Roche Gets FDA Approval for Acute Ischemic Stroke Drug for Adults

Roche’s RHHBY member company, Genentech, announced the FDA approval of TNKase (tenecteplase), a thrombolytic or clot-dissolving agent, for the treatment of acute ischemic stroke (AIS) in adults.As a result of the approval, Genentech has the only two FDA-approved medicines to treat AIS in its portfolio, namely TNKase and Activase (alteplase).TNKase is a tissue plasminogen activator, clot-dissolving, thrombolytic medicine. It is delivered as a single five-second intravenous (IV) bolus, a faster and simpler administration compared to the standard-of-care Activase, which is administered as an IV bolus followed by a 60-minute infusion.The FDA approval is based on a large multi-center non-inferiority study that showed that TNKase is comparable to Activase in terms of safety and efficacy in AIS patients.Stroke is the fifth leading cause of death. It is also the leading cause of long-term disability in the United States and affects more than 795,000 people annually.TNKase is also FDA-approved for the treatment of acute ST-elevation myocardial infarction in adults.Roche’s shares have risen 30.6% year to date compared with the large cap pharmaceutical industry’s rise of 2.1%.Image Source: Zacks Investment ResearchResults of RHHBY’s Phase III Study on XolairRoche reported new positive data from Stage 2 and Stage 3 of the phase III OUtMATCH study on Xolair. The data provide further evidence supporting the role of Xolair (omalizumab) in treating one or more food allergies. The study is sponsored by the National Institutes of Health.Xolair is the only FDA-approved drug to reduce allergic reactions in children and adults with one or more food allergies. Stage 1 of the OUtMATCH study served as the basis for the FDA approval of Xolair for the treatment of food allergies.In the first head-to-head trial comparing Xolair to multi-allergen oral immunotherapy (OIT), the study met its primary endpoint, showing 36% of food allergy patients treated with Xolair monotherapy could tolerate at least 2,000 mg of peanut protein and two other food allergens without experiencing an allergic reaction compared to 19% in the OIT group.Xolair Found More Effective Than Oral ImmunotherapyXolair was more effective with fewer side effects than OIT, which involves ingesting the food allergen, initially with a very small amount, which is then gradually increased.  These findings were largely driven by the high rates of adverse events (AEs) leading to study discontinuation in the OIT-treated group.The first 60 patients (median age: 8.5 years) from Stage 1 of the OUtMATCH study entered a 24-week open-label extension followed by Stage 3, wherein allergenic foods were introduced after treatment with Xolair.  Each of the 60 patients received a treatment plan for each of their three study allergens. Of the 180 treatment plans, 82% of initial treatment plans included dietary consumption of allergenic foods. Data observed after 12 months of follow-up showed that many patients were able to introduce allergenic foods in dietary form, although success rates were higher for milk, egg and wheat (61-70%) than for peanuts and tree nuts (38-56%).The study found that reduced consumption of allergenic foods appeared to be related to symptoms and other factors (such as taste and aversion), with no clear predictors of dietary consumption success. Stage 3 is currently ongoing. Investigators continue to evaluate data from additional patients who completed Stage 2 and then entered Stage 3.Roche and Novartis co-promote Xolair in the United States.RHHBY Targets Mid-Single-Digit Growth in 2025Roche’s performance in 2024 was good as high demand for key drugs offset the decline in sales of legacy drugs. Ophthalmology drug Vabysmo continued its stellar performance. The drug posed stiff competition to Regeneron’s (REGN) ophthalmology drug Eylea. Positive data from additional studies bode well for the drug.Regeneron co-developed Eylea with Bayer.Growth in hemophilia treatment Hemlibra and multiple sclerosis drug Ocrevus also boosted the top line.The company launched two new drugs in 2024 — Itovebi for a hard-to-treat breast cancer and PiaSky for a serious blood disorder.However, pipeline setbacks weigh on the stock. Roche also expects the loss of exclusivity for key drugs to adversely impact sales to the tune of CHF 1.2 billion in 2025.Roche expects total sales to grow in the mid-single-digit range (at CER) in 2025. Core earnings per share are expected to grow in the high single-digit range. Roche expects to increase its dividend in Swiss francs further.RHHBY’s Zacks Rank and Other Stocks to ConsiderRoche currently carries a Zacks Rank #3 (Hold).A couple of better-ranked stocks in the biotech sector are Gilead Sciences GILD and BioMarin Pharmaceutical BMRN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Gilead SciencesIn the past 30 days, Gilead Sciences’ EPS estimate for 2025 has increased from $7.56 to $7.85. In the past 30 days, EPS estimate has increased from $7.56 to $7.85. During the same timeframe, the figure for 2026 has increased to $8.17 from $7.82.GILD’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.47%.BioMarin PharmaceuticalIn the past 30 days, estimates for BioMarin Pharmaceutical’s 2025 EPS have increased from $4.01 to $4.19. Estimate for 2026 EPS has decreased from $5.21 to $5.20 during the same timeframe. BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 32.36%. Only $1 to See All Zacks' Buys and SellsWe're not kidding.Several years ago, we shocked our members by offering them 30-day access to all our picks for the total sum of only $1. No obligation to spend another cent.Thousands have taken advantage of this opportunity. Thousands did not - they thought there must be a catch. Yes, we do have a reason. We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators,and more, that closed 256 positions with double- and triple-digit gains in 2024 alone.See Stocks Now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Roche Holding AG (RHHBY): Free Stock Analysis Report BioMarin Pharmaceutical Inc. (BMRN): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks