Spectrum Pharmaceuticals recently announced that it has initiated a phase II trial to evaluate its pipeline candidate, poziotinib. The candidate is expected to be used for the treatment of non-small cell lung cancer patients with EGFR exon 20 insertion mutations. This phase II study will be conducted in collaboration with The University of Texas MD Anderson Cancer Center.
Poziotinib is a novel pan-HER inhibitor that is used in the treatment of patients with a variety of solid tumors, including breast and lung cancer.
The study will assess objective response rate (ORR) as the primary endpoint and is expected to yield preliminary results before the year end.
Spectrum’s shares have outperformed the Zacks classified Medical-Drugs industry so far this year. Shares of the company gained 47.4% while the industry registered an increase of 5.3%.
We note that poziotinib is presently being evaluated in multiple phase II studies in several tumor types, including breast cancer, non-small cell lung cancer and gastric cancer. The studies are being conducted in South Korea by Hanmi Pharmaceuticals and National OncoVenture.
We remind investors that Spectrum submitted an Investigational new drug application (NDA) with the FDA in Nov 2015. Subsequently, in Mar 2016, the company initiated a phase II (SPI-POZ-201) breast cancer study in the U.S. The phase II open-label study is currently enrolling patients with HER-2 positive metastatic breast cancer, who have failed at least two but no more than four HER-2 directed therapies.
Meanwhile, Spectrum Pharma continues to progress with its product pipeline. The most advanced candidate is Rolontis (eflapegrastim; formerly known as SPI-2012) – a novel long-acting granulocyte stimulating factor. The company is currently enrolling patients in a phase III study on the candidate under a Special Protocol Assessment agreement with the FDA for the management of chemotherapy-induced neutropenia in patients with breast cancer. Positive results from the study would allow the company to seek FDA approval in 2018. This apart, the company is conducting an additional phase III study to evaluate patients in Europe.
Currently, Spectrum is evaluating another candidate, Qapzola (formerly referred to as apaziquone), in a phase III study under an SPA agreement. The product will be used for the treatment of patients with non-muscle invasive bladder cancer.
Given its robust portfolio, we expect investor focus to remain on further updates on the company’s pipeline, going forward.
Zacks Rank & Key Picks
Spectrum currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Heska Corporation , Galena Biopharma, Inc. and Retrophin, Inc. . Each of these stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.80 to $2.01 for 2018 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Galena’s loss per share estimates narrowed from $2.03 to 58 cents for 2017 and over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 53.83%.
Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>
Image: Bigstock
Spectrum (SPPI) Initiates Phase II Study for Cancer Candidate
Spectrum Pharmaceuticals recently announced that it has initiated a phase II trial to evaluate its pipeline candidate, poziotinib. The candidate is expected to be used for the treatment of non-small cell lung cancer patients with EGFR exon 20 insertion mutations. This phase II study will be conducted in collaboration with The University of Texas MD Anderson Cancer Center.
Poziotinib is a novel pan-HER inhibitor that is used in the treatment of patients with a variety of solid tumors, including breast and lung cancer.
The study will assess objective response rate (ORR) as the primary endpoint and is expected to yield preliminary results before the year end.
Spectrum’s shares have outperformed the Zacks classified Medical-Drugs industry so far this year. Shares of the company gained 47.4% while the industry registered an increase of 5.3%.
We note that poziotinib is presently being evaluated in multiple phase II studies in several tumor types, including breast cancer, non-small cell lung cancer and gastric cancer. The studies are being conducted in South Korea by Hanmi Pharmaceuticals and National OncoVenture.
We remind investors that Spectrum submitted an Investigational new drug application (NDA) with the FDA in Nov 2015. Subsequently, in Mar 2016, the company initiated a phase II (SPI-POZ-201) breast cancer study in the U.S. The phase II open-label study is currently enrolling patients with HER-2 positive metastatic breast cancer, who have failed at least two but no more than four HER-2 directed therapies.
Meanwhile, Spectrum Pharma continues to progress with its product pipeline. The most advanced candidate is Rolontis (eflapegrastim; formerly known as SPI-2012) – a novel long-acting granulocyte stimulating factor. The company is currently enrolling patients in a phase III study on the candidate under a Special Protocol Assessment agreement with the FDA for the management of chemotherapy-induced neutropenia in patients with breast cancer. Positive results from the study would allow the company to seek FDA approval in 2018. This apart, the company is conducting an additional phase III study to evaluate patients in Europe.
Currently, Spectrum is evaluating another candidate, Qapzola (formerly referred to as apaziquone), in a phase III study under an SPA agreement. The product will be used for the treatment of patients with non-muscle invasive bladder cancer.
Given its robust portfolio, we expect investor focus to remain on further updates on the company’s pipeline, going forward.
Spectrum Pharmaceuticals, Inc. Price
Spectrum Pharmaceuticals, Inc. Price | Spectrum Pharmaceuticals, Inc. Quote
Zacks Rank & Key Picks
Spectrum currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Heska Corporation , Galena Biopharma, Inc. and Retrophin, Inc. . Each of these stock sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings per share estimates increased from $1.53 to $1.65 for 2017 and from $1.80 to $2.01 for 2018 over the last 30 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 291.54%.
Galena’s loss per share estimates narrowed from $2.03 to 58 cents for 2017 and over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 53.83%.
Retrophin’s loss per share estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018 over the last 30 days. The company posted positive earnings surprises in two of the four trailing quarters, with an average beat of 80.55%.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>