Pharma Stock Roundup: MRK, PFE, GSK, BMY Q3 Earnings, Other Updates
Zacks Investment Research | Oct 31, 2019 10:55PM ET
Pfizer (NYSE:PFE) , Merck (NYSE:MRK) , Bristol-Myers (NYSE:BMY) , Sanofi (NASDAQ:SNY) , Glaxo (NYSE:GSK) and Bayer (DE:BAYGN) released their third-quarter results this week. In other important news, AstraZeneca’s first-line lung cancer study on Imfinzi showed positive results and J&J’s (NYSE:JNJ) new tests revealed no asbestos in its baby powder.
Recap of the Week’s Most Important Stories:
Earnings Update: Baby Powder. The recall was initiated following a test done by the FDA, which revealed traces of asbestos in samples from one bottle purchased online. J&J also said that an additional 48 independent third-party lab tests of samples from the same lot that was recalled also confirm that the talc does not contain asbestos.
Pfizer Gets EU Nod for Bavencio+Inlyta Combo in Kidney Cancer: Pfizer and partner Merck KGaA gained approval from the European Commission for Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC), the most common form of kidney cancer. The combination of Bavencio and Inlyta received approval in the United States for a similar indication in May. In January, a similar application had been submitted in Japan.
Glaxo Begins Phase III Program on New Antibiotic: Glaxo announced initiation of patient dosing in a phase III program on its investigational oral antibiotic, gepotidacin, which Glaxo claims has mechanism of action distinct from any currently approved antibiotic. The program will comprise two studies with one evaluating the use of gepotidacin for uncomplicated urinary tract infection and the other for urogenital gonorrhea, a common sexually transmitted infection.
Meanwhile, the European Commission gave approval to the intravenous formulation of Benlysta for systemic lupus erythematosus in children aged five years and above. The intravenous formulation is already approved in EU as well as the United States for adults while it was approved in the United States for children in April.
AbbVie’s Rinvoq Meets Goal in Psoriatic Arthritis Study: AbbVie’s (NYSE:ABBV) phase III study evaluating Rinvoq (upadacitinib) for active psoriatic arthritis in adult patients who had an inadequate response to other bDMARDs met the primary endpoint. Top-line data from the study (SELECT-PsA 2) showed that both doses of Rinvoq (15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response or at least a 20% reduction in the number of both tender and swollen joint counts, at week 12 versus placebo. After 12 weeks of treatment, the ACR20 response (primary endpoint) was achieved in 57% of the patients receiving the 15 mg oral once-daily dose of upadacitinib and 64% of the patients taking the 30 mg dose versus 24% for patients in the placebo group. In addition, patients treated with Rinvoq (both doses) achieved significantly greater responses for all ranked secondary endpoints compared to placebo. Rinvoq was approved for the treatment of moderate-to-severe rheumatoid arthritis in August.
FDA Puts Hold on Novartis’ AVXS-101 Intrathecal Studies: The FDA placed a partial clinical hold on studies testing intrathecal administration of its newly approved spinal muscular atrophy (SMA) treatment, Zolgensma (AVXS-101) based on findings of a small pre-clinical animal study. Zolgensma is presently available as an intravenous administration after FDA granted approval in May this year for pediatric SMA patients. Novartis said that the clinical hold has no impact on intravenous Zolgensma.
FDA and EMA Accept Roche’s Applications for Satralizumab: Roche’s marketing applications for satralizumab developed to treat neuromyelitis optica spectrum disorder were accepted for review by the European Medicines Agency and FDA. The regulatory applications were based on data from two studies, SAkuraStar and SAkuraSky.
The NYSE ARCA Pharmaceutical Index rose 3.3% in the last five trading sessions.
Get The News You Want
Large Cap Pharmaceuticals Industry 5YR % Return
Original post
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.