TGTX

Moderna (MRNA), TG Therapeutics (TGTX), and Agios Pharmaceuticals (AGIO) will see increased scrutiny

A month has gone by since the last earnings report for Immunovant, Inc. (IMVT). Shares have added about 3.6% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Immunovant due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at its most recent earnings report in order to get a better handle on the important drivers. Immunovant's Q4 Loss Wider Than Expected, Pipeline in Focus Immunovant incurred a fourth-quarter 2026 net loss of 73 cents per share, wider than the Zacks Consensus Estimate of a loss of 60 cents. The company had reported a loss of 64 cents per share in the year-ago quarter.Excluding stock-based compensation expense, IMVT reported a net loss of 67 cents per share.Currently, Immunovant does not have any approved products in its portfolio and has yet to generate revenues. IMVT’s Q4 Results in Detail Research and development expenses totaled $142.3 million, up 51.9% from the year-ago quarter’s figure. The increase was primarily due to clinical activities for IMVT-1402, as well as $39 million in costs associated with the discontinuation of batoclimab, partially offset by lower expenses related to batoclimab studies.General and administrative expenses were $17.3 million, down 14.4% year over year, primarily due to lower personnel-related expenses, market research and information technology costs, legal and other professional fees.As of March 31, 2026, Immunovant’s cash and cash equivalents totaled approximately $902.1 million compared with $994.5 million as of Dec. 31, 2025. The cash balance is expected to extend IMVT’s cash runway through the commercial launch of IMVT-1402 for GD. IMVT’s Full-Year 2026 Results For full-year 2026, Immunovant recorded a net loss of $2.77 per share compared with a net loss of $2.73 per share reported in 2025. In the past month, investors have witnessed a downward trend in estimates review. At this time, Immunovant has a subpar Growth Score of D, though it is lagging a bit on the Momentum Score front with an F. Charting a somewhat similar path, the stock was allocated a score of D on the value side, putting it in the bottom 40% for value investors. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be inter...

It has been about a month since the last earnings report for TG Therapeutics (TGTX). Shares have lost about 5.7% 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 TG Therapeutics due for a breakout? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent drivers for TG Therapeutics, Inc. before we dive into how investors and analysts have reacted as of late. TG Therapeutics reported earnings of 17 cents per share (excluding the loss on extinguishment of debt) for the first quarter of 2026, missing the Zacks Consensus Estimate of 23 cents. The company had reported earnings of 3 cents per share in the year-ago quarter. Total revenues in the first quarter were $204.9 million, up almost 69.5% year over year, driven by strong demand for Briumvi. The figure beat the Zacks Consensus Estimate of $199 million. The top line comprised product sales from Briumvi and license, royalty and other revenues. Total product revenues were $201.3 million in the first quarter, reflecting 68.2% year-over-year increase. Briumvi’s net product sales in the United States were $194.8 million in the first quarter, up 63% year over year. Sales of the drug came in ahead of management’s guided range of $185-$190 million. Sales of Briumvi to Neuraxpharm were $6.5 million in the quarter and included in total product revenues. License, milestone, royalty and other revenues were $3.6 million in the first quarter, compared with $1.2 million reported in the year-ago quarter. Research and development (R&D) expenses (excluding non-cash compensation) rose around 1.2% year over year to $43.5 million due to higher expenses related to ongoing clinical studies. Selling, general and administrative (SG&A) expenses (excluding non-cash compensation) totaled $73.1 million, up almost 88.9% from the year-ago quarter’s level, due to higher commercialization costs for Briumvi as well as other personnel costs. As of March 31, 2026, TG Therapeutics had cash, cash equivalents and investments worth $572.8 million compared with $199.5 million as of Dec. 31, 2025. TG Therapeutics raised its total revenue guidance. The company now expects worldwide total revenues of around $925 million in 2026, including net product revenues of $885-$900 m...

Pharmacokinetic and pharmacodynamic data support quarterly subcutaneous BRIUMVI dosing regimen currently under evaluation in fully enrolled Phase 3 trial; Top-line Phase 3 data expected year-end 2026 or early 2027 Novel Investigational high concentration subcutaneous formulation of BRIUMVI was well-tolerated with no new safety signals observed NEW YORK, June 03, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (the “Company” or “TG Therapeutics”), today announced positive pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability data from its Phase 1 clinical trial evaluating subcutaneous formulation of ublituximab (the active agent in BRIUMVI®) as compared to IV BRIUMVI. Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “We are very pleased to report these positive Phase 1 results demonstrating that our proprietary high-concentration, low-volume subcutaneous formulation of BRIUMVI was well tolerated and achieved sustained drug exposure. Importantly, these data strengthen our confidence that the quarterly subcutaneous dosing regimen, currently being evaluated in the ongoing Phase 3 study, can achieve its primary endpoint.” Mr. Weiss continued, “If approved, subcutaneous BRIUMVI would be the first and only self-administered, at-home, quarterly anti-CD20 therapy for people living with multiple sclerosis, significantly reducing the total number of injections per year as compared to currently available options. Strategically, given the distinct nature of the self-administered portion of the anti-CD20 market, a subcutaneous option could nearly double the addressable market opportunity for the BRIUMVI franchise. We look forward to reporting Phase 3 data later this year or early next year and, if successful, advancing toward a potential approval in 2028.”KEY FINDINGS FROM THE PHASE 1 SUBCUTANEOUS BRIUMVI TRIAL Design: The Phase 1 trial is evaluating the bioavailability, pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a high-concentration (400 mg/2 mL) subcutaneous formulation of BRIUMVI compared to the currently approved intravenous (“IV”) formulation. To date, over 100 patients have been treated in the trial, including more than 80 patients who received subcutaneous BRIUMVI across multiple dose levels (50 mg – 400 mg) in single and multiple dose cohorts. More than 225 subcutaneous i...

Phase 3 trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved BRIUMVI Day 1 and Day 15 initiation dosing and a new single infusion on Day 1 only Safety and tolerability of the consolidated first infusion were consistent with the established BRIUMVI safety profile Supplemental BLA filing targeted 2H-2026 NEW YORK, May 27, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced positive topline results from the Phase 3 ENHANCE trial, a randomized, double-blind study evaluating a consolidated single infusion regimen for initiation of BRIUMVI® (ublituximab-xiiy) in adults with relapsing forms of multiple sclerosis (RMS). The trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved initiation dosing regimen of 150 mg on Day 1 and 450 mg on Day 15 and a consolidated single 600 mg infusion on Day 1, eliminating the need for a Day 15 infusion. Topline outcomes from the ENHANCE Phase 3 study are highlighted below, and full results are expected to be presented at an upcoming medical meeting. Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated: “We are very pleased to share these positive results from our ENHANCE Phase 3 trial. By eliminating the need for a second infusion visit two weeks after treatment initiation, this streamlined dosing regimen has the potential to accelerate time from prescription to treatment and reduce scheduling burdens at busy infusion centers. If this consolidated dosing is approved, BRIUMVI would be the first and only IV anti-CD20 for which therapy can be initiated with a single infusion.” Mr. Weiss continued, “People living with RMS already manage significant complexity in their daily lives, and we believe treatment simplicity matters. These results reflect our broader commitment not only to developing effective therapies, but also to improving the treatment experience for patients and healthcare providers. We look forward to engaging with regulatory authorities regarding these data, with the goal of submitting a supplemental BLA in the second half of 2026.” OVERVIEW OF THE ENHANCE PHASE 3 STUDY AND KEY FINDINGS Design: The Phase 3b ENHANCE trial is a randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the pharmacokinetics, safety, and MRI outcomes of a consol...

After announcing healthy earnings, TG Therapeutics, Inc.'s (NASDAQ:TGTX) stock rose over the last week. However, we think that shareholders should be aware of some other factors beyond the profit numbers. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. As finance nerds would already know, the accrual ratio from cashflow is a key measure for assessing how well a company's free cash flow (FCF) matches its profit. In plain english, this ratio subtracts FCF from net profit, and divides that number by the company's average operating assets over that period. You could think of the accrual ratio from cashflow as the 'non-FCF profit ratio'. That means a negative accrual ratio is a good thing, because it shows that the company is bringing in more free cash flow than its profit would suggest. While having an accrual ratio above zero is of little concern, we do think it's worth noting when a company has a relatively high accrual ratio. That's because some academic studies have suggested that high accruals ratios tend to lead to lower profit or less profit growth. TG Therapeutics has an accrual ratio of 0.93 for the year to March 2026. Statistically speaking, that's a real negative for future earnings. And indeed, during the period the company didn't produce any free cash flow whatsoever. In the last twelve months it actually had negative free cash flow, with an outflow of US$14m despite its profit of US$461.9m, mentioned above. We also note that TG Therapeutics' free cash flow was actually negative last year as well, so we could understand if shareholders were bothered by its outflow of US$14m. However, as we will discuss below, we can see that the company's accrual ratio has been impacted by its tax situation. This would certainly have contributed to the weak cash conversion. That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. In addition to the notable accrual ratio, we can see that TG Therapeutics received a tax benefit of US$340m. This is meaningful because companies usually pay tax rather than receive tax benefits. Of course, prima facie it's great to receive a tax benefit. However, our data indicates that tax benefits can temporarily boo...

TG Therapeutics TGTX reported earnings of 17 cents per share (excluding the loss on extinguishment of debt) for the first quarter of 2026, missing the Zacks Consensus Estimate of 23 cents. The company had reported earnings of 3 cents per share in the year-ago quarter. Total revenues in the first quarter were $204.9 million, up almost 69.5% year over year, driven by strong demand for the company’s sole marketed drug, Briumvi (ublituximab-xiiy). The figure beat the Zacks Consensus Estimate of $199 million. Briumvi, an anti-CD20 monoclonal antibody, was approved by the FDA for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) in December 2022. The drug is also approved in the European Union, the United Kingdom, Australia, Switzerland and certain other countries. The top line comprised product sales from Briumvi and license, royalty and other revenues. Total product revenues were $201.3 million in the first quarter, reflecting a 68.2% year-over-year increase. Total product revenues included sales of Briumvi to TGTX’s licensing partner, in ex-U.S. markets, Neuraxpharm, of $6.5 million. TG Therapeutics has an agreement with Neuraxpharm Pharmaceuticals for the ex-U.S. commercialization of Briumvi, wherein the company is entitled to receive payments upon the achievement of certain commercial milestones and targets. Briumvi's net product sales in the United States were $194.8 million in the first quarter, up 63% year over year. Sales of the drug came in ahead of management’s guided range of $185-$190 million. License, milestone, royalty and other revenues were $3.6 million in the first quarter, compared with $1.2 million reported in the year-ago quarter. Research and development (R&D) expenses (excluding non-cash compensation) rose around 1.2% year over year to $43.5 million due to higher expenses related to ongoing clinical studies. Selling, general and administrative (SG&A) expenses (excluding non-cash compensation) totaled $73.1 million, up almost 88.9% from the year-ago quarter’s level, due to higher commercialization costs for Briumvi as well as other personnel costs. As of March 31, 2026, TG Therapeutics had cash, cash equivalents and investments worth $572.8 million compared with $199.5 million as of Dec. 31, 2025. TG Therapeutics raised its total revenue guidance. The company now expects worldwide total revenues of around $925 m...

The Most Shorted Stocks in June: Hold, Short, or Squeeze? TG Therapeutics (NASDAQ:TGTX) reported first-quarter 2026 results that management characterized as “record-setting” across most of its commercial metrics, led by sales of multiple sclerosis therapy BRIUMVI. The company posted U.S. BRIUMVI net product revenue of approximately $195 million, exceeding its prior guidance range of $185 million to $190 million, and said total net product revenue reached $201 million when including product sales to its ex-U.S. partner Neuraxpharm. Chairman and CEO Michael Weiss said the quarter reflected “consistency and durability” across the business, noting that global revenue exceeded $200 million and that the company expects to approach a $1 billion annualized run rate before year-end. → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? TG Therapeutics Stock 300% Rally Has Legs Yet Chief Commercial Officer Adam Waldman said U.S. net revenue grew 63% year-over-year and represented the “12th consecutive quarter of sequential growth since launch.” He added that the company saw record new patient enrollments, with March described as its highest month ever. Following the stronger quarter, Waldman said TG Therapeutics is raising full-year 2026 U.S. revenue guidance to $885 million to $900 million and is providing second-quarter guidance targeting approximately $220 million in U.S. BRIUMVI net revenue. CFO Sean Power also said the company raised its full-year total global revenue guidance to approximately $925 million. → A Prada Payday: Is AMC Back in Style? Waldman said more than 25,000 patients have been prescribed BRIUMVI globally, framing the milestone as evidence the company is moving beyond “early adoption” and building an “installed base” in a recurring, twice-yearly dosing model. He said persistence has been “strong,” and later added in Q&A that trends have been “better than expected” as patients move into their second year of treatment, though he emphasized it is still early and the company will continue to monitor as data matures. Waldman also pointed to direct-to-consumer (DTC) outreach as a contributor to awareness, saying the company has been investing over the last year and is encouraged by “markers and indicators of success,” with more patients arriving at physicians’ offices already informed about BRIUMVI. → Insider Sales: Top AST SpaceMobile Insider...

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Achieved record-setting Q1 performance with $195 million in U.S. BRIUMVI revenue, driven by a growing installed base and better-than-expected patient persistence. Transitioned from an early adoption phase to a recurring treatment model where each new patient cohort builds upon an expanding base of predictable demand. Established BRIUMVI as the leading anti-CD20 therapy by dynamic share in private practices with infusion capabilities, attributed to operational simplicity and a 1-hour infusion profile. Observed a rising mix of treatment-naive patients, which management views as the strongest leading indicator of long-term market dominance and brand loyalty. Leveraged a lean commercial engine to drive operating income growth that significantly outpaces expense growth, demonstrating scalable operating leverage. Maintained a disciplined capital allocation strategy, repurchasing $100 million in stock during the quarter based on management's view that the company remains undervalued. Raised full-year global revenue guidance to approximately $925 million., reflecting confidence in sustained new patient demand and high retention rates. Anticipating top-line Phase III data from the ENHANCE study in the coming weeks, which aims to simplify the IV dosing schedule by eliminating the day 15 infusion. The company is targeting the subcutaneous patient-administered segment, which represents roughly 35% of the anti-CD20 market and would allow the franchise to reach patients who prefer or require at-home self-administration. Expanding the 'pipeline within a product' strategy by initiating a Phase II registration-directed study in Myasthenia Gravis and exploratory work in treatment-resistant schizophrenia. Advancing the Azer-cel allogeneic CAR-T program in progressive MS, with plans to share biomarker and safety updates later this year as dose escalation continues. Incurred a one-time $9.2 million charge related to the refinancing of the Blue Owl facility, intended to enhance long-term financial flexibility for share buybacks and M&A. Directing approximately $100 million toward subcutaneous manufacturing as part of the current full-year expense guidance. and secondary manufacturer start-up activities to ensure supply chain redundancy. Noted that while gross-to-net discounts may fluctuate quarterly, they are expected to average approximately 65% for the full year. Acknowledged t...

Image source: The Motley Fool. Wednesday, May 6, 2026 at 8:30 a.m. ET Chief Executive Officer — Michael Weiss Chief Commercialization Officer — Adam Waldman Chief Financial Officer — Sean Power Need a quote from a Motley Fool analyst? Email [email protected] Michael Weiss: Thank you, Jenna, and good morning, everyone. We appreciate you joining us. The first quarter of 2026 was, in my view, exceptional, not because of any single milestone, but because of the consistency and durability we're now seeing across the business. Let me start with the commercial side. At a high level, Q1 was a record-setting quarter across nearly every metric we track. The momentum puts us in a very strong position as we move through the rest of the year. From a revenue standpoint, we delivered approximately $195 million in U.S. BRIUMVI net product revenue in quarter 1, ahead of our guidance of $185 million to $190 million. On a global basis, revenue exceeded $200 million for the quarter, marking another important milestone. And as we move toward $1 billion annualized run rate expected before year-end, we continue to believe we are still early in the BRIUMVI adoption curve, making peak revenue from the IV franchise alone still years ahead of us and multiples of where we are today. Physicians are increasingly recognizing the value of BRIUMVI, not just on efficacy, but on the overall treatment experience, thus translating into durable, repeatable growth. And importantly, the data continues to support that differentiation. Earlier this year, we were pleased to see our 5-year follow-up data from the ULTIMATE I and II open-label extension study published in JAMA Neurology, reinforcing sustained efficacy of BRIUMVI along with a consistent safety and tolerability profile over time. At AAN earlier this month, we continue to build on that story with real-world data demonstrating sustained and rapid B-cell depletion, low annualized relapse rates maintained over time and continued evidence of a favorable infusion experience and tolerability profile. And for the first time, we presented prospective data from patients who switched from a prior anti-CD20 therapy to BRIUMVI, which showed improvement in patient-reported wearing off symptoms, sometimes referred to as the clot gap after switching to BRIUMVI. Given that meaningful number of patients report this wearing off effect, the potential to address it...

TG Therapeutics (TGTX) reported Q1 earnings Wednesday of $0.12 per diluted share, up from $0.03 a ye