Target $12
Monday, November 1, 2021
4 sell siders start Theseus Pharma at Buy
Target
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Galmed Announces Positive Results from First 16 Patients in Liver Study
-- Treatment with Aramchol 300mg BID reduced fibrosis progression measured by histology in 15 out of the 16 patients completed as of data cutoff --
-- 50% of the 16 patients showed fibrosis improvement by ≥1 stage, seen as early as 24 weeks --
--Data demonstrates that treatment with Aramchol 300mg BID resulted in clinically significant greater histological improvement than observed previously with Aramchol 600mg QD --
-- Data add to body of evidence from prior studies demonstrating the benefit of Aramchol for patients with histologically confirmed NASH and fibrosis and provides clinical support for the hypothesis that a higher daily dose will result in improved clinical benefit --
-- Data will be presented at a late-breaking poster presentation at The Liver Meeting Digital Experience 2021, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will be held from November 12-15, 2021 --
Galmed's management team will host a conference call and webcast to provide an update on current developments with respect to its clinical programs for Aramchol including NASH Expert Insights on the ongoing Open-Label Part of the ARMOR study, and to discuss financial results for the quarter ended September 30, 2021 on November 8th @ 8.30am Eastern Time
Conference Call & Webcast:
Monday November 8, 2021, 8:30 AM ET
Toll Free: 1-877-425-9470
Toll/International: 1-201-389-0878
Israel Toll Free: 1 809 406 247
Conference ID: 13724243
Webcast: https://78449.themediaframe.com/dataconf/productusers/vvdb/mediaframe/47052/indexl.html
Replay Dial-In Numbers
Toll Free: 1-844-512-2921
Toll/International: 1-412-317-6671
Replay Pin Number: 13724243
Replay Start: Monday November 8, 2021, 11:30 AM ET
Replay Expiry: Monday November 22, 2021, 11:59 PM ET
https://finance.yahoo.com/news/galmed-announces-positive-results-first-141000189.html
Outset Medical’s Tablo® Hemodialysis System Receives Landmark TPNIES Approval From CMS
TPNIES approval to provide additional reimbursement for Tablo home dialysis treatments
Outset Medical, Inc. (Nasdaq: OM) ("Outset") today announced that its Tablo® Hemodialysis System has received the first-ever approval from the Centers for Medicare & Medicaid Services (CMS) for a Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES). This pioneering decision will help encourage healthcare providers to embrace new technology enabling more patients to dialyze at home and reclaim their independence.
https://finance.yahoo.com/news/outset-medical-tablo-hemodialysis-system-120300770.html
Shionogi Negotiating With Companies Over Partnership on Covid-19 Pill
Japanese pharmaceutical maker Shionogi & Co. said it is discussing a partnership with several global companies to market a pill for Covid-19 that is now undergoing human trials.
Shionogi said the pill showed superior safety in a small-scale Phase 1 trial and lowered virus levels in humans in line with expectations from animal studies.
It said a mid-stage Phase 2 trial is under way and it is trying to recruit more patients by looking to countries such as the U.K. and Singapore that have many Covid-19 cases. Currently Japan is recording only a few hundred new Covid-19 cases a day, limiting the potential pool for clinical trials.
Shionogi said it is in discussions with the Food and Drug Administration in the U.S. and the European Medicines Agency over plans for a large-scale Phase 3 trial of the pill, code-named S-217622. It said it is building up production capacity for the drug but didn't say when it might reach the market.
Merck & Co. recently released results from a large-scale trial showing its Covid-19 pill, co-developed with Ridgeback Biotherapeutics LP, helped prevent high-risk patients from becoming seriously ill.
Novavax COVID-19 vaccine receives emergency use authorization in Indonesia
Novavax Inc and partner Serum Institute of India said On Monday they received the emergency use authorization from Indonesia, making it the first authorization anywhere for Novavax.
The shot will be sold under Serum Institute's brand name for the vaccine, Covovax.
Glaxo denies Mail on Sunday report of interest in Aurinia
GlaxoSmithKline on Monday dismissed a Mail on Sunday report that said that the British pharma group could be interested in bidding for autoimmune disease drug developer Aurinia Pharmaceuticals Inc.
Britain's Mail on Sunday newspaper said, citing mounting speculation, that GSK is preparing a bid for Canada's Aurinia. The report is not true, a GSK spokesperson said in an email.
Aurinia shares jumped almost 27% on Oct. 22 when Bloomberg News cited people familiar with the matter as saying that U.S. group Bristol Myers Squibb Co had expressed interest in buying the company.
The stock has been up almost 50% since the report, giving the biotech firm a market value of about $4.2 billion.
Aurinia's drug Lupkynis is approved to treat a form of kidney inflammation caused by autoimmune disease lupus and the company is working on other treatments for autoimmune and kidney diseases.
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