White House says Trump 'not incapacitated,' working from isolation

The White House tried to reassure Americans on Friday that President Donald Trump was still working from isolation, after his bombshell announcement that he had caught the coronavirus threw the administration and presidential election campaign into uncertainty.

Trump, who has played down the threat of the coronavirus pandemic from the outset, said he and his wife Melania had tested positive for the deadly virus and were going into quarantine.

Trump is experiencing “mild symptoms” of COVID-19, a White House official said according to the Associated Press and the New York Times. Two people familiar with his condition told the Times they were cold-like symptoms.

Wall Street tumbled at news of one of the biggest health scares involving an American president for decades, with the S&P 500 plunging more than %1.5 at the opening.

“The president is not incapacitated. He is actually working from the residence,” a senior White House official said.

https://www.reuters.com/article/us-health-coronavirus-usa-trump/white-house-says-trump-not-incapacitated-working-from-isolation-pence-negative-idUSKBN26N0K4

C4 Therapeutics prices upsized IPO above range at $19

• C4 Therapeutics (CCCC) has priced its upsized IPO of 9.6M shares of common stock at $19/share, for gross proceeds of $182.4M.
• The company initially planned to offer 8.824M shares at a price range of $16-$18.
• Underwriters' over-allotment is an additional 1.44M shares.
• Trading commences October 2. Closing date is October 6.
• https://seekingalpha.com/news/3619267-c4-therapeutics-prices-upsized-ipo-above-range-19
  

AstraZeneca’s Farxiga nabs accelerated review in U.S. for kidney disease

• The FDA has granted Breakthrough Therapy Designation to AstraZeneca’s (NASDAQ:AZN) Farxiga for the treatment of patients with chronic kidney disease, with and without type-2 diabetes.
• Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
• https://seekingalpha.com/news/3619311-astrazeneca-s-farxiga-nabs-accelerated-review-in-u-s-for-kidney-disease
  
  

Study of AstraZeneca COVID-19 vaccine resumes in Japan

• Following a review of safety data by an independent committee, a Phase 3 clinical trial evaluating AstraZeneca's (NASDAQ:AZN) COVID-19 vaccine candidate, AZD1222, has resumed in Japan following earlier restarts in the U.K., Brazil, South Africa and India.
• The U.S. study has yet to resume.
• https://seekingalpha.com/news/3619310-study-of-astrazeneca-covidminus-19-vaccine-resumes-in-japan
  

FDA OKs emergency use of LabCorp RNA extraction method for coronavirus test

The FDA has signed off on emergency use of LabCorp's (NYSE:LH) high-throughput method using heat and technology to extract RNA from swab samples for SARS-CoV-2 molecular testing. The company says the heat extraction process, which eliminates the need for RNA extraction reagents, improves the speed and efficiency of real-time polymerase chain reaction (RT-PCR) tests.

https://seekingalpha.com/news/3619319-fda-oks-emergency-use-of-labcorp-rna-extraction-method-for-coronavirus-testing

Bristol to present late-stage results on ulcerative colitis med ozanimod Oct. 12

• Bristol Myers Squibb (NYSE:BMY) will host a virtual investor event on Monday, October 12, at 8:00 am ET to discuss results from a Phase 3 clinical trial, True North, evaluating Zeposia (ozanimod) in patients with moderate-to-severe ulcerative colitis. In June, it announced that the study met both primary endpoints and key secondary endpoints.
• The data are being virtually presented at United European Gastroenterology Week.
• Ozanimod is an oral, once-daily selective sphingosine 1-phosphate 1 and 5 receptor modulator being developed for the treatment of autoimmune diseases. It diminishes the activity of autoreactive lymphocytes (white blood cells), which is the cause of many types of autoimmune disorders. BMY unit Celgene obtained the rights to the drug via its $7.2B acquisition of Receptos. It was approved in the U.S. in March for relapsing forms of multiple sclerosis.
• https://seekingalpha.com/news/3619333-bristol-myers-to-present-late-stage-results-on-ulcerative-colitis-med-ozanimod-october-12
  

Protalix Bio launches expanded access program for Fabry Disease med

• Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., and Protalix BioTherapeutics (NYSEMKT:PLX) announce the launch of an Expanded Access Program (EAP) in the U.S. for pegunigalsidase alfa for the proposed treatment of Fabry disease, a rare inherited disorder characterized by the buildup of a type of fat in the body's cells due to the absence or dysfunction of an essential enzyme called alpha-galactosidase A.
• A BLA for pegunigalsidase alfa is currently under review by the FDA. This EAP will run concurrently with Protalix’s ongoing Phase III clinical program.
• Patients participating in the EAP will receive infusions of pegunigalsidase alfa every two weeks at 1mg/kg body weight. Information related to adverse events and other limited data will be collected from participants.
• https://seekingalpha.com/news/3619377-protalix-bio-launches-expanded-access-program-for-pegunigalsidase-alfa-for-fabry-disease-in-u