Biotechs Move Toward First U.S. Covid-19 Vaccinations by Yearend

Cristin Flanagan

02 Oct 2020, 03:42 AM IST

(Bloomberg) -- October is a critical month in the race for a Covid-19 vaccine, with developments that could lead to some Americans getting inoculated in the final days of 2020.

Pfizer Inc. and German partner BioNTech SE this month plan to reveal late-stage results showing whether or not their two-shot regimen is effective in preventing the spread of the virus.

“This could be a key catalyst for not only the companies, but the entire market,” JPMorgan analyst Cory Kasimov said.

Another potential market-moving event comes on Oct. 22. A Food and Drug Administration advisory committee made up of outside experts is likely to review new results and updates on trial enrollments as well as hash out distribution plans. Biotech investors are waiting for the agency’s guidance on how a shot could secure an emergency use authorization before that meeting.

Vaccine Updates

While President Trump dangles the hope that a vaccine is approved before the Nov. 3 election, FDA officials have asserted the need for two months of follow-up data on study volunteers after they are inoculated before an emergency approval.

“As much as our president would like to, we’re not going to have a vaccine before the election,” said Cowen analyst Yaron Werber. Pfizer management is “messaging that they are very confident in a positive readout,” and betting that theirs is at least 60% effective, ahead of the FDA’s 50% bar for approval, Werber said. As do many others on Wall Street, he expects the U.S. will have a vaccine on an emergency basis before yearend.

Pfizer options suggest that its stock could move more than 7% between now and November, Goldman Sachs analysts led by Terence Flynn wrote in a research note. Pfizer also could potentially file for FDA approval of its vaccine this month. The stock is down almost 8% year to date.

Moderna Inc., running a close second to Pfizer in the race to a vaccine, is expected to release Phase 2 results this month and data from a 30,000-patient trial as early as November. Options are pricing in an 18% swing in Moderna’s stock between now and December, according to Goldman Sachs. Its shares have more than tripled this year.

Novavax Inc. is planning to start enrollment in its own 30,000-person vaccine study in the U.S. in mid-October.

A U.S. study of AstraZeneca Plc’s vaccine with the University of Oxford remains on hold, though European regulators plan to review those shots on a rolling basis.

Sanofi and partner Translate Bio Inc. are among the companies taking a more measured approach. They may kick off a clinical trial of a messenger-RNA vaccine before the year is out. Sanofi is also pursuing a vaccine with GlaxoSmithKline Plc that uses technology from flu shots that could be in Phase 3 testing in December.

Small-cap Arcturus Therapeutics Holdings Inc. is pursuing a single-shot messenger-RNA vaccine with first in human data from its study expected imminently.

Covid Therapies

While the Street debates the potential of a vaccine before the election, Bloomberg Intelligence analyst Sam Fazeli made the case that antibody therapies from Regeneron Pharmaceuticals Inc. and Eli Lilly & Co. could be used in a similar manner for prevention. While he questioned if these treatments should be rushed through, he said he saw potential for an emergency nod that might loosely match Trump’s promise of a vaccine.

Regeneron’s antibody cocktail, REGN-COV2, is expected to have more results in hospitalized patients this month after it reported early data late last month. Lilly’s LY-COV555 may also have new results. Meanwhile, Phase 2 results from Merck & Co.’s antiviral licensed from Ridgeback, MK-4482, are expected in October, with a larger, late-stage study starting around the same time. Options imply moves in the low to mid-single digits for the large-cap drugmakers, according to Goldman.

Vir Biotechnology Inc. may also have antibody therapy results before year-end.

Outside Covid

While vaccine and Covid-19 therapies have been the main focus for the past two quarters, the biotech-led chase for potentially lucrative new Alzheimer’s disease and cancer treatments has continued.

Biogen Inc.’s controversial Alzheimer’s treatment, aducanumab, will face an FDA panel on Nov. 6.
Updates from two competing cancer medicines known as KRAS-inhibitors are also expected; Amgen Inc.’s sotorasib should have updated lung cancer results in the fourth quarter, while Mirati Therapeutics Inc.’s MRTX849 should release updated Phase 1 results at the EORTC-NCI-AACR Symposium (Oct. 24-25)
- Citi opened up a a positive catalyst watch on Amgen on Thursday. In addition to sotorasib results, the bank was bullish on the biotech ahead of fourth-quarter data for its experimental asthma medicine, tezepelumab, and a heart failure study known as “Galactic-HF”
The American Society of Hematology meeting (Dec. 5-8) could bring key updates for biotechs including: Agios Pharmaceuticals Inc., Allogene Therapeutics Inc., Crispr Therapeutics AG, and Legend Biotech Corp.