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Novartis AG released new data Wednesday from the ALITHIOS open-label extension study.
Data show first-line Kesimpta (ofatumumab) treatment for up to six years led to less disability and disease progression in recently diagnosed (≤3 years) and treatment-naïve (RDTN) people with relapsing multiple sclerosis (RMS), compared to those who switched from Sanofi SA’s Aubagio (teriflunomide).
These data will be presented at the European Committee for Treatment and Research in Multiple Sclerosis.
Also Read: Goldman Sachs Shifts Stance On Novartis, Cites Lack Of Near-Term Catalysts.
Data from the overall ALITHIOS study population showed that continuous use of Kesimpta was associated with numerically fewer six-month confirmed disability worsening (6mCDW) and progression independent of relapse activity (6mPIRA) events up to six years compared to those who switched from teriflunomide.
RDTN patients receiving continuous Kesimpta were more likely to remain free from 6mCDW than those who switched to Kesimpta from teriflunomide (83.4% vs. 76.3%).
RDTN patients receiving continuous Kesimpta were also more likely to be free of 6mPIRA vs. switching from teriflunomide (88.9% vs. 83.3%).
A separate U.S.-based single-arm OLIKOS Phase 3b study showed that at 12 months, all clinically stable RMS patients who switched from intravenous (IV) anti-CD20 therapy to Kesimpta showed no new gadolinium-enhancing (Gd+) T1 lesions, a commonly used marker of disease activity, compared to baseline.
Tuesday, the FDA approved Novartis’ Kisqali (ribociclib) in combination with an aromatase inhibitor for the adjuvant treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative stage II and III early breast cancer at high risk of recurrence, including those with node-negative disease.
The approval is based on results from the pivotal Phase 3 NATALEE trial, which showed a significant and clinically meaningful 25.1% reduction in risk of disease recurrence.
Price Action: Novartis stock is down 0.1% at $115.85 at last check Wednesday.
Read Next:
Image: Wikimedia Commons
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
AstraZeneca AZN announced that the FDA has approved its marketed asthma drug, Fasenra (benralizumab) for a new indication. The regulatory body has now approved Fasenra for treating adult patients with eosinophilic granulomatosis with polyangiitis (“EGPA”).
EGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues and is the second approved indication for Fasenra.
Fasenra is already approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA).
Shares of AstraZeneca have increased 16.6% so far this year compared with the industry’s rise of 25.9%.
Latest Approval for AZN’s Fasenra Based on MANDARA Study
The FDA nod for Fasenra in EGPA was based on data from the phase III MANDARA study.
The MANDARA head-to-head study compared a single monthly injection of Fasenra to three injections per month of GSK’s GSK blockbuster drug, Nucala (mepolizumab), which until now was the only approved drug for EGPA.
Data from the study showed that nearly 60% of patients who were treated with Fasenra achieved remission, which was comparable to GSK’s Nucala-treated patients.
Also, 41% of patients who were treated with Fasenra fully stopped taking oral corticosteroids compared to 26% of patients in the Nucala arm.
The latest approval of Fasenra is likely to offer a convenient single monthly subcutaneous injection to patients living with EGPA.
AZN’s Fasenra a Key Revenue Driver
Fasenra is currently approved in more than 80 countries across the world, including the United States, European Union and Japan for SEA. Several label expansion studies are going on for Fasenra for eosinophil-driven diseases beyond severe asthma, like chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.
Fasenra generated sales worth $781 million in the first half of 2024, reflecting an increase of 6% year over year at a constant exchange rate. Sales of the drug have been rising, driven by strong demand growth and market share.
Continued label expansion for Fasenra into additional indications and patient populations should boost drug sales in the days ahead.
Other Players in the Respiratory Diseases Market
Apart from GSK’s Nucala, Sanofi SNY and Regeneron’s REGN Dupixent (dupilumab), an IL-4 and IL-13 inhibitor, is also approved in several countries, including the United States and EU, for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.
REGN and SNY are jointly marketing Dupixent under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the drug’s global sales. The companies are also studying the drug in late-stage studies in a broad range of diseases driven by type II inflammation, like bullous pemphigoid and chronic pruritus of unknown origin.
Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks Investment Research
Eli Lilly and Company LLY announced that the FDA has granted approval to its IL-13 inhibitor Ebglyss (lebrikizumab) for treating moderate-to-severe atopic dermatitis, also called eczema. Ebglyss is approved for use in adults and children aged 12 and above who weigh at least 40 kgs and whose moderate-to-severe atopic dermatitis is not well controlled with topical prescription medicines.
Ebglyss was approved in the European Union in 2023 and in Japan in January this year. The drug generated sales of $7.5 million in the first half of 2024.
Year to date, Lilly’s stock has risen 58.5% compared with the industry’s 25.2% growth. The stock has also outperformed the sector as well as the S&P 500.
LLY Stock Outperforms Industry, Sector & S&P 500
More on LLY’s Ebglyss
Ebglyss’ approval in the United States was based on data from ADvocate 1, ADvocate 2 and ADhere studies. Data from these studies showed that patients treated with Ebglyss experienced significant skin clearance as early as four weeks and meaningful itch relief as early as two weeks. Many people living with eczema experience poor long-term disease control and severe itch despite treatment with topicals. Ebglyss offers such patients a new first-line biologic treatment option for treating their moderate-to-severe eczema. The injection will be launched in the United States in the coming weeks.
In the United States and some countries other than Europe, Lilly owns exclusive development and commercialization rights to Ebglyss. However, in Europe, it has out-licensed rights to develop and commercialize Ebglyss for the treatment of dermatology indications to its partner Almirall.
Lilly’s Several New Drug Approvals in Past Year
Lilly gained approvals for some other new drugs in the past year, with the most important being Mounjaro and Zepbound. Mounjaro and Zepbound include the same compound, tirzepatide, a dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA). Mounjaro was approved in May 2022 for type II diabetes. Zepbound was launched in November 2023 to treat obesity.
Despite a short time on the market, Mounjaro and Zepbound have become key top-line drivers for Lilly in 2024, with demand rising rapidly. Mounjaro and Zepbound generated sales of almost $6.7 billion in the first half of 2024, accounting for around 44% of the company’s total revenues.
Other than Mounjaro and Zepbound, other new drug approvals include Omvoh for ulcerative colitis and BTK inhibitor Jaypirca for mantle cell lymphoma and chronic lymphocytic leukemia. Lilly expects its new drugs — Mounjaro, Omvoh, Zepbound, Ebglyss and Jaypirca — to drive its top line in the second half of 2024.
In July, Lilly won a long-awaited FDA approval for Kisunla (donanemab) for treating early symptomatic Alzheimer's disease. Lilly believes Kisunla can generate blockbuster sales. Kisunla is only the second drug on the market to treat Alzheimer's disease after Biogen BIIB and its Japan-based partner Eisai’s Leqembi.
Lilly’s Zacks Rank and Other Stocks to Consider
Lilly sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Eli Lilly and Company Stock Price and Consensus
Eli Lilly and Company price-consensus-chart | Eli Lilly and Company Quote
Some other top-ranked large drugmakers are Novartis NVS and Pfizer PFE, each carrying a Zacks Rank #2 (Buy).
In the past 60 days, 2024 earnings estimates for Pfizer have improved from $2.38 per share to $2.62 per share. For 2025, earnings estimates have improved from $2.75 per share to $2.85 per share over the same timeframe. Pfizer shares have risen 1.6% year to date.
Pfizer’s earnings beat estimates in each of the last four quarters. PFE delivered a four-quarter average earnings surprise of 69.82%
Estimates for Novartis’ 2024 earnings have risen from $7.31 to $7.50 per share over the past 60 days. For 2025, earnings estimates have increased from $8.21 to $8.29 per share over the same timeframe. Year to date, Novartis stock has risen 14.5 %.
Novartis beat estimates in three of the last four quarters while missing in one, delivering a four-quarter average earnings surprise of 1.26%.
Zacks Investment Research
COVID-19 Positive Rate Spikes
With more knowledge about the virus, ample funding, and new treatments, the worst of the COVID-19 pandemic seems to be behind us (from a death perspective). However, just because the Coronavirus death rate has dropped dramatically since its major peak in 2020 (and a subsequent spike in 2021) doesn’t mean that COVID-19 is still not negatively impacting people who get it.
Data from the CDC website shows that the number of people testing positive for COVID-19 has reached its highest level since early about two years.
Image Source: CDC
Though fewer people are dying from the virus, “long COVID” is something that people want to avoid because it can cause complications (not yet fully understood) that can include extreme fatigue, digestion issues, and potential brain issues in younger patients.
Novavax: A New Entrant in the COVID-19 Vaccine Realm
From a vaccine perspective, the two biggest winners from the COVID-19 vaccine race were Pfizer (PFE) and Moderna (MRNA). However, with COVID-19 stubbornly sticking around, investors should focus on an obscure, up-and-coming COVID-19 vaccine maker called Novavax.
Novavax Sanofi Deal Offers Distribution and Funding
Novavax (NVAX) is a biotech company that develops innovative vaccines to prevent serious infectious diseases. In May, the company entered into a multi-billion-dollar partnership with French biotech giant Sanofi (SNY). NVAX shares jumped 80% for the week when the deal was announced because it offered NVAX a critical component it did not have – distribution.
Per the deal terms, Sanofi took a minority stake in NVAX (a $70 million equity investment), will gain rights to co-market Novavax’s COVID-19 vaccine globally, and will have the sole license to develop and market NVAX’s COVID vaccine in combination with its influenza vaccine. NVAX also received a payment of $570 million from Sanofi, which was included in the deal.
Florida DOH Advises Against mRNA COVID-19 Vaccine
Distribution is one way that Novavax can tighten the vaccine race and catch up to more prominent players like PFE and MRNA. Another way is through its differentiated, non-mRNA vaccine. Friday, Moderna shares dove more than 12% on massive volume after the Florida Department of Health (DOH) advised against mRNA COVID-19 vaccines, citing seven safety and efficacy concerns. Novavax, which uses protein-based vaccines, is the clear beneficiary. NVAX shares jumped 14% Friday in reaction to the news.
COVID-Influenza Combo Vaccine Could be Game-Changer
Novavax’s COVID-influenza drug is slated to reach late-stage trials by the end of 2024. Should the drug pass trials, this unique, first-of-its-kind drug should act as a bullish catalyst into year-end.
NVAX Stock's Bullish Chart Pattern
NVAX’s share price and volume action is mimicking its strong fundamental possibilities. The stock is carving out a bullish monthly bull flag pattern. Shares should accelerate to the upside if they can clear last month’s hammer candle highs of $14.09.
Bottom Line
Though Novavax is behind in the COVID-19 vaccine race, a blockbuster deal with Sanofi and a differentiated product means the stock offers the best reward prospects in the industry moving forward.
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