Spectrum Pharmaceuticals, Inc.NASDAQ
Fri, Nov. 18, 6:52 AM
- As expected, Spectrum Pharmaceuticals (NASDAQ:SPPI) receives a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking approval of QAPZOLA (apaziquone) for the immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer.
- The company met with the review team earlier this week to discuss the next steps and is evaluating a new smaller clinical trial that would replace the ongoing Phase 3 program that has stopped enrollment.
- In September, the FDA's advisory committee voted 14-0 against approval.
- Previously: Ad Comm review today for Spectrum Pharma's apaziquone (Sept. 14)
Mon, Nov. 14, 11:55 AM
- Spectrum Pharmaceuticals (SPPI +0.7%) Q3 results ($M): Total Revenues: 33.4 (+16.8%); Product Sales: 30.3 (+6.3%).
- Net Loss: (17.5) (+6.8%); Non-GAAP Net Loss: (5.3) (+33.0%); Loss Per Share: (0.22) (+21.4%); Non-GAAP Loss Per Share: (0.07) (+41.7%).
- Key Product Sales: Folotyn: 11.3; ; Evomela: 5.9; Fusilev: 4.9; Zevalin: 2.6.
- Consensus view was a loss/share of ($0.30) on revenues of $30.5M.
- No guidance given.
Mon, Nov. 14, 7:22 AM
Fri, Nov. 4, 5:37 PM
Thu, Nov. 3, 4:18 PM
Wed, Nov. 2, 5:35 PM
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Wed, Sep. 14, 12:35 PM
- The FDA's Oncologic Drugs Advisory Committee votes 14 - 0 against approving Spectrum Pharmaceuticals' (SPPI -3.6%) apaziquone NDA for bladder cancer.
Wed, Sep. 14, 7:05 AM
- The FDA's Oncologic Drugs Advisory Committee meets today to review and discuss Spectrum Pharmaceuticals' (NASDAQ:SPPI) New Drug Application (NDA) seeking approval of apaziquone, branded as Qapzola, for the immediate intravesical instillation post-transurethral resection of bladder tumors in patients with non-muscle invasive bladder cancer.
- Draft questions
- FDA briefing doc
- Spectrum briefing doc
- Update: The panel voted 14 - 0 against approval.
Wed, Aug. 10, 11:00 AM
Tue, Aug. 9, 4:21 PM
Mon, Aug. 8, 5:35 PM
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Wed, Jul. 13, 7:51 AM
- Spectrum Pharmaceuticals' (NASDAQ:SPPI) Allos Therapeutics and Fresenius Kabi USA have entered into settlement agreement to resolve their patent litigation relating to Folotyn (pralatrexate injection). Under the terms of the settlement, Fresenius will be permitted to market a generic version of Folotyn in the U.S. on November 15, 2022 or earlier under certain circumstances.
- The Company has also settled with Teva Pharmaceuticals USA (NYSE:TEVA), Dr. Reddy’s Laboratories (NYSE:RDY) and Sandoz (NYSE:NVS).
Thu, Jun. 9, 7:17 AM
- Spectrum Pharmaceuticals (NASDAQ:SPPI) unit Allos Therapeutics and Novartis (NYSE:NVS) unit Sandoz settle their patent litigation related to lymphoma drug Folotyn (pralatrexate injection). Sandoz will be permitted to sell a generic version in the U.S. on November 15, 2022 or earlier under certain circumstances.
Wed, May 25, 7:25 AM
- Spectrum Pharmaceuticals' (NASDAQ:SPPI) wholly owned subsidiary Allos Therapeutics settles its patent litigation with Teva Pharmaceuticals USA (NYSE:TEVA) related to lymphoma drug Folotyn (pralatrexate injection). The settlement allows Teva to market a generic version of Folotyn in the U.S. on December 1, 2022 or earlier under certain circumstances.
- Allos' litigation with other would-be generic competitors continues.
Thu, May 5, 4:13 PM
- Spectrum Pharmaceuticals (NASDAQ:SPPI): Q1 EPS of -$0.14 beats by $0.18.
- Revenue of $43.87M (+13.6% Y/Y) beats by $15.04M.
Wed, May 4, 5:35 PM
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