Genmab (GMAB) - Get Genmab A/S Sponsored ADR Report and Seagen (SGEN) - Get Seagen, Inc. (SGEN) Report said they won accelerated FDA approval for a cervical cancer treatment the companies developed together.
The medication, TIVDAK, was approved “based on tumor response and the durability of the response,” the companies said in a statement. “Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials,” they added.
“We are pleased with the accelerated approval of TIVDAK, Seagen’s third FDA-approved antibody-drug conjugate, and fourth approved medicine,” said Roger Dansey, M.D., chief medical officer of Seagen, in the statement.
“TIVDAK’s approval as a monotherapy in the U.S. is an important milestone for women with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, as they are in need of a new treatment option,” Jan van de Winkel, Genmab's CEO, said in the statement.
Shares of Genmab and Seagen rose in after-hours trading following the announcement. Genmab shares gained $2.06, or 4.8%, to $45 in after-hours trading.
Seagen gained $2.89, or 1.8%, to $161.95.
SmileDirectClub (SDC) - Get SmileDirectClub Inc Class A Report said it plans to begin offering its services in France at the beginning of the fourth quarter. It is the seventh European country where the company has begun operations. “SmileDirectClub is pleased to expand further into Europe and to introduce the French market to our innovative clear aligners and our industry-first telehealth platform,” said David Katzman, CEO, in a statement. Shares of SmileDirectClub rose 28 cents, or 4.3%, to $6.77 in after-hours trading.
Home builder Lennar Corp. (LEN) - Get Lennar Corporation Class A Report said its latest earnings were affected by “unprecedented supply chain challenges.” The company reported earnings of $4.52 a share on revenue of $6.9 billion. It said it delivered 15,199 homes in the latest quarter, about 600 below the low end of its previous guidance.
The company said it was cutting its fourth-quarter delivery guidance to “more or less, 18,000 homes, reflecting this supply chain constraint."
Shares of Lennar fell $2.30, or 2.3%, to $96 in after-hours trading.