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Key Developments: Spectrum Pharmaceuticals Inc (SPPI.O)

SPPI.O on Nasdaq

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31 May 2016
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Latest Key Developments (Source: Significant Developments)

Spectrum Pharma says Dr Reddy's will be permitted to market generic version of Folotyn in US on Dec 1, 2022 or earlier
7:02am EDT 

Spectrum Pharmaceuticals : Co's unit, dr. Reddy's labs, ltd entered into settlement agreement to resolve their patent litigation relating to folotyn .dr. Reddy's will be permitted to market generic version of folotyn in u.s. On december 1, 2022 or earlier under certain circumstances.  Full Article

Spectrum Pharma says unit, Teva enter settlement agreement
Wednesday, 25 May 2016 07:06am EDT 

Spectrum Pharmaceuticals Inc : Unit, teva pharmaceuticals usa, inc. Entered into settlement agreement to resolve patent litigation relating to Folotyn . Teva will be permitted to market generic version of folotyn in u.s. On december 1, 2022 or earlier under certain terms . Details of settlement are confidential, and parties will submit agreement to federal trade commission and doj .Parties will request that court enter an order, in which it will dismiss company's litigation against teva.  Full Article

Spectrum Pharmaceuticals says FDA grants orphan drug exclusivity to EVOMELA
Wednesday, 20 Apr 2016 07:00am EDT 

Spectrum Pharmaceuticals:Says FDA office of orphan products development has granted 7 years of Orphan Drug Exclusivity for EVOMELA for use as a high-dose conditioning treatment prior to hematopoietic progenitor cell transplantation in patients with multiple myeloma.  Full Article

Spectrum Pharmaceuticals says FDA grants approval of EVOMELA for Injection
Tuesday, 15 Mar 2016 07:00am EDT 

Spectrum Pharmaceuticals:Says FDA grants approval of EVOMELA for Injection.Received FDA Approval for Two Indications : High-Dose Conditioning Treatment for Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplantation (ASCT) , Palliative Treatment of Patients with MM Who Cannot Take Oral Therapy.Plans to Launch EVOMELA with Existing Sales Force in a Market Estimated at Approximately $100 Million.  Full Article

Spectrum Pharma says FDA's accepts NDA filing for eoquin
Friday, 19 Feb 2016 07:00am EST 

Spectrum Pharmaceuticals Inc:Announces FDA's acceptance of nda filing for eoquin® (apaziquone for intravesical instillation).Says FDA also indicated that it plans to hold an advisory committee meeting regarding the nda.Says FDA has set a target action date under the prescription drug user fee act (pdufa) of December 11, 2016.  Full Article

Spectrum Pharmaceuticals announces agreement with FDA on Special Protocol Assessment (SPA) for Registrational Trial of SPI-2012
Wednesday, 16 Dec 2015 07:00am EST 

Spectrum Pharmaceuticals, Inc:Says it has reached agreement with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA) for the Phase 3 clinical trial of long-acting G-CSF, SPI-2012 (eflapegrastim).Trial will evaluate the safety and efficacy of SPI-2012 as a treatment for chemotherapy-induced neutropenia in patients with breast cancer, and will serve as the basis for the Biologics License Application (BLA) filing.  Full Article

Spectrum Pharmaceuticals and Onxeo announce Phase 1 trial results of Belinostat with CHOP
Sunday, 6 Dec 2015 12:00pm EST 

Onxeo SA and Spectrum Pharmaceuticals:Reported complete response in 67 pct of patients with peripheral T-cell lymphoma in combination of Belinostat (Beleodaq) and standard CHOP (Cyclophosphamide, Hydroxyl-doxorubicin; Vincristine, and Prednisone).Study shows 86 pct objective response rate with 67 pct complete responses in newly diagnosed patients with Peripheral T-cell Lymphoma (PTCL).At full dose intensity the belinostat-chop combination was well-tolerated.  Full Article

Spectrum Pharmaceuticals announces agreement with FDA on the special protocol assessment
Monday, 17 Aug 2015 07:00am EDT 

Spectrum Pharmaceuticals Inc:Announces that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA) of the planned Phase 3 clinical trial of its novel, potent pro-drug, apaziquone.  Full Article

Spectrum Pharmaceuticals Inc files New Drug Application with FDA for Captisol-Enabled (Propylene Glycol-Free) Melphalan
Friday, 26 Dec 2014 07:00am EST 

Spectrum Pharmaceuticals Inc:Says it has submitted New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for approval of Captisol-Enabled Melphalan (CE-Melphalan) HCl for injection (propylene glycol-free).For use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.Spectrum is also seeking approval for palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.  Full Article

Spectrum Pharmaceuticals Inc announces issue of new patent for beleodaq for injection with patent term adjustment till 2027
Tuesday, 16 Sep 2014 07:00am EDT 

Spectrum Pharmaceuticals Inc:Says United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 8835501, which covers Beleodaq (belinostat) for Injection on Sept. 16 with patent term adjustment from May 2026 to Oct. 2027.Says in addition to the existing patent, covering the chemical entity of Beleodaq, this new patent covers the formulation of the product, strengthening and expanding significantly its industrial property protection.  Full Article

BRIEF-Spectrum Pharma says Dr Reddy's will be permitted to market generic version of Folotyn in US on Dec 1, 2022 or earlier

* Co's unit, dr. Reddy's labs, ltd entered into settlement agreement to resolve their patent litigation relating to folotyn