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Galapagos' Ziritaxestat successful in systemic sclerosis study Sep. 11, 2020 5:47 AM ET|About: Galapagos NV (GLPG)|By: Mamta Mayani, SA News Editor Galapagos (NASDAQ:GLPG) perks 8% premarket on the heels of positive top line results in the Phase 2a NOVESA trial with investigational ziritaxestat (GLPG1690) in patients with diffuse cutaneous systemic sclerosis (dcSSc), a severe autoimmune disease. The trial enrolled 33 patients. Ziritaxestat reached the primary endpoint of the study with a statistically significant change from baseline in the modified Rodnan Skin Score (mRSS) at Week 24, of -8.3 (1.2), p=0.0411 vs -5.7 (1.7) for placebo. GLPG1690 was generally well-tolerated. No deaths were reported. 94% of patients (31 of the 33) who completed the trial continued in the long-term open-label extension trial. Ziritaxestat is a small molecule, selective autotaxin inhibitor co-developed with Gilead Sciences.
Shortage of Gilead's remdesivir in U.S. appears over Sep. 11, 2020 4:27 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor Reuters National Post reports that, since July, U.S. hospitals have turned down about 1/3 of their allocated supplies of Gilead Sciences' (NASDAQ:GILD) Veklury (remdesivir) for treating COVID-19 patients according to unpublished government statistics provided to Reuters by a U.S. pharmacists' group. Some hospitals are still buying the antiviral to beef up inventories in case the pandemic ramps back up this winter, but they say current supplies are adequate, in part because they are limiting use to severely ill patients. Six of eight hospital systems contacted by Reuters stated that they were not using the nucleoside ribonucleic acid polymerase inhibitor for moderately ill patients despite the FDA's emergency use nod for the indication. The U.S. Department of Health and Human Services (HHS) told hospitals and other healthcare organizations that state and territorial public health systems accepted ~72% of supplies offered between July 6 and September 8, according to Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists. Government-led distribution of remdesivir will expire at month-end. Some experts are unconvinced that remdesivir would benefit COVID-19 patients with moderate symptoms. Cleveland Clinic's Dr. Adarsh Bhimraj is not "terribly impressed" with the study (supporting the drug's use in this population) and remains “skeptical” about using remdesivir in patients with moderate COVID, especially given the price ($3,120/five-day course). Another factor could be the alternative use of inexpensive corticosteroids in severely ill COVID-19 patients. Recent studies showed a mortality benefit compared to standard-of-care treatment. Shares have sold off 17% since touching $78.94 on July 20.
Gilead nears $20B-plus deal to buy Immunomedics - WSJ Sep. 12, 2020 3:31 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Carl Surran, SA News Editor Gilead Sciences (NASDAQ:GILD) is close to a deal to buy Immunomedics (NASDAQ:IMMU) and its prized Trodelvy breast cancer drug for more than $20B, with an announcement expected by Monday or sooner, WSJ reports. The acquisition would come at a hefty premium, even after a recent surge in its stock has lifted Immunomedics' market value to ~$10B. In April, Trodelvy was approved in the U.S. to treat triple-negative breast cancer, an aggressive form of the disease that has spread to other parts of the body. Trodelvy has shown signs of success in treating lung and other cancers too, and Immunomedics is expected to present data on the drug's performance against bladder cancer at a medical conference this coming week. Now read: Dividend Changes: August 29-September 4, 2020 »
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Column: Brand uw vingers niet in de Covid-rush Datum 11 september 2020 Sommige bedrijven presteren het om meerdere keren als een feniks uit hun eigen as te herrijzen. Eastman Kodak is zo’n bedrijf. Voor particuliere beleggers is deze categorie echter vooral gevaarlijk. Regelmatig gaan aandelenkoersen door het dak van bedrijven die doorbraken weten te melden in de zoektocht naar een geneesmiddel voor Covid-19. Vaak volgt daar al snel een even grote daling op, als het nieuws moet worden genuanceerd. Een mooi recent voorbeeld van ‘Covid-rush’ is Eastman Kodak, voorheen groot in fotorolletjes, in 2012 failliet, en tegenwoordig na een doorstart actief in geavanceerde materialen en chemicaliën. Eind juli meldde Kodak dat het een overheidslening zou krijgen van 765 miljoen dollar uit hoofde van de Defense Production Act die was opgezet om de binnenlandse productie van geneesmiddelen te versnellen. Kodak zou het geld gebruiken om ingrediënten voor het anti-malariamiddel hydroxychloroquine te gaan maken. De koers van Kodak vertwintigvoudigde in enkele dagen, om bijna net zo snel weer in te storten op het nieuws dat het bedrijf verdacht wordt van handel met voorkennis rond de aankondiging van de lening. Bestuursvoorzitter Continenza bleek kort voor de aankondiging van de lening 46.737 aandelen Kodak gekocht te hebben. Alleen al bij de Amerikaanse discountbroker Robinhood gingen eind juli meer dan 60.000 particuliere beleggers het schip in met dit aandeel. Verblind door hebzucht dachten zij de gouden Covid-belegging gevonden te hebben. In deze fase van de strijd om het Covid-vaccin is het voor beleggers bijna onmogelijk om de winnaar aan te wijzen. En daarnaast is het nog zeer de vraag tegen welke prijs die winnaar het product gaat verkopen. Verschillende farmaceuten hebben al geroepen dat ze de prijs niet hoog zullen maken. Imago speelt daarbij een grote rol. Beleggers doen er beter aan, de plotseling in Covid-koorts omhoogschietende aandelen links te laten liggen. Zoek liever naar bedrijven die langdurig een goed rendement op het geïnvesteerde kapitaal weten te behalen. De VEB-Barometer, u vindt er in deze Effect weer twee, is voor die zoektocht een prima instrument. | Dit is een column van Paul Koster, directeur van de VEB
Gilead Sciences to Acquire Immunomedics -- Gilead Adds TrodelvyTM, First-in-Class Antibody-Drug Conjugate Approved to Treat Triple-Negative Breast Cancer, With Promise in Other Forms of Breast Cancer and Additional Solid Tumors -- -- Acquisition Transforms Gilead’s Portfolio with First-in-Class Commercial Product with Significant Revenue and Best-in-Class Potential -- -- Trodelvy will Accelerate Gilead’s Emerging and Complementary Oncology Pipeline, Building on Agreements Executed Earlier This Year -- -- Immunomedics to Present Latest Clinical Findings on Trodelvy at European Society for Medical Oncology Virtual Congress 2020 This Coming Week -- FOSTER CITY, Calif. & MORRIS PLAINS, N.J.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Immunomedics (Nasdaq: IMMU) announced today that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Immunomedics for $88.00 per share in cash. The transaction, which values Immunomedics at approximately $21 billion, was unanimously approved by both the Gilead and Immunomedics Boards of Directors and is anticipated to close during the fourth quarter of 2020. This press release features multimedia. View the full release here: www.businesswire.com/news/home/202009... The agreement will provide Gilead with TrodelvyTM (sacituzumab govitecan-hziy), a first-in-class Trop-2 directed antibody-drug conjugate (ADC) that was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in April for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Immunomedics plans to submit a supplemental Biologics License Application (BLA) to support full approval of Trodelvy in the United States in the fourth quarter of 2020. Immunomedics is also on track to file for regulatory approval in Europe in the first half of 2021. In the Phase 3 ASCENT study, which was halted early due to efficacy based on the unanimous recommendation of the independent Data Safety Monitoring Committee, Trodelvy significantly improved progression-free survival (PFS) and overall survival (OS) in previously treated patients with advanced mTNBC. Detailed results from this study are expected to be presented at the upcoming European Society for Medical Oncology (ESMO) Virtual Congress 2020. Beyond mTNBC, Trodelvy is also being studied in an ongoing Phase 3 trial in third line HR+/HER2- breast cancer and a registrational Phase 2 study in bladder cancer. Additional ongoing studies are evaluating the potential of Trodelvy as a treatment for non-small cell lung cancer and other solid tumor types. Trodelvy is being studied as both a monotherapy and in combination with checkpoint inhibitors and other non-immuno-oncology products by Immunomedics and independent investigators. Additional clinical data for Trodelvy in bladder cancer and other solid tumors will also be presented at ESMO this coming week. “This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio. Trodelvy is an approved, transformational medicine for a form of cancer that is particularly challenging to treat. We will now continue to explore its potential to treat many other types of cancer, both as a monotherapy and in combination with other treatments,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “We look forward to welcoming the talented Immunomedics team to Gilead so we can continue to advance this important new medicine for the benefit of patients with cancer worldwide.” “We are very pleased that Gilead recognized the value of Trodelvy – both for the important role it has already begun to play for patients with metastatic triple-negative breast cancer and for its potential to help many other patients with cancer in the future,” said Behzad Aghazadeh, PhD, Executive Chairman of Immunomedics. “We are excited for the opportunities ahead of us as we join with Gilead to advance our shared mission in defeating cancer. By working with Gilead, we have the opportunity to accelerate our progress and improve care for patients in need of new therapies.”
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