clinical development of COM902 will enable testing the combination treatment with COM701, Compugen’s anti-PVRIG inhibitor Compugen (CGEN) is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel …
The Week in Review #46 The Quarterly Financial Results The quarterly financial results that analysts and investors relied on for years to evaluate biotech firms, including development stage firms, seem to change. Investors have finally realized that development-stage firms have no marketed drugs and no revenues, hence, no incomes and should be evaluated based on the clinical trial results of their pipeline products. They saw …
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 …
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