Spectrum Pharmaceuticals, Inc. (SPPI - Free Report) announced that it has received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Qapzola (apaziquone).
The company was looking to get Qapzola approved for the immediate intravesical instillation, post transurethral resection of bladder tumors (post-TURBT) in patients with non-muscle invasive bladder cancer (NMIBC).
Consequently, Spectrum has stopped enrolling patients in the ongoing phase III program on Qapzola and is currently conducting a new smaller study on the candidate, following discussions with the FDA.
Note that this September, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted against the approval of Qapzola. The ODAC stated that Qapzola failed to demonstrate a substantial evidence of a treatment effect in comparison with placebo.
We remind investors that Spectrum reacquired global development and commercialization rights to Qapzola in the U.S., Europe and other territories from Allergan plc (AGN - Free Report) under an amended collaboration agreement in 2013.
The unfavorable response from the FDA is highly disappointing. Considering the lack of FDA-approved treatments for post-TURBT instillation in patients with NMIBC, there exists significant unmet for new treatment options.
Although Spectrum’s product portfolio currently comprises six marketed products, the company has been unable to generate substantial revenues for most of them. Therefore, approval of pipeline candidates is crucial for the company.
Encouragingly though, Spectrum’s shares were unaffected by the announcement.
Going forward, investor focus is expected to remain on further updates by the company on Qapzola.
Zacks Rank & Key Picks
Spectrum currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Vanda Pharmaceuticals, Inc. (VNDA - Free Report) and Cambrex Corp. (CBM - Free Report) . Both the stocks currently sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vanda’s loss estimates narrowed from 68 cents to 56 cents for 2016 over the last 60 days, while its earnings estimates increased from 16 cents to 17 cents for 2017. The company posted a positive earnings surprise in three of the last four quarters with an average beat of 56.65%.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the trailing four quarters with an average beat of 19.78%.
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