In This Article:
Investing.com -- Shares in Sanofi (EPA:SASY) (NASDAQ:SNY) and Regeneron (NASDAQ:REGN) fell Friday after the pharmaceutical giants reported mixed results from two phase 3 trials of their investigational chronic obstructive pulmonary disease (COPD) treatment, Itepekimab.
Sanofi’s U.S.-listed shares plunged more than 6% by 09:50 GMT, while Regeneron plummeted over 18%.
Advertisement: High Yield Savings Offers
In one study involving former smokers with uncontrolled chronic obstructive pulmonary disease, the drug achieved its primary goal, showing a 27% reduction in moderate or severe exacerbations over 52 weeks compared to placebo.
However, the second late-stage trial did not meet its primary endpoint, though the companies noted signs of benefit earlier in the study period.
Itepekimab was generally well tolerated across both trials, Sanofi said in a release.
“While we are encouraged by the results of AERIFY-1, the results of both studies merit further exploration to have a full understanding of the data and the role that IL33 plays in this complex disease,” said Houman Ashrafian, Executive Vice President and Head of Research and Development at Sanofi.
“Certain people with COPD are in desperate need of new treatment options, especially those who continue to experience exacerbations despite being on maximal therapy, and we remain committed to discussing these data with regulatory agencies to evaluate our path forward.”
The French drugmaker said it is reviewing the findings with Regeneron and plans to consult with regulatory agencies to determine potential next steps.
Itepekimab is an experimental monoclonal antibody targeting interleukin-33 (IL-33), a cytokine believed to play a role in airway inflammation.
It is being developed by Sanofi and Regeneron as a treatment for COPD, particularly in patients who remain symptomatic despite standard therapies. The drug aims to reduce disease exacerbations by modulating inflammatory pathways linked to COPD progression.
"We think Itepekimab’s disappointing data create a big challenge for REGN in the long term," Wells Fargo analysts said in a note reacting to the news. "We also see consensus down revision potential for Eylea. We are downgrading to Equal Weight due to lack of near-term value unlocking events. New PT $580/sh."
Leerink Partners told investors in a note that they are "surprised and disappointed." However, they maintained Outperform ratings on REGN and SNY, stating that "itepekimab’s failure appears discounted in both companies’ stocks."
UBS said the path to approval is now unclear and "approval based on the current P3 data alone is unlikely."