BC Extra | Mar 15, 2019
Company News

Another setback for Spectrum's remaining pipeline after Rolontis BLA withdrawal

Spectrum said Friday that it withdrew a BLA for Rolontis eflapegrastim to treat chemotherapy-induced neutropenia. Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said it needs more time to provide additional manufacturing-related information to FDA, which was due before...
BC Week In Review | Oct 6, 2017
Financial News

Spectrum raises $90.2M in at-the-market offering

On Sept. 29, Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said it raised $90.2 million since Aug. 11 in an at-the-market offering through the sale of about 9.3 million shares. Last year, Spectrum received a complete response letter...
BC Extra | Sep 29, 2017
Financial News

Spectrum raises $90M in at-the-market offering

Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said it raised $90.2 million since Aug. 11 in an at-the-market offering through the sale of about 9.3 million shares. Last year, Spectrum received a complete response letter from FDA for...
BioCentury | Jan 6, 2017
Finance

Tiers of disappointment

A bad year for biotech was closed with an even worse 4Q16 as volatility ahead of the U.S. elections and continued concerns around drug pricing held every market cap band in the red despite a...
BioCentury | Dec 16, 2016
Regulation

Blip or dip?

In a ritual held each year a couple of weeks before the winter solstice, pundits pore over FDA’s new drug approval statistics and use them to pontificate about the health of the biopharma industry and...
BC Week In Review | Dec 2, 2016
Clinical News

Qapzola regulatory update

FDA issued a complete response letter to Spectrum for Qapzola apaziquone to treat non-muscle invasive bladder cancer (NMIBC). Based on discussions with the agency, Spectrum is considering a new smaller study of Qapzola that would...
BC Extra | Nov 18, 2016
Company News

Complete response letter for Spectrum's Qapzola

Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said it received a complete response letter from FDA for its non-muscle invasive bladder cancer (NMIBC) candidate Qapzola apaziquone. Based on discussions with the agency, Spectrum is considering a new smaller...
BioCentury | Oct 3, 2016
Finance

ASH and others

Cancer and hematology companies are likely to garner the most headlines in 4Q16 thanks to ESMO in October and ASH in December, but some investors also are branching out to events that typically receive less...
BC Week In Review | Sep 26, 2016
Clinical News

Qapzola apaziquone regulatory update

FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-0 that Qapzola apaziquone from Spectrum has not shown substantial efficacy over placebo in treating non-muscle invasive bladder cancer (NMIBC) following transurethral resection of bladder tumors (TURBT). The...
BioCentury | Jul 11, 2016
Finance

Rethinking risk

Steve Edelson, Senior Editor   The second half does not contain the high-impact, sector-moving milestones seen in the first six months of the year, but investors still have at least 90 late-stage milestones from which...
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