We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
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.
Merck (MRK) & Daiichi Sankyo's Lung Cancer ADC Gets Priority Tag
Read MoreHide Full Article
Merck (MRK - Free Report) and its partner Daiichi Sankyo announced that the FDA has granted priority review to the biologics license application (BLA) seeking approval for patritumab deruxtecan (HER3-DXd) to treat certain lung cancer in adult patients.
The BLA seeks approval for patritumab deruxtecan to treat adult patients with locally advanced or metastatic (la/m) EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. A filing designated as a priority review reduces the review period by four months. A final decision is expected on Jun 26, 2024.
If approved, patritumab deruxtecan could become the first HER3 directed medicine approved in the United States.
The BLA is supported by positive results from the HERTHENA-Lung01 pivotal phase II study. The study met its primary endpoint of a clinically meaningful objective response rate (29.8%) in patients treated with HER3-DXd. A clinically meaningful median duration of response (6.4 months), a secondary endpoint, was also observed. Treatment with the drug also demonstrated a favorable safety profile consistent with that observed in previous phase I studies in NSCLC.
Per the press release, the BLA is being reviewed under the Real-Time Oncology Review (RTOR) program, the FDA’s new initiative focused on bringing safe and effective cancer treatments to patients as early as possible. The unique nature of the RTOR program allows the FDA to review the components of an application before submission of the complete application.
Year to date, shares of Merck have lost 2.9% against the industry’s 6% growth.
Image Source: Zacks Investment Research
In October, MRK and Daiichi Sankyo entered into an agreement to co-develop and co-commercialize three investigational cancer therapies for a total potential consideration of up to $22 billion. One of these candidates is patritumab deruxtecan, which is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC). The candidate already enjoys the FDA’s Breakthrough Therapy designation in the United States for the treatment of patients with la/m EGFR-mutated NSCLC.
The deal also involves Daiichi’s other DXd ADC candidates — ifinatamab deruxtecan and raludotatug deruxtecan. All these candidates are being evaluated in different stages of clinical development across multiple solid tumor indications, both as monotherapy and/or in combination with other treatments.
Currently, Merck markets Keytruda (pembrolizumab) as the standard of care in the frontline treatment of metastatic NSCLC. Notably, Keytruda, an anti-PD-1 therapy, is MRK’s blockbuster oncology drug and is approved for several types of cancer, accounting alone for around 45% of the company’s pharmaceutical sales.
Keytruda is presently approved to treat eight indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck’s position in the oncology market.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has decreased from 73 cents to 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. Year to date, shares of PBYI have lost 2.6%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 18 cents. Year to date, shares of ADMA have gained 9.3%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. Year to date, shares of AGEN have plunged 67.4%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Shutterstock
Merck (MRK) & Daiichi Sankyo's Lung Cancer ADC Gets Priority Tag
Merck (MRK - Free Report) and its partner Daiichi Sankyo announced that the FDA has granted priority review to the biologics license application (BLA) seeking approval for patritumab deruxtecan (HER3-DXd) to treat certain lung cancer in adult patients.
The BLA seeks approval for patritumab deruxtecan to treat adult patients with locally advanced or metastatic (la/m) EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. A filing designated as a priority review reduces the review period by four months. A final decision is expected on Jun 26, 2024.
If approved, patritumab deruxtecan could become the first HER3 directed medicine approved in the United States.
The BLA is supported by positive results from the HERTHENA-Lung01 pivotal phase II study. The study met its primary endpoint of a clinically meaningful objective response rate (29.8%) in patients treated with HER3-DXd. A clinically meaningful median duration of response (6.4 months), a secondary endpoint, was also observed. Treatment with the drug also demonstrated a favorable safety profile consistent with that observed in previous phase I studies in NSCLC.
Per the press release, the BLA is being reviewed under the Real-Time Oncology Review (RTOR) program, the FDA’s new initiative focused on bringing safe and effective cancer treatments to patients as early as possible. The unique nature of the RTOR program allows the FDA to review the components of an application before submission of the complete application.
Year to date, shares of Merck have lost 2.9% against the industry’s 6% growth.
Image Source: Zacks Investment Research
In October, MRK and Daiichi Sankyo entered into an agreement to co-develop and co-commercialize three investigational cancer therapies for a total potential consideration of up to $22 billion. One of these candidates is patritumab deruxtecan, which is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC). The candidate already enjoys the FDA’s Breakthrough Therapy designation in the United States for the treatment of patients with la/m EGFR-mutated NSCLC.
The deal also involves Daiichi’s other DXd ADC candidates — ifinatamab deruxtecan and raludotatug deruxtecan. All these candidates are being evaluated in different stages of clinical development across multiple solid tumor indications, both as monotherapy and/or in combination with other treatments.
Currently, Merck markets Keytruda (pembrolizumab) as the standard of care in the frontline treatment of metastatic NSCLC. Notably, Keytruda, an anti-PD-1 therapy, is MRK’s blockbuster oncology drug and is approved for several types of cancer, accounting alone for around 45% of the company’s pharmaceutical sales.
Keytruda is presently approved to treat eight indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck’s position in the oncology market.
Merck & Co., Inc. Price and Consensus
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
Zacks Rank and Stocks to Consider
Merck currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Agenus (AGEN - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA and AGEN carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has decreased from 73 cents to 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. Year to date, shares of PBYI have lost 2.6%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 18 cents. Year to date, shares of ADMA have gained 9.3%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. Year to date, shares of AGEN have plunged 67.4%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.