San Diego Union-Tribune

BIOTECH STOCKS READY FOR MORE COVID-19 RESULTS

Momentum rising ahead of first quarter of 2021

- BY CRISTIN FLANAGAN Flanagan writes for Bloomberg News.

Potential approval of an Alzheimer’s medicine, new gene therapy data and more late-stage clinical trial results for COVID-19 vaccines will keep momentum up for biotech stocks in the next three months.

The benchmark Nasdaq Biotech Index has climbed 26 percent this year, compared with a 15 percent gain in the S&P 500 Index, pointing to no let-up in marketmovi­ng drug trial data even during the pandemic.

While the index hit a bump this week amid worries of delays in distributi­on of the two U.S.-approved inoculatio­ns, investors are on the lookout as a second group of vaccine developers race to test shots, including those from Novavax, Johnson & Johnson and partners GlaxoSmith­Kline and

Sanofi.

After Novavax’s 30-fold stock surge this year, the first late-stage results from its shot developed using

armyworm moth cells will be among the most watched. Data from the U.K. trial showing 90 percent or greater efficacy with a better safe

ty profile could send shares soaring to $300, according to B Riley analyst Mayank Mamtani. The stock closed Wednesday at $118.96.

Efficacy of 80 percent or lower would be the bear case for Novavax’s vaccine and that could beat back shares by about 45 percent, according to Mamtani’s analysis. The emergency authorized jabs from Moderna along with Pfizer and its German partner, BioNTech, have demonstrat­ed rates above 90 percent.

Also top of mind will be updates from leading vaccine makers GlaxoSmith­Kline and Sanofi. Investors will be looking for progress

from the pair after disappoint­ing data about their experiment­al shot in older people led them to delay the start of advanced trials earlier this month.

Johnson & Johnson said it expects interim results for its one-shot regimen by the end of January. “If J&J can establish themselves as a viable competitor with one injection, that’s a very meaningful event for the stock and also for the other COVID players,” said Jared Holz, a Jefferies health-care equity strategist. He likened the euphoric trading in vaccine stocks to Bitcoin mania.

Vaccine distributi­on and production will be key and could have an impact on broader sentiment outside biopharma, as could continued positive data from new shots, said Peter Hughes, a fund manager at AXA Investment Managers.

One of the most binary single-stock events of the quarter will be results from Sarepta Therapeuti­cs’s gene therapy for Duchenne muscular dystrophy. Results from “Study 102” are expected as early as January.

“This could be the first time we really see signs of efficacy,” Hughes said in a phone interview. Early data suggest the gene therapy is generating a key protein in combating the disease, microdystr­ophin. The results should answer “if that expression of microdystr­ophin translates into functional benefits for patients,” he said.

Positive data could send the stock soaring 45 percent, according to analysis from Cowen’s Ritu Baral. Sarepta has gained 33 percent this year.

Expectatio­ns are low for Biogen’s controvers­ial medicine for Alzheimer’s disease after an advisory committee advised the Food and Drug Administra­tion against approving the drug known as aducanumab.

There are no approved treatments that can slow the spread of the brain-destroying disease. While the agency tends to heed the panel’s advice, positive briefing documents and safety data could drive the FDA to go against the recommenda­tion, according to Paul Matteis, an analyst at Stifel.

“This situation is unpreceden­ted,” he wrote in a research note. A regulatory nod could drive the shares up to about $350 while failure to win approval could send them lower to about $180. Biogen closed Wednesday at $243.58.

A surprise approval could also be another positive catalyst for the whole biotech sector, according to AXA’s Hughes.

 ?? COURTESY PHOTO ?? An experiment­al COVID-19 vaccine made by Novavax is administer­ed to a health volunteer.
COURTESY PHOTO An experiment­al COVID-19 vaccine made by Novavax is administer­ed to a health volunteer.

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