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Pharma Stock Roundup: AZN Voydeya Gets FDA Nod, MRK KRAS Inhibitor Enters Phase III
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This week, the FDA approved AstraZeneca’s (AZN - Free Report) Voydeya (danicopan) for a rare blood disorder. Merck’s (MRK - Free Report) oral KRAS inhibitor candidate, MK-1084, enters phase III development. Jazz Pharmaceuticals (JAZZ - Free Report) completed filing a regulatory application of zanidatamab, a targeted treatment option, for previously treated HER2-positive metastatic biliary tract cancer (BTC).
Recap of the Week’s Most Important Stories
FDA Approves AstraZeneca’s Voydeya: The FDA approved AstraZeneca’s Voydeya (danicopan) in the United States as add-on therapy to its other C5 inhibitors, Ultomiris (ravulizumab) or Soliris (eculizumab), for treatment of extravascular hemolysis in adults with the rare disease, paroxysmal nocturnal hemoglobinuria (PNH).
Voydeya is approved for 10-20% of PNH patients who experience “hemolysis” or destruction of red blood cells despite treatment with other C5 inhibitors. Voydeya’s approval is based on data from the pivotal ALPHA phase III study. The drug was approved in Japan in January while regulatory applications seeking approval for Voydeya are under review in several countries, including the European Union.
The FDA accepted AstraZeneca and Japanese partner Daiichi Sankyo’s biologics license application (BLA) seeking approval of the antibody-drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd), for previously treated metastatic HR-positive, HER2-negative breast cancer. The FDA is expected to give its decision on the BLA in the first quarter of 2025 as the application has been granted a standard review. The application was based on data from the TROPION-Breast01 phase III study.
Merck Begins Phase III NSCLC Study on KRAS Inhibitor: Merck initiated a phase III study on its oral KRAS G12C inhibitor candidate, MK-1084, in combination with its blockbuster PD-L1 inhibitor, Keytruda, for first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC). The study will enroll approximately 600 patients globally. The primary endpoints of the study are progression-free survival and overall survival. MK-1084 is currently being evaluated in a phase I study as a monotherapy as well as in combination with other therapies for KRAS G12C mutant advanced solid tumors.
Merck also announced that the first patient has been dosed in a phase II/III study called REJOICE-Ovarian01 on its CDH6-directed DXd ADC, raludotatug deruxtecan (R-DXd), in patients with platinum-resistant ovarian cancer.
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. Merck is co-developing R-DXd in partnership with Daiichi Sankyo along with two other ADCs patritumab deruxtecan/MK-1022 and ifinatamab deruxtecan/MK-2400, under a global partnership deal formed in October 2023.
Jazz Files BLA for Zanidatamab for BTC: Jazz Pharmaceuticals completed the submission of a rolling BLA seeking approval of HER2-targeted bispecific antibody zanidatamab for treating previously-treated metastatic HER2-positive BTC, a type of cancer with a poor survival rate. The BLA is based on data from the phase IIb HERIZON-BTC-01 study, which met its primary endpoint in patients receiving zanidatamab for previously treated HER2-positive BTC. Zanidatamab is also being evaluated in phase III studies in first-line BTC, first-line gastroesophageal adenocarcinoma (GEA) and previously treated breast cancer.
The NYSE ARCA Pharmaceutical Index declined 2.96% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: AZN Voydeya Gets FDA Nod, MRK KRAS Inhibitor Enters Phase III
This week, the FDA approved AstraZeneca’s (AZN - Free Report) Voydeya (danicopan) for a rare blood disorder. Merck’s (MRK - Free Report) oral KRAS inhibitor candidate, MK-1084, enters phase III development. Jazz Pharmaceuticals (JAZZ - Free Report) completed filing a regulatory application of zanidatamab, a targeted treatment option, for previously treated HER2-positive metastatic biliary tract cancer (BTC).
Recap of the Week’s Most Important Stories
FDA Approves AstraZeneca’s Voydeya: The FDA approved AstraZeneca’s Voydeya (danicopan) in the United States as add-on therapy to its other C5 inhibitors, Ultomiris (ravulizumab) or Soliris (eculizumab), for treatment of extravascular hemolysis in adults with the rare disease, paroxysmal nocturnal hemoglobinuria (PNH).
Voydeya is approved for 10-20% of PNH patients who experience “hemolysis” or destruction of red blood cells despite treatment with other C5 inhibitors. Voydeya’s approval is based on data from the pivotal ALPHA phase III study. The drug was approved in Japan in January while regulatory applications seeking approval for Voydeya are under review in several countries, including the European Union.
The FDA accepted AstraZeneca and Japanese partner Daiichi Sankyo’s biologics license application (BLA) seeking approval of the antibody-drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd), for previously treated metastatic HR-positive, HER2-negative breast cancer. The FDA is expected to give its decision on the BLA in the first quarter of 2025 as the application has been granted a standard review. The application was based on data from the TROPION-Breast01 phase III study.
Merck Begins Phase III NSCLC Study on KRAS Inhibitor: Merck initiated a phase III study on its oral KRAS G12C inhibitor candidate, MK-1084, in combination with its blockbuster PD-L1 inhibitor, Keytruda, for first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC). The study will enroll approximately 600 patients globally. The primary endpoints of the study are progression-free survival and overall survival. MK-1084 is currently being evaluated in a phase I study as a monotherapy as well as in combination with other therapies for KRAS G12C mutant advanced solid tumors.
Merck also announced that the first patient has been dosed in a phase II/III study called REJOICE-Ovarian01 on its CDH6-directed DXd ADC, raludotatug deruxtecan (R-DXd), in patients with platinum-resistant ovarian cancer.
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. Merck is co-developing R-DXd in partnership with Daiichi Sankyo along with two other ADCs patritumab deruxtecan/MK-1022 and ifinatamab deruxtecan/MK-2400, under a global partnership deal formed in October 2023.
Jazz Files BLA for Zanidatamab for BTC: Jazz Pharmaceuticals completed the submission of a rolling BLA seeking approval of HER2-targeted bispecific antibody zanidatamab for treating previously-treated metastatic HER2-positive BTC, a type of cancer with a poor survival rate. The BLA is based on data from the phase IIb HERIZON-BTC-01 study, which met its primary endpoint in patients receiving zanidatamab for previously treated HER2-positive BTC. Zanidatamab is also being evaluated in phase III studies in first-line BTC, first-line gastroesophageal adenocarcinoma (GEA) and previously treated breast cancer.
The NYSE ARCA Pharmaceutical Index declined 2.96% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, Novartis was the top gainer (0.2%), while AbbVie declined the most (7.8%).
In the past six months, Lilly has risen the highest (35.8%), while Pfizer has declined the most (19.6%).
(See the last pharma stock roundup here:ABBV & NVO’s New M&As, FDA Nod to JNJ & MRK PAH Drugs)
What's Next in the Pharma World?
Watch for regular pipeline and regulatory updates next week.
Jazz Pharma, Merck and AstraZeneca have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.