Shares of Shionogi & Co on Thursday saw their sharpest drop in three months after a Health Ministry panel again delayed emergency use approval for the Japanese drugmaker’s oral treatment for COVID-19.
The stock fell 8.5% to 6,901 yen as of 10:22 JST, its strongest reading since April 13, and led declines against the benchmark Nikkei index, which fell 0.4%.
Health experts on the panel on Wednesday voted to await further data from ongoing clinical trials and continue discussions on the drug, dealing another blow to Shionogi’s global ambitions for the antiviral pill.
“Shionogi bulls may now be pinning their hopes on new (Phase III) data that may be available in August and new Phase II/III data that may be available in September,” wrote Jefferies analyst Stephen Barker in a note.
Authorities last month delayed a decision on the drug known as S-217622 and brand name Xocova, which Shionogi hopes will compete with products from US drugmakers Pfizer and Merck & Co, which are already approved in Japan and elsewhere are.
The company has signed an agreement to sell about a million doses to the Japanese government pending approval of the drug.
Chief Executive Isao Teshirogi said annual production of the drug could reach 10 million doses.
It has received US government support for a global Phase III trial.
Speculations about the treatment have sent Shionogi’s stock on a rollercoaster ride.
Last month, a Health Department panel delayed a decision on the drug because of uncertainty about its effectiveness and animal studies showing it could pose a risk to pregnancy.
Shionogi said this month it is preparing to apply for regulatory approval in China for the drug, which has been shown in preclinical studies to have potent antiviral activity against Omicron variants BA.4 and BA.5.
Some members of the health panel said that while the study data had not proven the drug’s effectiveness, the results were positive enough to warrant an emergency use authorization to help fight a seventh wave of infections and potentially reduce the incidence of what is known as “long COVID.” ” Effects in Patients.
New infections in Japan surpassed 150,000 on Wednesday, an all-time high, the Nikkei newspaper reported.
Shionogi drops in trade in Tokyo after panel delays approval of COVID pill again – SABC News
Source link Shionogi drops in trade in Tokyo after panel delays approval of COVID pill again – SABC News