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Moderna Shares Under Pressure as Flu Vaccine Fails to Meet All Endpoints

By Shane NeagleStock MarketsFeb 21, 2023 18:55
ng.investing.com/analysis/moderna-shares-under-pressure-as-flu-vaccine-fails-to-meet-all-endpoints-154540
Moderna Shares Under Pressure as Flu Vaccine Fails to Meet All Endpoints
By Shane Neagle   |  Feb 21, 2023 18:55
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Biotech company Moderna (NASDAQ:MRNA) is seeing its shares trade under pressure in recent days after the company reported last week Phase 3 trial results for its flu vaccine candidate, mRNA-1010, in adults older than 18 years.

The interim findings suggest that the vaccine “achieved superiority on seroconversion rates for A/H3N2 and A/H1N1, as well as superiority on geometric mean titer ratios for A/H3N2 and non-inferiority on geometric mean titer ratios for A/H1N1,” Moderna said in the press release.

Mixed Phase 3 Results

The vaccine candidate failed to meet the endpoints for the influenza B/Victoria- and B/Yamagata-lineage strains, sending its shares tumbling late last week. Moderna President Dr. Stephen Hoge said the interim results signaled a crucial advancement in the development of mRNA-based influenza vaccines, with the company feeling “encouraged by the safety and the tolerability profile.”

He noted that these viruses are responsible for the majority of flu-related illnesses in older adults, with the ongoing pivotal Phase 3 efficacy tests set to determine the efficacy of the vaccine.

While Moderna could not reach non-inferiority for the Influenza B strains, which are more prevalent in younger populations, the biotech firm “already updated the vaccine that we believe could improve immune responses against Influenza B” and plans to confirm those developments as soon as possible in the next clinical study, Dr. Hoge noted.

Analysts at Goldman Sachs said the mixed trial results are likely to raise concerns over mRNA-1010’s regulatory outlook, though the flu vaccine demonstrated a "well-tolerated profile."

"We emphasize that A strains account for >99% of positive flu tests by clinical laboratories this season and thus the more positive profile against these strains may bode well into the interim analysis from the separate Ph3 efficacy study expected by the end of 1Q," the analysts said in a note.

More Positive RSV Results

The results for Moderna’s flu vaccine candidate came a month after Moderna said its mRNA-1345 vaccine targeting respiratory syncytial virus (RSV) proved to be effective at treating the disease in older persons.

According to the findings, mRNA-1345 was almost 84% effective at preventing lower respiratory tract disease in patients aged 60 and older that had two or more symptoms. In addition, the vaccine was 82.4% effective in patients that had three or more symptoms. Moderna said there were no safety issues that emerged during the trials, which saw participation from around 37,000 people across 22 countries.

The Boston-based biotech company intends to file an application to get the vaccine approved by the Food and Drug Administration (FDA) in the first half of 2023. At the moment, there are no FDA-approved vaccines for RSV.

The virus kills between 6,000 and 10,000 older adults each year, while 60,000 to 120,000 people get hospitalized on an annual basis, according to data from the Centers for Disease Control and Prevention.

The number of RSV infections spiked significantly in the fall in the U.S. as children and older adults stopped exercising public health measures implemented to prevent the spread of the devastating coronavirus pandemic over the past two years.

The RSV vaccine developed by Moderna utilizes the same RNA technology as the company’s COVID jabs, which had one of the best efficacy rates among all vaccines. Moderna’s success during the COVID-19 chaos turned the company into a globally-recognized name and helped it achieve substantial profits, however, the vaccine remains its only commercially available product, with a waning demand.

Now the biotech company faces a challenge to prove that its other products can also achieve success on a global level. The Wall Street giant Morgan Stanley values the market for an adult RSV shot between $7 billion and $10 billion.

More Near-term Challenges

Meanwhile, Moderna is bracing for its legal battle against the U.S.-based rival Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ:BNTX) over their rival COVID-19 jabs. The trial, which is set to have a preliminary hearing later this week, is scheduled for April 2024 at London’s High Court.

Pfizer and BioNTech filed a lawsuit against Moderna last September in an effort to revoke two of its patents related to its messenger mRNA vaccines. Later that month, Moderna filed its own lawsuit over Pfizer and BioNTech’s Comirnaty vaccine, citing alleged infringement of its patents.

Last week, the U.S. Department of Justice (DoJ) voiced its support for Moderna, saying it is the government that should face a patent lawsuit over the coronavirus vaccine, not the Cambridge-based vaccine maker.

In its filing to the Delaware federal court, the DoJ argued the U.S. should be liable for any violation of Arbutus Biopharma (NASDAQ:ABUS) Corp and Genevant Sciences’ patents that emerged under Moderna's contract to provide jabs for the government's nationwide vaccination program.

In the meantime, Moderna continues to rely on sales of its COVID vaccine. The biotech company said it secured around $18.4 billion in coronavirus sales in 2022, in line with the company’s annual forecast. Further, Moderna said it expects its COVID-19 sales will reach a minimum of $5 billion in 2023, compared to its earlier forecast range of $4.5 billion to $5.5 billion in November.

Summary

Moderna rode the bull market of 2021 as its mRNA COVID-19 vaccine was reported to feature a 94.5% vaccine effectiveness rate in November of 2020. In September of 2021, Moderna stock reached its high of $449.

Moderna shares are trading lower in recent days after the company’s Phase 3 trial results for the flu vaccine candidate didn’t meet all endpoints. The results come after Moderna’s RSV vaccine candidate performed well in trials, helping Moderna stock to trade higher in January.

. . .

Shane Neagle is the EIC of The Tokenist. Check out The Tokenist’s free newsletter, Five Minute Finance, for weekly analysis of the biggest trends in finance and technology.

Moderna Shares Under Pressure as Flu Vaccine Fails to Meet All Endpoints
 

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Moderna Shares Under Pressure as Flu Vaccine Fails to Meet All Endpoints

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