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By Chris Wack
Innate Pharma shares were up 16% to $2.25 after the company said the Food and Drug Administration has granted Breakthrough Therapy Designation to lacutamab for the treatment of adult patients with relapsed or refractory Sezary Syndrome.
The company said the designation is granted based on Phase 1 study results as well as results from a Phase 2 where lacutamab demonstrated encouraging efficacy and a favorable safety profile in heavily pretreated, post-mogamulizumab patients with advanced Sezary syndrome.
Sezary Syndrome is a type of skin cancer that affects white blood cells called T lymphocytes.
A Breakthrough Therapy Designation by the FDA is intended to accelerate the development and regulatory review in the U.S. of drugs that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically significant endpoint over available medicines.
Lacutamab previously received a Fast Track designation by the FDA in 2019 for the treatment of adult patients with relapsed or refractory Sezary syndrome who have received at least two prior systemic therapies, as well as a PRIME designation by European Medicines Agency in 2020.
Write to Chris Wack at chris.wack@wsj.com
US equity futures rose ahead of Tuesday's opening bell as investors returned after the Presidents Day holiday.
Dow Jones Industrial Average futures were up 0.2%, S&P 500 futures increased 0.4%, and Nasdaq futures were up 0.4%.
Oil prices were mixed, with front-month global benchmark North Sea Brent crude flat at $75.22 per barrel and US West Texas Intermediate crude up 0.8% at $71.25 per barrel.
The Empire State manufacturing index, released at 8:30 am ET, came at 5.7 in February, rebounding from minus 12.6 in January, and topping estimates compiled by Bloomberg for minus 2.0.
The housing market index, slated for 10 am ET, is seen at 46.0 in February, compared with January's 47.0.
In other world markets, Japan's Nikkei closed 0.3% higher, Hong Kong's Hang Seng ended 1.6% higher, and China's Shanghai Composite finished 0.9% lower. Meanwhile, the UK's FTSE 100 and Germany's DAX index each increased 0.2% in Europe's early afternoon session.
In equities, shares of GameStop were 1% higher pre-bell after the company said it would pursue the sale of its French and Canadian operations. Innate Pharma shares were up 26% after the company said Monday the US Food and Drug Administration granted breakthrough therapy designation to the company's treatment candidate for Sezary Syndrome.
On the losing side, Conagra shares fell 5% after the company lowered its fiscal 2025 earnings guidance.
Energy Focus shares surged 67% pre-bell Tuesday after a 5.7% increase in the previous session.
FG Merger II F shares advanced 24%, extending Friday's rally.
Innate Pharma shares were up 29% after the company said Monday the US Food and Drug Administration has granted breakthrough therapy designation to the company's treatment candidate for Sezary Syndrome.
Innate Pharma said Monday the US Food and Drug Administration granted breakthrough therapy designation for lacutamab, which is under review as a treatment for adults with Sezary syndrome.
The French oncology-focused biotechnology company said the designation was based on the results of a phase 1 study and the phase 2 Tellomak trial.
The designation under review is specifically for patients with relapsed or refractory Sezary syndrome who underwent at least two systemic therapies including mogamulizumab.
Health care stocks were mixed premarket Monday, with The Health Care Select Sector SPDR Fund up 0.4% and the iShares Biotechnology ETF 0.3% lower.
Akero Therapeutics shares were up over 110% after the company said a phase 2b study of its lead product candidate efruxifermin showed a "statistically significant" reversal of compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis, or MASH.
Allakos stock was down past 73% after the company said its phase 1 trial of AK006 in chronic spontaneous urticaria failed to demonstrate therapeutic efficacy and its development will be terminated immediately.
Innate Pharma shares were up over 7% after the company said it has dosed its first patient in a phase 1 study to investigate the safety and tolerability of IPH4502, an antibody-drug conjugate for the potential treatment of patients with advanced solid tumors known to express Nectin-4.
Innate Pharma SA said Monday it has dosed its first patient in a phase 1 study to investigate the safety and tolerability of IPH4502, an antibody-drug conjugate for the potential treatment of patients with advanced solid tumors known to express Nectin-4.
IPH4502 is designed to target Nectin-4, a cell adhesion molecule in several types of solid tumors, including urothelial carcinoma, breast cancer, non-small cell lung cancer, and gastrointestinal cancer, the company said.
The study plans to enroll about 105 patients, the company said.
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