- Shionogi & Co stock slumped 16% in Tokyo after preclinical studies showed its experimental COVID-19 drug disturbed fetal development, triggering concerns about its approval.
- Kyodo News reported that the drug likely wouldn’t be recommended for pregnant women without giving attribution.
- The animal data, which showed harm when given at high doses, was submitted to Japanese regulators in February when the company sought a priority review required for conditional approval, a Shionogi spokesman said.
- The pill’s chance of commercial success fell to 5% from 50% after the report tying it to birth defects, making it less competitive, said Stephen Baker, an equities analyst at Jefferies & Co.
- He cut his rating on the stock to “underperform” from “buy”, after trimming the profit estimates and target price.
- “The Japanese will probably approve it but probably on strict conditions,” Barker said. “I think it will impact the company’s ability to conclude a licensing deal with a third party because I don’t think it will be a major commercial success.”
- Merck & Co Inc’s (NYSE: MRK) Lagevrio (molnupiravir) has a boxed warning saying pregnant women shouldn’t take it after it was linked to fetal harm in animal studies.
- Pfizer Inc’s (NYSE: PFE) Paxlovid at high doses led to a decrease in fetal body weight in a rabbit study, though there aren’t restrictions on its use during pregnancy.
- Photo by Thomas Breher from Pixabay
