RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
The U.S. should be able to distribute enough coronavirus vaccines from Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) to immunize 100M people by the end of February, which would protect the elderly, healthcare workers and people with pre-existing conditions.
There could even be more doses than expected if Johnson & Johnson’s (NYSE:JNJ) potential vaccine is authorized before then, according to Dr. Moncef Slaoui, who is leading the Trump administration’s vaccine program Operation Warp Speed.
CVS (NYSE:CVS) and Walgreens (NASDAQ:WBA) are gearing up to deliver most of the vaccine doses for the nation’s approximately 15,600 nursing homes and 29,000 assisted-living communities, but the effort will need to navigate rollout details that may vary by state.
Grim milestone… More than 100,000 people are currently sick with coronavirus in hospitals across the U.S., pushing healthcare workers to their limits.
JD Health, the healthcare unit of Chinese e-commerce giant JD.com (NASDAQ:JD), has raised $3.5B in a Hong Kong initial public offering, as the U.S. passed a law to kick Chinese companies off U.S. stock exchanges if they do not fully comply with U.S. auditing rules.
The company issued 381.9M shares priced at 70.58 Hong Kong dollars ($9.11) per share, sources told CNBC, valuing the listing at the top end of of the 62.8 Hong Kong dollars to 70.58 Hong Kong dollars marketed to investors.
JD Health is focused on online health-care services such as consultations with doctors as well as its online pharmacy. Shares are expected to start trading on Dec. 8.
JD.com itself carried out a secondary listing in Hong Kong in June and another Chinese internet firm, NetEase, pulled off a secondary listing in Hong Kong the same month.
Moderna (NASDAQ:MRNA) says participants in the Phase 1 study led by the National Institute of Allergy and Infectious Diseases of mRNA-1273, its COVID-19 vaccine candidate, retained high levels of neutralizing antibodies through 119 days following the first vaccination and 90 days following the second vaccination.
The interim Phase 1 data suggests that mRNA-1273 “can generate durable neutralizing antibodies across all age groups including in older and elderly adults,” Moderna Chief Medical Officer Tal Zaks says. “These data give us further optimism to expect that the high level of efficacy recently demonstrated by mRNA-1273 to prevent COVID-19 disease will be durable.”
The company reaffirms it expects to have 100M-125M doses available globally in Q1 2021, including 85M-100M in the U.S. and 15M-25M available outside the U.S.
The update follows Moderna’s Nov. 30 announcement that the mRNA-1273’s primary efficacy analysis of the Phase 3 study conducted on 196 cases confirmed the high efficacy observed at the first interim analysis, with the data analysis indicating a vaccine efficacy of 94.1%.
MRNA -2% post-market after soaring more than 8x so far this year.
The partnership will leverage the latter’s proprietary nuclease-targeting discovery platform with Merck’s knowhow and resources in DNA damage response (DDR), a network of cellular pathways that sense, signal and repair DNA lesions preventing the generation of potentially deleterious mutations (the most prevalent environmental DNA-damaging agent in ultraviolet light).
Merck will have exclusive global rights to develop and commercialize selected therapeutics discovered under the collaboration. It will pay Artios $30M in upfront and near-term payments, double-digit option fees on selected candidates, up to $860M in milestones per target and double-digit royalties on net sales.
Pfizer (PFE -2.1%) expects to ship only half of the COVID-19 vaccine doses this year that it originally planned due to supply chain obstacles, a near-term problem considering its ultra-cold storage requirement of minus 70 degrees Celsius. A company spokesperson stated that the headwinds were due to a later-than-expected data readout from the pivotal trial and challenges scaling up the raw material supply chain.
Ultra-cold chain requires special refrigerators for storage and dry ice for shipping, both out of the norm for the distribution of vaccines.
It expects to ship 50M doses globally by the end of the month compared to its original plan of 100M. It still expects to ship more than 1B doses in 2021. Shipments will be made from final assembly and distribution centers in Kalamazoo, MI and Puurs, Belgium.