This week, AbbVie (ABBV - Free Report) and Allergan (AGN - Free Report) reported fourth-quarter results. Meanwhile, a phase II/III investigator-led study in inherited Alzheimer's disease conducted on Roche (RHHBY - Free Report) and Lilly’s (LLY - Free Report) candidates, gantenerumab and solanezumab, respectively, failed to meet the primary endpoint.
Recap of the Week’s Most Important Stories:
Earnings Update: Both AbbVie and Allergan beat estimates for earnings and sales in the fourth quarter. While AbbVie’s earnings rose 16.3% year over year, sales rose 4.8% as higher sales of Humira in the United States, Imbruvica and Venclexta made up for the negative impact of international biosimilar competition for Humira. AbbVie issued financial guidance for 2020. It expects adjusted EPS to be in the range of $9.61-$9.71 for 2020 for the standalone company.
Allergan’s earnings rose 21.7% year over year, revenues increased 6.6%. Higher sales of key products like Botox, Juvéderm, Vraylar, Linzess and Lo Loestrin made up for the loss of exclusivity on some brands and currency headwinds.
Roche/Lilly’s Investigator-led Alzheimer’s Study Fails: A phase II/III Alzheimer’s disease study sponsored by the Washington University School of Medicine, and conducted on Roche and Lilly’s Alzheimer’s disease candidates, gantenerumab and solanezumab, respectively, failed to meet the primary endpoint.
The phase II/III study, DIAN-TU-001, tested gantenerumab and solanezumab compared to placebo to determine if either of these treatments could slow down the rate of cognitive decline in patients with dominantly inherited Alzheimer's disease, which is caused by rare gene mutations. The study failed with neither gantenerumab nor solanezumab slowing the rate of cognitive decline in such patients. Meanwhile, additional analyses of the study are ongoing to understand the totality of the data.
J&J Files Darzalex sBLA: J&J (JNJ - Free Report) submitted a supplemental biologics license application (sBLA) to the FDA, seeking label expansion of its blockbuster cancer drug, Darzalex. The sBLA , based on data from the phase III CANDOR study, is seeking approval of Darzalex in combination with Amgen’s Kyprolis plusdexamethasone (DKd) in patients with relapsed/refractory multiple myeloma as second to fourth-line treatment option.
J&J announced an expanded agreement with BARDA, part of U.S. Department of Health and Human Services to speed up development of a vaccine for the newly found coronavirus.
FDA’s Priority Review to Novartis’ & Bristol-Myers’ Cancer Candidates: The FDA granted priority review to Novartis/Incyte’s new drug application, seeking approval of their MET inhibitor capmatinib for the treatment for MET exon 14 skipping (METex14) mutated advanced non-small cell lung cancer (NSCLC). There are presently no medicines available that specifically target METex14 mutated advanced NSCLC, an aggressive form of lung cancer. The FDA is expected to give its decision on capmatinib NDA in six months’ time.
The FDA also granted priority review to Bristol-Myers’ (BMY - Free Report) biologics license application (BLA) seeking approval for its CAR-T-cell immunotherapy, lisocabtagene maraleucel (liso-cel) for the treatment of relapsed or refractory large B-cell lymphoma. The FDA is expected to give its decision on Aug 17. The BLA filing was based on results from the TRANSCEND NHL 001 study. The candidate was added to Bristol-Myers’ portfolio with the $74 billion- acquisition of Celgene.
Merck’s Keytruda First-Line Breast Cancer Study Meets Goal: A pivotal phase III study evaluating Merck’s (MRK - Free Report) blockbuster PD-L1 inhibitor, Keytruda plus chemotherapy, as first-line treatment for metastatic triple-negative breast cancer (mTNBC), met the primary endpoint. Interim data from the pivotal KEYNOTE-355 study showed that Keytruda plus chemotherapy significantly improved progression-free survival, one of the dual primary endpoints, compared to chemotherapy alone in these patients. The independent Data Monitoring Committee recommended that the study will continue without modifications to evaluate the other dual primary endpoint of overall survival.
The NYSE ARCA Pharmaceutical Index declined 1.2% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions.
Last week, all the stocks were in the red with Merck declining the most (4.4%).
In the past six months, Bristol-Myers has risen the most (44.4%) while Merck declined the most (1.8%).
(See the last pharma stock roundup here: BMY, GSK, SNY Q4 Results, MRK Earnings & Split)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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