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Amgen's (AMGN) Tarlatamab BLA Gets FDA Priority Tag for SCLC
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Amgen Inc. (AMGN - Free Report) announced that the FDA has accepted its biologics license application (BLA) seeking approval for investigational therapy, tarlatamab. for third-line treatment of advanced small cell lung cancer (SCLC).
With the FDA granting a priority review to BLA, a decision from the regulatory body is expected on Jun 12, 2024.
Tarlatamab is an investigational delta-like ligand 3 targeting Bispecific T-cell Engager (BiTE) therapy, which is being studied for the treatment of adult patients with advanced SCLC whose disease has progressed on or after treatment with platinum-based chemotherapy.
If approved for the given indication, tarlatamab is likely to become the first BiTE therapy to treat third-line advanced SCLC. Currently, there is no FDA-approved therapy for the given indication.
The above BLA was based on data from the phase II DeLLphi-301 study, which evaluated tarlatamab for treating patients with advanced-stage SCLC who had failed two or more prior lines of treatment.
Shares of Amgen have rallied 5.8% in the past year against the industry’s decline of 21.5%.
Image Source: Zacks Investment Research
In October 2023, Amgen announced data from the phase II DeLLphi-301 study. In a median follow-up of 10.6 months, an intention-to-treat analysis that included 100 patients at the selected 10 mg dose, tarlatamab demonstrated an objective response rate (ORR; primary endpoint) of 40%. For key secondary endpoints, median progression-free survival (mPFS) was 4.9 months and median overall survival (mOS) was 14.3 months.
Per the company, SCLC patients often experience aggressive recurrences despite showing strong response in first-line treatment, which adversely impacts long-term survival. Upon potential approval, tarlatamab is likely to offer a new treatment option for the given patient population.
The FDA has already granted Breakthrough Therapy designation to tarlatamab for advanced-stage SCLC.
Several studies are currently ongoing on tarlatamab both as monotherapy and in combination in earlier/second or later line setting in SCLC.
The phase Ib DeLLphi-302 study is evaluating tarlatamab in combination with an anti-PD-1 therapy in second-line or later SCLC. Another phase Ib DeLLphi-303 study is investigating tarlatamab in combination with standard-of-care therapies in first-line SCLC. The phase III DeLLphi-304 is evaluating tarlatamab monotherapy versus standard-of-care chemotherapy in second-line SCLC. The phase III DeLLphi-306 study is evaluating tarlatamab, following chemoradiotherapy in earlier settings of SCLC. Meanwhile, the phase Ib DeLLpro-300 is evaluating tarlatamab in de novo or treatment-emergent neuroendocrine prostate cancer.
Amgen also plans to initiate another phase III study of tarlatamab in first-line SCLC.
In the past 60 days, estimates for Journey Medical’s 2023 loss per share have narrowed from $1.28 to 16 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 41 cents to 35 cents. In the past year, shares of DERM have surged 340.8%.
Earnings of Journey Medical beat estimates in one of the last four quarters while missing the same on the remaining three occasions. DERM delivered a four-quarter earnings surprise of 118.25%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. In the past year, shares of TRDA have decreased 32.6%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 64 cents. In the past year, shares of PBYI have lost 18.5%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Amgen's (AMGN) Tarlatamab BLA Gets FDA Priority Tag for SCLC
Amgen Inc. (AMGN - Free Report) announced that the FDA has accepted its biologics license application (BLA) seeking approval for investigational therapy, tarlatamab. for third-line treatment of advanced small cell lung cancer (SCLC).
With the FDA granting a priority review to BLA, a decision from the regulatory body is expected on Jun 12, 2024.
Tarlatamab is an investigational delta-like ligand 3 targeting Bispecific T-cell Engager (BiTE) therapy, which is being studied for the treatment of adult patients with advanced SCLC whose disease has progressed on or after treatment with platinum-based chemotherapy.
If approved for the given indication, tarlatamab is likely to become the first BiTE therapy to treat third-line advanced SCLC. Currently, there is no FDA-approved therapy for the given indication.
The above BLA was based on data from the phase II DeLLphi-301 study, which evaluated tarlatamab for treating patients with advanced-stage SCLC who had failed two or more prior lines of treatment.
Shares of Amgen have rallied 5.8% in the past year against the industry’s decline of 21.5%.
In October 2023, Amgen announced data from the phase II DeLLphi-301 study. In a median follow-up of 10.6 months, an intention-to-treat analysis that included 100 patients at the selected 10 mg dose, tarlatamab demonstrated an objective response rate (ORR; primary endpoint) of 40%. For key secondary endpoints, median progression-free survival (mPFS) was 4.9 months and median overall survival (mOS) was 14.3 months.
Per the company, SCLC patients often experience aggressive recurrences despite showing strong response in first-line treatment, which adversely impacts long-term survival. Upon potential approval, tarlatamab is likely to offer a new treatment option for the given patient population.
The FDA has already granted Breakthrough Therapy designation to tarlatamab for advanced-stage SCLC.
Several studies are currently ongoing on tarlatamab both as monotherapy and in combination in earlier/second or later line setting in SCLC.
The phase Ib DeLLphi-302 study is evaluating tarlatamab in combination with an anti-PD-1 therapy in second-line or later SCLC. Another phase Ib DeLLphi-303 study is investigating tarlatamab in combination with standard-of-care therapies in first-line SCLC. The phase III DeLLphi-304 is evaluating tarlatamab monotherapy versus standard-of-care chemotherapy in second-line SCLC. The phase III DeLLphi-306 study is evaluating tarlatamab, following chemoradiotherapy in earlier settings of SCLC. Meanwhile, the phase Ib DeLLpro-300 is evaluating tarlatamab in de novo or treatment-emergent neuroendocrine prostate cancer.
Amgen also plans to initiate another phase III study of tarlatamab in first-line SCLC.
Zacks Rank & Stocks to Consider
Amgen currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Journey Medical Corporation (DERM - Free Report) , Entrada Therapeutics, Inc. (TRDA - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Journey Medical’s 2023 loss per share have narrowed from $1.28 to 16 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 41 cents to 35 cents. In the past year, shares of DERM have surged 340.8%.
Earnings of Journey Medical beat estimates in one of the last four quarters while missing the same on the remaining three occasions. DERM delivered a four-quarter earnings surprise of 118.25%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. In the past year, shares of TRDA have decreased 32.6%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 64 cents. In the past year, shares of PBYI have lost 18.5%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.