Puma Biotechnology PBYI 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%.
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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, Anika Therapeutics ANIK and Precigen PGEN, 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%.
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