Spectrum Pharmaceuticals, Inc. SPPI announced that the company has initiated the registrational phase III study of qapzola (apaziquone) in patients with non-muscle invasive bladder cancer (NMIBC).
NMIBC is the fifth most common cancer in the U.S. and is an unmet medical need due to high recurrence rates and no FDA-approved drugs.
Shares of the company have skyrocketed 111.7% against the Zacks classified industry’s decline of 2.4% on a year-to-date basis.
In November 2016, Spectrum suffered a regulatory setback when the FDA issued a complete response letter (CRL) for its new drug application (NDA) for Qapzola. In fact, the company was looking to get Qapzola approved for immediate intravesical instillation, post transurethral resection of bladder tumors (post-TURBT) in patients with non-muscle invasive bladder cancer (NMIBC).
Notably, now the phase III study is being conducted under a special protocol assessment (SPA) from the FDA and includes feedback from the FDA and key opinion leaders (KOLs) as well as learnings from earlier studies. The study will enroll patients with low and intermediate risk NMIBC as per the American Urology Association (AUA) Guidelines. The study will have lesser patients enrolled (425 patients compared with 1557) and the duration of the study will be reduced.
The protocol includes a single instillation of Qapzola 60 ± 30 minute post-TURBT, to avoid inactivation of Qapzola by blood that is present after surgery. Furthermore, the patients will be randomized 2:1 to receive either 8 mg instillation of Qapzola or placebo post-TURBT. The primary endpoint for this trial is time to recurrence.
Spectrum Pharmaceuticals, Inc. Price
Spectrum Pharmaceuticals, Inc. Price | Spectrum Pharmaceuticals, Inc. Quote
Zacks Rank & Key Picks
Spectrum currently holds a Zacks Rank #2 (Buy). Some other top-ranked stocks in health care sector include Alexion Pharmaceuticals, Inc. ALXN, Regeneron Pharmaceuticals, Inc. REGN and Sanofi SNY. While Alexion and Regeneron sport a Zacks Rank #1 (Strong Buy), Sanofi carries the same bullish rank as Spectrum. You can see the complete list of today’s Zacks #1 Rank stocks here.
Alexion Pharmaceuticals’ earnings per share estimates have moved up from $4.55 to $4.77 for 2017 and from $5.49 to $6.43 for 2018 over the last 30 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 12.26%. The share price of the company has increased 10.6% year to date.
Regeneron’s earnings per share estimates have increased from $10.52 to $13.81 for 2017 and from $12.10 to $14.54 for 2018 over the last 30 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 6.29%. The share price of the company has increased 28.7% year to date.
Sanofi’s earnings per share estimates have moved up from $3.20 to $3.31 for 2017 and from $3.36 to $3.38 for 2018 over last 30 days. The company came up with positive earnings surprises in three of the trailing four quarters, with an average beat of 5.10%. The share price of the company has increased 18.3% year to date.
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