October is a critical month in the race for a Covid-19 vaccine, with developments that could lead to some Americans getting vaccinated in the final days of 2020.
Pfizer Inc. and German partner BioNTech SE plan this month to reveal the results of the last stage showing whether or not their two-injection regimen is effective in preventing the spread of the virus.
“This could be a key catalyst not just for companies, but for the entire market,” said JPMorgan analyst Cory Kasimov.
Another potential market movement event will occur on October 22. An advisory committee of the Food and Drug Administration made up of outside experts is likely to review new results and updates on trial registrations, as well as distribution plans. Investors in biotech are awaiting guidance from the agency on how an injection could secure an emergency use authorization before that meeting.
Vaccine updates
While President Trump is hopeful that a vaccine will be approved before the Nov. 3 election, FDA officials have affirmed the need for two months of follow-up data on study volunteers after they get vaccinated before an emergency approval.
“As much as our president would like, we are not going to have a vaccine before the election,” said Cowen analyst Yaron Werber. Pfizer management is “sending a message that they have a lot of confidence in a positive reading” and betting that theirs is at least 60% effective, ahead of the FDA’s 50% approval bar, Werber said. . Like many others on Wall Street, he hopes the United States has an emergency vaccine before the end of the year.
Pfizer’s options suggest its shares could move more than 7% between now and November, Goldman Sachs analysts led by Terence Flynn wrote in a research note. Pfizer could also request FDA approval of the vaccine this month. The shares are down nearly 8% so far this year.
Moderna Inc., almost second to Pfizer in the race for a vaccine, is expected to release Phase 2 results this month and data from a 30,000-patient trial in early November. Options are trading in an 18% swing in Moderna shares between now and December, according to Goldman Sachs. Its shares have more than tripled this year.
Novavax Inc. plans to begin enrolling in its own vaccine study of 30,000 people in the US in mid-October.
A US study of AstraZeneca Plc’s vaccine with the University of Oxford remains on hold, although European regulators plan to review those vaccines on an ongoing basis.
Sanofi and its partner Translate Bio Inc. are among the companies that take a more measured approach. They can start a clinical trial of a messenger RNA vaccine before the year is out. Sanofi is also seeking a vaccine with GlaxoSmithKline Plc that uses flu vaccine technology that could be in phase 3 testing in December.
Small-cap Arcturus Therapeutics Holdings Inc. is seeking a single-shot messenger RNA vaccine and the first human data from its study is expected to be imminent.
Covid Therapies
As The Street debated the potential for a pre-election vaccine, Bloomberg Intelligence analyst Sam Fazeli argued that antibody therapies from Regeneron Pharmaceuticals Inc. and Eli Lilly & Co. could be used in similar ways for prevention. While he questioned whether these treatments should be rushed, he said he saw the possibility of an emergency nod that could loosely coincide with Trump’s promise of a vaccine.
Regeneron’s antibody cocktail, REGN-COV2, is expected to do more in hospitalized patients this month after it reported the first data late last month. Lilly’s LY-COV555 may also have new results. Meanwhile, Phase 2 results of Ridgeback’s licensed Merck & Co. antiviral, MK-4482, are expected in October, with a larger study in the latter phase starting around the same time. Options involve low to mid single digit moves for large-cap pharmaceuticals, according to Goldman.
Vir Biotechnology Inc. may also have antibody therapy results before the end of the year.
Outside of Covid
While vaccine therapies and Covid-19 have been the main focus for the past two quarters, the biotech-led pursuit of potentially lucrative new treatments for Alzheimer’s disease and cancer has continued.
- Biogen Inc.’s controversial Alzheimer’s treatment aducanumab will face an FDA panel on November 6.
- Updates are also expected for two competing cancer drugs known as KRAS inhibitors; Amgen Inc.’s sotorasib should have updated fourth-quarter lung cancer results, while Mirati Therapeutics Inc.’s MRTX849 should publish updated Phase 1 results at the EORTC-NCI-AACR Symposium (24-25 October)
- Citi opened a positive catalyst watch at Amgen on Thursday. In addition to the sotorasib results, the bank was optimistic about biotechnology ahead of the fourth quarter data for its experimental asthma drug tezepelumab and a heart failure study known as “Galactic-HF.”
- The American Hematology Society meeting (December 5-8) could bring key updates for biotech companies, including: Agios Pharmaceuticals Inc., Allogene Therapeutics Inc., Crispr Therapeutics AG, and Legend Biotech Corp.
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