Pfizer Said It Is Likely To File For Emergency Use Authorization For Its COVID-19 Vaccine At The End Of November

Plus, stimulus negotiations are making little progress, Boeing shares are up after Europe’s top aviation official said the 737 MAX could return to the skies in the region before the end of the year, and Navistar shares are up on reports that it has agreed to a deal to merge with Traton.

Stocks were higher to start Friday with the Dow adding 308 points, or 1.1%. The S&P 500 gained 0.8%, while the Nasdaq traded 0.9% higher.

Pfizer said this morning that it may file for emergency authorization for its COVID-19 vaccine it has developed with BioNTech by late November, making it unlikely a vaccine will be available before the presidential election early next month. Safety reviews will dictate the timeline, with the FDA requiring that at least half the people in the study be watched for side effects for two months, a milestone Pfizer CEO Alert Bourla said should be achieved in the third week of November. “Let me be clear, assuming positive data, Pfizer will apply for emergency authorization use in the U.S. soon after the safety milestone is achieved in the third week of November,” Bourla said in a statement. “All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.”

In other coronavirus news, the World Health Organization said that a study showed that Gilead’s remdesivir, along with three other potential drug treatments for the coronavirus, has “little or no effect” on 28-day mortality rates among hospitalized patients. The WHO’s Solidarity Therapeutics Trial, said to be the world’s largest randomized control trial of coronavirus treatments, released interim results on Thursday. Those results indicated that remdesivir, hydroxychloroquine, lopinavir/ritonavir, and interferon drug treatment regimens “appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.” The randomized study included 11,266 patients across 405 hospitals in 30 countries. “No study drug definitely reduced mortality (in unventilated patients or any other subgroup of entry characteristics), initiation of ventilation or hospitalization duration,” the authors of the study wrote. Gilead questioned the findings, saying the test data had “not undergone the rigorous review required to allow for constructive scientific discussion, particularly given the limitations of the trial design.”

House Speaker Nancy Pelosi told Democratic colleagues that divides persist with the White House over stimulus negotiations, even as an agreement nears on a coronavirus testing program. Pelosi has been pushing for the establishment of a national testing strategy, and has said it has been a roadblock during talks with Treasury Secretary Steven Mnuchin. After a call with Pelosi yesterday, Mnuchin said the administration would only make minor edits to a Democratic proposal on such a strategy. Still, “Many other disagreements remain,” Pelosi said in a note to colleagues sent last night. “These include but are not limited to funding for state and local government, tax benefits for working families, support for vulnerable small businesses, and child care funding.” Also on Thursday, President Donald Trump said he was prepared to go beyond the $1.8 trillion his team has offered to Pelosi, who favors a $2.2 trillion plan. But Senate Majority Leader Mitch McConnell said that Trump is “talking about a much larger amount than I can sell to my members,” and will instead push a vote next week on a bill for roughly $500 billion to aid an economy still reeling from pandemic-induced shutdowns. That amount is “what we think is appropriate to tackle this dread disease,” McConnell said.

Boeing shares are up 3% this morning after Europe’s top aviation regulator said he’s satisfied that changes to the 737 MAX have made the plane safe enough to return to the region’s skies before the end of 2020, even as a further upgrade his agency demanded won’t be ready for up to two years. Patrick Ky, executive director of the European Union Aviation Safety Agency, said the EASA is performing final document reviews ahead of a draft airworthiness directive it expects to issue next month after completing test flights in September. “Our analysis is showing that this is safe, and the level of safety reached is high enough for us,” Ky said in an interview. “What we discussed with Boeing is the fact that with the third sensor, we could reach even higher safety levels.”

And Navistar shares are up more than 20% today on news that it and its German counterpart Traton are trying to salvage their deal to merge. CNBC reported Traton is nearing a deal to buy Navistar for $44.50 a share, which is up from the $35 per share it offered in January and the $43 offered in September. The American heavy-duty truck maker rejected both bids, pushing Navistar shares lower. The two companies have been in long-term negotiations, and have reportedly verbally agreed to the $44.50 offer and are prepared to move forward with a deal.

Stocks We’re Watching

Cambium Networks Corp (NASDAQ: CMBM): Cambium Networks shares are up 15% this morning after announcing this week that it supplying Tizeti Network Limited, Nigeria’s leading public Wi-Fi operator, with an end-to-end wireless fabric solution. “Tizeti is at the vanguard of the data communications revolution sweeping across Africa,” said Martín de la Serna, Cambium Networks’ Regional Vice President of Europe, Middle East, and Africa. “With their highly capital-efficient business model, Tizeti has rapidly deployed a complete Cambium wireless fabric solution in record time and under budget. We look forward to supporting their ongoing acceleration across Nigeria, Ghana, and beyond.”

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