Shares of the big pharma firm
continue to climb a day after the company unveiled promising, and detailed, data on a trial of its experimental Covid-19 vaccine. Analysts said that the highly aggressive timeline the company spelled out Wednesday was exciting, but far from a sure thing.
Shares of Pfizer (PFE) were up 2.4% Thursday morning, after climbing 3.2% on Wednesday. Shares of
(BNTX), Pfizer’s partner on the program, were up 7.3% Thursday morning, after falling 3.9% on Wednesday.
“The biggest disclosure, and surprise, from the two company’s conference calls, was the suggestion that the pivotal trials might open in July, and then be fully recruited in August, and then have interim efficacy data in September,” wrote SVB Leerink analyst Daina Graybosch in a note out Thursday. “The ambition of this timeline is laudable, but seems challenging.”
RBC Capital Markets analyst Randall Stanicky wrote that the positive data, and the proposed timeline, “amplifies a catalyst for a stock that has seen a pullback.”
Shares of Pfizer are down 13.9% so far this year. The stock trades at 12.6 times earnings expected over the next 12 months, below its five-year average of 13.4 times. Analysts are mixed on the stock: Of the 16 tracked by FactSet who follow it, half rate it a Hold, while half rate it a Buy.
BioNTech shares, meanwhile, are up 89.3% this year. Five of the seven analysts who cover it rate it a Hold, according to FactSet.
Pfizer and BioNTech said Tuesday morning that patients who received its experimental Covid-19 vaccine at low and midlevel doses developed levels of neutralizing antibodies that were roughly two times higher than those found in patients who had recovered from Covid-19 infections.
On an investor call, Mikael Dolsten, Pfizer’s president of world-wide research and development, said that a Phase 2b/3 study that the company expects to begin this month could finish recruiting patients by late August or early September, and that the company could file for Food and Drug Administration approval in late October.
The FDA released guidance early this week for vaccine developers that some analysts had taken to indicate that the agency would be unwilling to even give emergency-use authorization to a vaccine before next year. But Pfizer’s timeline suggests the company may disagree.
“Given Pfizer’s experience with running large vaccine trials, the companies believe they can enroll the pivotal trial in four weeks and have data in the late August/early September ahead of a potential regulatory filing in October,” Mizuho analyst Vamil Divan wrote in a note on Wednesday.
“While achieving those timelines would be unprecedented in vaccine development, the companies believe they may be able to accomplish this and still meet the requirements of the recently-released FDA guidance on COVID-19 vaccine development.”
SVB Leerink’s Graybosch remains uncertain. “Though a lift in clinical operations and increasing COVID-19 transmission may yield efficacy results in 4Q2020, we are skeptical FDA will approve the vaccine for broad use until longer-term safety data is collected,” she wrote.
Write to Josh Nathan-Kazis at email@example.com