We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
PBYI's Alisertib Combo Phase II Study in Small Cell Lung Cancer Begins
Read MoreHide Full Article
Key Takeaways
PBYI began the phase II ALISCA-Lung2 study of alisertib plus paclitaxel in small cell lung cancer.
The ALISCA-Lung2 study will assess safety and tolerability, along with response and survival outcomes.
The ALISCA-Lung1 study is investigating alisertib as a monotherapy for extensive-stage small cell lung cancer.
Puma Biotechnology (PBYI - Free Report) announced that it has initiated the phase II ALISCA-Lung2 study evaluating its pipeline candidate, alisertib, in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer.
The ALISCA-Lung2 study is a sequential dose-escalation study that is likely to enroll around 50 patients with small cell lung cancer whose disease has progressed on or after treatment with platinum-based chemotherapy and immunotherapy.
PBYI’s Price Performance
Year to date, shares of Puma Biotechnology have rallied 60% compared with the industry’s rise of 6.7%.
Image Source: Zacks Investment Research
The primary endpoint of the ALISCA-Lung2 study is to check the safety and tolerability of alisertib in combination with paclitaxel. Secondary endpoints include objective response rate, duration of response, disease control rate, progression-free survival and overall survival.
Management also plans to evaluate clinical biomarkers to identify patients who may derive the greatest benefit from the combination, which could help guide the future development of alisertib.
Puma Biotechnology is also evaluating alisertib as a monotherapy in the ongoing ALISCA-Lung1 study for the treatment of patients with extensive-stage small cell lung cancer. The company expects both studies to advance the clinical development of alisertib in small cell lung cancer.
PBYI's Ongoing Development Activities With Alisertib
Puma Biotechnology in-licensed the global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda in 2022.
Besides lung cancer, the company is also developing alisertib for hormone receptor-positive breast cancer.
The phase II ALISCA-Breast1 study is investigating alisertib in combination with endocrine treatment for treating patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer. Updated data from the study are expected in the fourth quarter of 2026.
Per management, alisertib has huge potential in HR-positive, HER2-negative breast cancer, triple-negative breast cancer, head and neck cancer and SCLC. If successfully developed for the given indications, alisertib has the potential to boost the company’s position in the anticancer drug market while creating long-term growth visibility.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 8.8% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 bottom line have moved from a loss of 12 cents per share to earnings of $1.05 per share. Earnings estimates for 2027 have increased from 16 cents to 95 cents during the same time frame. ANIK’s shares have surged 118.8% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 88.3% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.
View the Zacks #1 Rank List
Image: Bigstock
PBYI's Alisertib Combo Phase II Study in Small Cell Lung Cancer Begins
Key Takeaways
Puma Biotechnology (PBYI - Free Report) announced that it has initiated the phase II ALISCA-Lung2 study evaluating its pipeline candidate, alisertib, in combination with paclitaxel for the treatment of patients with advanced small cell lung cancer.
The ALISCA-Lung2 study is a sequential dose-escalation study that is likely to enroll around 50 patients with small cell lung cancer whose disease has progressed on or after treatment with platinum-based chemotherapy and immunotherapy.
PBYI’s Price Performance
Year to date, shares of Puma Biotechnology have rallied 60% compared with the industry’s rise of 6.7%.
Image Source: Zacks Investment Research
The primary endpoint of the ALISCA-Lung2 study is to check the safety and tolerability of alisertib in combination with paclitaxel. Secondary endpoints include objective response rate, duration of response, disease control rate, progression-free survival and overall survival.
Management also plans to evaluate clinical biomarkers to identify patients who may derive the greatest benefit from the combination, which could help guide the future development of alisertib.
Puma Biotechnology is also evaluating alisertib as a monotherapy in the ongoing ALISCA-Lung1 study for the treatment of patients with extensive-stage small cell lung cancer. The company expects both studies to advance the clinical development of alisertib in small cell lung cancer.
PBYI's Ongoing Development Activities With Alisertib
Puma Biotechnology in-licensed the global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda in 2022.
Besides lung cancer, the company is also developing alisertib for hormone receptor-positive breast cancer.
The phase II ALISCA-Breast1 study is investigating alisertib in combination with endocrine treatment for treating patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer. Updated data from the study are expected in the fourth quarter of 2026.
Per management, alisertib has huge potential in HR-positive, HER2-negative breast cancer, triple-negative breast cancer, head and neck cancer and SCLC. If successfully developed for the given indications, alisertib has the potential to boost the company’s position in the anticancer drug market while creating long-term growth visibility.
Puma Biotechnology, Inc. Price
Puma Biotechnology, Inc. price | Puma Biotechnology, Inc. Quote
PBYI's Zacks Rank & Stocks to Consider
Puma Biotechnology currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Repligen (RGEN - Free Report) , Anika Therapeutics (ANIK - Free Report) and Precigen (PGEN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 8.8% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Anika Therapeutics’ 2026 bottom line have moved from a loss of 12 cents per share to earnings of $1.05 per share. Earnings estimates for 2027 have increased from 16 cents to 95 cents during the same time frame. ANIK’s shares have surged 118.8% year to date.
Anika Therapeutics’ earnings beat estimates in each of the trailing three quarters, with the average surprise being 950.00%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 88.3% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.