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TG Therapeutics Publishes Long-Term Efficacy Results for BRIUMVI
TG Therapeutics announced the publication of results from a five-year matching-adjusted indirect comparison evaluating long-term relapse activity and disability progression outcomes with BRIUMVI compared with ocrelizumab and ofatumumab in patients with relapsing multiple sclerosis. For the analysis, individual patient data from the Phase 3 ULTIMATE I/II pivotal trials for BRIUMVI were reweighted to match published baseline characteristics from the pivotal studies for ocrelizumab and ofatumumab in patients with RMS, revealing favorable long-term outcomes with BRIUMVI compared to the other two comparators. The manuscript, entitled "Long-Term Comparative Outcomes in Relapse Activity and Disability Progression Among Anti-CD20 Therapies in Relapsing Multiple Sclerosis: An Unanchored Matching-Adjusted Indirect Comparison," was published online in Multiple Sclerosis and Related Disorders. Five-year anti-CD20 outcomes from the pivotal studies of BRIUMVI, ocrelizumab, and ofatumumab were compared using an unanchored MAIC. The analysis used individual patient-level data from 545 BRIUMVI-treated participants in the Phase 3 ULTIMATE I and II trials and their open-label extension and compared outcomes with published aggregate data from the Phase 3 OPERA I/II trials of ocrelizumab and ASCLEPIOS I/II trials of ofatumumab. In the analysis, BRIUMVI patient-level data were re-weighted to align baseline characteristics with the respective comparator trial populations. These adjustments are designed to mitigate the effects of any demographic differences in the study populations on the efficacy results. The findings included: BRIUMVI was associated with a lower risk of 24-week confirmed disability progression compared with both ocrelizumab and ofatumumab, with a 44% lower relative hazard versus ocrelizumab and a 49% lower relative hazard versus ofatumumab. BRIUMVI was associated with a lower cumulative incidence of CDP24 at 240 weeks, with estimated rates of 9.3% versus 16.1% for ocrelizumab and 9.4% versus 17.9% for ofatumumab. BRIUMVI was associated with more time free from confirmed disability progression over 240 weeks, with an average of 8.1 additional weeks compared with ocrelizumab and 13.1 additional weeks compared with ofatumumab. BRIUMVI demonstrated consistently low annualized relapse rates over five years of treatment, with MAIC-adjusted ARR declining from 0.118 in Year 1 to 0.032 in Year 5 in the comparison with ocrelizumab, and from 0.116 to 0.030 in the comparison with ofatumumab. These findings are considered exploratory and require confirmation in direct comparative studies.
Major Averages Rise as Investors Focus on Inflation and Treasury Yields
The major averages were broadly higher near noon, potentially ending the week on a high note as investors attempt to shake off a yield-driven selloff.Long-dated Treasury yields surged this week amid concerns about rising government debt, financing needs and persistent inflation, with the 30-year yield earlier reaching its highest level since 2007. Treasury Secretary Scott Bessent said the government could further expand its Treasury repurchases after this week's intervention, but yields remain near recent highs and investors remain concerned that buybacks do not address the underlying deficit and debt outlook.Meanwhile, oil and geopolitics are adding to inflation concerns. Diplomatic progress with Iran remains limited, while the U.S. is threatening tougher economic measures and Middle Eastern supply disruptions continue to support crude prices. That leaves investors weighing the prospect of renewed energy-driven inflation just as they are trying to determine the Federal Reserve's next move.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:BJ's Wholesaleprovided areport for Q2Ross Storesalso reported, increased its FY26 earnings outlook, and provided an upbeat earnings outlook for Q3Broadcomis in discussions with a group of lenders to raise over $60B in debt for an AI semiconductor financing deal that will benefit Anthropic and other firms,FedExand UPSwerefor Transportation Command contract modificationsThe Dutch Data Protection Authority is fining UberEUR825M, or about $966M, under European data protection rules for deactivating driver accounts through automated systems without properly telling them about it,2. WALL STREET CALLS:BMO Capitalcoverage of Nvidia (NVDA) with an Outperform rating and $340 price targetEquifaxto Buy from Neutral at Rothschild & Co RedburnBairdParsonsto Outperform, says investor sentiment is lowTeradyneto Neutral at Baird on valuationJPMorganLimbachto Underweight from Neutral3. AROUND THE WEB:A buyout approach rumor regarding TG Therapeuticswas highlighted in Ben Harrington's takeover-focused Betaville blog, contacts tell The FlyFugazi Research said in a short report that Aeva's"valuation is disconnected from the business the company actually reports"Poolside AI, an AI model-building startup, has struck a non-exclusive $6B licensing deal with Nvidia, plus a $1B investment at a $12B pre-money valuation, Newcomer saysSamsung Electronicsis expected to hold a board meeting and disclose the details of a shareholder return program that could be worth as much as $79B, Bloomberg reportsCitiis said to join Morgan Stanley, Goldman Sachs, and JPMorganas one of the banks working on bringing Anthropic to public markets, Bloomberg says4. MOVERS:O-I Glassincreases after Citithe stock to BuyArbutus Biopharmagains after announcing plans to commence atender offer to repurchase up to $230M sharesCleveland-Cliffshigher after announcing ain Middletown WorksAmerican Electric (AEP) falls after Morgan Stanleyon the stockAlibabadeclines in New York after Citi and Bairdon the stock5. EARNINGS/GUIDANCE:The Buckle, with EPS lower year-over-yearKE Holdings, with EPS and revenue beating consensusFlowers Foodsand cut its guidance for FY26, with CEO Ryals McMullian commenting, "Our second quarter results reflect the continued challenges across the fresh packaged bread category"OSI Systems, with EPS beating consensusUbiquiti (UI) reported year-over-year increases inINDEXES:Near midday, the Dow was up 425.63, or 0.81%, to 53,184.84, the Nasdaq was up 164.71, or 0.63%, to 26,231.88, and the S&P 500 was up 47.36, or 0.62%, to 7,688.52.
Rumor of Buyout Approach for TG Therapeutics Highlighted
A buyout approach rumor regarding TG Therapeutics was highlighted in Ben Harrington's takeover-focused Betaville blog, contacts tell The Fly.
TG Therapeutics Stock Jumps 4% to $52.82 After Betaville Mention
TG Therapeutics jumps 4% to $52.82 after Betaville mention
TG Therapeutics Stock Falls 10.6% to $46.52
TG Therapeutics is down -10.6%, or -$5.51 to $46.52.
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