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This week, Eli Lilly (LLY - Free Report) announced that Anat Ashkenazi, who served the company for 23 years, has resigned from her position as chief financial officer (CFO). J&J (JNJ - Free Report) filed applications in the United States and Europe for the expanded use of a HIV therapy for pediatric patients. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the expanded use of AbbVie’s (ABBV - Free Report) immunology therapy Skyrizi (risankizumab) and AstraZeneca’s (AZN - Free Report) cancer drug Tagrisso in Europe.
Recap of the Week’s Most Important Stories
Lilly’s CFO Departs: Lilly’s executive vice president and CFO, Anat Ashkenazi has resigned to join Alphabet, Google’s parent company, as CFO and senior vice president, effective from Jul 31, 2024. Until then, she will continue to serve in her present role at Lilly. Ashkenazi replaces present CFO Ruth Porat, who moved to a new role as president & chief investment officer of Alphabet and Google, effective from September 2023, but will continue as CFO till her successor takes office. Ashkenazi will be based in the San Francisco Bay Area and will report directly to Google and Alphabet CEO Sundar Pichai.
Ashkenazi has been Lilly’s CFO since 2021. In the last three years of her tenure as CFO, Lilly experienced tremendous growth. Lilly launched its successful tirzepatide medicines, diabetes drug Mounjaro and weight loss medicine, Zepbound, during Ashkenazi’s time as CFO. It is believed that Ashkenazi’s deep experience at Lilly will be good for Google and Alphabet, which is investing heavily in generative artificial intelligence, growing rapidly in the booming cloud-computing market and cutting costs through layoffs.
AbbVie Starts Phase III Multiple Myeloma Study on BCMA Therapy, ABBV-383: AbbVie announced that it has initiated a phase III study on ABBV-383, a B-cell maturation antigen (BCMA) bispecific antibody T-cell engager, for treating relapsed/refractory multiple myeloma (r/r MM). The study called CERVINO will evaluate the efficacy, safety, and tolerability of ABBV-383 as a single agent in r/r MM patients who have received at least two lines of prior therapy. The study, which will enroll approximately 380 total patients, will compare ABBV-383 to standard available therapies. The study’s dual primary endpoints are progression-free survival and overall response rate (ORR).
AbbVie announced positive top-line data from the phase II PICCOLO study evaluating Elahere (mirvetuximab soravtansine) for heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The study met its primary endpoint of ORR. In the study, the ORR was 51.9%, while the median duration of response (DOR), a key secondary endpoint, was 8.25 months. Elahere was added to AbbVie’s cancer portfolio with the acquisition of Immunogen, which closed in February 2024.
J&J Seeks Approval of HIV Therapy for Kids in U.S. and EU: J&J filed regulatory applications in the United States and the EU seeking expanded use of its HIV-1 therapy, Prezcobix/Rezolsta, for younger kids aged 6 and older. Prezcobix/Rezolsta is a two-drug fixed-dose combination tablet for treating HIV-1 infection in treatment-naïve and treatment-experienced adults and adolescent patients. It combines darunavir, J&J’s HIV-1 protease inhibitor, and cobicistat, Gilead Sciences CYP3A inhibitor. Prezcobix/Rezolsta is also marketed under a collaboration between J&J and Gilead. The companies have developed a separate new combination tablet containing a weight-adjusted pediatric dose (darunavir 675 mg/cobicistat 150 mg) for younger kids.
CHMP Nods: The CHMP gave a positive opinion, recommending approval of AbbVie’s Skyrizi (risankizumab) in the EU to treat adults with moderately to severely active ulcerative colitis (UC). Skyrizi is already approved in the United States and the EU for treating plaque psoriasis, psoriatic arthritis and Crohn's disease. AbbVie has also submitted an application to the FDA, seeking approval for Skyrizi for the UC indication in the United States.
The CHMP also recommended the expanded use of AstraZeneca’s Tagrisso plus chemotherapy for first-line treatment of locally advanced or metastatic EGFR mutated non-small cell lung cancer (NSCLC). The application was based on data from the FLAURA2 phase III study. Tagrisso was approved for frontline NSCLC based on FLAURA2 data in February 2024.
The NYSE ARCA Pharmaceutical Index rose 3.9% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: LLY's CFO Departs, ABBV, AZN Drugs Get CHMP Approval
This week, Eli Lilly (LLY - Free Report) announced that Anat Ashkenazi, who served the company for 23 years, has resigned from her position as chief financial officer (CFO). J&J (JNJ - Free Report) filed applications in the United States and Europe for the expanded use of a HIV therapy for pediatric patients. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the expanded use of AbbVie’s (ABBV - Free Report) immunology therapy Skyrizi (risankizumab) and AstraZeneca’s (AZN - Free Report) cancer drug Tagrisso in Europe.
Recap of the Week’s Most Important Stories
Lilly’s CFO Departs: Lilly’s executive vice president and CFO, Anat Ashkenazi has resigned to join Alphabet, Google’s parent company, as CFO and senior vice president, effective from Jul 31, 2024. Until then, she will continue to serve in her present role at Lilly. Ashkenazi replaces present CFO Ruth Porat, who moved to a new role as president & chief investment officer of Alphabet and Google, effective from September 2023, but will continue as CFO till her successor takes office. Ashkenazi will be based in the San Francisco Bay Area and will report directly to Google and Alphabet CEO Sundar Pichai.
Ashkenazi has been Lilly’s CFO since 2021. In the last three years of her tenure as CFO, Lilly experienced tremendous growth. Lilly launched its successful tirzepatide medicines, diabetes drug Mounjaro and weight loss medicine, Zepbound, during Ashkenazi’s time as CFO. It is believed that Ashkenazi’s deep experience at Lilly will be good for Google and Alphabet, which is investing heavily in generative artificial intelligence, growing rapidly in the booming cloud-computing market and cutting costs through layoffs.
AbbVie Starts Phase III Multiple Myeloma Study on BCMA Therapy, ABBV-383: AbbVie announced that it has initiated a phase III study on ABBV-383, a B-cell maturation antigen (BCMA) bispecific antibody T-cell engager, for treating relapsed/refractory multiple myeloma (r/r MM). The study called CERVINO will evaluate the efficacy, safety, and tolerability of ABBV-383 as a single agent in r/r MM patients who have received at least two lines of prior therapy. The study, which will enroll approximately 380 total patients, will compare ABBV-383 to standard available therapies. The study’s dual primary endpoints are progression-free survival and overall response rate (ORR).
AbbVie announced positive top-line data from the phase II PICCOLO study evaluating Elahere (mirvetuximab soravtansine) for heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The study met its primary endpoint of ORR. In the study, the ORR was 51.9%, while the median duration of response (DOR), a key secondary endpoint, was 8.25 months. Elahere was added to AbbVie’s cancer portfolio with the acquisition of Immunogen, which closed in February 2024.
J&J Seeks Approval of HIV Therapy for Kids in U.S. and EU: J&J filed regulatory applications in the United States and the EU seeking expanded use of its HIV-1 therapy, Prezcobix/Rezolsta, for younger kids aged 6 and older. Prezcobix/Rezolsta is a two-drug fixed-dose combination tablet for treating HIV-1 infection in treatment-naïve and treatment-experienced adults and adolescent patients. It combines darunavir, J&J’s HIV-1 protease inhibitor, and cobicistat, Gilead Sciences CYP3A inhibitor. Prezcobix/Rezolsta is also marketed under a collaboration between J&J and Gilead. The companies have developed a separate new combination tablet containing a weight-adjusted pediatric dose (darunavir 675 mg/cobicistat 150 mg) for younger kids.
CHMP Nods: The CHMP gave a positive opinion, recommending approval of AbbVie’s Skyrizi (risankizumab) in the EU to treat adults with moderately to severely active ulcerative colitis (UC). Skyrizi is already approved in the United States and the EU for treating plaque psoriasis, psoriatic arthritis and Crohn's disease. AbbVie has also submitted an application to the FDA, seeking approval for Skyrizi for the UC indication in the United States.
The CHMP also recommended the expanded use of AstraZeneca’s Tagrisso plus chemotherapy for first-line treatment of locally advanced or metastatic EGFR mutated non-small cell lung cancer (NSCLC). The application was based on data from the FLAURA2 phase III study. Tagrisso was approved for frontline NSCLC based on FLAURA2 data in February 2024.
The NYSE ARCA Pharmaceutical Index rose 3.9% 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, all the stocks were in the green except J&J which declined 0.2%. Novo Nordisk rose the most (5.2%).
In the past six months, Lilly has risen the most (47.4%), while J&J has declined the most (5.1%).
(See the last pharma stock roundup here: Pharma Stock Roundup: JNJ, MRK M&A Deals, SNY, RHHBY Drugs’ Priority Review & More)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
J&J, AbbVie, Lilly 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.