BHVN

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...

A month has gone by since the last earnings report for Myriad Genetics (MYGN). Shares have added about 7.1% in that time frame, outperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Myriad due for a pullback? Well, first let's take a quick look at the latest earnings report in order to get a better handle on the recent drivers for Myriad Genetics, Inc. before we dive into how investors and analysts have reacted as of late. Myriad Genetics, Inc. reported first-quarter 2026 adjusted loss of 9 cents per share, compared with the Zacks Consensus Estimate of 6 cents. The reported figure came wider than the year-ago period’s loss of 3 cents per share. Adjusted earnings exclude amortization expenses from acquired intangible assets, equity compensation and real estate optimization. GAAP loss per share came in at 36 cents in the quarter compared with the prior-year quarter’s flat earnings. MYGN’s Revenues Total revenues rose 2% year over year to $200.4 million but missed the Zacks Consensus Estimate by 1.09%. Testing volumes remained stable in the quarter. Detailed Breakdown of MYGN’s Q1 Revenues The Cancer Care Continuum business delivered $120.2 million in revenues in the first quarter of 2026, up 4% year over year. Within this, hereditary cancer testing revenue increased 5%, driven by a 14% increase in volume. Prolaris testing revenue grew 3% year over year. The Prenatal Health business revenues dropped 15% year over year to $41.9 million. This was due to a 12% decline in volume decreased, reflecting a difficult prior year comparison as the company continues to engage with customers and address the disruption caused by the 2025 second-quarter implementation of its new order management system. Meanwhile, the GeneSight test revenues within Mental Health grew 24% year over year, reflecting 7% volume growth, and overall improved reimbursement trends. MYGN’s Q1 Margin Performance The gross margin rose 16 basis points (bps) to 68.7% due to a 1.8% increase in the cost of revenues. Research and development expenses dropped 1.5% year over year to $27.1 million. Sales and marketing expenses rose 6.4% to $74 million in the reported quarter. General and administration expenses were $62.2 million, down 6.5% year over year. The adjusted operating loss was $25.3 million compared with a loss of $29 million in the year-ago...

Biohaven to update clinical, regulatory, and operational progress at annual R&D Day at the upcoming Yale Innovation Summit on May 27, 2026. Advancement of high-value, late-stage priority programs: Pivotal epilepsy program with selective Kv7 ion channel activator, opakalim, with expected topline results in 2H 2026. Phase 2 obesity study with myostatin-activin pathway inhibitor, taldefgrobep alfa, completed enrollment and topline data expected in 2H 2026. TRAP™ and MoDE™ Degraders Advancing to Pivotal Trials Pivotal trials in both IgA nephropathy (IgAN) with Gd-IgA1 TRAP degrader, BHV-1400, and Graves' disease with IgG MoDE degrader, BHV-1300, expected to initiate by mid-year. Sustained progress across development pipeline: Enrollment in Phase 2 early Parkinson's disease trial with brain-penetrant TYK2/JAK1 inhibitor, BHV-8000, continues to advance. Enrollment advances in advanced endometrial cancer expansion cohort with the next-generation TROP-2 directed ADC BHV-1510 in combination with Libtayo®. Dose escalation advances with BHV-1530, a first-in-class FGFR3-directed antibody-drug conjugate (ADC). No dose-limiting toxicities observed to date. A total of 5 abstracts, including 1 oral presentation and 4 posters, featured at the American Academy of Neurology ("AAN") Annual Meeting Highlight's Biohaven leadership, innovative science, and development programs evaluating novel therapies to treat neurological and immunological diseases, including Kv7 ion channel activation, extracellular protein degradation, and TYK2/JAK1 inhibition. NEW HAVEN, Conn., May 4, 2026 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today reported financial results for the first quarter ended March 31, 2026, and provided a review of recent accomplishments and anticipated upcoming developments. Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "We are planning for a transformative year ahead at Biohaven, with multiple potential value-driving milestones on the horizon. In the coming several weeks, we expect the initiation of our pivotal clinical trials to advance our novel MoDE and TRAP extracellular protein degradation platform into two pivotal studies,...

Prioritizing three key, late-stage clinical programs including Molecular Degrader of Extracellular Proteins (MoDETM) and Targeted Removal of Aberrant Protein (TRAPTM) extracellular protein degradation for immunological diseases, Kv7 ion channel modulation for epilepsy; and myostatin-activin pathway targeting obesity: Inflammation and Immunology: Graves' Disease: First-in-patient clinical experience with IgG MoDE degrader BHV-1300 resulted in complete suppression of disease-causing TSH receptor-stimulating antibodies, normalization of previously elevated thyroid hormones within weeks after dosing a patient with Graves' disease. BHV-1300 has shown the potential for best-in-class reductions of IgG, with maximum reductions of up to an 87% decrease from baseline within weeks of dosing in a study conducted in healthy volunteers. The Company intends to initiate a pivotal study with BHV-1300 in Graves' disease in the second half of 2026. IgA Nephropathy (IgAN): First dosing of BHV-1400 TRAP degrader in IgAN patients achieved early observations of both biomarker and clinical responses. BHV-1400 previously achieved rapid lowering of Gd-IgA1 with a mean reduction of >60% within hours and maximum reduction exceeding 80% in a study conducted in healthy volunteers. A pivotal study is set to initiate in the first quarter of 2026. Ion Channel: Epilepsy: In an ongoing open-label extension study of Biohaven's selective Kv7 channel activator, the majority of participants who completed at least 6 months of open-label extension (OLE) treatment with opakalim 75 mg once daily showed ≥50% reductions in seizure frequency compared to pretreatment baseline. Opakalim was well-tolerated in the OLE with a low incidence of central nervous system adverse events, representing a potential paradigm-shift for patients with a highly favorable and differentiated safety profile compared to other approved or investigational antiseizure medicines. Pivotal results for opakalim in the treatment of focal epilepsy are expected in the second half of 2026. Myostatin-Activin: Obesity: In 4Q 2025, Biohaven initiated a Phase 2 study in people living with overweight and obesity, with topline results expected in the second half of 2026. The study is evaluating the ability of taldefgrobep, administered once-weekly or once-monthly via autoinjector, to achieve high quality weight loss including reducing fat mass...

NEW HAVEN, Conn., Nov. 10, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today reported financial results for the third quarter ended September 30, 2025, and provided a review of recent accomplishments and anticipated upcoming developments. Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "Biohaven remains energized and focused on our mission to advance innovative medicines to patients who are waiting every day for new treatments. Our pipeline consists of multiple novel approaches for unmet medical needs and has the potential to deliver paradigm shifting treatments for conditions such as epilepsy, autoimmune disease, obesity, depression and cancer. We are particularly excited about the continued progress across our key programs and clinical-stage assets including: MoDE™ and TRAP™ degrader programs, where our two lead assets, BHV-1300 and BHV-1400, show compelling evidence to change the treatment paradigm in immune-mediated diseases; opakalim, a novel Kv7 ion channel activator, for the treatment of epilepsy and depression; and taldefgrobep alfa, myostatin-activin targeting therapy for obesity and SMA." Dr. Coric continued, "Our late-stage clinical programs are poised to transform their respective treatment paradigms, given their novel mechanistic foundations and the body of clinical and non-clinical data generated to date. Our redirected approach to 'right-sizing' innovation is an important step we have undertaken to ultimately drive growth and resources to the most critical areas of our business. With this thoughtful approach to rebalancing our portfolio, we believe Biohaven remains well-positioned to execute on our commitment to transforming the treatment landscape for patients with serious and underserved diseases and we remain unwaveringly committed to delivering on our promise to advance our programs for patients, families, and shareholders in the balance of the year and in the years ahead. We will also continue to provide updates on any progress determining a path forward in SCA." Third Quarter 2025 and Recent Business Updates Initiated strategic cost optimization efforts across portfolio to focus forward-look...

Cash, cash equivalents, marketable securities and restricted cash as of June 30, 2025, totaled approximately $408.2 million VYGLXIA NDA for spinocerebellar ataxia (SCA) PDUFA date 4Q2025, completed clinical trial inspections by FDA without observations or findings, and filing review remains ongoing MoDE and TRAP degrader platforms advance in clinical development, IgG reductions of up to 87% observed with MoDE degrader BHV-1300 in Phase 1 with the potential to address IgG-mediated diseases including Graves' disease and rheumatoid arthritis; sustained and deep Gd-IgA1 reductions over 80% reported with TRAP degrader BHV-1400 highlight its potential for treating IgA Nephropathy Next -generation Trop2 Antibody Drug Conjugate (ADC) BHV-1510 demonstrated early clinical activity, favorable PK and differentiated safety profile in a Phase 1/2 study as a monotherapy and in combination with Regeneron's anti-PD-1 cemiplimab (Libtayo®); Tumor reduction was observed in first 6 out of 6 patients treated with BHV-1510 plus cemiplimab including confirmed partial responses Commenced dosing with BHV-1530, a novel FGFR3-directed ADC with potential application in urothelial cancers and other FGFR3-expressing solid tumors Compassionate use of opakalim (BHV-7000) in a child with intractable epilepsy due to Kv7 gene mutation (KCNQ2 Developmental and Epileptic Encephalopathy [KCNQ2-DEE]) provides early evidence of potential clinical benefit associated with Biohaven's next-generation Kv7 activator Enrolled first patient in pivotal Phase 2/3 study in Parkinson's disease (PD) with BHV-8000, a highly selective, brain-penetrant TYK2/JAK1 inhibitor with the potential to modulate critical inflammatory pathways that underpin the widespread immune dysregulation and neurodegeneration that drive functional decline in people with PD NEW HAVEN, Conn., Aug. 11, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today reported financial results for the second quarter ended June 30, 2025, and provided a review of recent accomplishments and anticipated upcoming developments. Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "As we eagerly await a regulatory decis...

Cash, cash equivalents, marketable securities and restricted cash as of April 30, 2025 totaled approximately $518 million. Announced up to $600 million non-dilutive capital agreement with Oberland Capital Management LLC ("Oberland Capital"), with $250 million in gross proceeds received on closing on April 30, 2025, expected to support commercial launch planning in spinocerebellar ataxia ("SCA"), clinical development activities, and ongoing business operations. Completed U.S. Food and Drug Administration ("FDA") mid-cycle review meeting and regulatory inspections of Biohaven and key clinical research sites for troriluzole new drug application ("NDA") for the treatment of SCA (all genotypes); continuity of the review process and timelines maintained throughout troriluzole's review. Presented 13 abstracts, including 3 oral presentations and 10 posters, featured at the American Academy of Neurology ("AAN") Annual Meeting; breadth of presentations highlights Biohaven's leadership in neuroscience and immunoscience, as well as extensive development programs evaluating novel therapies to treat neurological and immunological diseases, with abstracts covering programs including Kv7 ion channel modulation, extracellular protein degradation, TYK2/JAK1 inhibition, glutamate modulation, and TRPM3 antagonism. Company to expound on clinical, regulatory, and operational progress across five platforms, including more than 10 assets in 6 therapeutic areas spanning immunology & inflammation, neuroscience, and oncology, at annual R&D Day at the Yale Innovation Summit on May 28, 2025. NEW HAVEN, Conn., May 12, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today reported financial results for the first quarter ended March 31, 2025, and provided a review of recent accomplishments and anticipated upcoming developments. Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "In spite of a challenging macroeconomic climate and economic uncertainty, our team has remained more focused than ever on strategic execution and creating a strong financial balance sheet to create value across our broad portfolio of innovative product candidates. Enthusiasm...