Vir Biotech­nol­o­gy is mov­ing away from some of its Covid-19 am­bi­tions.

Months af­ter the FDA re­voked the emer­gency use au­tho­riza­tion on Vir and GSK’s mon­o­clon­al an­ti­body sotro­vimab, Vir an­nounced Tues­day that it no longer plans to sub­mit a Bi­o­log­ics Li­cense Ap­pli­ca­tion for the ther­a­py.

Ad­di­tion­al­ly, Vir an­nounced it does not plan to pur­sue the Phase III COMET-STAR pro­phy­lax­is tri­al. The tri­al aimed to ad­min­is­ter sotro­vimab to un­in­fect­ed adults at high risk of Covid-19 to pre­vent symp­to­matic in­fec­tion.

“Due to the evolv­ing COVID-19 land­scape and based on dis­cus­sions with the US Food and Drug Ad­min­is­tra­tion (FDA), the Com­pa­ny and GSK do not plan to file a Bi­o­log­ics Li­cense Ap­pli­ca­tion for sotro­vimab at this time,” Vir said in a press state­ment on Tues­day.

Sotro­vimab is a nov­el mon­o­clon­al an­ti­body treat­ment which mim­ics nat­ur­al an­ti­bod­ies pro­duced by the hu­man im­mune sys­tem.

In April 2022, the FDA re­voked the emer­gency use au­tho­riza­tion of sotro­vimab af­ter it found the drug to be in­ef­fec­tive against new Omi­cron vari­ants. The de­ci­sion had come in af­ter new CDC es­ti­mates showed that the pro­por­tion of Covid-19 cas­es caused by BA.2 was above 50% na­tion­wide. “Sotro­vimab is no longer au­tho­rized to treat COVID-19 in any U.S. re­gion due to in­creas­es in the pro­por­tion of COVID-19 cas­es caused by the Omi­cron BA.2 sub-vari­ant,” the FDA had said in a state­ment.

While the sales stopped in the US, the com­pa­ny de­liv­ered ap­prox­i­mate­ly 265,000 sotro­vimab dos­es to coun­tries out­side of the US in the sec­ond quar­ter of 2022.

“This ex­ceed­ed ex­pec­ta­tions for de­liv­ery of ap­prox­i­mate­ly 100,000 dos­es in the quar­ter due to ad­di­tion­al agree­ments with coun­tries out­side of the US,” Vir said.

To­tal rev­enues for the quar­ter end­ing June 30, 2022 were just $40.6 mil­lion, com­pared to $177.1 mil­lion for the same pe­ri­od in 2021. Share prices $VIR of Vir al­so sunk on the news, with the stock open­ing about 7% low­er than Tues­day’s close.

Mean­while, oth­er mon­o­clon­al an­ti­bod­ies, such as Eli Lil­ly’s an­ti­body cock­tail of bam­lanivimab and ete­se­vimab with Re­gen­eron’s RE­GEN-COV, were al­so ground­ed af­ter they were found in­ef­fec­tive against the Omi­cron vari­ants. Cur­rent­ly, Lil­ly’s bebtelovimab is the on­ly FDA-au­tho­rized mon­o­clon­al treat­ment against Omi­cron vari­ants.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.