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Daniel Acker / Bloomberg
Shares of the large pharmaceutical company Pfizer continue to rise one day after the company revealed promising and detailed data on a trial of its experimental vaccine Covid-19. Analysts said the highly aggressive timeline the company outlined on Wednesday was exciting, but far from certain.
Shares of Pfizer (PFE) rose 2.4% on Thursday morning, after rising 3.2% on Wednesday. Shares of BioNTech (BNTX), a partner with Pfizer in the program, rose 7.3% on Thursday morning, after falling 3.9% on Wednesday.
“The biggest revelation, and surprise, from the conference calls from the two companies was the suggestion that core trials could open in July, and then be recruited in full in August, and then have provisional efficacy data in September.” , wrote Daina, an analyst at SVB Leerink. Graybosch in a note Thursday. “The ambition of this timeline is laudable, but it seems challenging.”
RBC Capital Markets analyst Randall Stanicky wrote that the positive data and the proposed timeline “amplify a catalyst for a stock that has experienced a pullback.”
Pfizer shares have fallen 13.9% so far this year. The stock is trading at 12.6 times expected earnings in the next 12 months, below its five-year average of 13.4 times. Analysts mingle in the action: of the 16 FactSet tracked that follow, half rate it as Hold, while half rate it as Buy.
BioNTech shares, meanwhile, are up 89.3% this year. Five of the seven analysts who cover it rate it as Hold, according to FactSet.
Pfizer and BioNTech said Tuesday morning that patients who received their experimental low and medium dose Covid-19 vaccine developed levels of neutralizing antibodies that were approximately twice as high as those found in patients who had recovered from infections with Covid-19.
In a call to investors, Mikael Dolsten, president of global research and development at Pfizer, said that a Phase 2b / 3 study the company hopes to start this month could end up recruiting patients in late August or early September, and the company could seek approval from the Food and Drug Administration in late October.
The FDA released a guide earlier this week for vaccine developers that some analysts had taken to indicate that the agency would not be willing to even give an emergency use authorization to a vaccine before next year. But Pfizer’s timeline suggests that the company may disagree.
“Given Pfizer’s experience with running large vaccine trials, companies believe they can enroll in the core trial in four weeks and have data in late August / early September before a possible regulatory filing in October,” he wrote. Mizuho analyst Vamil Divan in a note. on Wednesday.
“While meeting those deadlines would be unprecedented in vaccine development, companies believe they can achieve this and still meet the requirements of the recently released FDA guideline on the development of the COVID-19 vaccine.”
SVB Leerink’s Graybosch remains uncertain. “While an increase in clinical operations and increased transmission of COVID-19 may produce efficacy results in 4Q2020, we are skeptical that the FDA will approve the vaccine for wide use until longer safety data is collected. term, “he wrote.
Write to Josh Nathan-Kazis at [email protected]
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