Shares of Loxo Oncology (LOXO) rose 41.5% to $69.29 in premarket trading on Monday after the Stamford, Conn.-based firm on Saturday unveiled interim data from three ongoing larotrectinib (LOXO-101) clinical studies in patients whose tumors harbor tropomyosin receptor kinase (TRK) fusions. Loxo said the data demonstrated a 76% confirmed objective response rate (ORR) across tumor types.
TheStreet's Adam Feuerstein wrote that it's a "strikingly high response rate, particularly in patients with advanced cancer, so notch these study results as a win for Loxo."
The data were presented at the American Society of Clinical Oncology annual meeting in Chicago.
Also on Saturday, Loxo announced that a research brief was published in Cancer Discovery that outlines the preclinical rationale for LOXO-195 and clinical proof-of-concept data from the first two patients treated. LOXO-195 was developed as a treatment for patients with TRK fusion cancers who become resistant while receiving another TRK inhibitor, such as Loxo's larotrectinib.
Meanwhile, shares of NewLink Genetics (NLNK) were down 7.2% to $11.69. The Ames, Iowa-based firm after the market close on Friday said top-line data from a phase two study of indoximod in tandem with taxane chemotherapy for patients with metastatic breast cancer did not meet its pre-specified endpoints.
In other NewLink news, the company announced the presentation of results from a randomized phase two investigator initiated study with indoximod in tandem with the therapeutic cancer vaccine, PROVENGE (sipuleucel-T), for patients that have metastatic castration resistant prostate cancer.
"The indoximod treatment arm for the study showed a statistically significant improvement in radiographic progression-free survival (rPFS) when compared to placebo and was well tolerated," NewLink said.
Findings from the study will be presented Monday morning at the ASCO meeting.
Other biotech stock movers include BioCryst Pharmaceuticals (BCRX) , up 6.2% to $5.86. The Research Triangle Park, N.C.-based company said Monday that the U.S. Food and Drug Administration has accepted for review its supplemental new drug application for a pediatric indication of RAPIVAB (peramivir injection).
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