J&J JNJ began the earnings season for the pharma sector this week with a beat. In other news, the FDA granted fast track status to two of Pfizer PFE and its Germany-based partner BioNTech’s coronavirus vaccine candidates. Meanwhile, the regulatory body approved J&J’s Tremfya for a new indication and granted priority review to Bayer BAYRY/Merck’s MRK heart failure candidate, vericiguat.
Recap of the Week’s Most Important Stories
J&J’s Q2 Earnings Beat: J&J beat second-quarter estimates for earnings as well as sales. Its Pharmaceuticals unit continued to do well despite the coronavirus crisis. However, the pandemic continued to hurt sales in its Medical Devices segment due to widespread decline in elective surgical procedures and redeployment of hospital resources to address patients affected by COVID-19. Meanwhile, J&J raised its outlook for earnings and sales for the year probably due to lower-than-expected decline in sales of the Medical Devices unit.
Meanwhile, the FDA granted approval to J&J’s IL-23 inhibitor, Tremfya for the treatment of active psoriatic arthritis in adults. The approval was based on data from the DISCOVER-1 and DISCOVER-2 pivotal phase III studies on Tremfya. The studies showed that the drug significantly improved signs and symptoms in joints, skin and soft tissue in adults with active psoriatic arthritis. Tremfya is presently approved to treat moderate-to-severe plaque psoriasis.
FDA Grants Fast Track Status to Pfizer’s COVID-19 Vaccine Candidates: The FDA granted fast track designation to two out of four of Pfizer and its German partner BioNTech’s experimental mRNA-based vaccines, being evaluated under BioNTech’s BNT162 program, to prevent COVID-19. The fast track designation was assigned to BNT162b1 and BNT162b2, which are the most advanced in the program. The designation was based on preliminary data from the phase I/II studies as well as pre-clinical data.
FDA’s Fast Track Status to AstraZeneca’s Farxiga for New Indication: The FDA granted fast track status to AstraZeneca’s AZN diabetes medicine, Farxiga to reduce mortality and the risk of heart failure, following an acute myocardial infarction or heart attack. The prestigious status has been granted based on the phase III DAPA-MI outcomes study that will evaluate the efficacy and safety of SGLT2 inhibitor, Farxiga in this patient group. The study is expected to begin recruiting patients in the fourth quarter of 2020.
FDA Grants Priority Review to Merck/Bayer’s Vericiguat NDA: The FDA granted priority review to Bayer/Merck’s new drug application (NDA) seeking approval of vericiguat to treat patients with symptomatic chronic heart failure with an ejection fraction less than 45% following a worsening heart failure event. The NDA filing for the candidate was based on data from the phase III VICTORIA study. The candidate is being jointly developed by Bayer and Merck. The FDA’s decision on the NDA is expected on Jan 20, 2021
FDA Panel Recommends Glaxo’s Belantamab Mafodotin: The FDA’s Oncologic Drugs Advisory Committee voted 12-0 in favor of the benefits of Glaxo’s GSK antibody drug conjugate, belantamab mafodotin, outweighing risks in heavily pre-treated patients with relapsed/refractory multiple myeloma. Though the FDA is not obligated to follow the advisory committee’s decision, it usually does. The FDA had earlier granted priority review to Glaxo’s biologics license application for belantamab mafodotin.
Roche’s Tecentriq Study in Front-Line Ovarian Cancer Fails: Roche’s RHHBY phase III study evaluating a Tecentriq combo for first-line treatment of women with newly diagnosed advanced stage ovarian cancer failed to meet the primary endpoint of progression-free survival. The study evaluated Tecentriq in combination with Avastin, paclitaxel and carboplatin in the above patient population. Data for the other co-primary endpoint, overall survival, are currently immature and follow-up will continue until the next planned analysis.
The NYSE ARCA Pharmaceutical Index rose 3.09% in the last five trading sessions.
Here is how the nine major stocks performed in the last five trading sessions.
Last week, all the stocks were in the green except Lilly, which declined 0.8%. Pfizer and AstraZeneca recorded the highest increase (6.4%).
In the past six months, Lilly (LLY) has risen the most (18.2%) while Merck declined the most (12.8%).
(See the last pharma stock roundup here: MRK, AZN Regulatory Updates, GSK’s New Coronavirus Deal)
What’s Next in the Pharma World?
Watch out for Novartis & Roche’s second-quarter earnings and regular pipeline and regulatory updates next week.
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