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Monday, February 3, 2020

Coronavirus outbreak-related actions rippling through global economy

The effects of the coronavirus outbreak in China, specifically the actions taken by governments and certain private sector companies to contain the spread of the respiratory ailment, are being felt across a wide swath of the globe’s economy.
Governments in the U.S., Europe and Asia have restricted visitors to China while returning citizens are screened (mostly for high temperatures) for potential infection.
Major airlines, including American, United and Delta, have suspended flights to China.
Pharmaceutical, financial and tech companies are pulling out expatriate employees.
Apple plans to close all of its stores and corporate offices in China through February 9. It is also dealing with work stoppages at factories that produce components for its wares sold around the world.
Levi Strauss & Co., McDonald’s and Starbucks have closed thousands of outlets around China, in part to comply with the government’s request for people to remain off the streets.
The demand for crude oil has dropped, leading to a 16% tumble in prices since the outbreak was announced (China is the world’s largest importer). Refinery use plummeted 15% last week alone.
Chinese markets dropped sharply on Monday after reopening for the first time since January 23. The benchmark Shanghai Composite Index was off 7.7%, its steepest one-day decline since August 2015.
Many global firms are cueing their actions from the World Health Organization (WHO) which declared the outbreak a public health emergency last week despite it being less deadly than SARS and still largely confined to Wuhan (there have been ~140 reported cases in ~20 ex-China countries thus far).
About 14,500 Chinese have been infected to date, although this figure is certainly underreported, with ~700 deaths. For comparison purposes, the flu epidemic in the U.S. in 2017/18 infected 48M Americans and killed 61K.
https://seekingalpha.com/news/3537193-coronavirus-outbreak-related-actions-rippling-through-global-economy

GW Pharma files U.S. application for expanded use of Epidiolex

GW Pharmaceuticals (NASDAQ:GWPH) has filed a supplemental marketing application in the U.S. seeking approval to use Epidiolex (cannabidiol) oral solution to treat seizures associated tuberous sclerosis complex, a rare inherited disorder characterized by the growth on non-cancerous tumors in many parts of the body.
The FDA approved Epidiolex in June 2018 for Lennox-Gastaut syndrome and Dravet syndrome.
https://seekingalpha.com/news/3537202-gw-pharma-files-u-s-application-for-expanded-use-of-epidiolex

Catalent +2% premarket on raising guidance and revenue beat

Catalent (CTLT) Q2 results: Revenues: $721.4M (+15.8%).
Net Income: $34.3M (-30.0%); EPS: $0.23 (-30.3%); non-GAAP Net Income: $72M (+10.1%); non-GAAP EPS: $0.45 (unch); CF Ops: $145.9M (+72.7%).
FY 2020 Guidance: Revenue: $2.87B – 2.95B from $2.78B – 2.88B; non-GAAP Net Income: $307M – 331M from $300M – 330M; non-GAAP EBITDA: $711M – 735M from $700M – 730M.
Shares are up 2% premarket.
https://seekingalpha.com/news/3537205-catalentplus-2-premarket-on-raising-guidance-and-revenue-beat

Clovis Oncology’s Rubraca now available in France; shares up

Clovis Oncology (NASDAQ:CLVS) announces that Rubraca (rucaparib), an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 is now available and reimbursed in France.
Rubraca is an option for monotherapy maintenance treatment for adults with relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy.
With Rubraca now available in France, it is now a treatment option for eligible patients in Germany, England and Italy.
Shares are up 4% premarket.
https://seekingalpha.com/news/3537241-clovis-oncologys-rubraca-now-available-in-france-shares-up-4-premarket

Insmed up 48% premarket on positive INS1007 data

Insmed (NASDAQ:INSM) jumps 48% premarket on increased volume in reaction to positive results from a Phase 2 clinical trial, WILLOW, evaluating INS1007 in adults with non-cystic fibrosis bronchiectasis (NCFBE).
Both doses tested (10 mg and 25 mg) met the primary endpoint of time to first pulmonary exacerbation over a 24-week treatment period compared to placebo. A key secondary endpoint, frequency of pulmonary exacerbations, was also met.
On the safety front, INS1007, an inhibitor of an enzyme called dipeptidyl peptidase 1 (DPP1), was generally well-tolerated. The rates of adverse events in the 10 mg, 25 mg and placebo arms leading to discontinuation were 7.4%, 6.7% and 10.6%, respectively. The most common treatment-related adverse events were cough, headache, sputum increase, dyspnea, fatigue and upper respiratory tract infection.
Adverse events of special interest were periodontal disease (7.4% and 10.1% and 2.4%, respectively), hyperkeratosis (thickening of the skin’s outer layer) (3.7%, 1.1% and 0%, respectively) and infection rates (16.0%, 16.9% and 18.8%, respectively).
Detailed results will be submitted for presentation at a future medical conference and will be discussed during the company’s upcoming Q4 earnings call.
https://seekingalpha.com/news/3537247-insmed-up-48-premarket-on-positive-ins1007-data

FDA accepts Merck application for expanded use of Recarbrio

The FDA has accepted for review Merck’s (NYSE:MRK) supplemental marketing application seeking approval to use combo antibiotic Recarbrio (imipenem, cilastatin and relebactam) to treat adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative microorganisms.
The agency’s action date is June 4.
The FDA approved Recarbrio in June 2019 for complicated urinary tract and complicated intra-abdominal bacterial infections.
https://seekingalpha.com/news/3537216-fda-accepts-merck-application-for-expanded-use-of-recarbrio

Anavex up 12% premarket on Fast Track of lead candidate for Rett syndrome

Anavex Life Sciences (NASDAQ:AVXL) is up 12% premarket on average volume in response to its announcement that the FDA has designated AVAVEX 2-73 (blarcamesine) for Fast Track review for the treatment of Rett syndrome, a rare inherited neurological disorder occurring primarily in girls.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
Phase 2 studies (AVATAR and 001) are ongoing.
https://seekingalpha.com/news/3537211-anavex-up-12-premarket-on-fast-track-of-lead-candidate-for-rett-syndrome