By RTT News,
December 22, 2013, 11:59:00 PM EDT
(RTTNews.com) - Shares of ARIAD Pharmaceuticals Inc. ( ARIA ), which have taken a drubbing over the past 2 months on safety concerns over the company's leukemia drug Iclusig, rose as much as 40 percent in intraday trading on Friday, following news about immediate resumption of marketing and commercial distribution of the drug.
Iclusig was approved last December under the FDA's accelerated approval program. In October of 2013, the company reported that serious arterial thrombosis, cardiovascular events, cerebrovascular events and peripheral vascular events were observed in Iclusig-treated patients in a pivotal follow up of trial, dubbed PACE.
Due to the adverse events in the PACE trial, the FDA placed a partial clinical hold on all new patient enrollment in clinical trials of Iclusig. However, on Friday, the company announced that it has been allowed to resume marketing and commercial distribution of Iclusig, with the FDA approving revised U.S. Prescribing Information and a Risk Evaluation and Mitigation Strategy for the drug.
The USPI includes a revised indication statement and boxed warning, updated safety information and recommendations regarding dosing considerations for prescribers.
ARIA closed Friday's trading at $6.43, up 16.49%.
Endologix Inc. ( ELGX ) has received FDA's Investigational Device Exemption approval to begin a pivotal clinical trial of Nellix EndoVascular Aneurysm Sealing System for the endovascular repair of infrarenal abdominal aortic aneurysms.
The study, dubbed EVAS FORWARD-IDE, is designed to enroll 180 patients at up to 30 sites in the U.S., Canada and Europe. If all goes well as planned, Nellix is expected to be available to physicians and patients in the U.S. in the second half of 2016.
ELGX closed Friday's trading at $16.62, up 2.72%.
Intrexon Corp. (XON) has agreed to acquire Medistem Inc. (MEDS), a pioneer in the development of Endometrial Regenerative Cells, for approximately $26 million.
Medistem's ERCs are said to have the potential to provide treatments for conditions such as cancer, wound healing, and cardiovascular disease. Intrexon intends to employ its integrated synthetic biology platforms to engineer a diverse array of cell-based therapeutic candidates using Medistem's multipotent ERCs.
XON closed Friday's trading 1.19% higher at $20.36.
NuVasive Inc. ( NUVA ) is all set to expand its workforce in its manufacturing facility by more than 25 percent in 2014. Known as NuVasive Manufacturing LLC, the 35,000-square-foot manufacturing facility produces the company's PEEK, Armada and Precept implants.
NUVA closed Friday's trading 2% higher at $32.61.
Oramed Pharmaceuticals Inc. ( ORMP ) touched a new high of $13.69 on Friday before closing 48.95 percent higher at $10.65, following the company's successful results from ex-US pharmacokinetic study of its oral insulin capsule (ORMD-0801) in type 1 diabetes patients.
ORMD-0801 is also under a phase 2a trial in patients with type 2 diabetes, and the company expects results from this trial next month.
United Therapeutics Corp.'s ( UTHR ) Orenitram Extended-Release Tablet has been approved by FDA for the treatment of pulmonary arterial hypertension in WHO Group I patients to improve exercise capacity. This is the company's fifth approval from the FDA for the treatment of pulmonary arterial hypertension, or PAH.
Having been twice issued a complete response letter, the FDA's decision on the resubmitted Orenitram NDA comes almost 2 months ahead of the scheduled decision date of Feb.16, 2014.
United Therapeutics derives a major part of its total revenue from 2 PAH drugs namely, Remodulin injection and Tyvaso inhalation solution. Yet another approved PAH drug of the company is Adcirca tablets.
UTHR closed Friday's trading at $87.84, up 1.24%.
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