Key Developments: Pluristem Therapeutics Inc (PSTI.W)

PSTI.W on CBOE When Trading NASDAQ Global Select Market

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7 Mar 2014
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Latest Key Developments (Source: Significant Developments)

Pluristem Therapeutics Inc approves Pluristem's commercial scale cell manufacturing process
Thursday, 6 Mar 2014 03:00am EST 

Pluristem Therapeutics Inc:United States Food and Drug Administration (FDA) has reviewed Pluristem's comparability studies of PLacental eXpanded (PLX) cell products.Granted approval for to manufacture these products in new commercial-scale cell manufacturing facility.  Full Article

Pluristem Therapeutics Inc submits FDA orphan drug application for Preeclampsia
Thursday, 20 Feb 2014 03:00am EST 

Pluristem Therapeutics Inc:Says submitting its application to the United Stated Food and Drug Administration.Says requesting the company to be granted Orphan Drug Designation for its PLacental eXpanded (PLX-PAD) cells in the treatment of severe preeclampsia.Says Orphan Drug Designation may qualify a company for several benefits under the Orphan Drug Act of 1983 (ODA), as amended.  Full Article

Pluristem Therapeutics Inc receives key 3d cell expansion patent in Australia
Tuesday, 18 Feb 2014 03:00am EST 

Pluristem Therapeutics Inc:Says it has been granted a new patent by the Australian Patent Office.Says the Patent #2007228341 covers the method and composition of matter for three-dimensional (3D) expansion of placental or adipose (fat) stromal cells, Pluristem's key technology platform.Says Patent claims also include methods of treatment using placental cells for numerous diseases including graft vs. host disease (GvHD), heart disease, stroke, burns, loss of tissue, loss of blood, anemia, and autoimmune disorders.  Full Article

Pluristem Therapeutics Inc appoints President and Chief Financial Officer
Wednesday, 5 Feb 2014 05:00am EST 

Pluristem Therapeutics Inc:Says Yaky Yanay has been promoted to President and Chief Operating Officer.Says Boaz Gur-Lavie has been appointed to the position of Chief Financial Officer and Secretary.  Full Article

Chabio&Diostech Co Ltd amends transaction settlement date of acquiring shares of Pluristem Therapeutics Inc
Thursday, 5 Dec 2013 03:04am EST 

Chabio&Diostech Co Ltd:Says transaction settlement date of acquiring a 4.05 pct stake (2,500,000 shares) in Pluristem Therapeutics Inc, was amended to Dec. 17 from Dec. 5.  Full Article

Chabio&Diostech Co Ltd to acquire shares of Pluristem Therapeutics Inc
Thursday, 28 Nov 2013 03:40am EST 

Chabio&Diostech Co Ltd and Pluristem Therapeutics Inc:Says Chabio&Diostech Co Ltd to acquire 2,500,000 shares of Pluristem Therapeutics Inc (Pluristem), which is a bio-therapeutics company, by subscribing new shares of Pluristem in a private placement.Says acquisition amount of 11,000,106,000 won.Says expected transaction settlement date of Dec. 5.Says Chabio&Diostech Co Ltd's stake of 4.05 pct (2,500,000 shares) in Pluristem after transaction.  Full Article

Pluristem Therapeutics Inc Receives Israeli Ministry Of Health Approval To Expand Phase II Clinical Trial In Intermittent Claudication To Israel
Wednesday, 2 Oct 2013 03:59am EDT 

Pluristem Therapeutics Inc announced that the Israeli Ministry of Health has approved the Company's request to initiate a Phase II study using its PLacental eXpanded (PLX) cells in the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD). This approval is part of the Company's previously announced strategy to conduct a multi-national study for this indication. The protocol will be the same one used for the study previously approved in the U.S.  Full Article

FDA Lifts Clinical Hold Of Pluristem Therapeutics Inc's Phase II Intermittent Claudication Study
Monday, 16 Sep 2013 02:59am EDT 

Pluristem Therapeutics Inc announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on the Company's U.S. Phase II Intermittent Claudication (IC) study (IND 15038) on June 4, 2013. In its letter to Pluristem, the FDA indicated Pluristem had satisfactorily addressed all the clinical hold issues and the Company may proceed with the study.  Full Article

Pluristem Therapeutics Inc Receives Key U.S. Patent For Treatment Of Peripheral Artery Disease-DJ
Wednesday, 11 Sep 2013 02:59am EDT 

Dow Jones reported that the United States Patent and Trademark Office has granted Pluristem Therapeutics Inc U.S. Patent 8,529,888. This patent, the 26th issued to the Company, covers methods for the treatment of peripheral artery disease with placental-derived adherent stromal cells. The treatment for PAD is one of Pluristem's primary drug development areas. Based on priority date, the expected expiration date of this patent is at least until 2028.  Full Article

Pluristem Therapeutics Inc's Subsidiary Enters Into Exclusive License And Commercialization Agreement With CHA Bio&Diostech-Form 8-K
Thursday, 27 Jun 2013 05:15pm EDT 

Pluristem Therapeutics Inc reported in its Form 8-K that on June 26, 2013, a wholly owned subsidiary of Pluristem Therapeutics Inc. (Pluristem) entered into an Exclusive License and Commercialization Agreement with CHA Bio&Diostech (CHA), for conducting clinical trials and commercialization of Pluristem's PLX-PAD product in South Korea in connection with two indications: the treatment of Critical Limb Ischemia, and Intermediate Claudication (collectively Indications). Under the terms of the Agreement, CHA will receive exclusive rights in South Korea for conducting clinical trials with respect to the Indications, at the sole expense of CHA. Commencement of the clinical trials is conditioned upon the receipt of the necessary regulatory approvals. If Pluristem's products receive regulatory approvals in South Korea for marketing as treatment for the Indications, the parties will form a joint venture in order to sell, distribute and market Pluristem products for treating the Indications in South Korea. The joint venture would be owned equally by CHA and Pluristem. Pluristem would own any and all intellectual property rights to the extent conceived in connection with its products and license such rights to the joint venture.  Full Article

BRIEF-Pluristem Therapeutics up 7.2 percent premarket

NEW YORK, Jan 21 - Pluristem Therapeutics Inc : * Up 7.2 percent to $4.75 in premarket after muscle injury treatment trial results

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