For the quarter ended March 2026, Staar Surgical (STAA - Free Report) reported revenue of $93.52 million, up 119.6% over the same period last year. EPS came in at $0.38, compared to -$0.52 in the year-ago quarter.
The reported revenue represents a surprise of +1.88% over the Zacks Consensus Estimate of $91.8 million. With the consensus EPS estimate being $0.13, the EPS surprise was +192.31%.
While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance.
Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance.
Here is how Staar Surgical performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts:
Net Geographic Sales- United States: $6.67 million versus $6.02 million estimated by two analysts on average.Net Geographic Sales- Japan: $12.27 million versus $12.13 million estimated by two analysts on average. Compared to the year-ago quarter, this number represents a +7.7% change.Net Geographic Sales- China: $47.44 million versus the two-analyst average estimate of $33.75 million. The reported number represents a year-over-year change of +12095.9%.View all Key Company Metrics for Staar Surgical here>>>
Shares of Staar Surgical have returned +15.4% over the past month versus the Zacks S&P 500 composite's +8.6% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term.
Top 4 Stocks With Notable Insider BuyingSTAAR Surgical NASDAQ: STAA said its first quarter of 2026 marked a sharp rebound in sales and profitability, driven by strong demand in China, continued growth in the U.S. and tighter cost controls following a difficult 2025.
On the company’s earnings call, Interim Co-CEO, President and Chief Operating Officer Warren Foust said STAAR has “now largely moved past many of the challenges” it faced last year, citing disruption related to the potential Alcon merger process, elevated channel inventory in China and tariff risks. Foust said those issues are now “behind us.”
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Star Surgical Shines as U.S. Outlook Improves for 2024 STAAR reported first-quarter net sales of $93.5 million, up 119.6% from a year earlier. Deborah Andrews, Interim Co-CEO and Chief Financial Officer, said the increase was driven primarily by strong China sales and double-digit growth in the Americas. Adjusted EBITDA was $24.4 million, compared with an adjusted EBITDA loss of $26.3 million in the prior-year quarter.
Net income was $5.2 million, or $0.10 per diluted share, compared with a net loss of $54.2 million, or $1.10 per diluted share, in the first quarter of 2025. Operating income was $8 million, compared with an operating loss of $57.4 million a year earlier.
China Leads First-Quarter Growth China remained the company’s largest growth driver in the quarter. STAAR reported China net sales of $47.4 million, supported by the commercial launch of EVO+ ICL and continued demand for EVO ICL. Foust said China’s refractive market conditions were more stable in the first quarter than during the more volatile 2022-to-2024 period.
Foust said STAAR entered the quarter with China inventory levels normalized and aligned with contractual targets. He added that the company was able to grow sales while maintaining, and slightly reducing, inventory levels during the quarter. Andrews said the company was pleased that its sales “to the market approximated the sales into the market,” which she described as the desired result of stable distributor inventory.
During the question-and-answer session, Foust said distributor inventory in China is contractually targeted at about six months and is currently “at or below” those levels. He said STAAR had worked through elevated inventory during 2025 and brought it under control by September of that year.
The company also highlighted early demand for EVO+ in China. Foust said surgeon adoption and consumer interest were strong enough that STAAR needed more EVO+ product than initially planned. He said the company expects to fully supply market needs by the end of the second quarter and, for the rest of the year, to supply both EVO and EVO+ for China from its Nidau, Switzerland manufacturing facility.
U.S. Sales Rise Despite Weak Laser Vision Correction Market STAAR also reported its first quarter with more than $6 million in U.S. sales. Foust said U.S. net sales grew 22% year over year despite continued sluggishness in laser vision correction procedures that require removal of corneal tissue.
The company said it received U.S. Food and Drug Administration approval expanding the EVO ICL indication to patients aged 45 to 60. Foust said the expanded label increases STAAR’s addressable market and may open the product to roughly 8 million additional potential patients, though he said it is difficult to quantify the near-term contribution from the expanded indication.
Foust said the U.S. remains under-penetrated relative to more mature ICL markets and continues to represent an important long-term growth opportunity for the company.
Profitability Improves as Spending Falls Gross profit margin was 73.6% of net sales in the first quarter, up from 65.8% in the prior-year period. Andrews attributed the improvement to the elimination of period costs tied to the ramp-up of Swiss manufacturing, lower advanced manufacturing expenses, reduced inventory provisions and lower freight and other cost-of-sales items as a percentage of revenue. These benefits were partially offset by higher per-unit manufacturing costs resulting from lower production volumes in 2025.
Total operating expenses were $60.9 million, down from $85.4 million a year earlier. Excluding restructuring and merger-related costs, operating expenses were $51.5 million, an 18% decrease from $62.7 million in the prior-year quarter. Andrews said the company remains on track with its 2026 spending target of $225 million.
Andrews said STAAR is targeting gross margin of about 75% for the year, though she said the company knew it would fall short of that level in the first quarter. She said the company hopes to exit the year at that level and expects improved unit costs in the second half as volumes increase at the Swiss facility.
STAAR ended the quarter with $163.9 million in cash, cash equivalents and available-for-sale investments, and no outstanding debt. Andrews said cash declined sequentially due to items including seasonal bonuses, employee incentives, global sales meetings, severance and costs associated with a cooperation agreement with Broadwood Partners. She said the company expects to build cash during the rest of the year.
Company Declines to Provide Revenue Guidance STAAR did not provide formal revenue guidance for 2026. Analysts repeatedly asked management about expectations for the second quarter and the seasonal high-demand period in China, but Foust and Andrews declined to endorse consensus estimates or provide a specific forecast.
Foust said the company is optimistic but not ready to make predictions given macroeconomic and geopolitical uncertainty across multiple markets. Andrews said the second quarter is shaping up as she would expect “in a normal Q2 based on historical trends,” but added that STAAR wants more evidence before giving guidance.
“As soon as we feel like we have enough information to accurately predict for you is what we would need to have in order to provide it,” Foust said.
Outside China and the U.S., STAAR said geopolitical and trade-related disruption affected several markets, especially parts of the Middle East. Foust said the net sales impact was limited to less than $2 million. Andrews said ex-China sales grew 6%, with weakness in the Middle East and India limiting growth.
Foust said the broader trend toward lens-based refractive surgery remains a long-term growth driver for STAAR. He also said competition in China, including from Eyebright, has so far been “a non-issue” for STAAR, while adding that the presence of competitors helps validate the lens-based refractive surgery category.
The company also noted that it surpassed 4 million ICLs sold globally during the quarter and continues to roll out a new Oracle ERP system, which management said has caused limited disruption to date.
About STAAR Surgical NASDAQ: STAASTAAR Surgical Company, together with its subsidiaries, designs, develops, manufactures, markets, and sells implantable lenses for the eye, and companion delivery systems to deliver the lenses into the eye. The company provides implantable Collamer lens product family (ICLs) to treat visual disorders, such as myopia, hyperopia, astigmatism, and presbyopia. It markets its products to health care providers, including ophthalmic surgeons, vision and surgical centers, hospitals, government facilities, and distributors, as well as products are primarily used by ophthalmologists.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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Two AI Titans Flash Entries As Rocket Lab Readies For Launch Staar Surgical (STAA) shares catapulted into a profit-taking zone Thursday after the eye surgery outlet obliterated first-quarter profit expectations. The company, which makes implantable ocular lenses and other tools for ophthalmic surgery, put up adjusted earnings of 41 cents per share. Not only did earnings flip from a year-earlier loss of 52 cents a share, they also walloped forecasts for…
STAAR Surgical Company delivered a robust 1Q26 beat, with revenue up 119% YoY to $93.5M and a swing to $5.2M net income. China's market rebound, normalized inventory, and rapid EVO+ ICL adoption drove topline strength, while disciplined OpEx and manufacturing efficiency boosted margins to 73.6%. STAA is benefiting from a structural shift toward lens-based refractive surgery, gaining U.S. share despite a shrinking laser market and expanding its addressable market via FDA approval.
LAKE FOREST, Calif.--(BUSINESS WIRE)--STAAR Surgical Company (NASDAQ: STAA), the global leader in phakic IOLs with the EVO family of Implantable Collamer® Lenses (EVO ICL™) for vision correction, today announced that management will participate in the following upcoming conferences:
Stifel 2026 Virtual Ophthalmology Forum
Date: Tuesday, May 26, 2026
Format: Meetings and Webcast Fireside Chat
Details: Investor meeting participation is by invitation only from the sponsoring brokerage firm.
Webcast: 4:30 PM ET, Webcast Link
Canaccord Genuity Virtual Fireside Chat
Date: Wednesday, May 27, 2026
Format: Webcast Fireside Chat
Details: Registration for the webcast is by invitation only via the sponsoring brokerage firm.
Webcast: 2:30 PM ET
The live and archived webcast for each event, where applicable, will also be available on STAAR’s investor website at https://investors.staar.com.
About STAAR Surgical
STAAR Surgical (NASDAQ: STAA) is the global leader in implantable phakic intraocular lenses, a vision correction solution that reduces or eliminates the need for glasses or contact lenses. Since 1982, STAAR has been dedicated solely to ophthalmic surgery, and for 30 years, STAAR has been designing, developing, manufacturing, and marketing advanced Implantable Collamer® Lenses (ICLs), using its proprietary biocompatible Collamer material. STAAR ICL’s are clinically-proven to deliver safe long-term vision correction without removing corneal tissue or the eye’s natural crystalline lens. Its EVO ICL™ product line provides visual freedom through a quick, minimally invasive procedure. STAAR has sold more than 4 million ICLs in over 85 countries. Headquartered in Lake Forest, California, the company operates research, development, manufacturing, and packaging facilities in California and Switzerland. For more information about ICL, visit www.EVOICL.com. To learn more about STAAR, visit www.staar.com.
Safe Harbor
All statements that are not statements of historical fact are forward-looking statements, including statements about any of the following: any financial projections (including sales), plans, strategies, and objectives of management for 2026 and beyond or prospects for achieving such plans, expectations for sales, revenue, margin, expenses or earnings, and any statements of assumptions underlying any of the foregoing, including those relating to expected or future financial performance. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include risks and uncertainties related to global economic conditions, as well as the factors set forth in the Company’s Annual Report on Form 10-K for the year ended December 27, 2024 under the caption “Risk Factors,” which is on file with the Securities and Exchange Commission and available in the “Investor Information” section of the Company’s website under the heading “SEC Filings.” We disclaim any intention or obligation to update or revise any financial projections or forward-looking statement due to new information or events. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include the following: global economic conditions; the discretion of regulatory agencies to approve or reject existing, new or improved products, or to require additional actions before or after approval, or to take enforcement action; international trade disputes and substantial dependence on demand from Asia; and the willingness of surgeons and patients to adopt a new or improved product and procedure.
We intend to use our website as a means of disclosing material non-public information about the Company and for complying with our disclosure obligations under Regulation FD. Such disclosures will be included on our website in the ‘Investor Relations’ sections at investors.staar.com. Accordingly, investors should monitor such portion of our website, in addition to following our press releases, SEC filings and public conference calls and webcasts. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the News & Alerts section at https://investors.staar.com/.
On May 28, 2026, Staar Surgical Co STAA shares fell 7.3% to a current price of $29.08. This decline comes amidst a volatile trading period, as the stock has experienced a 52-week range of $15.59 to $35.87.
GF Value™ estimates the fair value at $30.94, indicating the stock is currently 6.0% undervalued.With a GF Score™ of 81/100, Staar Surgical Co is categorized as a strong investment opportunity.Insiders have actively purchased $12.3 million worth of shares in the last three months, signaling confidence in the company's future. Is STAA Overvalued or Undervalued? Staar Surgical Co's current price of $29.08 sits below its GF Value™ of $30.94, reflecting a 6.0% margin of safety for potential investors. This undervaluation suggests that the stock holds an opportunity for appreciation, given that its current market price does not fully reflect its estimated intrinsic value. However, it's crucial to consider that while the GF Valuation label categorizes the stock as fairly valued, the current dip in price might indicate short-term volatility that could affect investor sentiment.
GF Value™ is GuruFocus' proprietary measure of intrinsic value, calculated from historical trading multiples, past business growth, and future performance estimates. Therefore, the current undervaluation may present a buying opportunity, but investors should remain cautious and consider broader market conditions and company fundamentals before making decisions.
How Does STAA's Valuation Compare to Its History? Metric Current Historical P/E (TTM) 82.2x 105.2x Staar Surgical Co's current forward P/E ratio of 82.2x is significantly below its 5-year median P/E of 105.2x, indicating that the stock is trading at a lower valuation compared to its historical averages. This analysis aligns with the GF Value™ verdict of being undervalued, suggesting that the stock may be a compelling prospect for long-term investors seeking growth in the medical devices sector.
What Does STAA's GF Score™ Tell Us? Metric Rating GF Score™ 81/100 Financial Strength 7/10 Profitability 6/10 Growth 6/10 Valuation 9/10 Momentum 10/10 The GF Score™ of 81/100 indicates a strong overall performance, highlighting the company's solid financial strength (7/10) and exceptional momentum (10/10) as its strongest areas. However, the profitability and growth ranks (6/10) suggest there is room for improvement in these aspects. The valuation rank of 9/10 further emphasizes the stock's attractive pricing relative to its intrinsic value, reinforcing the potential upside for investors.
What Are Insiders Doing with STAA Stock? Recent insider activity at Staar Surgical Co has shown significant purchasing, with insiders acquiring $12.3 million in shares over the last three months and no recorded selling. This trend indicates a strong belief among insiders regarding the company's growth prospects and long-term value. Such activity often serves as a positive signal to the market, suggesting that those with the most insight into the company's operations are optimistic about its future performance.
What This Means for Investors Based on the current analysis, Staar Surgical Co is considered undervalued according to the GF Value™ framework. With a strong GF Score™ and favorable insider activity, the stock presents a potential opportunity for investors looking to enter the medical devices market at a reasonable price.
For the complete analysis, visit the Staar Surgical Co STAA stock page. You can also explore the GF Value™ page for detailed valuation methodology, or use the GuruFocus Stock Screener to find similar opportunities.
Frequently Asked Questions What is STAA's GF Score™?
Staar Surgical Co has a GF Score™ of 81/100, indicating a strong overall performance and potential for higher long-term returns.
Is STAA overvalued or undervalued?
According to GF Value™, Staar Surgical Co is currently undervalued, with a fair value estimate of $30.94 compared to its current price of $29.08.
What is STAA's P/E ratio?
The forward P/E ratio for Staar Surgical Co is 82.2x, which is below its 5-year median P/E of 105.2x, suggesting it is trading at a lower valuation compared to its historical averages.
This stock alert was generated using automated technology and GuruFocus financial data to provide readers with timely and accurate market reporting. This content was reviewed by GuruFocus editorial team prior to publication. Please send any questions or comments about this story to [email protected].
What happenedAccording to an SEC filing dated May 14, 2026, Broadwood Capital purchased 1,104,351 shares of STAAR Surgical Company. (STAA 1.83%) during the first quarter, an estimated $21.08 million transaction based on the quarter’s average share price.
The fund’s quarter-end position in STAAR Surgical decreased in value by $45.28 million, a figure that reflects both the additional shares acquired and changes in the stock price over the period.
What else to knowThis was a buy, lifting the stake to 21.25% of Broadwood Capital’s reportable AUM as of March 31, 2026.Top holdings after this filing:NASDAQ:MNST: $587.49 million (41.4% of AUM)NASDAQ:STAA: $301.52 million (21.3% of AUM)NASDAQ:AXON: $294.52 million (20.8% of AUM)NYSEMKT:IWM: $117.78 million (8.3% of AUM)NYSEMKT:LCTX: $78.31 million (5.5% of AUM)As of May 14, 2026, shares were priced at $32.01, up 83.6% over the past year and outperforming the S&P 500 by 56.35 percentage points.Company OverviewMetricValuePrice (as of market close 2026-05-14)$32.01Market capitalization$1.48 billionRevenue (TTM)$290.38 millionNet income (TTM)($21.03 million)Company SnapshotSTAAR Surgical Company develops and sells implantable lenses for vision correction, including the Visian ICL product family for myopia, hyperopia, astigmatism, and presbyopia, as well as preloaded silicone cataract intraocular lenses and injector systems.The company generates revenue primarily through direct sales of its proprietary ophthalmic devices and related delivery systems to healthcare providers and distributors.Main customers are ophthalmic surgeons, vision and surgical centers, hospitals, and government facilities, with a global footprint spanning North America, Europe, and Asia.STAAR Surgical Company designs, develops, manufactures, and sells implantable lenses for the eye, leveraging proprietary lens technology to address a broad range of refractive errors.
The company sells its products directly through sales representatives in the United States, Japan, Germany, Spain, Canada, the United Kingdom, and Singapore, and through representatives and independent distributors in China, Korea, India, France, Benelux, Italy, and internationally.
What this transaction means for investorsNew York-based Broadwood Capital’s purchase of STAAR Surgical Company shares during the first quarter signals the hedge fund has a bullish outlook towards the stock. It already owned over 15 million shares at the end of the fourth quarter of 2025, so adding more in Q1 signals the firm believed the stock would appreciate in value.
The buy made sense at the time. STAAR Surgical shares had dropped to a 52-week low of $15.59 on Feb. 27, which may have been the catalyst for the hedge fund to add to its stake.
Broadwood Capital’s move turned out to be a good one. STARR Surgical’s fiscal Q1 revenue of $93.5 million was the highest first quarter sales in its history. It represented a massive 120% year-over-year increase. The company’s outstanding Q1 was helped by sales growth in the China market.
As a result, STARR Surgical shares soared to a 52-week high of $35.87 on May 14. Due to the increase in its stock price, STARR Surgical’s valuation has skyrocketed. Its forward price-to-earnings ratio is an eye-popping 130. While Broadwood Capital’s Q1 purchase was brilliant, for investors who did not buy, now is not the time to do so.
Robert Izquierdo has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Axon Enterprise, Lineage Cell Therapeutics, and Monster Beverage. The Motley Fool has a disclosure policy.
Investors might want to bet on Align Technology (ALGN - Free Report) , as it has been recently upgraded to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.
A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.
Since a changing earnings picture is a powerful factor influencing near-term stock price movements, the Zacks rating system is very useful for individual investors. They may find it difficult to make decisions based on rating upgrades by Wall Street analysts, as these are mostly driven by subjective factors that are hard to see and measure in real time.
Therefore, the Zacks rating upgrade for Align Technology basically reflects positivity about its earnings outlook that could translate into buying pressure and an increase in its stock price.
Most Powerful Force Impacting Stock PricesThe change in a company's future earnings potential, as reflected in earnings estimate revisions, and the near-term price movement of its stock are proven to be strongly correlated. That's partly because of the influence of institutional investors that use earnings and earnings estimates for calculating the fair value of a company's shares. An increase or decrease in earnings estimates in their valuation models simply results in higher or lower fair value for a stock, and institutional investors typically buy or sell it. Their transaction of large amounts of shares then leads to price movement for the stock.
Fundamentally speaking, rising earnings estimates and the consequent rating upgrade for Align Technology imply an improvement in the company's underlying business. Investors should show their appreciation for this improving business trend by pushing the stock higher.
Harnessing the Power of Earnings Estimate RevisionsEmpirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock movements, so it could be truly rewarding if such revisions are tracked for making an investment decision. Here is where the tried-and-tested Zacks Rank stock-rating system plays an important role, as it effectively harnesses the power of earnings estimate revisions.
The Zacks Rank stock-rating system, which uses four factors related to earnings estimates to classify stocks into five groups, ranging from Zacks Rank #1 (Strong Buy) to Zacks Rank #5 (Strong Sell), has an impressive externally-audited track record, with Zacks Rank #1 stocks generating an average annual return of +25% since 1988. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here >>>> .
Earnings Estimate Revisions for Align TechnologyThis maker of the Invisalign tooth-straightening system is expected to earn $11.32 per share for the fiscal year ending December 2026, which represents no year-over-year change.
Analysts have been steadily raising their estimates for Align Technology. Over the past three months, the Zacks Consensus Estimate for the company has increased 4.2%.
Bottom LineUnlike the overly optimistic Wall Street analysts whose rating systems tend to be weighted toward favorable recommendations, the Zacks rating system maintains an equal proportion of "buy" and "sell" ratings for its entire universe of more than 4,000 stocks at any point in time. Irrespective of market conditions, only the top 5% of the Zacks-covered stocks get a "Strong Buy" rating and the next 15% get a "Buy" rating. So, the placement of a stock in the top 20% of the Zacks-covered stocks indicates its superior earnings estimate revision feature, making it a solid candidate for producing market-beating returns in the near term.
You can learn more about the Zacks Rank here >>>
The upgrade of Align Technology to a Zacks Rank #2 positions it in the top 20% of the Zacks-covered stocks in terms of estimate revisions, implying that the stock might move higher in the near term.
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What are the Zacks Style Scores? Developed alongside the Zacks Rank, the Zacks Style Scores are a group of complementary indicators that help investors pick stocks with the best chances of beating the market over the next 30 days.
Each stock is given an alphabetic rating of A, B, C, D or F based on their value, growth, and momentum qualities. With this system, an A is better than a B, a B is better than a C, and so on, meaning the better the score, the better chance the stock will outperform.
The Style Scores are broken down into four categories:
Value ScoreFinding good stocks at good prices, and discovering which companies are trading under their true value, are what value investors like to focus on. So, the Value Style Score takes into account ratios like P/E, PEG, Price/Sales, Price/Cash Flow, and a host of other multiples to highlight the most attractive and discounted stocks.
Growth ScoreGrowth investors, on the other hand, are more concerned with a company's financial strength and health, and its future outlook. The Growth Style Score examines things like projected and historic earnings, sales, and cash flow to find stocks that will experience sustainable growth over time.
Momentum ScoreMomentum trading is all about taking advantage of upward or downward trends in a stock's price or earnings outlook, and these investors live by the saying "the trend is your friend." The Momentum Style Score can pinpoint good times to build a position in a stock, using factors like one-week price change and the monthly percentage change in earnings estimates.
VGM ScoreIf you want a combination of all three Style Scores, then the VGM Score will be your friend. It rates each stock on their combined weighted styles, helping you find the companies with the most attractive value, best growth forecast, and most promising momentum. It's also one of the best indicators to use with the Zacks Rank.
How Style Scores Work with the Zacks Rank The Zacks Rank, which is a proprietary stock-rating model, employs earnings estimate revisions, or changes to a company's earnings expectations, to make building a winning portfolio easier.
It's highly successful, with #1 (Strong Buy) stocks producing an unmatched +23.7% average annual return since 1988. That's more than double the S&P 500. But because of the large number of stocks we rate, there are over 200 companies with a Strong Buy rank, plus another 600 with a #2 (Buy) rank, on any given day.
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Stock to Watch: Align Technology (ALGN - Free Report) Align Technology, based in California, manufactures and markets a system of clear aligner therapy, intra-oral scanners and CAD/CAM (computer-aided design and computer-aided manufacturing) digital services used in dentistry, orthodontics, and dental records storage. The clear aligner system corrects malocclusion using nearly invisible and removable appliances that gently move the tooth to a desired final position.
ALGN is a #2 (Buy) on the Zacks Rank, with a VGM Score of B.
It also boasts a Value Style Score of B thanks to attractive valuation metrics like a forward P/E ratio of 13.85; value investors should take notice.
Six analysts revised their earnings estimate higher in the last 60 days for fiscal 2026, while the Zacks Consensus Estimate has increased $0.12 to $11.35 per share. ALGN also boasts an average earnings surprise of +7.8%.
With a solid Zacks Rank and top-tier Value and VGM Style Scores, ALGN should be on investors' short list.
Key Takeaways Align Technology is rolling out Invisalign DSP touch-up, Palatal Expander and ART into more markets. ALGN says iTero Lumina now makes up most scanners, as new tools streamline digital dentistry workflows.ALGN has $1.06B cash and no debt, but expects Invisalign ASP to fall about 1-2% in 2026. Align Technology’s (ALGN - Free Report) successful efforts to broaden the Invisalign business are poised to bring significant growth in the upcoming quarters. Also, iTero is gaining from the rapidly evolving intraoral scanning technology in the industry. A sound financial stability is beneficial for the stock as well. However, a lower average sell price (ASP) raises concerns about the company’s sales growth.
In the past year, this Zacks Rank #2 (Buy) company’s shares have lost 9.8% against 3.3% growth of the industry. In contrast, the S&P 500 composite has risen 31.3%.
The renowned medical device company has a market capitalization of $11.26 billion. ALGN projects a long-term estimated earnings growth rate of 11.2% compared with 9.9% growth of the industry. Its earnings surpassed estimates in three of the trailing four quarters and missed in one, the average surprise being 7.8%.
Let’s delve deeper.
Upsides for ALGN StockInvisalign Business Expansion: Align Technology’s Invisalign portfolio offers orthodontic treatment to straighten teeth without metal braces. In recent quarters, the company has expanded Invisalign DSP touch-up cases to more countries and plans further rollouts, including in key APAC markets from 2026.
Among the recent developments, Align Technology continues to commercialize the Invisalign Palatal Expander with steady momentum in doctor submitters and shipments. The company commercially launched the Invisalign Palatal Expander System in India, Malaysia and Turkey. It also received the CE mark to market the Invisalign Palatal Expander system in most of Europe. The system also received regulatory approval in China.
Invisalign System with mandibular advancement featuring occlusal blocks is designed specifically to address Class II skeletal and dental correction by simultaneously advancing the mandible while aligning the teeth. Align Technology expanded the commercial launch of this system to India, Malaysia, Philippines, Thailand, United States, Canada, Australia and New Zealand.
Following the successful launch of its inaugural Invisalign Advanced Restorative Treatment (“ART”) pilot in EMEA, the company has expanded the program into the United States, with laboratories and doctors undergoing training across several markets.
iTero in Focus: Align Technology’s iTero intraoral scanners, alongside its Exocad CAD/CAM software, continue to gain traction globally as key tools in digital dentistry. The iTero Lumina now represents the majority of iTero scanner system mix. It continues to pilot integrations, such as x-ray diagnostics with the iTero Lumina, in select international markets.
New innovations, including the Invisalign Outcome Simulator Pro, iTero Design Suite, and Align Oral Health Suite, are being used to enhance diagnostic, restorative and orthodontic workflows. The company remains focused on scaling adoption through clinical utility, automation, and seamless integration into restorative and ortho-restorative workflows.
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Recently, the company has introduced a set of enhancements to its iTero Digital Solutions platform — a comprehensive system that puts together intra-oral scanners, software tools and digital workflows used by dental and orthodontic practices.
Strong Solvency: With no debt on its balance sheet, Align Technology looks quite comfortable from the liquidity point of view. The company’s cash and cash equivalents totaled $1.06 billion at the end of first-quarter 2026.
Concern for ALGNUnfavorable Product Mix Shift Lowers ASP: Align Technology continues to experience pressure on Invisalign ASPs, particularly for comprehensive treatment options. In the fourth quarter, it experienced continued pressure on ASP, reflecting a combination of geographic mix, product mix and higher discounts. Looking ahead, the company expects ASP to reduce approximately 1-2% year over year in 2026.
ALGN Stock Estimate TrendThe Zacks Consensus Estimate for 2026 earnings per share (EPS) has moved north 1.2% to $11.36 in the past 30 days.
The Zacks Consensus Estimate for 2026 revenues is pegged at $4.19 billion, suggesting a 3.8% rise from the year-ago reported number.
Other Key PicksSome other top-ranked stocks in the broader medical space are Globus Medical (GMED - Free Report) , Quest Diagnostics (DGX - Free Report) and Phibro Animal Health (PAHC - Free Report) .
Globus Medical has an earnings yield of 6.1% compared to the industry’s negative 1.1% yield. Its earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 26.3%. GMED shares have rallied 28.1% against the industry’s 12.5% decline over the past year.
GMED sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Quest Diagnostics, carrying a Zacks Rank #2, has an earnings yield of 5.7% compared with the industry’s 5.6% yield. Shares of the company have risen 6.6% compared with the industry’s 0.5% growth. DGX’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 3.5%.
Phibro Animal Health, carrying a Zacks Rank #2, has an estimated long-term earnings growth rate of 21.5% compared with the industry’s 12.1%. Its earnings surpassed the Zacks Consensus Estimate in each of the trailing four quarters, with the average surprise being 16.3%. PAHC’s shares have rallied 41.8% against the industry’s 32.8% decline over the past year.
TEMPE, Ariz.--(BUSINESS WIRE)--Align Technology, Inc. (“Align”) (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, today announced that the company is scheduled to speak at upcoming financial conferences. As noted below, the presentations will be webcast live via the Investor Relations section of Align Technology's website at http://investor.aligntech.com. An archived replay will remain on the website for approximately one month.
Conference:
Stifel 2026 Jaws & Paws Conference
Date:
Thursday, May 28, 2026
Presentation:
8:00 – 8:30 a.m. ET
Location:
New York, NY
Speakers:
John Morici, EVP Global Finance and CFO
Shirley Stacy, VP Finance, Global Communications and IRO
Conference:
William Blair 46th Annual Growth Stock Conference
Date:
Wednesday, June 3, 2026
Presentation:
9:20 – 9:50 a.m. CT
Location:
Chicago, IL
Speakers:
Joseph Hogan, CEO
John Morici, EVP Global Finance and CFO
Shirley Stacy, VP Finance, Global Communications and IRO
Conference:
2026 Jefferies Global Healthcare Conference
Date:
Thursday, June 4, 2026
Presentation:
8:10 – 8:40 a.m. ET
Location:
New York, NY
Speakers:
John Morici, EVP Global Finance and CFO
Shirley Stacy, VP Finance, Global Communications and IRO
Conference:
Goldman Sachs 47th Annual Global Healthcare Conference
Date:
Monday, June 8, 2026
Presentation:
8:40 – 9:15 a.m. ET
Location:
Miami, FL
Speakers:
John Morici, EVP Global Finance and CFO
Shirley Stacy, VP Finance, Global Communications and IRO
About Align Technology, Inc.
Align Technology designs and manufactures the Invisalign® System, the most advanced clear aligner system in the world, iTero™ intraoral scanners and services, and exocad™ CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for approximately 299.5 thousand doctor customers and are key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 29 years, Align has helped doctors treat approximately 22.8 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align™ Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.
For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.
Invisalign, iTero, exocad, Align, Align Digital Platform and iTero Lumina are trademarks of Align Technology, Inc.
On May 20, 2026, Align Technology Inc ALGN shares rose 5.3% today, closing at $163.42. The stock has been trading in a 52-week range from a low of $122.00 to a high of $208.31, reflecting significant volatility over the past year.
GF Value™ verdict: ALGN's current price is $163.42, while GF Value™ estimates fair value at $238.92, indicating it is 31.6% undervalued.GF Score™: 86/100, which is considered strong, suggesting a favorable long-term investment potential.Most notable signal: No insider transactions have occurred in the last three months, indicating a period of stability in insider activity. Is ALGN Overvalued or Undervalued? Align Technology Inc ALGN is currently trading significantly below its estimated fair value, as indicated by the GF Value™ of $238.92. This suggests that there is a substantial margin of safety for potential investors, as the shares are priced 31.6% lower than their intrinsic value. The GF Valuation label categorizes ALGN as "Significantly Undervalued," highlighting a potential opportunity for growth as the market corrects itself over time. However, it is essential to consider that while the undervaluation presents an opportunity, external factors such as market conditions and company performance should also be monitored to mitigate risks.
GF Value™ is GuruFocus' proprietary measure of intrinsic value, calculated from historical trading multiples, past business growth, and future performance estimates.
How Does ALGN's Valuation Compare to Its History? Metric Current Historical P/E (TTM) 27.4x 40.7x Forward P/E 14.4x - Align Technology's current P/E ratio of 27.4x is significantly below its 5-year median P/E of 40.7x, indicating that the stock is trading at a discount compared to its historical valuation. The forward P/E of 14.4x further reinforces this finding, suggesting a favorable outlook for earnings. This P/E analysis supports the GF Value™ verdict of undervaluation, indicating that the stock may be an attractive investment opportunity based on historical performance metrics.
What Does ALGN's GF Score™ Tell Us? Metric Rating GF Score™ 86 Financial Strength 7/10 Profitability 9/10 Growth 7/10 Valuation 4/10 Momentum 8/10 The GF Score™ of 86/100 indicates that Align Technology is positioned well across various dimensions. The strongest aspect is its profitability, rated 9/10, suggesting robust profit generation capabilities. However, the valuation rank of 4/10 indicates that while the company is undervalued, there may be some concerns regarding its price relative to fundamentals. The financial strength and growth ranks of 7/10 highlight a solid foundation for future performance, contributing to a favorable long-term outlook.
What Are Insiders Doing with ALGN Stock? There have been no insider transactions for Align Technology Inc in the last three months. This lack of activity might suggest that insiders are not currently buying or selling shares, which can indicate a period of confidence in the company's operations or a wait-and-see approach, reflecting stability in the company's leadership and prospects.
What This Means for Investors Based on the analysis of the GF Value™, Align Technology Inc ALGN is considered undervalued at its current price of $163.42 compared to its GF Value™ of $238.92. This presents a potential opportunity for investors looking for growth in the medical devices sector.
For the complete analysis, visit the Align Technology Inc ALGN stock page. You can also explore the GF Value™ page for detailed valuation methodology, or use the GuruFocus Stock Screener to find similar opportunities.
Frequently Asked Questions What is ALGN's GF Score™?
ALGN's GF Score™ is 86, indicating a strong overall ranking based on key factors that have historically correlated with long-term returns.
Is ALGN overvalued or undervalued?
ALGN is currently undervalued, with a GF Value™ of $238.92 compared to its current price of $163.42, representing a significant opportunity for growth.
What is ALGN's P/E ratio?
Align Technology's P/E ratio (TTM) is 27.4x, which is substantially below its 5-year median P/E of 40.7x, indicating it is trading at a discount historically.
This stock alert was generated using automated technology and GuruFocus financial data to provide readers with timely and accurate market reporting. This content was reviewed by GuruFocus editorial team prior to publication. Please send any questions or comments about this story to [email protected].
BARCELONA, Spain & TEMPE, Ariz.--(BUSINESS WIRE)--Align Technology, Inc. (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, today shared highlights of its 2026 Invisalign® EMEA Ortho Summit, which brought together approximately 400 orthodontists and dental professionals from across Europe, the Middle East, and Africa (EMEA).
The three-day summit, held May 14–16, 2026 in Barcelona, Spain provided an immersive peer to peer learning experience focused on Align’s next generation digital technologies. These innovations are designed to address the most complex clinical indications for kids, teens and adults, including Class II malocclusions, while improving treatment precision, practice efficiency, and the overall patient experience.
Commenting on the 2026 Invisalign EMEA Ortho Summit, David Carr, Align Technology executive vice president and managing director, EMEA, said, “The Summit was designed to foster connection and collaboration with Invisalign providers. It was built around a simple idea: experience matters. Delivering effective and predictable outcomes, improving efficiency, and elevating the patient experience through digital orthodontics takes more than innovation, it requires experienced doctors who can apply it effectively in everyday practice. By bringing together Align integrated digital solutions and real-world clinical insights, the Invisalign EMEA Ortho Summit brought the region together, and provided an opportunity to collaborate with experts, expand clinical confidence, and share our latest innovations. I was also thrilled that we could offer participants early access to 3D Soft Tissue Animation, becoming the first Invisalign customers in the EMEA region to gain access to this innovation.”
Immersive Innovation Hub Showcases the Future of Orthodontics
At the center of the Summit was the Align Innovation Hub – an interactive end-to-end representation of a modern digital orthodontic practice. Designed as a “live” patient journey, the experience guided attendees from consultation through treatment to retention, demonstrating how digital tools can work seamlessly together.
The Hub featured:
A simulated clinical environment showcasing doctor-led consultations for teens and adults alongside integrated workflows Collaborative spaces for peer learning and exchange A gallery of current and upcoming innovations “The Innovation Hub showed how seamlessly everything can connect in a digital workflow,” said Dr. Jesús Veres, an orthodontist from Valencia, Spain, who attended the Summit. “Getting hands-on with each step of the process, from digital scanning to treatment planning to how we engage patients, gave me ideas I can take back to my practice to improve the experience for my patients.”
In addition to showcasing current Invisalign System innovations, the Summit’s Innovation Hub offered previews of several solutions expected by mid-2026, each aimed at bringing greater digital precision and consistency to traditionally manual procedures.* Highlights included:
The Invisalign Specifix™ Attachment System – a 3D printed attachment solution that combines attachments 3D-printed to the exact shape and size indicated in the doctor’s treatment plan with a novel bonding accessory for precise placement1. The Specifix system is designed to reduce variability in attachment size and placement, increase consistency, and streamline the attachment workflow. Invisalign® integrated buttons – a new digital approach to the small, bonded accessories used to anchor elastics and apply targeted forces during treatment. Digitally integrated buttons incorporate button planning into the ClinCheck® treatment planning workflow, replacing the standard manual process. With this digital approach, button type and position are determined within the software during treatment planning, helping to reduce chairside guesswork, improve placement accuracy, and deliver a more flexible, precise, and efficient bite correction. Invisalign® Palatal Expander with integrated hook features– a further evolution of Align’s 3D-printed palatal expander system designed to help doctors treat a broader range of patients with added flexibility. Building on the clinically effective2 Invisalign Palatal Expander (IPE) system, the new forward- and backward-facing integrated hooks are compatible with elastics3, offering intuitive enhancements to palatal expansion treatment. Invisalign clear aligner custom trimline option gives doctors greater control over aligner gingival margins to support improved aesthetics, comfort, and clinical flexibility. In cases where doctors feel there is insufficient retention, they can consider an extended scalloped trimline for short clinical crowns, erupting dentition cases, preferences for fewer attachments, extended tooth coverage in gingival recession and in extending to include the undercut of the clinical crowns. Integrated directly into the ClinCheck® digital treatment planning workflow, custom trim lines allow doctors to personalize aligner design based on individual patient anatomy and treatment. 3D Soft Tissue Animation, EMEA Ortho Summit participants also received early access to this recent innovation, becoming the first customers in the EMEA region. “We’re excited about the innovations previewed at the EMEA Summit and what they signal for the day-to-day reality of running a practice,” said Prof. Dr. Anton Demling, Uelzen, Germany, who participated as a speaker during the Summit. “Invisalign integrated buttons and the Specifix attachment system will take things that have traditionally required a lot of manual steps and variability and make them far more straightforward and consistent. That means less guesswork for teams, more predictable outcomes, and a noticeably better experience for patients. It’s a simpler way of working that just makes sense.”
Peer-Led Education and Clinical Exchange
The Summit program featured dozens of orthodontist-led sessions covering complex case treatment for cases such as impacted canines, digital workflow optimization, and patient engagement strategies. Interactive formats including panel discussions, breakout lecture sessions, and live demonstrations encouraged open dialogue and knowledge sharing among clinicians.
“What made this event especially valuable was the openness among colleagues and the quality of peer-to-peer learning,” said Dr. Nelly Dilkova, an orthodontist from Bulgaria, who also participated as a speaker. “The conversations went beyond innovation alone and focused on how we can use digital tools more effectively for our patients. Hearing colleagues share real clinical cases and practical workflows gave me valuable insights I can immediately apply in my practice. This outstanding atmosphere inspired new ways of thinking about the future of digital orthodontics.”
Advancing Integrated Digital Orthodontics with the Invisalign System
The Invisalign EMEA Ortho Summit reflects Align’s broader strategy to advance connected, digitally enabled orthodontic care. Ongoing investments in the Align™ Digital Platform continue to integrate scanning, visualization, treatment planning, appliance fabrication, treatment monitoring, and retention into a unified ecosystem designed to support doctors and enhance patient outcomes. Strategic areas of progress include:
Advancing digital orthodontic workflows that connect intraoral scanning, digital treatment planning, aligner fabrication, monitoring, and retention into seamless, data-driven experiences for doctors and patients. Continued leadership in digital manufacturing and 3D printing, enabling consistent, high-quality Invisalign aligner production at global scale while supporting speed and reliability for orthodontic practices. Ongoing investment in automation, designed to help doctors work more efficiently while maintaining clinical oversight and control as case complexity and practice scale increase. Expansion of diagnostic and visualization capabilities, supporting earlier intervention, improved patient understanding, and more confident treatment planning across a broader range of malocclusions and growth patterns. Scaling of integrated solutions, reflecting growing adoption of digitally connected orthodontic workflows in diverse practice models. Independent validation of the Invisalign Palatal Expander (IPE) – A clinical study by researchers at the University of Insubria, Italy found that the Invisalign Palatal Expander was shown to effectively widen the upper jaw by opening the natural growth seam in the palate, achieving bone and bite changes similar to a traditional metal Hyrax expander. IPE also delivered more controlled and predictable results than Hyrax, supporting its use as a reliable option for growing patients and highlighting its role as a key step toward fully digital orthodontic care4. Together, these and other planned innovations reinforce Align’s long‑term strategy to move beyond individual products toward connected experiences and outcomes, supporting prevention, early intervention, and digitally driven care delivery across orthodontic practices worldwide.
About Align Technology, Inc. Align Technology designs and manufactures the Invisalign® System, the most advanced clear aligner system in the world, iTero™ intraoral scanners and services, and exocad™ CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for approximately 299.5 thousand doctor customers and are key to accessing Align's 600 million consumer market opportunity worldwide. Over the past 29 years, Align has helped doctors treat approximately 22.8 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align™ Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.
For additional information about the Invisalign System or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.
Invisalign, iTero, exocad, Align, Align Digital Platform, and iTero Lumina are trademarks of Align Technology, Inc.
* The availability of products may vary by market and is subject to applicable regulatory approvals and clearances. Please check with your local Align team for further information.
Based on bench testing conducted in August 2025 according to Design Verification on Specifix™ attachment volume precision (A035851). Data on File at Align Technology, as of January 28, 2026. Based on data from a multi-site US IDE (Investigational Device Exemption) clinical study (n=29 subjects, ages 7-10 years) of expansion treatment with Invisalign® Palatal Expanders. Data on file at Align Technology, as of October 30, 2023 Elastics are not supplied/provided by Align Technology, Inc Levrini L, Saran S, Imbesi E, Vanini I, Russo V, Rimoldi V, Carganico A, Giannotta N and Perugini M (2026), Skeletal and dentoalveolar effects on the midpalatal suture and maxillary arch assessed by occlusal radiographs and three-dimensional digital models in patients treated with Invisalign palatal expander and rapid palatal expander: a pilot study. Front. Dent. Med. 7:1757094. doi: 10.3389/fdmed.2026.1757094 More News From Align Technology, Inc.
The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Align Technology (ALGN - Free Report) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? Let's take a closer look at the stock's year-to-date performance to find out.
Align Technology is one of 884 individual stocks in the Medical sector. Collectively, these companies sit at #5 in the Zacks Sector Rank. The Zacks Sector Rank includes 16 different groups and is listed in order from best to worst in terms of the average Zacks Rank of the individual companies within each of these sectors.
The Zacks Rank is a successful stock-picking model that emphasizes earnings estimates and estimate revisions. The system highlights a number of different stocks that could be poised to outperform the broader market over the next one to three months. Align Technology is currently sporting a Zacks Rank of #2 (Buy).
Within the past quarter, the Zacks Consensus Estimate for ALGN's full-year earnings has moved 3.9% higher. This signals that analyst sentiment is improving and the stock's earnings outlook is more positive.
According to our latest data, ALGN has moved about 4.4% on a year-to-date basis. Meanwhile, the Medical sector has returned an average of -5.9% on a year-to-date basis. This means that Align Technology is performing better than its sector in terms of year-to-date returns.
One other Medical stock that has outperformed the sector so far this year is Carlsmed, Inc. (CARL - Free Report) . The stock is up 2.4% year-to-date.
For Carlsmed, Inc., the consensus EPS estimate for the current year has increased 21.1% over the past three months. The stock currently has a Zacks Rank #2 (Buy).
To break things down more, Align Technology belongs to the Medical - Dental Supplies industry, a group that includes 13 individual companies and currently sits at #65 in the Zacks Industry Rank. On average, stocks in this group have lost 8.4% this year, meaning that ALGN is performing better in terms of year-to-date returns.
In contrast, Carlsmed, Inc. falls under the Medical Info Systems industry. Currently, this industry has 41 stocks and is ranked #94. Since the beginning of the year, the industry has moved -24.1%.
Going forward, investors interested in Medical stocks should continue to pay close attention to Align Technology and Carlsmed, Inc. as they could maintain their solid performance.
HYDERABAD, India & TEMPE, Ariz.--(BUSINESS WIRE)--Align Technology, Inc. (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, iTero™ intraoral scanners and services, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, today announced plans to open a new manufacturing facility in Hyderabad, India in 2027, create more than 300 direct jobs, and spend approximately $200 million in both capital and operational expense over the next several years. This new facility reflects Align’s strategy to get closer to customers and scale its operations to support high-growth markets like India, while strengthening its supply chain resilience and operational efficiency to drive shareholder value. It also demonstrates Align’s continued investments in aligner fabrication manufacturing and treatment planning capabilities in each of its regions, to better serve doctor customers and their patients, and contribute to their local economy through investment and employment.
“India represents an important growth market for Align, and we are excited about the opportunity to expand our global manufacturing network with a new facility in Hyderabad,” said Jitse Marrée, Align executive vice president, global operations. “This investment underscores our commitment to scaling our advanced manufacturing capabilities, supporting our doctor customers, and bringing the benefits of the Invisalign® System to more patients worldwide. Hyderabad’s strong talent base, infrastructure, and innovation ecosystem make it an ideal location for our next phase of growth.”
Align’s Hyderabad manufacturing facility will complement Align’s existing footprint in Hyderabad, which includes its Global Capability Center, the Align Innovation Center, further reinforcing the city’s strategic importance within Align’s global operations network. It would mark the company’s first manufacturing presence in India and its fourth globally. The proposed facility is expected to commence operations in 2027 and be margin accretive in the first year.
“We are proud to expand Align’s global manufacturing footprint with our first manufacturing facility in India and a new state-of-the-art site in Hyderabad,” said JunHo Han, Align executive vice president and managing director, Asia Pacific. “This investment reflects our long-term commitment to the Asia-Pacific region and builds on our continued expansion across key markets, where we have been investing in local teams, capabilities, and digital treatment planning infrastructure to support growing adoption of the Invisalign® System. The Hyderabad facility represents an important milestone as we scale our operations in high-growth markets and further strengthen our ability to support Invisalign-trained doctors and their patients. With this investment, we expect to enhance service levels across the region through more localized, customized support.”
About Align Technology, Inc.
Align Technology designs and manufactures the Invisalign® System, the most advanced clear aligner system in the world, iTero™ intraoral scanners and services, and exocad™ CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for approximately 299.5 thousand doctor customers and are key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 29 years, Align has helped doctors treat approximately 22.8 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align™ Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.
For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.
Invisalign, iTero, exocad, Align, Align Digital Platform and iTero Lumina are trademarks of Align Technology, Inc.
About the Invisalign System
Invisalign clear aligners are a removable and transparent teeth-straightening solution produced using digital and 3D technologies. This type of solution differs from other orthodontic devices in that they are more comfortable and can be easily removed for eating or drinking. Used to treat minor to complex types of malocclusions, Invisalign clear aligners are replaced every one or two weeks, depending on a doctor’s recommendation, gradually moving teeth towards the projected final position.
Forward-Looking Statement
This news release contains forward-looking statements, including statements regarding the expected timing, scope, and benefits of Align Technology’s planned manufacturing facility in Hyderabad, India, including anticipated job creation, production capacity, and operational impact. Forward-looking statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially.
Factors that may cause such differences include, but are not limited to:
changes in global or regional economic conditions; fluctuating customer demand; regulatory and approval processes; construction and operational timelines; supply chain disruptions; competitive dynamics; and other risks detailed in Align Technology’s filings with the Securities and Exchange Commission. Align undertakes no obligation to update forward-looking statements except as required by law.
Why These 3 Tech Stocks Could Be the Best Opportunities You're OverlookingAlign Technology NASDAQ: ALGN executives highlighted product innovation, financing initiatives and international expansion as key growth drivers during a discussion at the 2026 Stifel Jaws & Paws Conference.
Chief Financial Officer John Morici, joined by Shirley Stacy, vice president of finance, global communications and investor relations, spoke with Stifel healthcare managing director Jonathan Block following a technology update the company held the prior day. Morici said Align is moving beyond individual products toward broader treatment “solutions,” including enhancements to its Invisalign Palatal Expander and mandibular advancement products.
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Buy the Dip? These Earnings Misses Offer Long-Term UpsideMorici said the company is adding features such as hooks and buttons to the palatal expander and developing products that can move teeth while also addressing jaw and skeletal issues. He said direct fabrication technology helps support that shift by making it easier for doctors to treat multiple issues at the same time, particularly in teenagers.
Financing and Conversion Initiatives Remain a Focus Morici said Align is also emphasizing “active conversion” strategies that it has learned from dental service organization partners and large practices. Those strategies include working with outside financing companies such as HFD to provide patients with more affordable monthly payment options and improve treatment acceptance rates.
MarketBeat Week in Review: 12/25 - 12/29He said Align typically pilots new initiatives, learns from the pilots and then moves toward broader releases. That approach applies to both ortho-restorative initiatives involving labs and patient financing programs. Morici said many of those efforts were piloted last year and have begun rolling out into this year.
Direct Fabrication Expected to Scale Over Time Discussing direct fabrication, Morici said the technology remains dilutive to gross margins this year, but the company expects it to become more neutral as volume scales. He said reaching more than 10% to 15% of volume for directly fabricated products could allow the company to offset the initial margin drag.
Morici said the main margin opportunity comes from lower material costs compared with traditional manufacturing, where Align must create and discard a negative mold. He said the company initially is scaling direct fabrication through products with attachments and specialty retainers, before moving into broader retention products and then aligners. He said aligners could become more regular direct fabrication products in the later part of next year.
Morici said direct fabrication for aligners will require FDA approval, and Align is in the process of working through that. He said biocompatibility and other requirements are “well along,” and that the bigger focus is scaling the resin and manufacturing processes.
North America Remains Challenging, DSOs Grow Faster Morici said the U.S. represents more than 40% of Align’s business and that the company has been operating in a low consumer confidence environment for several quarters. He said recent changes in consumer confidence readings have not materially changed the company’s business environment.
In North America, Morici described a split between DSOs and more traditional independent practices. He said U.S. DSOs are growing at double-digit rates by using more active conversion strategies, including scanning every patient, showing treatment visualizations, offering competitive pricing and providing financing options that lower monthly payments.
By contrast, Morici said some independent or retail-oriented doctors have taken a more passive approach and have not grown as much. Still, he said those practices are becoming “less negative,” and North America was about flat in the first quarter against a tough comparison from the prior year. Morici said the expectation is for North America to return to growth as initiatives such as financing and conversion tools gain traction, though he acknowledged macroeconomic pressures including inflation remain a factor.
International Markets Continue Double-Digit Growth Outside North America, Morici said Align continues to see double-digit growth across APAC, EMEA and Latin America. He said growth is not uniform across every country, but larger and emerging markets are driving results, including Turkey, India, Eastern Europe and Southeast Asia.
Stacy added that continued expansion outside the United States remains an important opportunity, describing emerging markets as “still very fertile.”
Morici said Align benefits from underpenetrated markets and a direct sales force focused on bringing more doctors into the company’s ecosystem, training them, reducing churn and increasing utilization.
Margins, ASPs and New Offerings Morici said Align expects 100 basis points of margin expansion this year, aided by restructuring, but he also pointed to additional opportunities in gross margin and operating expense leverage. He said products without refinements, including “no AA” or “Zero AA” style offerings, carry higher gross margins because they rely on more efficient treatment planning and do not include built-in refinements.
He said Align is also pursuing productivity improvements in manufacturing, including resin, labor and freight cost reductions. Morici said the company posted 250 basis points of operating margin improvement and 200 basis points of gross margin improvement in the first quarter excluding foreign exchange effects.
On research and development spending, Morici said R&D as a percentage of revenue should begin to normalize over time as products move closer to commercialization and revenue from those products increases.
Morici said average selling prices are typically affected by mix, including country mix and product mix, and that Align usually sees one to two points of ASP pressure from those factors excluding foreign exchange. For 2026, he said foreign exchange and a U.K. VAT-related benefit are expected to reduce that pressure closer to about 1%.
Discussing the no-refinement product, Morici said it is intended in part to compete more effectively with wires and brackets by narrowing the price gap for doctors. He said a doctor who might pay about $350 in material costs for wires and brackets could face a much higher cost for Invisalign, but the no-refinement product may be priced in the $700 to $800 range depending on discounts. He said doctors can purchase refinements as needed, with a U.S. refinement costing $170.
Morici said the product is designed to win more share from wires and brackets while also helping regain volume from doctors who had shifted to lower-cost clear aligner competitors. He said some competitors have increased prices, while Align has not.
For the second quarter, Morici said Align typically sees sequential revenue growth of 3% to 4% from the first quarter to the second quarter. This year, he said the midpoint of the company’s second-quarter guidance implies about 1% sequential growth, reflecting prudence around geopolitical uncertainty and patient decisions.
Morici also said DSOs account for about 35% of Align’s North America volume and about 25% of global volume. He said their gross margins are comparable to the broader business and that DSOs can be favorable from an operating margin standpoint because they handle training, local marketing and other activities. He described DSOs as a “force multiplier” for Align.
About Align Technology NASDAQ: ALGNAlign Technology, Inc NASDAQ: ALGN pioneered the use of digital technology in orthodontics through the development of the Invisalign system, a series of clear, removable aligners that provide an alternative to traditional metal braces. Since its founding in 1997 by Zia Chishti and Kelsey Wirth, the Tempe, Arizona–based company has expanded its focus to include intraoral scanners, CAD/CAM software for dental laboratories and comprehensive digital dentistry solutions.
The company's signature Invisalign system leverages 3D imaging and computer-aided design (CAD) to create customized aligners that gradually reposition teeth, improving patient comfort and treatment predictability.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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It has been about a month since the last earnings report for Align Technology (ALGN - Free Report) . Shares have lost about 1.6% in that time frame, underperforming the S&P 500.
But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Align Technology due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its latest earnings report in order to get a better handle on the important catalysts.
ALGN Q1 Earnings and Revenues Beat, Margins RiseAlign Technology, Inc. (ALGN - Free Report) reported first-quarter 2026 non-GAAP earnings of $2.58 per share, which rose 21.1% year over year and beat the Zacks Consensus Estimate by 14.41%. Total revenues of $1.04 billion increased 6.2% from the year-ago quarter and beat the consensus mark by 1.81%.
The results were supported by record Invisalign clear aligner shipments of 685.7 thousand cases, up 6.7% year over year, reflecting double-digit growth in EMEA, APAC and Latin America and continued stability in North America.
ALGN’s Clear Aligner Strength Drives Top-Line GrowthClear Aligner revenues rose 7.4% year over year to $856.0 million, supported by higher volumes and increased average selling prices. Management also attributed the year-over-year increase to favorable foreign exchange, price actions and lower net deferrals, partially offset by higher discounts and a mix shift toward lower-priced countries and products.
On the demand side, shipments to orthodontists and GP dentists increased 7.4% and 5.6%, respectively, year over year. By patient cohort, Invisalign adult shipments increased 7.8% year over year, while teen and kid patients improved 4.8%, aided by continued adoption of Invisalign First, the Invisalign Palatal Expander and mandibular advancement with occlusal blocks.
Align Sees Mixed Scanner Seasonality, Solid Year-Over-Year GainImaging Systems and CAD/CAM Services revenues increased 0.9% year over year to $184.1 million. However, the segment’s sale declined sequentially as first-quarter capital equipment seasonality weighed on results.
Management noted that the number of scanners sold to new doctors increased by double digits year over year, while the installed base of active scanners exceeded 125,000 globally during the quarter. The company highlighted double-digit year-over-year revenue growth for exocad, reinforcing its strategy to integrate orthodontics and restorative dentistry workflows.
ALGN’s Margins Improve Y/Y, Legal Costs Hit ExpensesFirst-quarter gross margin expanded 160 basis points (bps) year over year to 70.8%, primarily reflecting operational efficiencies and higher Clear Aligner ASP. The company noted foreign exchange was an unfavorable 0.4-point headwind to gross margin on a year-over-year basis. On a non-GAAP basis, gross margin was 71.8%, also up 160 bps.
Operating expenses increased 8.3% year over year to $594.6 million, caused mainly by legal settlement costs and higher employee compensation. GAAP operating margin improved 20 bps year over year to 13.6%, while non-GAAP operating margin expanded 240 bps to 21.5%, reflecting the benefit of excluding items, such as stock-based compensation and legal settlement costs.
ALGN’s Cash Flow Rises, Buybacks Stay in FocusALGN ended the quarter with $1.06 billion in cash and cash equivalents compared with $1.09 billion at the end of 2025. Operating cash flow totaled $151.0 million in the quarter, and free cash flow was $120.3 million after $30.8 million of capital expenditures, largely tied to investments in manufacturing capacity and facilities.
Regarding capital allocation, the company said it finished its earlier $200 million stock repurchase program between August 2025 and January 2026, with $800 million still available under its $1.0 billion authorization as of March 31, 2026. The company further disclosed plans for an additional share buyback of up to $200 million over a six-month period beginning on or about May 1, 2026.
ALGN Reaffirms 2026 View, Sets Q2 Revenue RangeFor full-year 2026, Align reaffirmed its outlook for worldwide revenue growth of 3-4% year over year and Clear Aligner volume growth in the mid-single digits. The Zacks Consensus Estimate for 2026 revenues is currently pegged at $4.18 billion, implying 3.5% growth. The company continues to expect GAAP operating margin slightly below 18.0% and a non-GAAP operating margin of about 23.7%, along with capital expenditures of $125-$150 million.
For the second quarter of 2026, management expects worldwide revenues of $1.040-$1.060 billion, up about 3-5% year over year. The Zacks Consensus Estimate for the metric projects 3.8% growth to $1.05 billion. The company forecasts sequential and year-over-year growth in Clear Aligner volume, with ASP expected to stay flat on both a sequential and annual basis. Systems and Services revenues are expected to rise sequentially.
How Have Estimates Been Moving Since Then?In the past month, investors have witnessed a downward trend in estimates review.
VGM ScoresCurrently, Align Technology has a nice Growth Score of B, though it is lagging a lot on the Momentum Score front with an F. However, the stock was allocated a score of C on the value side, putting it in the middle 20% for this investment strategy.
Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in.
OutlookEstimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Notably, Align Technology has a Zacks Rank #2 (Buy). We expect an above average return from the stock in the next few months.
Performance of an Industry PlayerAlign Technology belongs to the Zacks Medical - Dental Supplies industry. Another stock from the same industry, West Pharmaceutical Services (WST - Free Report) , has gained 8.1% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026.
West Pharmaceutical reported revenues of $844.9 million in the last reported quarter, representing a year-over-year change of +21%. EPS of $2.13 for the same period compares with $1.45 a year ago.
For the current quarter, West Pharmaceutical is expected to post earnings of $2.08 per share, indicating a change of +13% from the year-ago quarter. The Zacks Consensus Estimate has changed -0.2% over the last 30 days.
The overall direction and magnitude of estimate revisions translate into a Zacks Rank #1 (Strong Buy) for West Pharmaceutical. Also, the stock has a VGM Score of F.
$300,000 in Research Grants Awarded as Part of its Ongoing Annual Research Awards Program
TEMPE, Ariz.--(BUSINESS WIRE)--Align Technology, Inc. (“Align”) (Nasdaq: ALGN), a leading global medical device company that designs, manufactures, and sells the Invisalign® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, today announced the award of twelve research grants to universities under the company’s fifteenth Annual Research Award Program.
“Research and clinical evidence continue to be at the core of advancing science, which furthers innovation and clinical treatments,” said Dr. Mitra Derakhshan, Align executive vice president, chief clinical officer, global treatment planning and clinical services. “We remain committed to supporting university research worldwide and the meaningful impact it drives in shaping the future of the orthodontic and dental profession.”
The Americas research award recipients for 2026 are:
University of Florida (Gainesville, FL) Primary Investigator - Dr. Isil Aras University of Florida (Gainesville, FL) Primary Investigator - Dr. Sarah Hisham Abu Arqub Southern Illinois University (Edwardsville, IL) Primary Investigator - Dr. Feras Al Khatib University of Alabama (Birmingham, AL) Primary Investigator - Dr. Navdeep Bhusri The European research award recipients for 2026 are:
Francisco de Vitoria University (Madrid, Spain) Primary Investigator - Dr. Iván Nieto Sánchez Johann Wolfgang Goethe University (Frankfurt, Germany) Primary Investigator - Dr. Babak Sayahpour University of Insubria (Varese and Como, Italy) Primary Investigator - Dr. Luca Levrini Vita-Salute San Raffaele University (Milan, Italy) Primary Investigator - Dr. Andrea Boggio The Asia Pacific research award recipients for 2026 are:
Wuhan University (Wuhan, China) Primary Investigator - Dr. Sanjie Yeweng Sichuan University (Chengdu, China) Primary Investigator - Dr. Juan Li Taipei Medical University (Taipei City, Taiwan) Primary Investigator - Dr. Daniel De-Shing Chen Shandong University (Jinan, China) Primary Investigator - Dr. Hui Chen “The scope of research supported through this program highlights the important role of scientific inquiry in advancing dentistry,” said John Morton, Align vice president, technical fellow. “We are proud to support investigators whose work can deepen clinical understanding, inform treatment approaches, and ultimately improve patient care worldwide.”
The funded research studies cover a wide range of topics, including:
Apical root resorption during anterior retraction, early and late restoration of maxillary laterals during aligner treatment, evaluation of the Invisalign Palatal Expander and traditional expanders in mixed dentition, white spot lesion activity between fixed appliances and aligners, stability of alignment in retention with various protocols, anterior tooth movement with lingual versus buccal attachments, and characteristics of enamel during aligner treatment by using scanning electron microscopy and optical microscopy.
All award applications received were first reviewed and prioritized in a blind evaluation by an independent academic committee. The final recipients were then determined by Align Technology.
About Align Technology, Inc.
Align Technology designs and manufactures the Invisalign® System, the most advanced clear aligner system in the world, iTero™ intraoral scanners and services, and exocad™ CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for approximately 299.5 thousand doctor customers and are key to accessing Align’s 600 million consumer market opportunity worldwide. Over the past 29 years, Align has helped doctors treat approximately 22.8 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align™ Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.
For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about the iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.
Invisalign, iTero, exocad, Align, Align Digital Platform and iTero Lumina are trademarks of Align Technology, Inc.
Why These 3 Tech Stocks Could Be the Best Opportunities You're OverlookingAlign Technology NASDAQ: ALGN executives used a William Blair investor presentation to emphasize the company’s broader digital dentistry platform, positioning Invisalign as part of a workflow that spans consumer engagement, scanning, treatment planning, monitoring and retention.
President and CEO Joe Hogan said Align’s competitive position is not based solely on clear aligners, pointing instead to the company’s ability to connect consumers with doctors and support a digital process from diagnosis through treatment. He said 95% of Align cases are now scanned, compared with 5% about 10 years ago.
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Buy the Dip? These Earnings Misses Offer Long-Term UpsideHogan said the company can produce treatment plans quickly for a growing portion of patients, with about 20% to 25% of cases completed live in the chair and moved toward manufacturing with limited back-and-forth. He said many ClinCheck cases that previously took up to two weeks are now completed in a day, and it is “odd” to see them take more than two or three days.
Executives Highlight Teen and Early-Intervention Opportunity Hogan said roughly 75% of global malocclusions involve crooked teeth, but the market is weighted toward teens while Align’s business is weighted toward adults. He said Align’s case mix is approximately 73% adults and 23% teens, a gap he attributed to orthodontists’ continued use of wires and brackets rather than clinical limitations of Invisalign.
MarketBeat Week in Review: 12/25 - 12/29Align is targeting younger patients through early-intervention products, including Invisalign Teen and Invisalign Palatal Expander. Hogan described the younger “tween” population as the company’s most compliant patient group because children at that age are still responsive to parental direction and bone is more malleable.
Hogan said Invisalign Palatal Expander is a removable device and the first 3D-printed medical orthodontic device of its kind. He said the product can provide up to nearly seven millimeters of expansion, while the teen product can provide five millimeters. Align also expects a new 3D-printed Vivera retainer to begin entering the market in the third and fourth quarters of this year, according to Hogan.
AI and ClinCheck Are Central to Treatment Planning Chief Financial Officer John Morici said Align’s ClinCheck platform is supported by the company’s experience with more than 23 million cases, allowing it to learn doctors’ treatment tendencies and apply those preferences to new cases. He said the goal is to provide a treatment plan while the patient is still in the chair, helping doctors have a more immediate conversation with potential patients.
Hogan said Align has invested heavily in ClinCheck since moving the system from individual computers to servers and the cloud in 2021. He said features such as ClinCheck Live Plan, Plan Editor and global clinical preferences allow doctors to adjust plans, incorporate their own protocols and send cases to manufacturing faster.
Morici said the company is also using AI tools in Invisalign Virtual Care to monitor patient progress. Hogan said virtual monitoring can reduce patient office visits by about 30% to 35% by allowing patients to submit weekly images and receive guidance on whether they are tracking to plan.
Digital Dentistry and General Practitioner Adoption Hogan said the general practitioner opportunity is significant because many dentists historically were not taught how to move teeth in dental school. Align is trying to bring those capabilities to general dentists through sales, training and key opinion leaders.
Executives framed malocclusion treatment as part of broader oral health rather than only aesthetics. Hogan said teeth that do not align properly can wear over time, and Morici said digital scans can help dentists show patients issues such as tooth wear, cavities or restorative needs.
Hogan also emphasized visualization as a key part of modern dentistry, saying patients should be able to see scans and understand what is happening with their teeth. Morici said visualization tools, including before-and-after treatment videos, can help doctors improve conversion. Hogan said showing video can produce a roughly 50% higher close rate.
Restorative Dentistry and exocad Integration Align also discussed its advanced restorative treatment initiative, Invisalign Art, which uses tooth movement to make some restorative procedures less invasive. Hogan said the approach can help move teeth “out of harm’s way” before procedures such as veneers or implants, potentially reducing the need to grind down enamel.
Hogan tied the initiative to Align’s 2020 acquisition of exocad, a software business used by dental labs. He said Align uses exocad to embed ClinCheck tooth movement into restorative planning so labs and doctors can present patients with options, including taking additional months to move teeth rather than grinding them down.
Business Models Focus on Conversion and Flexibility Morici said Align is also developing business models intended to help doctors drive patient conversion, especially in the current economic environment. He highlighted a doctor subscription program that allows practices to commit to a certain number of cases or aligners, including aligners used for retention or minor “touch-up” cases.
Morici also pointed to patient financing as a way to reduce “financial friction.” He said Align does not take the end risk on financing but partners with external companies, citing HFD as an example. He said such arrangements can offer high approval rates, pre-qualification and upfront cash for practices while reducing collection burdens.
The company also discussed a comprehensive product without refinements included upfront, giving doctors flexibility to purchase additional service later if needed. Morici said the model started with Dental Service Organizations and has helped drive utilization by lowering initial pricing for customers that do not want service included at the outset.
Morici said Align is focused on using technology, product options and financing tools to drive conversion, particularly in the U.S. market. “You want to hit those potential patients in the moment and drive that conversion,” he said.
About Align Technology NASDAQ: ALGNAlign Technology, Inc NASDAQ: ALGN pioneered the use of digital technology in orthodontics through the development of the Invisalign system, a series of clear, removable aligners that provide an alternative to traditional metal braces. Since its founding in 1997 by Zia Chishti and Kelsey Wirth, the Tempe, Arizona–based company has expanded its focus to include intraoral scanners, CAD/CAM software for dental laboratories and comprehensive digital dentistry solutions.
The company's signature Invisalign system leverages 3D imaging and computer-aided design (CAD) to create customized aligners that gradually reposition teeth, improving patient comfort and treatment predictability.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
Should You Invest $1,000 in Align Technology Right Now?Before you consider Align Technology, you'll want to hear this.
MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Align Technology wasn't on the list.
While Align Technology currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys.
View The Five Stocks Here
Click the link to see MarketBeat's list of seven stocks and why their long-term outlooks are very promising.
Why These 3 Tech Stocks Could Be the Best Opportunities You're OverlookingAlign Technology NASDAQ: ALGN CFO John Morici said the company continues to navigate a challenging but stable demand environment, with international markets and dental service organizations offsetting pressure in parts of North America.
Speaking at the Jefferies Global Healthcare Conference in a fireside chat moderated by Jefferies analyst Mike Sarcone, Morici said macroeconomic conditions have been broadly consistent over the past several quarters, including the effects of inflation. He said Align has seen double-digit growth outside North America, including in Asia-Pacific, EMEA and Latin America, while dental service organizations, or DSOs, in North America have also been growing at a double-digit rate.
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Buy the Dip? These Earnings Misses Offer Long-Term UpsideThe area of pressure, Morici said, remains the U.S. and North America retail channel among independent doctors. In that environment, Align is focused on helping doctors convert interested patients into treatment starts.
“Where you have to go and really try to drive that conversion is be much more active,” Morici said, adding that the company is using tools and tactics to help doctors move patients “from being interested in treatment to actually going into treatment.”
Company Reiterates Focus on Profitable Growth MarketBeat Week in Review: 12/25 - 12/29Morici said Align’s full-year outlook reflects expectations for 3% to 4% growth and a 100-basis-point improvement in operating margin. He said the company has taken cost actions from last year into this year to improve productivity.
In the first quarter, Morici said Align delivered a 250-basis-point improvement in operating margin on an ex-FX basis. He said volume increases should provide additional operating margin leverage.
Asked about second-quarter assumptions, including potential effects from conflicts in the Middle East, Morici said Align’s typical sequential revenue increase from the first to second quarter has historically been around 3% to 4%, helped by North America’s teen season, stronger volume in Western Europe and improved systems and services demand. For the current framework, he said the midpoint was set at 1% sequential growth, reflecting prudence in an uncertain environment.
Comp Zero Offering Aims to Expand Invisalign Utilization Morici discussed Align’s comprehensive product with no refinements, which Sarcone referred to as “Comp Zero.” He said the product reflects advances in Align’s technology compared with earlier comprehensive offerings that included unlimited refinements over five years.
Morici said earlier versions were designed to give doctors confidence that they could reach a final outcome, but improvements in technology now allow some cases to be completed with no refinements or one refinement. The no-refinement product is being tested and adopted across DSOs, where Morici said doctors are showing increasing usage.
He described the product as helping Align win “gray areas,” particularly when orthodontists are deciding whether to use wires and brackets or Invisalign. Morici said the pricing is closer to the material cost of wires and brackets than Align’s comprehensive unlimited product, while also being competitive with other clear aligner offerings.
Morici said versions of the product are available in North America, Europe and Asia-Pacific, and he said he expects it to be broadly rolled out by the end of the year. He also noted that Align’s “3-and-3” product, which includes three years of treatment and three refinements, became the company’s top-selling product after being introduced about three and a half years ago.
From a margin standpoint, Morici said products with fewer refinements can carry attractive gross margins because there is less back-and-forth after the initial shipment. If refinements are needed later, doctors pay for them separately.
Financing Programs Target Patient Conversion Align is also emphasizing financing options to help doctors convert patients. Sarcone referenced Align’s HFD partnership and Smile Advance program, including a $99 down payment and 0% APR for 24 months, and said more than 6,000 offices were enrolled.
Morici said Align is already seeing benefits from HFD and other financing programs, particularly in a more challenging market. He said the goal is to give patients low down payment options and, where possible, little or no interest, while helping doctors receive much of their cash upfront and outsource collections.
Morici emphasized that the financing is not on Align’s balance sheet. Instead, Align’s role is to help facilitate adoption by educating doctors and equipping sales representatives to present the programs.
He said DSOs can move faster on programs like these because they often operate with a top-down approach. Independent doctors also represent an opportunity, though Morici said general dentists may be more accustomed to patient financing than orthodontists, who often use internal pay-as-you-go models.
Practice Management Integrations and Lab Pilots Morici said Align is working to integrate with practice management platforms to reduce handoffs in the patient journey. He cited the company’s integration with Greyfinch as producing immediate benefits by improving patient flow, appointment scheduling and follow-up.
He said Align Link integrations with additional practice management systems are on the company’s roadmap, with Align proceeding system by system. Morici said the goal is to connect interested consumers with doctors, move them through scans and visualizations, and support financing where appropriate.
Morici also highlighted pilots with dental labs aimed at restorative workflows. He said Align’s view is that teeth should be moved before restorative procedures when appropriate, potentially preserving more healthy tooth structure before veneers or other restorative work.
The lab model, Morici said, allows labs to act similarly to distributors. Align charges for the case, while labs can add a markup for treatment planning, education and related services provided to their dentist networks. He said this creates revenue opportunities for labs and doctors while generating incremental volume for Align.
Morici said there are about 2 million general dentists globally, and Align currently sells to roughly 5% of them. He also said there are more than 30,000 labs worldwide, and many general dentists have existing trusted relationships with labs. Align’s exocad business, acquired six years ago, is part of the company’s effort to support these workflows.
For Align, Morici said the lab-related cases are typically moderate or minimal movement cases, often 26 stages or fewer and with no refinements, making the margin profile attractive. He said the company views the program as incremental and a potential way to access doctors who have not previously offered Invisalign or have done only one or two cases.
About Align Technology NASDAQ: ALGNAlign Technology, Inc NASDAQ: ALGN pioneered the use of digital technology in orthodontics through the development of the Invisalign system, a series of clear, removable aligners that provide an alternative to traditional metal braces. Since its founding in 1997 by Zia Chishti and Kelsey Wirth, the Tempe, Arizona–based company has expanded its focus to include intraoral scanners, CAD/CAM software for dental laboratories and comprehensive digital dentistry solutions.
The company's signature Invisalign system leverages 3D imaging and computer-aided design (CAD) to create customized aligners that gradually reposition teeth, improving patient comfort and treatment predictability.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
Should You Invest $1,000 in Align Technology Right Now?Before you consider Align Technology, you'll want to hear this.
MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Align Technology wasn't on the list.
While Align Technology currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys.
View The Five Stocks Here
Discover the next wave of investment opportunities with our report, 7 Stocks That Will Be Magnificent in 2026. Explore companies poised to replicate the growth, innovation, and value creation of the tech giants dominating today's markets.
After reaching an important support level, Align Technology (ALGN - Free Report) could be a good stock pick from a technical perspective. ALGN surpassed resistance at the 50-day moving average, suggesting a short-term bullish trend.
One of the three major moving averages, the 50-day simple moving average is commonly used by traders and analysts to determine support or resistance levels for different types of securities. However, the 50-day is considered to be more important since it's the first marker of an up or down trend.
ALGN has rallied 7.4% over the past four weeks, and the company is a Zacks Rank #1 (Strong Buy) at the moment. This combination suggests ALGN could be on the verge of another move higher.
The bullish case solidifies once investors consider ALGN's positive earnings estimate revisions. No estimate has gone lower in the past two months for the current fiscal year, compared to 6 higher, while the consensus estimate has increased too.
Given this move in earnings estimate revisions and the positive technical factor, investors may want to keep their eye on ALGN for more gains in the near future.
Riot Platforms, Inc. is executing a strategic pivot to Tier 3 data center hosting, anchored by a major partnership with AMD for up to 200MW capacity. RIOT's Corsicana site expansion and ESS Metron business position it for long-term growth, with robust engineering backlog and supply chain control. I reiterate a Strong Buy on RIOT with a $28.60 price target, justified by sustainable, high-visibility lease revenues and a shift away from bitcoin mining volatility.
Shares of Hut 8 (NASDAQ:HUT) are surging 35% in midday trading Wednesday. Riot Platforms (NASDAQ:RIOT | RIOT Price Prediction) stock is climbing 13% in tandem, as investors reprice former Bitcoin mining pure-plays as AI data center landlords.
HUT stock changed hands near $109 after opening at $80.51, extending a one-month rally of 67% and a one-year gain of 531%. RIOT shares, last quoted at around $23, are now up 82% year to date.
The shared catalyst is structural. Both companies are pivoting massive power-equipped campuses originally built for Bitcoin (CRYPTO:BTC) mining toward hyperscale AI workloads, and AI tenants pay multiples of mining economics per megawatt. Bitcoin trades near $81,660, well below the January highs, sharpening the appeal of long-duration AI lease revenue.
Beacon Point Lease Triggers Hut 8’s Re-Rating The primary trigger is Hut 8’s 15-year, 352 MW lease at the Beacon Point AI campus, valued at $9.8 billion in base-term contract value. The agreement with a high-investment-grade tenant triples Hut 8’s contracted AI capacity to 597 MW across two hyperscale campuses on triple-net, take-or-pay terms.
Hut 8 CEO Asher Genoot declared on the call, “Within five months, we have more than doubled our contracted capacity and secured $9.8 billion in incremental base-term contract value.” Hut 8’s total contracted revenue now sits at $16.8 billion, with a development pipeline spanning 8,375 MW.
The company also priced a $3.25 billion senior secured note offering at 6% to fund River Bend construction at 95% loan-to-cost, returning $184 million in equity to the parent. Hut 8’s quarterly results were mixed, with revenue of $71.02 million missing the $79.39 million consensus by 11%, but the long-dated lease backlog dwarfs the quarterly miss in investors’ eyes.
AMD Doubling Down Validates Riot’s Pivot Riot Platforms stock’s move builds on the company’s April 30 Q1 2026 print, which delivered revenue of $167.22 million, beating the $130.58 million estimate by 28%. The data center segment debuted at $33.15 million, the clearest signal yet that the pivot is generating real recurring revenue.
Advanced Micro Devices (NASDAQ:AMD) exercised an option to double its Rockdale footprint by 25 MW, lifting contracted capacity to 50 MW with options for an additional 150 MW. Riot Platforms CEO Jason Les asserted that Q1 2026 marks “a definitive inflection point for Riot, as we officially transitioned into an active, revenue-generating data center operator.”
Riot Platforms is targeting portfolio net operating income of $1.6 billion to $2.1 billion on full development of its 1.2 GW data center opportunity. Chardan recently initiated coverage with a Buy rating and $27.50 price target, while Piper Sandler raised its target to $23 citing AI/HPC conversion potential.
Why Bitcoin Miners Are Suddenly AI Infrastructure The thesis driving both names is straightforward: miners already control scarce, energization-ready power, and AI hyperscalers may pay a premium to skip multi-year grid queues. Long-duration leases like Hut 8’s Beacon Point deal swap volatile block reward income for predictable, investment-grade cash flow.
The infrastructure scarcity is real, with Electric Reliability Council of Texas (ERCOT) energization timelines exceeding four years creating barriers to entry that favor incumbents holding approved power. Vertical integration (energy plus compute) is the new differentiator, and AMD’s deepening commitment to Riot Platforms validates that miner-converted facilities can serve enterprise-grade tenants. For broader context on the buildout cycle, see this look at AI infrastructure stocks poised for a 2026 breakout.
What to Watch Into the Close Hut 8’s earnings call concluded at 8:30 a.m. ET, so the next leg depends on analyst note follow-through and whether gains hold through the closing bell. Insider activity bears watching as well, with Hut 8 Chief Legal Officer selling 10,518 shares at $76.83 on May 4 under a 10b5-1 plan.
For Riot Platforms, attention shifts to May delivery of remaining AMD capacity at Rockdale and progress on the first 168 MW core and shell building at Corsicana. The recent departure of Riot Platforms Chief Data Center Officer Jonathan Gibbs adds execution risk during a critical buildout phase, even as Cantor Fitzgerald maintains an Overweight rating.
Prudent investors should weigh today’s enthusiasm against real execution risk, potential equity dilution from aggressive debt financing, and ongoing Bitcoin price exposure on legacy mining segments. The pivot to AI infrastructure is genuine, yet rallies of this magnitude raise the bar for delivery on every subsequent lease, financing, and milestone. Watch for whether momentum traders defend these levels into Thursday’s session or whether profit-taking caps the move.
Keel Infrastructure (KEEL +1.27%), a developer and operator of data centers for high-performance computing and AI workloads, closed Wednesday at $4.12, up 16.71%. The stock moved higher during the regular session after Chardan framed Keel as a “story stock in transition” tied to its pivot toward AI and high-performance computing infrastructure. Investors will be watching how effectively the company executes on that AI data center strategy.
The company’s trading volume reached 61.5 million shares, which is about 86% above compared with its three-month average of 33.2 million shares.
How the markets moved todayThe S&P 500 (^GSPC +0.50%) advanced 1.46% to 7,365.12, while the Nasdaq Composite (^IXIC +0.31%) gained 2.02% to finish at 25,838.94. Among digital infrastructure and energy peers, Mara Holdings (MARA +3.45%) closed at $13.03, up 7.15%, and Riot Platforms (RIOT +1.78%) ended at $23.70, rising 16.49% as investors respond to AI and high-performance computing narratives.
What this means for investorsKeel Infrastructure shares rose after Chardan initiated coverage with a Buy rating and a $4.50 price target, citing the company’s pivot toward AI and high-performance computing data centers. The call gave investors a clearer framework for Keel’s shift away from bitcoin mining and toward North American power-backed infrastructure built for data center workloads.
The sale of Keel’s 70 MW Paso Pe site in Paraguay for approximately $13 million supports this repositioning by reallocating capital from non-core mining assets. The company’s future performance will depend on Keel’s ability to secure customers for its North American sites and convert available power capacity into leased AI and HPC data center revenue.
Eric Trie has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
Riot Platforms has pivoted from Bitcoin mining to building digital infrastructure, driving significant stock appreciation in 2026. RIOT's focus on data centers supports high-demand sectors like AI, 5G, and cloud technology, attracting investor enthusiasm. The stock has surged 90% year-to-date in 2026, reflecting strong market approval of RIOT's strategic shift.
On May 11, 2026, Riot Platforms Inc RIOT shares rose 5.2% today to a current price of $25.34. This increase has been part of a significant upward trend, with the stock gaining 35.6% over the past week and 52.6% in the past month. The year-to-date performance is impressive, showing a 100.0% increase, while the stock has surged by 198.8% over the past year. The 52-week range highlights this volatility, with a low of $7.93 and a high of $24.47.
GF Value™ verdict: The current price of $25.34 is 91.7% above the GF Value™ estimate of $13.22, indicating significant overvaluation.GF Score™: With a score of 73/100, RIOT is considered above average in terms of its overall quality.Most notable signal: The momentum rank of 8/10 indicates strong recent price performance, though insider activity has seen no transactions in the last three months. Is RIOT Overvalued or Undervalued? The disparity between Riot Platforms Inc's current price and its GF Value™ suggests that the stock is significantly overvalued. With a GF Value™ estimate of $13.22, RIOT shares are trading at a staggering 91.7% premium. This situation presents a considerable margin of safety for potential buyers, as a decline towards intrinsic value could lead to substantial losses. The GF Valuation label classifies RIOT as significantly overvalued, which poses risks for investors considering entry at current levels.
GF Value™ is GuruFocus' proprietary measure of intrinsic value, calculated from historical trading multiples, past business growth, and future performance estimates. The stark contrast between the market price and GF Value™ raises questions about sustainability in RIOT's recent price gains, especially given the volatility of the cryptocurrency market in which it operates.
How Does RIOT's Valuation Compare to Its History? Metric Current Historical P/E (TTM) 648.6x 52.8x Riot Platforms Inc is currently trading at a forward P/E of 648.6x, which is significantly above its 5-year median P/E of 52.8x. This analysis clearly indicates that RIOT is trading well above its historical valuation levels. The P/E analysis aligns with the GF Value™ verdict, reinforcing the conclusion that the stock is overvalued in the current market context.
What Does RIOT's GF Score™ Tell Us? Metric Rating GF Score™ 73 Financial Strength 5/10 Profitability 3/10 Growth 8/10 Valuation 3/10 Momentum 8/10 The GF Score™ for Riot Platforms Inc stands at 73/100, suggesting that the stock is above average in quality. The strongest aspect of RIOT's score is its growth rank at 8/10, indicating robust growth potential. However, the weakest area is profitability, with a rank of just 3/10, highlighting concerns regarding the company's ability to generate profits consistently. The financial strength rank of 5/10 suggests moderate stability, while the momentum rank reflects the recent strong performance, yet the valuation rank indicates significant overvaluation.
What Are Insiders Doing with RIOT Stock? In the last three months, there have been no insider transactions reported for Riot Platforms Inc. This lack of insider activity might suggest that executives are not making significant moves regarding their shares, which can be interpreted in various ways. On one hand, it indicates a lack of confidence in the stock's current price, while on the other hand, it may reflect a strategic decision to hold their positions amid the stock's volatile performance.
What This Means for Investors Based on the GF Value™ assessment, Riot Platforms Inc is currently overvalued. The significant gap between the stock's trading price and its intrinsic value suggests caution for potential investors. The risk of a price correction is substantial, given the current market dynamics and valuation metrics.
For the complete analysis, visit the Riot Platforms Inc RIOT stock page. You can also explore the GF Value™ page for detailed valuation methodology, or use the GuruFocus Stock Screener to find similar opportunities.
Frequently Asked Questions What is RIOT's GF Score™?
RIOT's GF Score™ is 73/100, indicating that it is above average in terms of quality and potential for long-term returns.
Is RIOT overvalued or undervalued?
Riot Platforms Inc is considered overvalued, with a current price that is significantly above its GF Value™ estimate.
What is RIOT's P/E ratio?
RIOT has a forward P/E of 648.6x, which is substantially higher than its 5-year median P/E of 52.8x, indicating that it is trading at a much higher valuation than its historical levels.
This stock alert was generated using automated technology and GuruFocus financial data to provide readers with timely and accurate market reporting. This content was reviewed by GuruFocus editorial team prior to publication. Please send any questions or comments about this story to [email protected].
These were last week’s top performing leveraged and inverse ETFs. Note that because of leverage, these kinds of funds can move quickly. Always do your homework.
1. RIOX – Defiance Daily Target 2X Long RIOT ETF
RIOX aims to provide 2x long daily price performance of Riot Platforms, Inc., focusing on cryptocurrencies and cryptocurrency mining computers, topped the levered ETFs list with 63.5% weekly gains. Riot Platforms (RIOT) shares experienced a significant increase last week, primarily driven by strong Q1 2026 earnings, a pivot towards AI-focused data center revenue, and an expanded partnership with AMD.
2. SMCX – Defiance Daily Target 2X Long SMCI ETF
SMCX seeks to deliver 2x leveraged exposure to the daily share price movement of Super Micro Computer, featured on the top-performing levered ETFs’ list. Super Micro Computer (SMCI) shares surged last week following its quarterly earnings report in May, driven by a strong recovery in gross margins, a robust AI server outlook, and an optimistic revenue forecast for the current quarter.
3. KORU – Direxion Daily MSCI South Korea Bull 3X ETF
KORU provides 300% daily leveraged exposure to an index of large- and mid-cap South Korean companies, also made it to the list of top performing leveraged ETFs last week with over ~56% returns. South Korean stocks surged, driven by an AI-led explosion in demand for semiconductor memory chips, record export data, and a surge in foreign/retail investments.
4. AMDL – GraniteShares 2x Long AMD Daily ETF
AMDL, which provides 2x leveraged exposure to the daily price movement for shares of Advanced Micro Devices stock, was one of the Levered ETFs’ list, with over 52% weekly gains. AMD shares surged last week, driven by blockbuster first-quarter 2026 earnings, strong AI-focused guidance, and investor enthusiasm for a potential server CPU supercycle beyond just GPUs.
SOXL, which offers 3x daily long leverage to the PHLX Semiconductor Index, was another contender on the list with over 35% returns last week. Semiconductor stocks surged last week due to an intensifying AI-driven supercycle that has triggered massive demand for chips, resulting in record-setting rallies.
The BULZ ETF was one of the best-performing levered ETFs with over 29% returns. The ETF focuses on top technology companies domiciled in the U.S. Tech stocks surged last week, primarily driven by intense investor enthusiasm for AI, strong Q1 earnings reports, and specific momentum in the chip sector. Major, sustained gains in AI infrastructure leaders, particularly a strong rally in Intel (INTC) following reports of a potential deal with Apple, boosted the NASDAQ.
7. TECL – Direxion Daily Technology Bull 3X ETF
The TECL ETF was another tech-focused fund on the list of top-performing levered ETFs, returning over 26% last week.
GDXU is a leveraged equity fund that provides 3x exposure to an index comprised of two of the largest gold miners’ ETFs that invest in the global gold mining industry. GDXU featured on the list with over 25% returns last week. Gold prices climbed last week, driven primarily by intensified safe-haven demand due to U.S.-Iran tensions in the Middle East, a weaker U.S. dollar, and sustained central bank buying. Investors also monitored high-stakes U.S.-China diplomatic talks and anticipated U.S. inflation data to gauge future Federal Reserve interest rate decisions.
9. KBDU – KraneShares 2x Long BIDU Daily ETF
KBDU, which provides 2x leveraged exposure to the daily price movement of Baidu, Inc. Sponsored ADR Class A (NASDAQ: BIDU), was another contender on the levered ETFs list. BAIDU shares gained last week, driven by intense investor optimism regarding its AI business advancements, specifically the potential IPO of its AI chip unit, Kunlunxin, and the rising valuation of its AI ecosystem, which has attracted increased foreign investment.
10. USD – ProShares Ultra Semiconductors
ProShares Ultra Semiconductors (USD), which provides leveraged exposure to U.S. Semiconductor stocks, gained ~22% last week. Semiconductor stocks hit record highs last week as an intensifying AI supercycle ignited a massive surge in chip demand.
For more news, information, and analysis, visit the Leveraged & Inverse Content Hub.
Shares of HIVE Digital Technologies (NASDAQ:HIVE) are up 34% in mid-morning trading Monday, while T1 Energy (NYSE:TE) shares have climbed 20%. The catalyst: a wave of social media buzz around a 13-F disclosure from Leopold Aschenbrenner’s Situational Awareness LP.
HIVE stock traded near $3.60 after closing Friday near $2.73. TE stock pushed to $6.76, from a Friday close of around $5.60.
Yet, some of the names Aschenbrenner verifiably increased in his Q1 2026 filing are sitting this rally out. That gap is the real story for HIVE and T1 Energy traders.
[wsr-stock-price-target ticker=”HIVE”]
[wsr-analyst-ratings ticker=”TE”]
Who Is Aschenbrenner and Why Traders Care Aschenbrenner is a German investor and former OpenAI Superalignment researcher who departed the company in 2024. He’s best known for the widely circulated 2024 essay Situational Awareness: The Decade Ahead, which argued for aggressive artificial general intelligence (AGI) timelines and the geopolitical stakes of the buildout.
He founded Situational Awareness LP in 2024 to invest behind the AI-buildout thesis. Per QuiverQuant analyst Matthew Kerr’s writeup, the fund holds roughly $3.85 billion across 34 positions as of the March 31 reporting period.
What the 13-F Actually Shows The headline move from Aschenbrenner’s fund is a pivot to massive downside hedges on AI chips. Per Kerr’s writeup, Aschenbrenner’s fund increased its equity stakes in CleanSpark (NASDAQ:CLSK | CLSK Price Prediction), Riot Platforms (NASDAQ:RIOT), and CoreWeave (NASDAQ:CRWV), among others. These are the verified beneficiaries of the filing per Kerr.
The Divergence Tells the Story Here’s the rub: HIVE and T1 Energy were flagged in a separate QuiverQuant X post, not the analyst writeup. HIVE fits a Bitcoin (CRYPTO:BTC)-miner-pivoting-to-AI parallel with Aschenbrenner’s verified picks, and TE fits a powering-AI-data-centers thesis. Neither, however, is explicitly named in the confirmed buys.
Meanwhile, the verified longs are quiet. CleanSpark stock is trading near $13.08, barely changed from a $13.03 Friday close. Riot shares are near $22.98 (down 2%), Applied Digital stock sits at around $39.20 (down 8%), and CoreWeave stock has slid to $101.24 from $107.33.
Bitcoin (CRYPTO:BTC) isn’t helping the bull case, either. BTC closed at $77,111, down from $81,079 on May 14. The miner rally isn’t a function of underlying crypto strength.
The Skeptical View HIVE’s Q3 FY2026 revenue jumped 219% year over year (YoY) to $93.1M. T1 Energy posted Q1 2026 revenue of $177.65M, beating estimates by 61%. Neither story is unfounded.
Note, however, that HIVE shares carry a beta of 3.44 and TE shares a beta of 1.78. Volatility cuts both ways.
The fact that Aschenbrenner’s verified longs in CleanSpark, Riot, Applied Digital, and CoreWeave are sluggish today suggests that institutional money might not be chasing the broader pair trade. Position sizing and stops matter here, and prudent investors should adjust their strategies accordingly.
[wsr-earnings-explorer ticker=”HIVE”]
What to Watch Watch for whether HIVE holds above the $3.35 level into the close, and whether sell-side analysts pick up the pair-trade angle later this week. A close near the morning’s highs could lend the move credibility.
Traders should also keep an eye on whether the aforementioned verified longs play catch-up. If they stay quiet by end of session, today’s HIVE and TE surge looks more like an anomaly than a thesis trade.
RIOT holds firm as key support levels contain volatility
May 22, 2026 at 1:23 PM
RIOT shrugs off heavy short interest and an "overbought" reading
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Blockchain name Riot Platforms (NASDAQ:RIOT) just saw a breakout above 2022 and 2023 highs, followed by a breakout and retest of its 2025 high. The shares are near $24, which is double this year’s twin lows in the $12 area.
Short interest is up nearly 30% since January -- suggesting shorts are at a loss -- and represents 17% of RIOT’s total available float. The crypto miner had an ‘overbought’ Relative Strength Index (RSI) reading last month, which has tended to spell trouble for RIOT over the past five years. However, the stock avoided such a fate this time around, suggesting now's the time for bulls to move in. This could be a trending situation, too, with added support from an implied volatility (IV) that is in line with historical volatility (HV).
Our recommended call has a leverage ratio of 2.8 and will double on a 42.3% rise in the underlying equity.
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Key Takeaways Strategy's Q1 2026 revenues rose 11.9% to $124.3M, while 818,334 Bitcoins were valued near $64B.MSTR posted a $14.47B operating loss, largely from a $14.46B unrealized digital asset loss.MARA and RIOT pair Bitcoin exposure with mining, energy or data center revenue strategies. Strategy Inc.’s (MSTR - Free Report) growing dependence on Bitcoin treasury operations is overshadowing growth in its core software business, raising concerns about whether the company’s operating revenue base is losing relevance. In first-quarter 2026, the company generated just $124.3 million in revenues, up 11.9% year over year, while holding more than 818,334 Bitcoins valued at roughly $64 billion. The widening gap highlights how rapidly Strategy’s Bitcoin-focused operations have expanded relative to its traditional enterprise analytics business.
At the same time, the company’s financial performance is becoming increasingly tied to Bitcoin price movements rather than underlying operating execution. Strategy reported a massive $14.47 billion operating loss in the first quarter, primarily caused by a $14.46 billion unrealized digital asset loss following Bitcoin’s decline during the period. Management also continues emphasizing Bitcoin-centric KPIs such as BTC Yield, BTC Gain and Bitcoin Per Share, reflecting the company’s growing focus on digital asset accumulation and treasury expansion.
Strategy has further accelerated capital raising to support additional Bitcoin purchases, generating nearly $11.7 billion year to date through common equity and preferred stock offerings. Recent company events and updates since April 2026 have also focused heavily on institutional Bitcoin adoption, Digital Credit products and treasury strategies rather than software-driven growth initiatives.
Although Strategy continues investing in AI-powered analytics offerings, the company’s broader growth narrative now appears increasingly dependent on Bitcoin-related activities. The Zacks Consensus Estimate projects revenue growth of just 5.59% for 2026 and relatively negative growth expected in 2027, raising concerns about the long-term growth of the core software business.
How Rivals Compare to MSTR's Bitcoin StrategyMARA Holdings (MARA - Free Report) is pursuing a more diversified Bitcoin treasury strategy than MSTR. While MSTR focuses on maximizing Bitcoin ownership, MARA combines Bitcoin holdings, mining operations and energy infrastructure. MARA held 35,303 Bitcoins in the first quarter of 2026 and used part of its treasury to reduce debt. It also benefits from low energy costs, strong hash rate growth and AI/data center opportunities, providing revenue streams beyond Bitcoin appreciation.
Riot Platforms, Inc. (RIOT - Free Report) follows a more balanced Bitcoin strategy. While MSTR primarily raises capital to acquire Bitcoin, RIOT uses its Bitcoin treasury to fund data center expansion and support its “power-first” strategy. RIOT benefits from 2 gigawatts of power capacity, ESS Metron and growing contracted data center revenues. Unlike MSTR’s pure Bitcoin accumulation model, RIOT combines Bitcoin ownership, mining operations and infrastructure monetization, although its smaller Bitcoin treasury limits direct Bitcoin exposure.
MSTR’s Price Performance, Valuation & EstimatesShares of Strategy have gained 5.2% in the year-to-date period, outperforming the Zacks Finance sector’s growth of 0.8% and the Financial - Miscellaneous Services industry’s decline of 7.7%.
MSTR’s YTD Price Performance
Image Source: Zacks Investment Research
MSTR has a Value Score of F. It is currently trading at a Price/Book ratio of 1.53X compared to the sector’s 4.37X.
MSTR’s Valuation
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for MSTR’s 2026 earnings is pegged at $116.7 per share, down 14.4% over the past 30 days. The estimate indicates a sharp year-over-year improvement from a loss of $15.23 per share.
Hive Digital Technologies (HIVE 1.58%), a green energy crypto‑mining data‑center operator, closed Monday at $4.76, up 5.31%. Shares moved higher as investors reacted to fresh analyst price target hikes and positioning ahead of fiscal results, and they are watching upcoming earnings details on digital-assets and AI data-center growth.
The company’s trading volume reached 50.1 million shares, which is about 154% above compared with its three-month average of 19.7 million shares. Hive Digital Technologies went public in 2011 and has grown 157% since its IPO.
How the markets moved todayThe S&P 500 (^GSPC +0.50%) added 0.27% to finish Monday at 7,599.96, while the Nasdaq Composite (^IXIC +0.31%) rose 0.42% to close at 27,086.81. Within cryptocurrency mining, industry peers Mara Holdings (MARA +3.45%) closed at $14.85 (+3.27%) and Riot Platforms (RIOT +1.78%) finished at $28.25 (+4.21%) as investors tracked sector demand and recent capacity expansions.
What this means for investorsHIVE Digital Technologies shares increased after Cantor Fitzgerald raised its price target to $4.60 from $3.00, providing support ahead of the company’s upcoming fiscal results. This development highlights HIVE’s access to power, renewable-powered Bitcoin mining, and its plans to expand into AI and high-performance computing data centers.
The next earnings call will give investors a look at HIVE’s mining profits, digital-asset holdings, power capacity, and what it needs to expand into AI and high-performance computing. Updates on future projects will matter most if they show HIVE can turn its land and power access into funded data centers, customer deals, and new revenue streams beyond Bitcoin mining.
Eric Trie has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
On June 01, 2026, Riot Platforms Inc RIOT shares rose 4.2% today, reaching a current price of $28.25. This move contributes to a robust performance over the past year, with shares up 250.1% and a year-to-date increase of 123.0%. The stock has traded within a 52-week range of $7.93 to $28.84.
GF Value™ verdict: The current price of $28.25 is 112.3% overvalued compared to the GF Value™ estimate of $13.31.GF Score™: The stock has a score of 67/100, indicating it is above average.Most notable signal: Insider activity reflects that insiders sold $5.4 million worth of stock in the last 3 months with no buying activity. Is RIOT Overvalued or Undervalued? The current price of Riot Platforms Inc RIOT at $28.25 is significantly above the GF Value™ estimate of $13.31. This indicates that the stock is overvalued by approximately 112.3%, suggesting a lack of margin of safety for potential investors. With the GF Valuation label indicating that RIOT is "Significantly Overvalued," it raises concerns regarding the sustainability of the current price level. If the stock price continues to trade at such a high premium, there may be a risk of price corrections in the future as market realities set in.
GF Value™ is GuruFocus' proprietary measure of intrinsic value, calculated from historical trading multiples, past business growth, and future performance estimates. Given the current valuation, potential investors should proceed with caution, as the elevated price could lead to heightened volatility and risk in the near term.
How Does RIOT's Valuation Compare to Its History? Metric Current Historical P/E (TTM) 690.2x 52.8x The current forward P/E of 690.2x is significantly higher than the 5-year median P/E of 52.8x, indicating that the stock is trading well above its historical valuation levels. This analysis aligns with the GF Value™ verdict that RIOT is overvalued, as the substantial increase in the P/E ratio underscores the challenges in justifying the current market price based on historical earnings performance.
What Does RIOT's GF Score™ Tell Us? Metric Rating GF Score™ 67/100 Financial Strength 5/10 Profitability 4/10 Growth 8/10 Valuation 1/10 Momentum 8/10 The GF Score™ of 67/100 indicates that Riot Platforms Inc is positioned above average compared to its peers. Notably, its growth rank of 8/10 suggests strong potential in earnings growth, while the valuation rank of only 1/10 highlights significant concerns regarding its current pricing. The financial strength and profitability scores of 5/10 and 4/10 respectively indicate moderate stability and performance, but the low valuation rank suggests that the stock may not be an attractive investment at its current price level.
What Are Insiders Doing with RIOT Stock? Recent insider activity has shown that insiders sold $5.4 million in shares over the past three months, with no reported buying during this period. This selling could indicate a lack of confidence among insiders regarding the future performance of the stock, which may be a signal for potential investors to consider carefully.
Insider selling, particularly in substantial amounts, can often reflect a belief that the stock is overvalued or that the company may face challenges ahead. Without insider buying to counterbalance this sentiment, the outlook remains cautious.
What This Means for Investors Based on the GF Value™ analysis, Riot Platforms Inc RIOT is currently overvalued. The significant disparity between the current price and the intrinsic value suggests that investors may need to exercise caution and consider potential risks associated with investing at this price level.
For the complete analysis, visit the Riot Platforms Inc RIOT stock page. You can also explore the GF Value™ page for detailed valuation methodology, or use the GuruFocus Stock Screener to find similar opportunities.
Frequently Asked Questions What is RIOT's GF Score™?
RIOT's GF Score™ is 67/100, indicating that the stock is above average in its ranking compared to peers. A higher GF Score™ suggests a greater potential for long-term returns.
Is RIOT overvalued or undervalued?
Riot Platforms Inc is currently overvalued, with a GF Value™ estimate of $13.31 compared to the current price of $28.25.
What is RIOT's P/E ratio?
The current forward P/E ratio for RIOT is 690.2x, which is significantly higher than its 5-year median P/E of 52.8x, indicating that the stock is trading above its historical valuation levels.
This stock alert was generated using automated technology and GuruFocus financial data to provide readers with timely and accurate market reporting. This content was reviewed by GuruFocus editorial team prior to publication. Please send any questions or comments about this story to [email protected].
Shares of Riot Platforms (RIOT +1.78%) rose 57.3% in May 2026, according to data from S&P Global Market Intelligence. In a broader sense, the Bitcoin (BTC +0.20%) mining and AI data center company has gained a staggering 114% year to date as of June 4.
So last month's move was part of a bigger story. Marketwide enthusiasm about AI computing is pushing Riot higher in 2026. The specific market-moving news in May is a piece of the AI puzzle, too; Riot's stock surged 27% in two days after the announcement of a new power source for future data centers.
Riot is going nuclear (probably, in a few years).
Image source: Getty Images.
The tech behind Riot's future power plants The company partnered up with nuclear power plant builder Terrestrial Energy (IMSR 0.28%), syncing up the expansion plans of both companies.
Here's the technical setup. Terrestrial Energy's molten salt reactors dissolve nuclear fuel directly into liquid salts such as lithium fluoride and beryllium fluoride. The mix acts as both fuel and coolant for the reactor core. This setup allows high-temperature operation, efficient power generation, and a compact modular design. The nuclear action can take place physically separated from the power conversion bits, and then you have power lines to the electricity-hogging data centers. In the end, the radioactive mixture could be miles away from the data center.
In plain English, Riot gets a dedicated nuclear power plant as a neighbor, Terrestrial Energy gets a customer who will happily consume every electron they produce, and everyone gets to say they're running AI on clean energy.
The companies hope to add molten salt reactors near Riot's existing data centers in Texas and Kentucky, and will work together to identify further growth opportunities. Terrestrial Energy's stock also rose on the news, ending the month 26% higher.
Today's Change
(
1.78
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0.47
Current Price
$
26.61
Riot's nuclear ambition is still just a plan Don't hold your breath for this long-term plan. Riot and Terrestrial Energy didn't clarify the time frame for construction, actual power generation, let alone any revenues from their pairing. For what it's worth, the reactor builder hopes to secure funding and regulatory approval for its first molten salt reactors "in the early 2030s."
The AI boom might still have legs in five years, but nothing is guaranteed. On the upside, Riot would have the option of leaning back into the Bitcoin mining business if that makes more economic sense at any time. And, Riot hasn't promised to buy anything from Terrestrial Energy yet. The partners are simply evaluating their shared opportunities. It's a long shot, but if both AI computing and Bitcoin mining run into lasting slowdowns by 2030, Riot hasn't committed to anything expensive.
After its AI-powered surge, Riot trades at a frothy 16 times trailing sales. That's well above peers such as MARA Holdings or CleanSpark, both of which are trying similar Bitcoin-plus-AI business plans. The nuclear deal is exciting, but it's a 2030s story bolted onto a 2026 stock price. Investors buying Riot here are betting that the AI tailwind keeps blowing for years to come.
In the latest trading session, Riot Platforms, Inc. (RIOT - Free Report) closed at $24.66, marking a -10.23% move from the previous day. The stock trailed the S&P 500, which registered a daily loss of 2.65%. Meanwhile, the Dow experienced a drop of 1.35%, and the technology-dominated Nasdaq saw a decrease of 4.18%.
Shares of the company witnessed a gain of 13.94% over the previous month, beating the performance of the Finance sector with its gain of 2.8%, and the S&P 500's gain of 5.47%.
The investment community will be paying close attention to the earnings performance of Riot Platforms, Inc. in its upcoming release. On that day, Riot Platforms, Inc. is projected to report earnings of -$0.21 per share, which would represent a year-over-year decline of 136.84%. In the meantime, our current consensus estimate forecasts the revenue to be $148.71 million, indicating a 2.8% decline compared to the corresponding quarter of the prior year.
For the annual period, the Zacks Consensus Estimates anticipate earnings of -$2.08 per share and a revenue of $647.34 million, signifying shifts of -6.67% and -0.02%, respectively, from the last year.
It is also important to note the recent changes to analyst estimates for Riot Platforms, Inc. These revisions help to show the ever-changing nature of near-term business trends. As such, positive estimate revisions reflect analyst optimism about the business and profitability.
Our research suggests that these changes in estimates have a direct relationship with upcoming stock price performance. We developed the Zacks Rank to capitalize on this phenomenon. Our system takes these estimate changes into account and delivers a clear, actionable rating model.
The Zacks Rank system ranges from #1 (Strong Buy) to #5 (Strong Sell). It has a remarkable, outside-audited track record of success, with #1 stocks delivering an average annual return of +25% since 1988. Over the past month, there's been a 8.52% fall in the Zacks Consensus EPS estimate. Riot Platforms, Inc. is holding a Zacks Rank of #3 (Hold) right now.
The Financial - Miscellaneous Services industry is part of the Finance sector. This industry currently has a Zacks Industry Rank of 146, which puts it in the bottom 41% of all 250+ industries.
The Zacks Industry Rank gauges the strength of our individual industry groups by measuring the average Zacks Rank of the individual stocks within the groups. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1.
Be sure to follow all of these stock-moving metrics, and many more, on Zacks.com.
When deciding whether to buy, sell, or hold a stock, investors often rely on analyst recommendations. Media reports about rating changes by these brokerage-firm-employed (or sell-side) analysts often influence a stock's price, but are they really important?
Let's take a look at what these Wall Street heavyweights have to say about Riot Platforms, Inc. (RIOT - Free Report) before we discuss the reliability of brokerage recommendations and how to use them to your advantage.
Riot Platforms, Inc. currently has an average brokerage recommendation (ABR) of 1.33, on a scale of 1 to 5 (Strong Buy to Strong Sell), calculated based on the actual recommendations (Buy, Hold, Sell, etc.) made by 20 brokerage firms. An ABR of 1.33 approximates between Strong Buy and Buy.
Of the 20 recommendations that derive the current ABR, 15 are Strong Buy and three are Buy. Strong Buy and Buy respectively account for 75% and 15% of all recommendations.
Brokerage Recommendation Trends for RIOT
Check price target & stock forecast for Riot Platforms, Inc. here>>>
The ABR suggests buying Riot Platforms, Inc., but making an investment decision solely on the basis of this information might not be a good idea. According to several studies, brokerage recommendations have little to no success guiding investors to choose stocks with the most potential for price appreciation.
Do you wonder why? As a result of the vested interest of brokerage firms in a stock they cover, their analysts tend to rate it with a strong positive bias. According to our research, brokerage firms assign five "Strong Buy" recommendations for every "Strong Sell" recommendation.
In other words, their interests aren't always aligned with retail investors, rarely indicating where the price of a stock could actually be heading. Therefore, the best use of this information could be validating your own research or an indicator that has proven to be highly successful in predicting a stock's price movement.
With an impressive externally audited track record, our proprietary stock rating tool, the Zacks Rank, which classifies stocks into five groups, ranging from Zacks Rank #1 (Strong Buy) to Zacks Rank #5 (Strong Sell), is a reliable indicator of a stock's near-term price performance. So, validating the Zacks Rank with ABR could go a long way in making a profitable investment decision.
ABR Should Not Be Confused With Zacks RankAlthough both Zacks Rank and ABR are displayed in a range of 1--5, they are different measures altogether.
The ABR is calculated solely based on brokerage recommendations and is typically displayed with decimals (example: 1.28). In contrast, the Zacks Rank is a quantitative model allowing investors to harness the power of earnings estimate revisions. It is displayed in whole numbers -- 1 to 5.
It has been and continues to be the case that analysts employed by brokerage firms are overly optimistic with their recommendations. Because of their employers' vested interests, these analysts issue more favorable ratings than their research would support, misguiding investors far more often than helping them.
On the other hand, earnings estimate revisions are at the core of the Zacks Rank. And empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements.
In addition, the different Zacks Rank grades are applied proportionately to all stocks for which brokerage analysts provide current-year earnings estimates. In other words, this tool always maintains a balance among its five ranks.
There is also a key difference between the ABR and Zacks Rank when it comes to freshness. When you look at the ABR, it may not be up-to-date. Nonetheless, since brokerage analysts constantly revise their earnings estimates to reflect changing business trends, and their actions get reflected in the Zacks Rank quickly enough, it is always timely in predicting future stock prices.
Is RIOT a Good Investment?Looking at the earnings estimate revisions for Riot Platforms, Inc., the Zacks Consensus Estimate for the current year has remained unchanged over the past month at -$2.08.
Analysts' steady views regarding the company's earnings prospects, as indicated by an unchanged consensus estimate, could be a legitimate reason for the stock to perform in line with the broader market in the near term.
The size of the recent change in the consensus estimate, along with three other factors related to earnings estimates, has resulted in a Zacks Rank #3 (Hold) for Riot Platforms, Inc. You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>>
It may therefore be prudent to be a little cautious with the Buy-equivalent ABR for Riot Platforms, Inc.
Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In Inovio (INO) To Contact Him Directly To Discuss Their Options
If you purchased or acquired Inovio securities between October 10, 2023 and December 26, 2025 and would like to discuss your legal rights, call Bragar Eagel & Squire partner Brandon Walker or Melissa Fortunato directly at (212) 355-4648.
Click here to participate in the action.
NEW YORK, April 06, 2026 (GLOBE NEWSWIRE) --
What’s Happening:
Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Inovio Pharmaceuticals, Inc. (“Inovio” or the “Company”) (NASDAQ:INO) in the United States District Court for the Eastern District of Pennsylvania on behalf of all persons and entities who purchased or otherwise acquired Inovio securities between October 10, 2023 and December 26, 2025, both dates inclusive (the “Class Period”). Investors have until April 7, 2026 to apply to the Court to be appointed as lead plaintiff in the lawsuit. Allegation Details:
According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) manufacturing for Inovio’s CELLECTRA device was deficient; (2) accordingly, Inovio was unlikely to submit the INO-3107 Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) by the second half of 2024; (3) Inovio had insufficient information to justify the INO-3107 BLA’s eligibility for FDA accelerated approval or priority review; (4) accordingly, INO-3107’s overall regulatory and commercial prospects were overstated; and (5) as a result, defendants’ public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages. On December 29, 2025, the U.S. Food and Drug Administration ("FDA") announced it had accepted Inovio's Biologics License Application ("BLA") for INO-3107, a treatment for recurrent respiratory papillomatosis, on a standard review timeline. Inovio filed its BLA under the accelerated approval pathway, but the FDA stated that the Company did not submit adequate information to justify eligibility for accelerated approval. Inovio also announced it does not currently plan to seek approval under the standard review timeline, and will request a meeting with the FDA to discuss how it may still pursue accelerated approval. On this news, Inovio's stock price fell $0.56 per share, or 24.45%, to close at $1.73 per share on December 29, 2025. Next Steps:
If you purchased or otherwise acquired Inovio shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Melissa Fortunato by email at [email protected], telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you. About Bragar Eagel & Squire, P.C.:
Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, South Carolina, and California. The firm represents individual and institutional investors in securities, derivative, and commercial litigation as well as individuals in consumer protection and data privacy litigation. The firm has a nationwide practice and routinely handles cases in both federal and state courts. For more information about the firm, please visit www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.
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, /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Inovio Pharmaceuticals, Inc. (NASDAQ: INO).
Shareholders who purchased shares of INO during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.
CLASS PERIOD: October 10, 2023 to December 26, 2025
ALLEGATIONS: The complaint alleges that during the class period, Defendants issued materially false and/or misleading statements and/or failed to disclose that: (i) manufacturing for Inovio's CELLECTRA device was deficient; (ii) accordingly, Inovio was unlikely to submit it's lead product candidate, INO-3107 BLA to the FDA by the second half of 2024; (iii) Inovio had insufficient information to justify the INO-3107 BLA's eligibility for FDA accelerated approval or priority review; (iv) accordingly, INO-3107's overall regulatory and commercial prospects were overstated; and (v) as a result, defendants' public statements were materially false and misleading at all relevant times.
DEADLINE: April 7, 2026 Shareholders should not delay in registering for this class action. Register your information here: https://securitiesclasslaw.com/securities/inovio-pharmaceuticals-inc-loss-submission-form-2/?id=185253&from=4
NEXT STEPS FOR SHAREHOLDERS: Once you register as a shareholder who purchased shares of INO during the timeframe listed above, you will be enrolled in a portfolio monitoring software to provide you with status updates throughout the lifecycle of the case. The deadline to seek to be a lead plaintiff is April 7, 2026. There is no cost or obligation to you to participate in this case.
WHY GROSS LAW FIRM? The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rights of all investors who have suffered as a result of deceit, fraud, and illegal business practices. The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship. The firm seeks recovery on behalf of investors who incurred losses when false and/or misleading statements or the omission of material information by a company lead to artificial inflation of the company's stock. Attorney advertising. Prior results do not guarantee similar outcomes.
CONTACT:
The Gross Law Firm
15 West 38th Street, 12th floor
New York, NY, 10018
Email: [email protected]
Phone: (646) 453-8903
Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses in Inovio to Contact Him Directly to Discuss Their Options
If you purchased or acquired securities in Inovio between October 10, 2023 and December 26, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310).
[You may also click here for additional information]
NEW YORK--(BUSINESS WIRE)--Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Inovio Pharmaceuticals, Inc. (“Inovio” or the “Company”) (NASDAQ: INO) and reminds investors of the April 7, 2026 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.
Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dollars for investors since its founding in 1995. See www.faruqilaw.com.
As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (1) manufacturing for Inovio's CELLECTRA device was deficient; (2) accordingly, Inovio was unlikely to submit the INO-3107 BLA to the FDA by the second half of 2024; (3) Inovio had insufficient information to justify the INO-3107 BLA's eligibility for FDA accelerated approval or priority review; (4) accordingly, INO-3107's overall regulatory and commercial prospects were overstated; and (5) as a result, Defendants' public statements were materially false and misleading at all relevant times.
On December 29, 2025, the U.S. Food and Drug Administration (“FDA”) announced it had accepted Inovio’s Biologics License Application (“BLA”) for INO-3107, a treatment for recurrent respiratory papillomatosis, on a standard review timeline. Inovio filed its BLA under the accelerated approval pathway, but the FDA stated that the Company did not submit adequate information to justify eligibility for accelerated approval. Inovio also announced it does not currently plan to seek approval under the standard review timeline, and will request a meeting with the FDA to discuss how it may still pursue accelerated approval.
On this news, Inovio’s stock price fell $0.56 per share, or 24.45%, to close at $1.73 per share on December 29, 2025.
The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.
Faruqi & Faruqi, LLP also encourages anyone with information regarding Inovio’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others.
To learn more about the Inovio class action, go to www.faruqilaw.com/INO or call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310).
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Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP (www.faruqilaw.com). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner.
NEW YORK--(BUSINESS WIRE)--Rosen Law Firm, a global investor rights law firm, announces a class action lawsuit on behalf of purchasers of securities of Inovio Pharmaceuticals, Inc. (NASDAQ: INO) between October 10, 2023 and December 26, 2025, inclusive (the “Class Period”). Inovio is a biotechnology company.
For more information, submit a form, email attorney Phillip Kim, or give us a call at 866-767-3653.
The Allegations: Rosen Law Firm is Investigating the Allegations that Inovio Pharmaceuticals, Inc. (NASDAQ: INO) Misled Investors Regarding its Business Operations.
According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) manufacturing for Inovio’s CELLECTRA device was deficient; (2) accordingly, Inovio was unlikely to submit the INO-3107 Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) by the second half of 2024; (3) Inovio had insufficient information to justify the INO-3107 BLA’s eligibility for FDA accelerated approval or priority review; (4) accordingly, INO-3107’s overall regulatory and commercial prospects were overstated; and (5) as a result, defendants’ public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.
What Now: You may be eligible to participate in the class action against Inovio Pharmaceuticals, Inc. Shareholders who want to serve as lead plaintiff for the class must file their motions with the court by April 7, 2026. A lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member. For more information, click here.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
About Rosen Law Firm: Some law firms issuing releases about this matter do not actually litigate securities class actions. Rosen Law Firm does. Rosen Law Firm is a recognized leader in shareholder rights litigation, dedicated to helping shareholders recover losses, improving corporate governance structures, and holding company executives accountable for their wrongdoing. Since its inception, Rosen Law Firm has obtained over $1 billion for shareholders.
Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.
Attorney Advertising. Prior results do not guarantee a similar outcome.
Why: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Inovio Pharmaceuticals, Inc. (NASDAQ: INO) between October 10, 2023 and December 26, 2025, inclusive (the "Class Period"), of the important April 7, 2026 lead plaintiff deadline.
So what: If you purchased Inovio securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.
What to do next: To join the Inovio class action, go to https://rosenlegal.com/submit-form/?case_id=52847 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than April 7, 2026. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
Why Rosen Law: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually handle securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved, at that time, the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.
Details of the case: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) manufacturing for Inovio's CELLECTRA device was deficient; (2) accordingly, Inovio was unlikely to submit the INO-3107 Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") by the second half of 2024; (3) Inovio had insufficient information to justify the INO-3107 BLA's eligibility for FDA accelerated approval or priority review; (4) accordingly, INO-3107's overall regulatory and commercial prospects were overstated; and (5) as a result, defendants' public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.
To join the Inovio class action, go to https://rosenlegal.com/submit-form/?case_id=52847 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.
Attorney Advertising. Prior results do not guarantee a similar outcome.
Contact Information:
Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
[email protected]
www.rosenlegal.com
NEW YORK, April 07, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Inovio Pharmaceuticals, Inc. (“Inovio” or the “Company”) (NASDAQ: INO) and certain officers. The class action, filed in the United States District Court for the Eastern District of Pennsylvania, and docketed under 26-cv-00803, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Inovio securities between October 10, 2023 and December 26, 2025, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are an investor who purchased or otherwise acquired Inovio securities during the Class Period, you have until April 7, 2026, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Danielle Peyton at [email protected] or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
[Click here for information about joining the class action]
Inovio is a biotechnology company focused on the discovery, development, and commercialization of DNA medicines to treat and protect people from diseases associated with, inter alia, human papilloma virus (“HPV”). The Company’s DNA medicines are comprised of two components: (i) DNA plasmids, which are small circular DNA molecules that purportedly work like software that the body’s cells can download to produce specific proteins to target and fight disease; and (ii) its proprietary investigational medical device, “CELLECTRA,” which it uses to help its DNA medicines enter the body’s cells for purported optimal effect.
Inovio’s lead product candidate is INO-3107 for the treatment of recurrent respiratory papillomatosis (“RRP”), a life-long, rare disease of the respiratory tract caused by HPV infection. At all relevant times, Defendants touted the prospects of the U.S. Food and Drug Administration (“FDA”) granting accelerated approval and/or priority review for the Biologics License Application (“BLA”) of INO-3107 for the treatment of RRP (the “INO-3107 BLA”). Defendants also touted their ability to complete rolling submission of the INO-3107 BLA by the second half of 2024. In so doing, Defendants consistently and repeatedly indicated to investors that Inovio was rapidly approaching its transition into a commercial-stage company—one with a lead product asset that, once approved, would fill an unmet medical need and significantly improve the safety or effectiveness of current RRP treatments. The commercial implications of this prospect, which Defendants consistently highlighted throughout the Class Period, were of the upmost importance to investors and analysts, and formed a core part of the Company’s overall investment thesis.
Simultaneously, while disseminating these positive statements to the market, throughout the Class Period Defendants conducted numerous offerings of Inovio’s securities, reaping profits of tens of millions of dollars per offering.
Throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) manufacturing for Inovio’s CELLECTRA device was deficient; (ii) accordingly, Inovio was unlikely to submit the INO-3107 BLA to the FDA by the second half of 2024; (iii) Inovio had insufficient information to justify the INO-3107 BLA’s eligibility for FDA accelerated approval or priority review; (iv) accordingly, INO-3107’s overall regulatory and commercial prospects were overstated; and (v) as a result, Defendants’ public statements were materially false and misleading at all relevant times.
The truth began to emerge on August 8, 2024, when, during post-market hours, Inovio issued a press release reporting its financial results and recent business highlights for the second quarter of 2024. Therein, Defendants revealed that Inovio expected to submit the INO-3107 BLA to the FDA in mid-2025—representing an approximate full-year delay from Defendants’ initially projected mid-2024 submission timeline—because of “a manufacturing issue” with a component of the CELLECTRA device.
On this news, Inovio’s stock price fell $0.27 per share, or 3.1%, to close at $8.44 per share on August 9, 2024.
Then, on December 29, 2025, during pre-market hours, Inovio issued a press release announcing that the FDA had accepted the INO-3107 BLA on a standard rather than accelerated review timeline. Defendants advised that the FDA had indicated that the Company did not submit adequate information to justify eligibility for accelerated approval. Defendants further advised that Inovio does not plan to seek approval under the standard review timeline and would request a meeting with the FDA to discuss how it may still pursue accelerated approval.
On this news, Inovio’s stock price fell $0.56 per share, or 24.45%, to close at $1.73 per share on December 29, 2025.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.
Attorney advertising. Prior results do not guarantee similar outcomes.
Resources Investor Relations Journalists Agencies Client Login Send a Release News Products Contact , /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that its first quarter 2026 financial results will be released after the market close on May 13th, 2026. Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss the financial results and provide a general business update.
The live webcast will be available online at http://ir.inovio.com/events-and-presentations/default.aspx. This is a listen-only event but will include a live Q&A with analysts. The webcast will be archived and available for replay for 90 days following the event.
About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing innovative DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com
, /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer and infectious diseases, today announced that it will participate in the following scientific conferences:
American Society of Gene and Cell Therapy Annual Meeting (Boston)
Poster Presentation: Bleeding phenotype correction in hemophilia A mice following in vivo Factor VIII gene transfer by electroporation in skeletal muscle cells
Date: Tuesday, May 12
Time: 5 - 6:30 PM ET
American Society of Clinical Oncology Annual Meeting (Chicago)
Poster Presentation: B cell responses in Recurrent Respiratory Papillomatosis patients treated with DNA immunotherapy INO-3107
Date: Saturday, May 30
Time: 1:30 - 4:30 PM CDT
Available abstracts will be shared on INOVIO's website following presentations.
About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com.
Biologics License Application (BLA) for INO-3107 actively being reviewed under the accelerated approval program by the U.S. Food and Drug Administration (FDA) with a target Prescription Drug User Fee Act (PDUFA) date of October 30, 2026 Commercial readiness plans continue to advance in anticipation of a potential commercial launch for INO-3107 as a treatment for adults with Recurrent Respiratory Papillomatosis (RRP) Clinical trial collaboration and supply agreement announced with Akeso Inc. to evaluate INO-5412 in combination with cadonilimab for the potential treatment of glioblastoma (GBM) in a Dana-Farber Cancer Institute-sponsored trial Current cash, cash equivalents, and short-term investments anticipated to fund operations into first quarter 2027, beyond the target PDUFA date , /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced its financial results for the first quarter ended March 31, 2026 and provided an update on recent company developments.
"We remain focused on advancing INO-3107 toward its target PDUFA date to ensure that every RRP patient has access to therapeutic options that work for them to reduce the need for surgery. We believe there remains a critical unmet need among patients diagnosed with this rare and devastating disease, and that INO-3107 has the potential to become the preferred product by patients and their physicians, if approved, based on clinical results, tolerability data and the simplicity of its patient-centric treatment regimen that does not require additional surgeries during the dosing window," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "While the BLA for INO-3107 is under active review, we continue to advance our commercial readiness plans in anticipation of a 2026 approval, as well as leverage the power of partnerships to advance other promising candidates in our pipeline."
Operational Highlights
INO-3107 – Recurrent Respiratory Papillomatosis (RRP)
INO-3107 is INOVIO's lead product candidate. It has been developed as a potential treatment for RRP, a rare and debilitating disease of the respiratory tract caused by infection with HPV-6 and/or HPV-11. In December 2025, the FDA accepted for review the company's BLA for INO-3107 under the accelerated approval program and set a target PDUFA date for October 30, 2026. Since then, the BLA has been under active review by the FDA, including the recent completion of the mid-cycle review meeting. INOVIO is focused on advancing INO-3107 through the regulatory process and working with the FDA as they complete their review of the BLA, including addressing the potential review issue they noted in their file acceptance letter regarding eligibility for review under the accelerated approval program. INOVIO continues to strongly believe that INO-3107 fulfills the criteria for accelerated approval by meeting a significant unmet need and providing a meaningful therapeutic benefit over existing treatments. As a part of communications about the mid-cycle review, the FDA has reiterated their intention to schedule the previously agreed to informal meeting to discuss their preliminary commentary on eligibility for review under the accelerated approval program.
INOVIO continues to engage with the RRP community, including presenting data from our Phase 1/2 trial of INO-3107 at the Combined Otolaryngology Spring Meeting (COSM), the premier educational and technology forum for the specialists who treat RRP. INOVIO will also be presenting at the upcoming American Society of Clinical Oncology (ASCO) Annual Conference.
In anticipation of a potential approval in 2026, INOVIO continues to advance commercial readiness plans, including incorporating key learnings from the launch of a competitor's recently approved RRP product. INOVIO believes INO-3107 has a positively differentiated product profile. INOVIO plans to commercialize INO-3107 itself in the U.S., with the support of a contract sales organization, and has engaged or identified key commercial partners, including a third-party logistics provider, Agency of Record, specialty distributor, specialty pharmacy, and patient HUB.
INO-5412
In March 2026, INOVIO announced a clinical trial collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 (INO-5401 plus INO-9012 in a single vial) in combination with cadonilimab, Akeso's first-in-class PD-1/CTLA-4 bispecific antibody, for the potential treatment of glioblastoma (GBM). The combination therapy will be studied as a part of the INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute and conducted by Mass General Brigham Cancer Care Inc. This novel combination builds on INOVIO's previous promising research in GBM and could potentially benefit patients by providing additional checkpoint inhibition through CTLA-4 binding.
Next-Generation DNA Medicine Candidates
INOVIO presented promising data from our next-generation DNA-Encoded Monoclonal Antibody (DMAb™) and DNA-Encoded Protein (DPROT) programs at several recent scientific conferences. Based on positive preclinical data on Factor VIII production for Hemophilia A, INOVIO is developing additional DPROT indications in the rare disease space, including Fabry disease and Hypophosphatasia (HPP), and is in discussions with potential partners to accelerate development of this promising platform.
General Corporate
INOVIO remains focused on financial discipline, directing resources to advance the INO-3107 program toward a potential 2026 approval and preparing for commercialization. The company strengthened its balance sheet with an underwritten public equity offering in April 2026. Net proceeds from the offering, after deducting underwriting discounts, commissions and offering expenses, were approximately $16.0 million.
First Quarter 2026 Financial Results
Research and Development (R&D) Expenses: R&D expenses for the three months ended March 31, 2026 decreased to $14.1 million from $16.1 million for the same period in 2025. The decrease was primarily the result of lower employee and consultant compensation, including stock-based compensation, lower engineering outside services related to our device development, and lower expensed inventory, among other variances. General and Administrative (G&A) Expenses: G&A expenses decreased to $7.9 million for the three months ended March 31, 2026 from $9.0 million for the same period in 2025. Total Operating Expenses: Total operating expenses decreased to $21.9 million for the three months ended March 31, 2026 from $25.1 million for the same period in 2025. Net Loss: INOVIO's net loss for the three months ended March 31, 2026 was $19.7 million, or $0.28 per basic and diluted share, compared to a net loss of $19.7 million, or $0.51 per basic and diluted share, for the three months ended March 31, 2025. Cash, Cash Equivalents and Short-term Investments: As of March 31, 2026, cash, cash equivalents and short-term investments were $37.7 million (excluding net proceeds from the April 2026 offering of $16.0 million), compared to $58.5 million as of December 31, 2025. Cash Guidance
INOVIO estimates that current cash, cash equivalents and short-term investments balances will support operations into the first quarter of 2027, beyond the target PDUFA date for INO-3107. This projection includes the net proceeds of $16.0 million from the public offering in April 2026, as well as an operational net cash burn estimate of approximately $18 million for the second quarter of 2026. These cash runway projections do not include any further capital-raising activities that INOVIO may undertake.
Conference Call / Webcast Information
INOVIO's management will host a live conference call and webcast with slides at 4:30 p.m. ET today to discuss INOVIO's financial results and provide a general business update. The live webcast and replay may be accessed by visiting INOVIO's website at http://ir.inovio.com/events-and-presentations/default.aspx.
About INOVIO's DNA Medicines Platform
INOVIO's DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO's proprietary investigational medical device, CELLECTRA. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software the body's cells can download to produce specific proteins to target and fight disease. INOVIO's proprietary CELLECTRA delivery devices are designed to optimally deliver its DNA medicines to the body's cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector response historically seen with viral vector platforms.
About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing innovative DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com.
Forward-Looking Statements
This press release contains certain forward-looking statements relating to our business, including the timing and success of preclinical studies and clinical trials; the ability to obtain and maintain regulatory approval of our product candidates; the FDA's acceptance of our BLA for INO-3107 with a PDUFA target action date set for October 30, 2026; a yet-to-be scheduled meeting with the FDA to discuss eligibility for the accelerated approval program; the potential benefits of INO-3107 and our other potential product candidates, including our belief that INO-3107 has a positively differentiated product profile and the potential to become the preferred product by patients and their physicians, if approved; the clinical collaboration and supply agreement with Akeso Inc. to evaluate INO-5412 in combination with cadonilimab for the potential treatment of GBM in the INSIGhT trial; the scope, progress and expansion of developing and commercializing our product candidates, including the anticipated commercial launch of INO-3107, if approved; our anticipated growth strategies; our ability to establish and maintain development partnerships; our estimated operational net cash burn of approximately $18 million for the second quarter of 2026; and the expected sufficiency of our cash resources into the first quarter of 2027. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.
