$SPPI (Spectrum Pharmaceuticals, Inc.)

$SPPI {{ '2016-07-15T18:09:43+0000' | timeago}} • Announcement

Biotechnology company $SPPI said that it has settled its ANDA patent litigation related to FOLOTYN. Due to the settlement with the last remaining ANDA filer, Fresenius Kabi and the previously reported settlements with $TEVA, $DRREDDY and Sandoz Inc., generic versions of FOLOTYN will not be permitted to be marketed in the US until Nov. 15, 2022.

$SPPI {{ '2017-09-29T12:00:08+0000' | timeago}} • Announcement

Biotechnology firm $SPPI said it issued an aggregate of about 9.3MM shares under an offering program. The company intends to use the proceeds from the offering, about $90MM, to further its drug development pipeline and to provide additional flexibility to capital structure.

$SPPI {{ '2017-08-14T11:41:44+0000' | timeago}} • Announcement

$SPPI enrolled the first patient in a Phase 3 trial of Qapzola, a potent tumor-activated drug being investigated for low and intermediate risk non-muscle invasive bladder cancer. The primary endpoint for this trial is Time to Recurrence.

$SPPI {{ '2017-08-01T15:21:52+0000' | timeago}} • Announcement

Biotechnology company $SPPI has completed enrollment in the phase-3 advance pivotal study involving its cancer drug Rolontis. The trial evaluates safety and efficacy of the drug in the management of chemotherapy-induced neutropenia in patients with breast cancer. Topline data from the study is expected to be published in Q118.

$SPPI {{ '2017-03-08T22:06:21+0000' | timeago}} • Webcast

$SPPI had total product sales of $32.2MM in 4Q16. The sales of the PTCL franchise, which drives the bulk of the company’s revenue, were $13.7MM. $SPPI’s  most recently launched product EVOMELA had sales of $9.4MM.

$SPPI {{ '2017-03-08T21:21:44+0000' | timeago}} • Announcement

$SPPI said Poziotinib, which is being developed for breast cancer, has recently emerged as a potential treatment for a high unmet medical need in lung cancer and is expected to yield results before year end. Data presented in December suggests that poziotinib has potential in lung cancer patients with certain genetic mutations.

$SPPI {{ '2017-03-08T21:20:29+0000' | timeago}} • Announcement

$SPPI said Rolontis (eflapegrastim) pivotal program is on track for $SPPI to file BLA next year. Qapzola (apaziquone) received a new Special Protocol Assessment (SPA) from the FDA that significantly reduces the number of patients required for NDA filing.

$SPPI {{ '2017-03-08T21:16:24+0000' | timeago}} • Announcement

$SPPI reported a wider 4Q16 loss due to lower product sales and a decline in license fees and service revenue. Net loss widened to $17.44MM or $0.22 per share from $4.15MM or $0.06 per share last year. Revenue dropped to $35.24MM from $50.33MM. Non-GAAP loss per share widened to $0.10 from $0.07.

$SPPI {{ '2016-11-14T19:33:09+0000' | timeago}} • Announcement

$SPPI posted net loss of $17.5MM or $0.22 per share in 3Q16, compared to net loss of $18.7MM or $0.28 per share a year ago. Revenues increased 16.6% to $33.4MM, including $30.3MM in product sales, helped by the contribution of $5.9MM by recently launched EVOMELA drug.

$SPPI {{ '2016-09-14T19:08:47+0000' | timeago}} • Announcement

$SPPI said FDA advisory committee Voted that Qapzola (apaziquone) has not shown substantial evidence of a treatment effect over placebo. The committee recommendation is not binding on the FDA, which makes the final decision on approval. The Prescription Drug User Fee Act (PDUFA) date for the Qapzola NDA is Dec. 11, 2016.

$SPPI {{ '2016-09-14T19:07:08+0000' | timeago}} • Announcement

$SPPI said FDA Oncologic Drugs Advisory Committee (ODAC) voted that Qapzola for immediate intravesical instillation post-transurethral resection of bladder tumors (post-TURBT) has not shown substantial evidence of a treatment effect over placebo in patients with non-muscle invasive bladder cancer (NMIBC).

$SPPI {{ '2016-07-15T18:09:43+0000' | timeago}} • Announcement

Biotechnology company $SPPI said that it has settled its ANDA patent litigation related to FOLOTYN. Due to the settlement with the last remaining ANDA filer, Fresenius Kabi and the previously reported settlements with $TEVA, $DRREDDY and Sandoz Inc., generic versions of FOLOTYN will not be permitted to be marketed in the US until Nov. 15, 2022.

$SPPI {{ '2016-04-20T19:04:45+0000' | timeago}} • Announcement

Biotechnology company $SPPI said the U.S. Food and Drug Administration Office of Orphan Products Development granted 7 years of Orphan Drug Exclusivity for its drug EVOMELA for use as a high-dose conditioning treatment in patients with multiple myeloma.

$SPPI {{ '2016-04-20T15:48:31+0000' | timeago}} • Announcement

Biotechnology company $SPPI said that the FDA Office of Orphan Products Development (OOPD) has granted 7 years of Orphan Drug Exclusivity for EVOMELA. This drug is used as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma, a bone marrow malignancy disorder.

$SPPI {{ '2016-03-07T12:25:12+0000' | timeago}} • Announcement

Biotechnology company $SPPI said it has started the planned Phase 2 clinical study for Poziotinib, its pan-HER inhibitor. The Phase 2 trial is an open-label study that will enroll about 70 patients with HER2-positive metastatic breast cancer who have failed at least 2 prior HER2-directed therapies.

$SPPI {{ '2016-02-19T12:21:56+0000' | timeago}} • Announcement

Biotechnology company $SPPI said the U.S. Food and Drug Administration has accepted EOquin (apaziquone for intravesical instillation) New Drug Application for review. EOquin is a drug developed for treatment of non-invasive bladder cancer.

$SPPI {{ '2016-01-11T16:19:48+0000' | timeago}} • Announcement

Biotechnology company $SPPI said it has signed a strategic partnership with Servier Canada Inc., an affiliate of Servier, to grant exclusive rights to develop and commercialize four of its hemato-oncology drugs in Canada. $SPPI will receive $6MM in upfront payments, plus development milestone payments and royalties based on net product sales.

$SPPI {{ '2015-12-16T15:40:24+0000' | timeago}} • Announcement

Biotech company $SPPI said it has reached an agreement with the US FDA on the Special Protocol Assessment (SPA) for the Registrational Trial of SPI-2012 (eflapegrastim), a novel, long acting G-CSF in patients with breast cancer. $SPPI expects to start the pivotal trial shortly and plans to complete enrollment in 2017.

$SPPI {{ '2015-12-07T12:12:42+0000' | timeago}} • Announcement

Biopharmaceutical companies $SPPI & Onxeo S.A. announced Phase 1 results of drug belinostat (Beleodaq) with the CHOP chemotherapy regimen as a first-line treatment for newly diagnosed peripheral T-cell lymphoma (PTCL), a type of blood cancer. Study shows 86% response rate with 67% complete responses in patients with PTCL.

$SPPI {{ '2015-11-20T13:39:14+0000' | timeago}} • Announcement

$SPPI said it submitted an investigational new drug application to the US FDA and intends to initiate a Phase 2 breast cancer study in the US soon. The study is planned to be an open-label study enrolling approx. 70 patients with HER-2 positive metastatic breast cancer which will be treated with oral pan-HER inhibitor poziotinib.

$SPPI {{ '2015-11-18T12:24:49+0000' | timeago}} • Announcement

Biotechnology company $SPPI announced its divestment rights of ZEVALIN (ibritumomab tiuxetan) in Japan & other countries in APAC, Middle East, Africa & Latin America to Mundipharma. $SPPI will receive $15MM as an up-front payment & $5MM as profits. $SPPI continues to own ZEVALIN rights for US, Canada & Europe.

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