F-star Ther­a­peu­tics won’t yet be able to close its deal with its Chi­nese buy­er, af­ter the US gov­ern­ment’s Com­mit­tee on For­eign In­vest­ment in the Unit­ed States pan­el put a hold on the takeover, cit­ing na­tion­al se­cu­ri­ty risks.

Chi­na’s Sino Bio­pharm made a $161 mil­lion deal with F-star in June, seek­ing to buy its bis­pe­cif­ic an­ti­body plat­form. The deal was be­ing done via Sino’s in­voX unit, a sub­sidiary meant to help the Hong Kong-based com­pa­ny ex­pand out­side of Chi­na. That deal now ap­pears to be at least tem­porar­i­ly blocked, giv­en the US’ or­der.

In a fil­ing with the SEC, F-star said the CFIUS pan­el had “is­sued an or­der (the “In­ter­im Or­der”) pre­vent­ing the con­sum­ma­tion of the trans­ac­tions pur­suant to the Merg­er Agree­ment, cit­ing un­re­solved na­tion­al se­cu­ri­ty risks.” The or­der will stay in place to “pro­vide CFIUS ad­e­quate op­por­tu­ni­ty to con­tin­ue its re­view and in­ves­ti­ga­tion.”

In a state­ment, in­voX said the com­pa­nies were work­ing with CFIUS and still planned to close their deal.

“We are seek­ing to move swift­ly to en­sure F-star has the fi­nanc­ing it needs to main­tain po­ten­tial­ly life sav­ing work on can­cer clin­i­cal tri­als, while avoid­ing ex­ten­sive lay­offs,” in­voX said in a state­ment. “Through our en­gage­ment with CFIUS staff, we un­der­stand that the Com­mit­tee has de­ter­mined that any na­tion­al se­cu­ri­ty con­cerns can be mit­i­gat­ed and will work ex­pe­di­tious­ly to reach a res­o­lu­tion.”

In No­vem­ber, F-star and Sino Bio­pharm an­nounced that a re­view by the for­eign in­vest­ments pan­el would have to push out their tar­get for clos­ing the deal. In a fil­ing Fri­day, the com­pa­nies ex­tend­ed their dead­line to close the merg­er to the end of Jan­u­ary.

F-star’s shares plunged 34% in trad­ing on Thurs­day, a sign of in­vestors’ skep­ti­cism about the takeover. The US gov­ern­ment has used CFIUS as a way of scru­ti­niz­ing Chi­na’s at­tempts to ex­pand its life sci­ences in­dus­try and to guard tech­nolo­gies de­vel­oped in the US.

John Fraunces, an out­side rep­re­sen­ta­tive for F-star, de­clined to com­ment fur­ther.

Ed­i­tor’s note: This sto­ry was up­dat­ed on Dec. 30 with a com­ment from Sino Bio­pharm’s in­voX unit.

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.