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) Begins Phase II/II Ovarian Cancer Study on ADC Drug (Revised)
Read MoreHide Full Article
Merck (MRK - Free Report) announced that a phase II/III study has been initiated on its CDH6-directed DXd antibody-drug conjugate, raludotatug deruxtecan (R-DXd), in patients with platinum-resistant ovarian cancer. The first patient has been dosed in the phase II/III study called REJOICE-Ovarian01. Merck is developing R-DXd in partnership with Japan’s Daiichi Sankyo.
The initiation of the REJOICE-Ovarian01 study is based on data from the ongoing phase I study in which R-DXd showed promising activity in patients with advanced ovarian cancer. The REJOICE-Ovarian01 study will evaluate the efficacy of R-DXd versus investigator’s choice of chemotherapy.
Merck’s stock has risen 16.1% in the past year compared with an increase of 21.5% for the industry.
Image Source: Zacks Investment Research
Merck acquired global co-development and co-commercialization rights to raludotatug deruxtecan and two other antibody-drug conjugates or ADCs, patritumab deruxtecan/MK-1022 and ifinatamab deruxtecan/MK-2400 from Daiichi Sankyo in October last year. However, Daiichi Sankyo has retained exclusive rights for the development of the candidates in Japan.
Patritumab deruxtecan, a HER3-directed ADC, is under priority review in the United States for previously treated locally advanced or metastatic EGFR-mutated NSCLC. The FDA’s decision is expected on Jun 26, 2024. Ifinatamab deruxtecan is in phase II for small-cell lung cancer.
For the deal, Merck made an upfront payment of $4 billion to Daiichi while being entitled to make $1.5 billion in continued payments over 24 months from October 2023. The deal also includes potential sales-based milestone payments of up to $16.5 billion.
ADCs are being considered a disruptive innovation in the pharmaceutical industry as these will enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
Daiichi Sankyo has six ADCs in clinical development across multiple types of cancer. It markets Enhertu, a HER2-directed ADC for HER2-mutated breast, lung and gastric cancers, in partnership with AstraZeneca (AZN - Free Report) . Daiichi Sankyo and AstraZeneca have also developed datopotamab deruxtecan (Dato-DXd), a TROP2-directed ADC. Dato-DXd is under FDA review for advanced nonsquamous NSCLC as well as previously treated metastatic HR-positive, HER2-negative breast cancer. The sixth ADC candidate is DS-3939, a TA-MUC1-directed ADC, which Daiichi Sankyo is developing on its own.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Estimates for 2025 have increased from 32 cents to 50 cents. In the past year, shares of ADMA Biologics have risen 100%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same once. ADMA delivered a four-quarter average earnings surprise of 85.0%.
In the past 60 days, estimates for MorphoSys’ 2024 loss per share have narrowed from $2.24 to $2.08. Estimates for 2025 have narrowed from a loss of $1.02 per share to a loss of 89 cents per share. In the past year, shares of MOR have risen 294.4%.
(We are reissuing this article to correct a mistake. The original article, issued on April 4, 2024, should no longer be relied upon.)
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Merck (MRK) Begins Phase II/II Ovarian Cancer Study on ADC Drug (Revised)
Merck (MRK - Free Report) announced that a phase II/III study has been initiated on its CDH6-directed DXd antibody-drug conjugate, raludotatug deruxtecan (R-DXd), in patients with platinum-resistant ovarian cancer. The first patient has been dosed in the phase II/III study called REJOICE-Ovarian01. Merck is developing R-DXd in partnership with Japan’s Daiichi Sankyo.
The initiation of the REJOICE-Ovarian01 study is based on data from the ongoing phase I study in which R-DXd showed promising activity in patients with advanced ovarian cancer. The REJOICE-Ovarian01 study will evaluate the efficacy of R-DXd versus investigator’s choice of chemotherapy.
Merck’s stock has risen 16.1% in the past year compared with an increase of 21.5% for the industry.
Image Source: Zacks Investment Research
Merck acquired global co-development and co-commercialization rights to raludotatug deruxtecan and two other antibody-drug conjugates or ADCs, patritumab deruxtecan/MK-1022 and ifinatamab deruxtecan/MK-2400 from Daiichi Sankyo in October last year. However, Daiichi Sankyo has retained exclusive rights for the development of the candidates in Japan.
Patritumab deruxtecan, a HER3-directed ADC, is under priority review in the United States for previously treated locally advanced or metastatic EGFR-mutated NSCLC. The FDA’s decision is expected on Jun 26, 2024. Ifinatamab deruxtecan is in phase II for small-cell lung cancer.
For the deal, Merck made an upfront payment of $4 billion to Daiichi while being entitled to make $1.5 billion in continued payments over 24 months from October 2023. The deal also includes potential sales-based milestone payments of up to $16.5 billion.
ADCs are being considered a disruptive innovation in the pharmaceutical industry as these will enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
Daiichi Sankyo has six ADCs in clinical development across multiple types of cancer. It markets Enhertu, a HER2-directed ADC for HER2-mutated breast, lung and gastric cancers, in partnership with AstraZeneca (AZN - Free Report) . Daiichi Sankyo and AstraZeneca have also developed datopotamab deruxtecan (Dato-DXd), a TROP2-directed ADC. Dato-DXd is under FDA review for advanced nonsquamous NSCLC as well as previously treated metastatic HR-positive, HER2-negative breast cancer. The sixth ADC candidate is DS-3939, a TA-MUC1-directed ADC, which Daiichi Sankyo is developing on its own.
Zacks Rank & Stocks to Consider
Merck has a Zacks Rank #3 (Hold) currently.
Merck & Co., Inc. Price and Consensus
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
Some better-ranked biotech stocks are ADMA Biologics (ADMA - Free Report) and MorphoSys (MOR - Free Report) , sporting a Zacks Rank #1 (Strong Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Estimates for 2025 have increased from 32 cents to 50 cents. In the past year, shares of ADMA Biologics have risen 100%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same once. ADMA delivered a four-quarter average earnings surprise of 85.0%.
In the past 60 days, estimates for MorphoSys’ 2024 loss per share have narrowed from $2.24 to $2.08. Estimates for 2025 have narrowed from a loss of $1.02 per share to a loss of 89 cents per share. In the past year, shares of MOR have risen 294.4%.
(We are reissuing this article to correct a mistake. The original article, issued on April 4, 2024, should no longer be relied upon.)