Global Cord Blood warns on impact of coronavirus outbreak
In a statement, Global Cord Blood (CO +1.2%) says the COVID-19 outbreak in China has placed “heavy pressure” on its sales and marketing efforts due to partial or complete lockdowns in certain cities in China.
Considering the effects thus far and the uncertainty in the duration of the outbreak, it expects the situation to negatively impact fiscal Q4 results (calendar quarter ending March 31), adding that it may need to revise its fiscal 2021 sales target.
Merck Ebola vaccine OK’d in four African countries
Merck (MRK +0.3%) announces that Ervebo (Ebola Zaire Vaccine, Live) is now approved in Democratic Republic of Congo, Burundi, Ghana and Zambia for prevention of disease caused by Zaire ebolavirus in people at least 18 years old.
Agile Therapeutics +13% on Twirla approval
Agile Therapeutics (NASDAQ:AGRX) is up 13% postmarket and on the move after announcing the FDA approved its Twirla contraceptive patch – its first approved product.
Twirla is a once-a-week transdermal treatment with a combined hormonal approach that delivers a 30 mcg daily dose of ethinyl estradiol (a type of estrogen) and a 120 mcg daily dose of levonorgestrel (a well-known progestin).
The patch can be worn on the abdomen, buttock or upper torso.
The approval followed a delayed decision from the FDA in November, to address questions coming from the advisory committee. It had a new action date of Feb. 16.
J&J’s Stelara shows positive action in late-stage Crohn’s study
Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceutical Companies announces positive preliminary data from a Phase 3b clinical trial, STARDUST, evaluating Stelara (ustekinumab) in patients with moderately to severely active Crohn’s disease. The results are being presented at the European Crohn’s and Colitis Organization (ECCO) Annual Congress in Vienna.
At week 16, 79% of patients achieved clinical response and 67% were in clinical remission after receiving one ~6 mg/kg intravenous dose followed by one 90 mg subcutaneous dose of Stelara.
It expects to present primary endpoint data later this year.
