Fate Therapeutics Inc. (FATE) - Get Report shares are up 7.12%, or 22 cents, in pre-market trading Tuesday Aug. 15, to $3.31 after the company reported progress in its FATE-NK100 program for treating cancer.
"Clinical momentum across our first-in-class cellular immunotherapy programs continues to accelerate," said Scott Wolchko, Fate CEO said in an update that accompanied Fate's second quarter earnings announcement. He said the first subject has been treated with FATE-NK100 for acute myeloid leukemia (AML) and two additional clinical trials of FATE-NK100 for the treatment of multiple advanced solid tumor types including in combination with monoclonal antibody therapy will soon open.
"Our productive discussions with the FDA continue regarding the advancement of our proprietary iPSC-derived cancer immunotherapy pipeline toward first-in-human studies. We currently remain on-track to file, in the first quarter of 2018, an investigational new drug application with the FDA for FT500i, a first-of-kind natural killer cell product candidate derived from a master pluripotent cell line. We are also prepared to initiate enrollment in the Phase 2 efficacy stage of PROTECT next month.
Six subjects received ProTmune and we have convened the study's data monitoring committee to review the Phase 1 data."
PROTECT is the study Fate is conducting for ProTmune, the company's cellular immunotherapy being developed as an allogeneic graft for the thousands of patients each year with hematologic malignancies and rare genetic disorders that seek curative outcomes through hematopoietic cell transplantation.
Shares of Interpace Diagnostics Group Inc. (IDXG) - Get Report were up 7.23%, or 6 cents, to 89 cents after Maxim Group initiated coverage with a Buy rating and $5 price target. Maxim pointed to key advantages of its IDXG's thyroid diagnostics platform compared to market leader Veracyte Inc. (VCYT) - Get Report . Maxim predicted IDXG's thyroid assay revenue could reach $50 million by 2022.
During IDXG's second quarter earnings call on Friday, Aug. 11, CEO Jack Stover said the second quarter and year to date have been "transformative" for the company. "We continued to improve our balance sheet in the second quarter by raising an additional $13.7 million of capital, eliminating all long term debt and related possible royalties and milestone obligations while continuing to make good commercial progress." IDXG's cash now exceeds $14 million. "We are now well-positioned to leverage our commercial resources and further build out our platforms,"Stover said.
LivaNova (LIVN) - Get Report shares had fallen 40 cents, or 0.64%, to $61.85 after its shares were downgraded to Sell from Hold by WBB Securities. On Thursday, Aug. 9, LivaNova reported slower that expected growth during the second quarter. Worldwide sales were $321.4 million, an increase of 0.1% on a reported basis and an increase of 1.4% when accounting for currency fluctuations compared to the same quarter of 2016.
LivaNova makes medical devices used for cardiac surgery, neuromodulation and cardiac rhythm management
"We made progress in many areas of our business during the second quarter, including strong margin and earnings performance," said Damien McDonald, CEO. "We hired a new chief financial officer and a new general counsel, strengthening LivaNova's executive leadership team."
He noted that in June, the approved the company's VNS Therapy device for use in patients four years and older with partial onset seizures that are refractory to antiepileptic medications. This makes VNS Therapy the first and only device approved by the FDA for drug-resistant epilepsy for this pediatric population.
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