Novavax (NASDAQ:NVAX) says it has started a phase 1 clinical trial of its coronavirus vaccine candidate code-named NVX-CoV2373, and expects to issue preliminary immunogenicity and safety results in July.
The company says it plans to enroll ~130 healthy people aged 18-59 at two sites in Australia for the phase 1 study.
If successful, Novavax would conduct a phase 2 study in multiple countries including the U.S. and in a broader age range, and would also test whether the vaccine reduces the risk of COVID-19.
Novavax CEO Stanley Erck tells WSJ that the company has started to scale up manufacturing before knowing whether the vaccine will be proven in the studies to work safely.
“Time is the most important thing here,” Erck says, adding that the company normally would have waited 6-9 months to start the buildup.
Sanofi (NASDAQ:SNY) plans to sell its equity investment in Regeneron (NASDAQ:REGN) though a public offering and related share repurchase by Regeneron.
Regeneron agrees to buy back $5B of its stock from Sanofi conditional on completion of the proposed public offering.
Sanofi expects to use the proceeds from the transactions to “further our ability to execute on our strategy to drive innovation and growth,” but didn’t say exactly what it would use the proceeds on.
Sanofi currently holds ~23.2M shares of Regeneron’s common stock, representing ~20.6% ownership.
If both the stock offering and repurchase are completed, and the underwriters fully exercise their option to buy additional shares, Sanofi will continue to own ~400,000 shares of REGN common stock.
The transactions will have no impact on the two companies’ ongoing collaboration, Sanofi said in a statement.
After restatement of Sanofi previously reported non-GAAP indicator (business net income) and change of its definition to exclude the effect of equity method accounting for Regeneron investment, Sanofi business EPS is expected to grow by ~+5% in 2020 at constant exchange rate compared to 2019 restated business EPS of €5.64, which is in line with Sanofi’s 2020 business EPS growth guidance.
Regeneron Pharmaceuticals (NASDAQ:REGN) and collaboration partner Sanofi (NASDAQ:SNY) announce positive results from Part A of a Phase 3 clinical trial evaluating Dupixent (dupilumab) in patients at least 12 years old with eosinophilic esophagitis, a chronic immune disorder in which white blood cells called eosinophils build up in the esophagus in reaction to foods, allergens or acid reflux that can lead to difficulty swallowing.
The study met both co-primary endpoints, the proportion of patients achieving a certain eosinophil count (a measure of esophageal inflammation) at week 24 and the change from baseline in a swallowing difficulty questionnaire at week 24, both versus placebo, as well as all key secondary endpoints.
No new safety signals were observed.
Detailed results will be presented at a future medical conference.
Dupixent is currently approved in the U.S. for atopic dermatitis, asthma and nasal polyposis.
Vaxcyte (PCVX) has filed a preliminary prospectus for a $100M IPO.
The Foster City, CA-based vaccine developer, formerly known as SutroVax, boasts a lineup of six programs, led by VAX-24, a 24-valent pneumococcal conjugate vaccine (PCV) that, it says, provides the broad-spectrum coverage of Merck’s (NYSE:MRK) Pneumovax 23 (pneumococcal vaccine polyvalent) with an immunogenicity profile on par with Pfizer’s (NYSE:PFE) Prevnar 13 [pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)]. Candidate #2, VAX-XP, is designed to expand the breadth of pneumococcal coverage to 30 strains.
2019 Financials: Operating Expenses: $54.2M (+53%); Net Loss: ($50.3M) (-71%); Cash Burn: ($47.1M) (-54%).
The Empire State allows sports leagues, campgrounds, and veterinarian offices to reopen with modifications.
Professional sports leagues now get the go-ahead to start training camps, New York Governor Andrew Cuomo said during his daily press conference.
“I believe that sports that can come back, without having people in the stadium, without having people in the arena, do it,” he said.
He also advised people not to relax social distancing of mask wearing practices.
The Yankees and Mets were reportedly considering starting spring training in Florida, but the announcement offers the option of the teams training at their stadiums in the Bronx and Queens..
New York state has had more than 361K confirmed COVID-19 cases out of the U.S.’s 1.64M and 29,141 deaths out of the country’s 97,679 deaths from the virus.
