Biotech & Genomic Medicine▲
Bioventus, Travere, Charles River, Odyssey, Aclaris Hit 52-Week Highs on Earnings
Several biotech stocks reached 52-week highs on August 5, 2026, driven by quarterly results. Bioventus rose over 13% to $15.89 after reporting a 4% revenue increase to $153 million and guiding full-year 2026 net sales of $600 million to $610 million. Travere Therapeutics climbed 12% to $66.24 as second-quarter revenue grew to $169 million, with FILSPARI U.S. sales exceeding $141 million following its April 2026 FDA approval for FSGS. Charles River Laboratories gained over 11% to $266 despite a 2.7% revenue dip to just over $1 billion, while Odyssey Therapeutics advanced over 4% to $21.41 after providing pipeline updates including Phase 2 progress for OD-001 in ulcerative colitis. Aclaris Therapeutics rose over 6% to $6.51, highlighting its Bosakitug Phase 2 trial in atopic dermatitis with topline results expected in the fourth quarter of 2026.
RTTNews·21dRead more ▾
Biotech & Genomic Medicine▲
Travere sees over $3 billion peak annual FILSPARI sales as FSGS launch exceeds expectations
Travere Therapeutics reported that the launch of FILSPARI for focal segmental glomerulosclerosis, or FSGS, exceeded expectations in its first quarter of commercial availability, and the company reiterated confidence in peak annual sales exceeding $3 billion across FSGS and IgA nephropathy. U.S. net product sales of FILSPARI grew approximately 96% year-over-year to $141.1 million in the second quarter of 2026, with total U.S. net product sales reaching $161.4 million including Thiola and Thiola EC. Over 2,000 new patient start forms were recorded across both indications, and management noted that early FSGS adoption metrics are ahead of the initial IgA nephropathy launch. The company expects gross-to-net discounts to be slightly higher in the third and fourth quarters due to increased CMS utilization among FSGS patients, while full-year discounts are still anticipated in the mid-20% range. Travere ended the quarter with cash, cash equivalents, and marketable securities of approximately $489.2 million, and it completed a convertible refinancing transaction that included issuing $525 million of 0.5% convertible notes due 2032.
Seeking Alpha·22dRead more ▾
TVTX▲
American Kidney Fund and IgA Nephropathy Foundation Create New IgA Nephropathy Patient Guidelines
The American Kidney Fund and the IgA Nephropathy Foundation have created new patient guidelines for IgA nephropathy, a rare kidney disease. The guidelines are based on recently updated KDIGO clinical practice guidelines and were developed using patient focus group input and clinician review. They provide plain language explanations of the disease, an overview of available treatment options, and practical guidance for discussing treatment with healthcare teams in a printable format. The resource is available on AKF’s website and will be offered in Spanish, Korean, and simplified Chinese, with an interactive version planned for later this year. The effort is part of AKF’s “A Step Ahead of IgA Nephropathy” educational campaign, supported by sponsors including Novartis Pharmaceuticals Corporation, Otsuka America Pharmaceutical Inc., Travere Therapeutics, Vertex Pharmaceuticals Incorporated, and Calliditas Therapeutics.
GlobeNewswire·37dRead more ▾
Biotech & Genomic Medicine▼
FDA Grants Full Approval to Novartis' Fabhalta for IgA Nephropathy
The FDA has granted traditional approval to Novartis' Fabhalta for slowing kidney function decline in adults with primary immunoglobulin A nephropathy who are at risk of disease progression. The decision converts the drug's August 2024 accelerated approval into a full approval after a priority review, supported by phase III APPLAUSE-IgAN study data showing an annualized eGFR decline of 3.0 mL/min/1.73 m² per year for Fabhalta versus 5.7 mL/min/1.73 m² per year for placebo. Fabhalta is an oral Factor B inhibitor that targets the alternative complement pathway, and its first-quarter 2026 sales more than doubled to $169 million, reflecting expansion in paroxysmal nocturnal hemoglobinuria and renal indications. The approval strengthens Novartis' kidney disease portfolio, which also includes Vanrafia and the investigational candidate zigakibart, as the company faces competition from Travere Therapeutics' Filspari and Vertex Pharmaceuticals' povetacicept, which has an FDA target action date of November 30, 2026.
Zacks Investment Research·40dRead more ▾
TVTX▼
Kuehn Law investigates Travere Therapeutics officers and directors for potential fiduciary breaches
Kuehn Law, PLLC is investigating whether certain officers and directors of Travere Therapeutics, Inc. breached their fiduciary duties to shareholders. The investigation concerns potential self-dealing, and shareholders may be entitled to damages and corporate governance reforms. Long-term TVTX stockholders are encouraged to contact Justin Kuehn, Esq. at justin@kuehn.law or (833) 672-0814 for a free consultation with no obligation, as the law firm pays all case costs and does not charge investor clients. Shareholders are urged to act promptly because there may be limited time to enforce their rights.
GlobeNewswire·41dRead more ▾
TVTX▲
Everest Medicines Closes Licensing Deal with Travere for Civorebrutinib
Everest Medicines has closed its exclusive licensing agreement with Travere Therapeutics for the development and commercialization of civorebrutinib, a potential best-in-class oral BTK inhibitor, in the U.S. and global markets outside Greater China and select Asian countries. Everest receives an upfront payment of $112.5 million and is eligible for up to approximately $1.03 billion in milestone payments across up to five indications, plus tiered royalties ranging from high single-digit to double-digit percentages on future sales.
PR Newswire·50dRead more ▾
Biotech & Genomic Medicine▲
QURE Surges 81% on FDA Reversal, Spotlighting Five Biotech Catalysts
UniQure NV shares surged 81% on Wednesday after the FDA reversed course and accepted its Huntington's disease therapy data for an accelerated approval filing, a move flagged days earlier by unusual options activity. The stock jumped from a prior close of $26.99 to an intraday high of $48.88, closing in the high $47s, after the agency indicated AMT-130 data would support a filing, reversing a March decision that had sent shares from $25 to $9. The rally was preceded by weeks of institutional call buying, including a multi-million dollar order on June 9 across October 33 and 43 strikes, which a trader highlighted as a signal of smart-money positioning. The same catalyst-driven approach is now being applied to five other biotech names: Celcuity faces a July 17 FDA decision for gedatolisib in breast cancer, with major funds holding through a prior drawdown; Ionis has two PDUFA dates—June 30 for olezarsen and September for zilganersen—though insider selling of $57.8 million warrants caution; Celldex awaits Phase 3 barzolvolimab data in chronic spontaneous urticaria in Q4 next year, with a Phase 2 readout this summer, but rich options premiums keep it on watch; Travere already won approval for FILSPARI in FSGS in April and is now a commercial execution and takeout story with Overweight ratings from Citi and JPMorgan; and Replimune resubmitted its BLA for RP1 after a second Complete Response Letter, with FDA alignment on May 29, drawing Baker Bros and other funds, though it remains the lowest-conviction name on the board.
InvestorPlace·68dRead more ▾