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Puma's (PBYI) Alisertib Gets FDA's Orphan Drug Tag for SCLC
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Puma Biotechnology (PBYI - Free Report) announced that its pipeline candidate alisertib was granted the Orphan Drug designation by the FDA for treating patients with small cell lung cancer (SCLC), an aggressive form of lung cancer. Following this development, shares of the company were up 3.45% in after-hours trading on Sep 21.
Puma in-licensed the global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda, in 2022.
The Orphan Drug designation is granted to experimental treatments intended for rare diseases affecting fewer than 200,000 individuals in the United States. The designation expedites development and review of drugs, along with the potential seven years of post-approval marketing exclusivity.
Last month, Puma received the FDA approval for the investigational new drug application, seeking to initiate a clinical study on alisertib for patients with SCLC. Following this approval, PBYI plans to initiate a phase II PUMA-ALI-4201 study by the end of 2023.
Shares of Puma have lost 31.5% year to date compared with the industry’s 14.8% decline.
Image Source: Zacks Investment Research
Puma plans to develop alisertib for the treatment of hormone receptor-positive breast cancer as well as SCLC. If the candidate is successfully developed for the above-mentioned indications, it has the potential to boost the company’s position in the anticancer drug market.
Puma’s sole marketed drug, Nerlynx, approved for third-line HER2-positive metastatic breast cancer, has been witnessing consistent growth in demand in the United States. In the first half of 2023, the drug generated sales of $98.3 million, a 7% growth year over year.
Nerlynx also received the Orphan Drug designation from the FDA in 2019, for treating breast cancer patients with brain metastases.
In the past 90 days, the Zacks Consensus Estimate forAnika Therapeutics has narrowed from a loss of $1.41 per share to a loss of $1.24 for 2023. The bottom-line estimate has widened from a loss of 79 cents to a loss of 82 cents for 2024 during the same time frame. Shares of the company have lost 38.7% year to date.
ANIK’s earnings beat estimates in one of the trailing four quarters and missed the mark in the remaining three, delivering an average negative surprise of 32.12%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to a loss of $2.77 for 2024 during the same time frame. Shares of the company have lost 22.2% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 62 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 61 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 57.3% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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Puma's (PBYI) Alisertib Gets FDA's Orphan Drug Tag for SCLC
Puma Biotechnology (PBYI - Free Report) announced that its pipeline candidate alisertib was granted the Orphan Drug designation by the FDA for treating patients with small cell lung cancer (SCLC), an aggressive form of lung cancer. Following this development, shares of the company were up 3.45% in after-hours trading on Sep 21.
Puma in-licensed the global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda, in 2022.
The Orphan Drug designation is granted to experimental treatments intended for rare diseases affecting fewer than 200,000 individuals in the United States. The designation expedites development and review of drugs, along with the potential seven years of post-approval marketing exclusivity.
Last month, Puma received the FDA approval for the investigational new drug application, seeking to initiate a clinical study on alisertib for patients with SCLC. Following this approval, PBYI plans to initiate a phase II PUMA-ALI-4201 study by the end of 2023.
Shares of Puma have lost 31.5% year to date compared with the industry’s 14.8% decline.
Image Source: Zacks Investment Research
Puma plans to develop alisertib for the treatment of hormone receptor-positive breast cancer as well as SCLC. If the candidate is successfully developed for the above-mentioned indications, it has the potential to boost the company’s position in the anticancer drug market.
Puma’s sole marketed drug, Nerlynx, approved for third-line HER2-positive metastatic breast cancer, has been witnessing consistent growth in demand in the United States. In the first half of 2023, the drug generated sales of $98.3 million, a 7% growth year over year.
Nerlynx also received the Orphan Drug designation from the FDA in 2019, for treating breast cancer patients with brain metastases.
Puma Biotechnology, Inc. Price and Consensus
Puma Biotechnology, Inc. price-consensus-chart | Puma Biotechnology, Inc. Quote
Zacks Rank & Stocks to Consider
Puma currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same industry are Anika Therapeutics (ANIK - Free Report) , Annovis Bio (ANVS - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate forAnika Therapeutics has narrowed from a loss of $1.41 per share to a loss of $1.24 for 2023. The bottom-line estimate has widened from a loss of 79 cents to a loss of 82 cents for 2024 during the same time frame. Shares of the company have lost 38.7% year to date.
ANIK’s earnings beat estimates in one of the trailing four quarters and missed the mark in the remaining three, delivering an average negative surprise of 32.12%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to a loss of $2.77 for 2024 during the same time frame. Shares of the company have lost 22.2% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 62 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 61 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 57.3% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.