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TG Therapeutics ($TGTX) announced that a combination of its experimental cancer drug ublituximab and AbbVie Inc's Imbruvica outperformed Imbruvica alone in high-risk leukemia patients. The late-stage study involved adult patients with high-risk chronic lymphocytic leukemia, who had undergone at least one prior therapy. TG Therapeutics said that the absolute difference between the two groups of patients was about 30 percent.
The company stock shot up more than 64 percent in its pre-market session, taking its YTD gain to 15 percent. The stock pared its 12 months loss to nearly 42 percent. TG Therapeutics said that it plans to meet the USFDA for possible accelerated approval.
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Mast Therapeutics Inc. ($MSTX) announced that it has entered into an agreement with the University of Pittsburgh related to a Phase 1/2 open-label safety and proof of concept clinical trial of the Company's lead product candidate, AIR001. The company has entered the agreement through its wholly owned subsidiary, Aires Pharmaceuticals. The drug is designed for treating Pseudomonas aeruginosa infection in cystic fibrosis patients.
The company stock has gained over 30 percent this year so far, erasing a part of the losses it had incurred in the previous year. The company had recently announced its merger with a privately held company Savara Inc.
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Karyopharm Therapeutics ($KPTI) reported the results of a planned interim analysis of the Phase 2 SOPRA study evaluating single agent selinexor in relapsed/refractory acute myeloid leukemia. In consultation with the study’s independent Data Safety Monitoring Board, the company has decided that SOPRA will not reach statistical significance for overall survival (OS), the study’s primary endpoint. However, the clinical development of selinexor in AML through investigator sponsored trials in multiple combination regimens, including with chemotherapy, given encouraging data to date across these settings will continue.
Scynexis Inc. ($SCYX) announced that it has decided to hold the initiation of any new clinical studies with the intravenous (IV) formulation of SCY-078 until the FDA completes a review of all available pre-clinical and clinical data of the IV formulation of SCY-078. The decision has been taken after a communique from the FDA to this effect. The company will schedule a meeting with the FDA for discussing the data during the second quarter of the year. The FDA took the decision following a review of three mild-to-moderate thrombotic events in healthy volunteers receiving the IV formulation of SCY-078 at the highest doses and highest concentrations in a Phase 1 study.
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aTyr Pharma ($LIFE) announced that its product Resolaris™, designed for the treatment of limb girdle muscular dystrophy (LGMD) patients has been granted Orphan Drug designation by the European Medicines Agency (EMA). EMA orphan designation is intended to encourage development of medicines for the diagnosis, treatment, or prevention of life-threatening or chronically debilitating conditions that affect no more than 5 in 10,000 people in the EU.
HMS Holdings Corp ($HMSY) is reportedly planning to delay the filing of its 2016 10-K due to a potential material weakness in its internal controls over its financial reporting. It has been reported by the StreetInsider that the company needs additional time to complete documentation related to its previously disclosed review of CMS reserves and related internal controls over reporting after its auditor identified a potential material weakness.
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Five Star Quality Care Inc. ($FVE) announced that it has changed its name to Five Star Senior Living Inc. The company also reported that its Senior living revenue for the fourth quarter of 2016 decreased 0.8% to $279.0 million from $281.2 million for 2015. Its loss from continuing operations for the fourth quarter of 2016 was $6.0 million, or $0.12 per diluted share, compared to loss from continuing operations of $6.3 million, or $0.13 per diluted share, for 2015.
Vertex Pharmaceuticals ($VRTX) announced that it has agreed to acquire an experimental, longer-acting version of its cystic fibrosis drug Kalydeco from Concert Pharmaceuticals. The firm plans to the use the drug for use in future combination regimens to treat the underlying cause of the inherited lung disorder. Concert will receive $160 million in cash from Vertex for worldwide rights to the drug. It is also entitled to receive another $90 million from Vertex if the drug CTP-656 is approved in the US and receives approval and reimbursement in Europe.
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