Merck recently announced the commencement of a phase II/III study focusing on its CDH6-directed DXd antibody-drug conjugate, known as raludotatug deruxtecan (R-DXd), for patients grappling with platinum-resistant ovarian cancer. This significant milestone marks the initiation of the phase II/III study named REJOICE-Ovarian01, with the first patient already receiving the dosed drug. Merck is working collaboratively with Japan’s Daiichi Sankyo in the development of R-DXd.
The genesis of the REJOICE-Ovarian01 study roots from data derived from an ongoing phase I study, demonstrating the promising effectiveness of R-DXd in patients battling advanced ovarian cancer. This new study will assess the efficacy of R-DXd when pitted against the investigator’s preferred choice of chemotherapy.
Positive Growth Despite Industry Comparison
Merck’s stock has witnessed a commendable 16.1% surge over the past year, showcasing commendable growth in contrast to the industry’s upsurge of 21.5%.
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Merck finalized the acquisition of global co-development and co-commercialization rights to raludotatug deruxtecan along with two other essential antibody-drug conjugates (ADCs), namely patritumab deruxtecan/MK-1022 and ifinatamab deruxtecan/MK-2400, from Daiichi Sankyo in October of the previous year. However, Daiichi Sankyo reserved the exclusive rights for developing these candidates in Japan.
Notably, patritumab deruxtecan, an ADC aimed at HER3, is currently under priority review in the United States for the treatment of previously handled locally advanced or metastatic EGFR-mutated NSCLC. The FDA is anticipated to render its decision by June 26, 2024. Concurrently, ifinatamab deruxtecan is undergoing phase II trials for small-cell lung cancer.
ADCs: A Game-Changer in Cancer Treatment
Antibody-drug conjugates (ADCs) are being hailed as a groundbreaking innovation within the pharmaceutical sector. Their utilization promises enhanced cancer treatment by leveraging the targeting capabilities of antibodies to deliver cytotoxic drugs to tumors.
Daiichi Sankyo boasts an arsenal of six ADCs currently in clinical development targeting various cancer types. Notably, Enhertu, a HER2-directed ADC for HER2-mutated breast, lung, and gastric cancers, is being marketed in collaboration with AstraZeneca. Moreover, Daiichi Sankyo and AstraZeneca have jointly developed datopotamab deruxtecan (Dato-DXd), an ADC focused on TROP2. Dato-DXd is presently under FDA review for advanced nonsquamous NSCLC as well as previously managed metastatic HR-positive, HER2-negative breast cancer. Lastly, the sixth ADC contender, DS-3939, a TA-MUC1-targeted ADC, remains under Daiichi Sankyo’s independent development.
Notable Stock Analysis & Recommendations
Merck is currently positioned at a Zacks Rank #3 (Hold).
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
If you’re on the lookout for promising biotech stocks, the Zacks Rank #1 (Strong Buy) rated ADMA Biologics (ADMA) and MorphoSys (MOR) come highly recommended currently. You can find the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have heightened from 22 cents to 30 cents. Furthermore, projections for 2025 have escalated from 32 cents to 50 cents. Impressively, shares of ADMA Biologics have surged by a remarkable 100% in the last year.
ADMA Biologics has outperformed earnings estimates in three out of the last four quarters, with a striking four-quarter average earnings surprise of 85.0%.
On the other hand, over the last 60 days, predictions for MorphoSys’ 2024 loss per share have narrowed from $2.24 to $2.08. Similarly, estimates for 2025 have been toned down from a loss of $1.02 per share to 89 cents per share. In the past year alone, stocks of MOR have witnessed an impressive surge of 294.4%.
(This article is being reissued to rectify an error. Kindly disregard the original article published on April 4, 2024.)
