CVS Health (NYSE:CVS) expects FY20 Adj. EPS of $7.14-$7.27 – same as previously expected, but at the midpoint shy of consensus forecasts for $7.23.
GAAP EPS guidance is trimmed from $5.59-$5.72 to $5.16-$5.29, thanks to charges on early payback of debt in Q3.
Cash flow from operations is still seen at $11B-$11.5B.
The company is presenting later today at the Morgan Stanley Global Healthcare Conference. Webcast here.
Novavax (NASDAQ:NVAX) has amended its agreement with Serum Institute of India Private Limited (SIIPL), under which the latter will manufacture the antigen component of COVID-19 vaccine candidate NVX-CoV2373. The deal increases manufacturing capacity to more than 2B doses annually when all planned changes are implemented by mid-2021.
NVAX says the antigen component is being made at its site in Bohumil, Czech Republic, plus six other locations, including SIIPL.
The Matrix-M adjuvant is being made at three locations, including its site in Uppsala, Sweden.
The FDA designates Gilead Sciences’ (NASDAQ:GILD) magrolimab a Breakthrough Therapy for the treatment of newly diagnosed myelodysplastic syndromes, a group of cancers in which immature blood cells in the bone marrow do not mature. It also has Fast Track status for the indication.
Magrolimab, acquired in its $4.9B takeover of Forty Seven in April, is a humanized IgG4 monoclonal antibody that binds to a certain CD47 receptor on immune cells called macrophages. Blocking the receptor eliminates the way cancer cells avoid being killed by these cells.
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.
A Phase 3 clinical trial, EMPACT-MI, is in process.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
The company is developing and commercializing the product, along with others, with Boehringer Ingelheim under a 2011 agreement.
“Nano-X (NASDAQ:NNOX) is the most blatant stock promotion we have seen in years,” says Andrew Left.
“The company has valued themselves at less than $1 per share. SEC should investigate false claims. No R&D, no FDA and no product, yet trades at over $2B market cap.”
Left’s target price: $0.
The company one month ago raised about $160M in its IPO, and proceeded to more than double in value shortly thereafter. Shares have been heading sharply lower since peaking above $65 late last week.
https://seekingalpha.com/news/3614142-nano-x-slides-citron-takes-aim-blatant-stock-promotion-seen
In an interview yesterday during the Morgan Stanley Healthcare Conference, Moderna (MRNA +4.6%) CEO Stéphane Bancel said its large-scale 30K-subject Phase 3 study had enrolled 23,497 participants as of Friday, September 11. A “significant” number have received the second shot so the base plan for data readouts is November with an upside of next month.
The enrollment rate has been slowed down to ensure robust diversity which was only 27% of target as of September 11.
Will transition into a pediatric setting after the FDA signs off on the safety profile in adults.
Neutralizing antibody responses similar in young adults, those aged 56-70 and 71+.
Production plan remains a firm 500M doses in 2021 with an upside to 1B. GMP space is not a problem. Additional capital equipment should be delivered soon. Unclear, at this time point, whether it can procure enough raw materials to make 1B doses next year. 800M doses may be more realistic.
Vaccine is stored at minus 20 degrees Celsius (many vaccines are minus 17). No on-site dilution required.
Bayer (OTCPK:BAYRY +2.3%) has settled thousands more U.S. lawsuits over its Roundup weedkiller, according to new court filings, following criticism that the company was failing to uphold an $11B deal it announced in June to resolve the litigation.
The latest settlements resolve ~15K U.S. lawsuits, Bloomberg reports, which says the value of the settlements was not disclosed; added to the 32K settlements previously disclosed by mediator Ken Feinberg, Bayer has resolved at least 47K of the suits but still faces 125K filed and unfiled Roundup claims.
Bayer last week extended the contract of CEO Werner Baumann, in a sign of continuity as the company works its way through the many lawsuits; Bayer also said it was making progress with plaintiff attorneys.
https://seekingalpha.com/news/3614219-bayer-settles-thousands-roundup-lawsuits-bloomberg
