2024 revenue is expected to be approximately $45.0 billion for the full year, $4.0 billion above the midpoint of first-time 2024 financial guidance Q4 2024 revenue is expected to be approximately $13.5 billion, approximately $400 million below the low end of recently issued financial guidance The company anticipates 2025 revenue to be in the range of $58.0 billion to $61.0 billion, growth of 32% at the midpoint compared to...Read more
The multi-year collaboration enables expanded access to quality diagnostic care for patients in California and provides Sutter physicians and clinicians with access to technology advances and innovations. It will also drive ongoing, comprehensive training and education, fostering future healthcare professionals representing the diverse communities they serve. Sutter Health, one of the top integrated health delivery systems in the country...Read more
SAN DIEGO, Jan. 14, 2025 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN) ("Illumina" or the "company") today announced unaudited preliminary financial results for the fourth quarter and fiscal year 2024 and preliminary outlook for fiscal year 2025 ahead of its presentation at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025 at 9:00 a.m. Pacific Time (12:00 p.m. Eastern Time). The webcast can be accessed through...Read more
Highlights Full year 2025 revenue guidance in the range of $8,050 - $8,650 million; midpoint of $8,350 million representing growth of approximately 1% over full year 2024 revenue guidance midpoint. Full year 2025 adjusted earnings per share* guidance in the range of $13.00 - $15.00; midpoint of $14.00, flat over full year 2024 adjusted earnings per share guidance midpoint. With respect to full year 2024, the company reaffirmed its...Read more
CHICAGO / Jan 14, 2025 / Business Wire / Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today introduced a suite of new, transformative capabilities available in Tempus One, the company’s generative AI assistant. Tempus One, which initially launched in 2023, provides both physicians and researchers AI-enabled services that leverage generative AI to propel...Read more
Preliminary U.S. BRIUMVI fourth quarter and full year 2024 net product revenue of $103.6 million and $310 million, respectively Full Year 2025 target total global revenue of approximately $540 million, including BRIUMVI U.S. net product revenue of approximately $525 million NEW YORK, Jan. 14, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), yesterday announced preliminary U.S. net product revenue for BRIUMVI® for...Read more
CLEVELAND, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Sotera Health Company (“Sotera Health” or the “Company”) (Nasdaq: SHC), a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry, is presenting today at the 43rd Annual J.P. Morgan Healthcare Conference. During the presentation, Chairman and CEO Michael B. Petras, Jr. will be providing an update on Sotera...Read more
Filing marks company’s first Marketing Authorization Application in Europe SAN DIEGO / Jan 14, 2025 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for trofinetide for the treatment of Rett syndrome in adults and pediatric patients two years of age and older. If granted marketing authorization,...Read more
‘Chronos-PD’ is looking for biological signals that could indicate increased chance of developing Parkinson’s disease (PD) years before symptoms appear, leading to new diagnostic tools and disease-modifying therapies Part of broad Grifols program to find disease-revealing clues in more than 100 million proprietary plasma samples connected to real-world data on thousands of disease states in many therapeutic areas Cutting-edge use of...Read more
311 subjects enrolled across various stages of loading and randomization in SOL-R, Ocular’s second registrational trial of AXPAXLI™ in wet AMD, as of January 10, 2024 First wet AMD registrational trial, SOL-1, completed randomization in December 2024 with topline data anticipated in Q4 2025 Company plans to seek FDA feedback in H1 2025 on clinical trial design for AXPAXLI in NPDR BEDFORD, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) --...Read more
SEATTLE and FORT MYERS, Fla., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (Nasdaq:ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, and NeoGenomics, Inc. (Nasdaq:NEO), a leading oncology testing services company, today announced a multi-year exclusive strategic commercial collaboration that will...Read more
MENLO PARK, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) -- PacBio (NASDAQ: PACB), a leading provider of highly accurate long-read sequencing solutions, announced a significant publication from Radboud University Medical Center (Radboudumc) and its research partners in the American Journal of Human Genetics. The study demonstrates the impact of PacBio’s HiFi long-read sequencing technology in identifying genetic causes of rare diseases,...Read more
Commenced shipment of the Vega™ benchtop system ahead of schedule, bringing HiFi sequencing to more customers Launched SPRQ chemistry, enabling the sub-$500 HiFi genome on the Revio® system MENLO PARK, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) -- PacBio (NASDAQ: PACB), a leading developer of high-quality, highly accurate sequencing solutions, announced preliminary unaudited revenue for the fourth quarter of 2024 and full year 2024 of...Read more
Alongside over-the-counter NARCAN® Nasal Spray 4 mg, prescription KLOXXADO® (naloxone HCl) Nasal Spray 8 mg will expand Emergent’s ability to distribute multiple life-saving opioid overdose emergency treatments to patients, customers and communities in need Focus remains on increasing access, raising awareness and ensuring strong supply to meet the ongoing demand of naloxone nasal spray GAITHERSBURG, Md., Jan. 14, 2025 (GLOBE...Read more
REGENXBIO to receive $110 million upfront, potential milestone payments of up to $700 million and meaningful double-digit royalties on net sales, and lead manufacturing Nippon Shinyaku to lead commercialization of first potential gene therapies for Mucopolysaccharidosis II (MPS II) and Mucopolysaccharidosis I (MPS I) in U.S. and Asia REGENXBIO retains rights to RGX-121 Priority Review Voucher (PRV) with potential accelerated approval...Read more
Cemsidomide Data Presented at American Society of Hematology (ASH) Annual Meeting Support Best-in-Class Profile; Program Advancing to Next Phase of Clinical Development in Multiple Myeloma and Non-Hodgkin’s Lymphoma CFT1946 Phase 1 Trial Continues to Progress in BRAF V600X Solid Tumors With Monotherapy Dose Escalation Expected to Complete in 1H 2025; Data in Melanoma and Colorectal Cancer Expected in Second Half of 2025 CFT8919...Read more
VS-7375 is a potential best-in-class oral and selective KRAS G12D (ON/OFF) inhibitor currently in Phase 1 development in China in advanced KRAS G12D mutant solid tumors; Verastem anticipates filing a U.S. IND application for VS-7375 during Q1 2025 and expects to initiate a Phase 1/2a study mid-2025 License establishes global development and commercialization rights for Verastem for VS-7375 outside of China, Hong Kong, Macau, and...Read more
NATICK, Mass. / Jan 14, 2025 / Business Wire / Allurion Technologies, Inc. (“Allurion” or the “Company”) (NYSE: ALUR), a company dedicated to ending obesity, today announced that it has entered into a subscription agreement with funds affiliated with RTW Investments, LP (“RTW”) for the purchase and sale of 841,751 shares of the Company’s common stock in a private placement at a purchase price of $2.97 per share. The private placement is...Read more
COVID-19 Phase 2b study poised to initiate 10,000 participant portion of trial pending U.S. Food and Drug Administration (FDA) review of sentinel cohort 30-day safety data Norovirus program to proceed with Phase 1 study following scientific advisory board and FDA feedback; Trial to initiate the first half of 2025 with topline data expected as early as mid-2025 New avian influenza vaccine candidate being tested in preclinical...Read more
MENLO PARK, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT) ("Sight Sciences" or the "Company"), an eyecare technology company focused on developing and commercializing innovative technology intended to transform care and improve patients' lives, today reported select preliminary, unaudited financial highlights for the fourth quarter and full year ended December 31, 2024. Select Preliminary Financial...Read more
STAFFORD, Texas, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the initiation of clinical sites in Germany. The Company has partnered with GBG (German Breast Group), the largest academic breast...Read more
ImmuneOnco announced dosing of first patient in its recently initiated Phase 1b/2 clinical trial of IMM2510/SYN-2510 in combination with chemotherapy in patients with advanced NSCLC in China ImmuneOnco announced initial clinical data from the 1L advanced NSCLC trial in China is expected as early as 2H 2025 Instil is targeting initiation of a potential first-line advanced NSCLC clinical trial of IMM2510/SYN-2510 combined with...Read more
VANCOUVER, British Columbia & DALLAS / Jan 14, 2025 / Business Wire / Alpha Cognition Inc. (Nasdaq: ACOG) (“Alpha Cognition”, or the “Company”), a biopharmaceutical company committed to developing novel therapies for debilitating neurodegenerative disorders, today announced the strategic appointments of Jen Pesa, Vice President of Commercial; Jack Kelly, Head of Market Access; Rommel Fernandez, Vice President of Corporate Strategy and...Read more
First FDA-Cleared Antibiotic-Eluting BioEnvelope Now Available in U.S. for Implantable Pacemakers, Defibrillators, and Neurostimulators SILVER SPRING, Md., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT), a pioneer in drug-eluting biomatrix technologies, announced the U.S. commercial launch of EluPro™, the first and only FDA-cleared antibiotic-eluting biomatrix designed for use with cardiac implantable electronic devices...Read more
PH284 nasal spray demonstrated improvements to subjective feelings of hunger in cancer patients PH284 is the fifth pherine product candidate in Vistagen’s neuroscience pipeline with a positive efficacy signal SOUTH SAN FRANCISCO, Calif. / Jan 14, 2025 / Business Wire / Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced positive results from...Read more
SAN DIEGO and SUZHOU, China, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced it will host a virtual key opinion leader (KOL) event on Saturday, January 25, 2025 at 1:00 PM ET, featuring Aurélien Marabelle, MD, PhD (Université Paris-Saclay), Daneng Li, MD (City of Hope), and Marwan Fakih, MD (City of Hope), who...Read more
LA JOLLA, Calif., Jan. 14, 2025 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today announced the appointment of Alan Glicklich, M.D. to the Company's Board of Directors effective on January 15,...Read more
CAMBRIDGE, Mass., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Eterna Therapeutics (Nasdaq: ERNA), a leader in cell therapies for the treatment of advanced solid tumors, today announced positive results from a preclinical study on the company’s lead cell therapy product, ERNA-101, which is designed to activate and regulate the immune system's response to recognize and attack ovarian cancer cells. This successful proof-of-concept study demonstrated...Read more
New collaboration enhances Dario's comprehensive GLP-1 offering with virtual physician management to meet growing demand from employers covering weight-loss medications, opening new revenue streams in direct-to-consumer and pharma channels NEW YORK, Jan. 14, 2025 /PRNewswire/ -- January 14, 2025 -- DarioHealth Corp. (Nasdaq: DRIO) ("Dario" or the "Company"), a leader in the global digital health market, today announced a...Read more
A 212-patient Confirmatory Registration Study for Multikine in PD-L1 low newly diagnosed head and neck cancer patients is currently in final stage of start-up preparations - full enrollment expected by Q2 2026 Plans to seek early approval based on pre-surgical response rates A positive study outcome will position Multikine as the first treatment in over 50 years for newly diagnosed locally advanced head and neck cancer patients – a...Read more
MOUNTAIN VIEW, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems and delivery devices for the treatment of glaucoma and retinal diseases, today announced preliminary unaudited operational and financial results for the fourth quarter and full year ended December 28, 2024. Fourth Quarter 2024 Results The Company’s strategic...Read more
Pivotal Phase 3 global study (TransportNPC™) evaluating Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (“NPC1”) to be highlighted in an oral presentation GAINESVILLE, Fla. / Jan 14, 2025 / Business Wire / Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living...Read more
OGM uniquely identified a complex chromosomal rearrangement missed by classical cytogenetics, helping clinical researchers apply targeted screening to select the most fit embryos for transfer Following in-vitro fertilization, preimplantation genetic testing and selection of fit embryos, a healthy baby was born to a couple that had previously experienced years of recurrent pregnancy loss SAN DIEGO, Jan. 14, 2025 (GLOBE NEWSWIRE) --...Read more
The technology has the potential to provide life-saving support for the approximately 20 million ICU patients with respiratory failure annually RA'ANANA, Israel, Jan. 14, 2025 /PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) ("Inspira" or the "Company"), a leader in life-support technology innovation, is proud to announce the development of a modular configuration for its groundbreaking VORTX blood...Read more
VANCOUVER, British Columbia, Jan. 14, 2025 (GLOBE NEWSWIRE) -- BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech company focused on the development of BETR-001, a non-hallucinogenic derivative of lysergic acid diethylamide (“LSD”), announced that the USPTO has granted the BETR-001 composition of matter patent US publication number US2023/0219955 with expiry in 2042....Read more
Highlights: Travelan® (IMM-124E) Phase 2 Clinical Study Report submitted to the FDA Travelan® (IMM-124E) Phase 2 Clinical Study Statistically Significant Immunology Results Travelan® (IMM-124E) Phase 2 Clinical Study Statistically Significant Microbiome Responses Travelan® P2TD (n=866) Uniformed Services University field study randomized 776 subjects MELBOURNE, Australia, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX:...Read more
Submission of a Prior Approval Supplement for a reduction in the number of patients in the NEPHRO CRRT study is expected within the coming week The FDA agreed to two additional protocol changes expected to accelerate enrollment in the NEPHRO CRRT study SAN MATEO, Calif., Jan. 14, 2025 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization...Read more
Study Supported by $2.6 Million FDA Orphan Products Development Grant PRINCETON, N.J., Jan. 14, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™...Read more
Marlborough, Massachusetts--(Newsfile Corp. - January 14, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage biotechnology company that develops therapeutics using its INTASYL® siRNA gene silencing technology to make the body's immune cells more effective in killing cancer cells, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,063,670 shares of its common stock...Read more
Continued Significant Improvement in Skin Appearance Observed in Study Subject’s Disease Classification Improved from “Severe” to “Mild” after 6 Weeks Dosing Treatment area expanded from 20% Body Surface Area to “Whole Body” ASHBURN, Va., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases,...Read more
Interim data from Cohort 4 expected Q1 2025 MIAMI, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, today announced it has opened three clinical trial sites in Eastern Europe. These...Read more
Follows Safety Review Committee (SRC) approval based on safety data from patients in Cohorts 1 and 2 No significant safety or dose limiting toxicities reported in Cohorts 1 and 2 PK data from Cohorts 1 and 2 consistent with preclinical and Phase 0 trial results BOSTON, Jan. 14, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA...Read more
The acquisition will expand Lilly's oncology pipeline with STX-478, the differentiated and potentially best-in-class, mutant-selective PI3Kα inhibitor currently in a Phase 1/2 clinical trial STX-478 could potentially address 30-40% of people with hormone-positive breast cancer, building on Lilly's advancements against this disease INDIANAPOLIS and BOSTON, Mass., Jan. 13, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)...Read more
Acquisition includes CAPLYTA® (lumateperone), the first and only U.S. FDA-approved treatment for bipolar I and II depression as an adjunctive and monotherapy; also approved for the treatment of schizophrenia in adults sNDA submitted to U.S. FDA for CAPLYTA® as adjunctive treatment for major depressive disorder; if approved, CAPLYTA® has potential to become a standard of care for most common depressive disorders CAPLYTA® adds to Johnson...Read more
Pivotal data evaluating the safety and efficacy of the subretinal delivery of ABBV-RGX-314 in patients with wet age-related macular degeneration (wet AMD) are expected in 2026 AbbVie and REGENXBIO will plan the Phase 3 clinical program of investigational ABBV-RGX-314 in diabetic retinopathy (DR) NORTH CHICAGO, Ill. and ROCKVILLE, Md., Jan. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) and REGENXBIO Inc. (Nasdaq: RGNX) today announced...Read more
NORTH CHICAGO, Ill. and SHANGHAI, Jan. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096) today announced an option to license agreement to develop SIM0500, an investigational new drug candidate. SIM0500 is currently in Phase 1 clinical trials in patients with relapsed or refractory multiple myeloma (MM), in both China and the U.S. SIM0500 is a humanized...Read more
Application based on TROPION-Lung05 trial and supported by data from TROPION-Lung01 and TROPION-PanTumor01 trials Approval would mark the first for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in lung cancer WILMINGTON, Del. / Jan 13, 2025 / Business Wire / AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the US for...Read more
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.1,2 The test helps differentiate a B-cell cancer from a normal, reactive immune response, offering diagnostic certainty for healthcare providers and their patients. B-cell lymphoma accounts for approximately 85 percent of...Read more
Bristol Myers Squibb exercises an exclusive license option for ArsenalBio’s AB-4000 series programs ArsenalBio is eligible for additional milestone payments and royalties as the programs advance SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Arsenal Biosciences, Inc. (ArsenalBio), a clinical-stage programmable cell therapy company focused on engineering advanced CAR T cell therapies for solid tumors,...Read more
European approval introduces the world's only closed-loop DBS system with real-time, self-adjusting brain stimulation for people with Parkinson's disease GALWAY, Ireland, Jan. 13, 2025 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, announced today CE (Conformité Européenne) Mark approval in the European Union (EU) and the United Kingdom (UK) for BrainSense™ Adaptive deep brain stimulation (aDBS)...Read more
National coverage analysis is the first-of-its kind for a minimally invasive, interventional treatment for high blood pressure Milestone is supported by large public health need and robust, long-term data from the SPYRAL-HTN global clinical program GALWAY, Ireland, Jan. 13, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the Centers for Medicare & Medicaid...Read more
Dupixent® is now used to treat over a million patients globally, with continued growth and expansion in multiple indications for diseases in which type 2 inflammation plays a role EYLEA HD® and EYLEA® remained the U.S. anti-VEGF category leader in 2024; aggregate U.S. net product sales were $6 billion for full-year 2024, up 1% based on preliminary (unaudited) results EYLEA HD pre-filled syringe (PFS) submission completed; launch...Read more
Primary endpoint of DFS met at first prespecified interim analysis, showing a 68% reduction in the risk of disease recurrence or death in patients with high-risk CSCC after surgery compared to placebo Libtayo is the first and only immunotherapy to show a statistically significant and clinically meaningful benefit in high-risk CSCC in the adjuvant setting; a recent Phase 3 trial with Keytruda® failed in the same setting1 Libtayo is...Read more
The Truveta collaboration will extend Regeneron Genetics Center’s® (RGCTM) world-leading DNA sequence-linked healthcare database (now including almost three million de-identified patient volunteers) through genetic sequencing of up to ten million additional patient volunteers, all with linked electronic health records, creating the Truveta Genome Project Extensively expanded database effort is designed to dramatically accelerate...Read more
Acquisition includes IDRX-42, a highly selective KIT tyrosine kinase inhibitor (TKI) designed to treat gastrointestinal stromal tumours (GIST) IDRX-42 offers potential to address all key KIT mutations in GIST that drive tumour growth and progression and improve tolerability, gaps in current therapies Acquisition adds to GSK’s growing portfolio in gastrointestinal (GI) cancers GSK to pay up to $1.15 billion PLYMOUTH, Mass. / Jan 13,...Read more
RESEARCH TRIANGLE PARK, N.C. / Jan 13, 2025 / Business Wire / IQVIA (NYSE:IQV), a leading global provider of clinical research services, commercial insights, and healthcare intelligence, today announced a strategic collaboration with NVIDIA to help realize the potential of AI in healthcare and life sciences. The healthcare and life sciences industries generate vast amounts of data, representing significant potential for AI-powered...Read more
PLEASANTON, Calif., Jan. 13, 2025 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today announced participation in the following investor conference: 27th Annual Needham Growth Conference. Brian Van Wagener, CFO, and Paul Shawah, EVP Strategy, will present on Thursday, January 16, 2025, at 1:30 p.m. Eastern Time. The above presentation will be webcast. Link to the live and archived webcast will be available on Veeva's...Read more
SAN DIEGO / Jan 13, 2025 / Business Wire / DexCom, Inc. (Nasdaq: DXCM) today reported preliminary, unaudited results for the fourth quarter ended December 31, 2024 with total revenue of at least $1.113 billion, an increase of 8% over the fourth quarter of 2023. U.S. revenue is expected to be approximately $803 million, representing growth of 4% over the fourth quarter of 2023. International revenue is expected to be approximately $310...Read more
Klinge Biopharma GmbH (Klinge) holds the exclusive global commercialization rights for FYB203, Formycon's biosimilar candidate to Eylea®1 Agreement builds on the proven and successful collaboration of commercialization of FYB201, Formycon's biosimilar to Lucentis®2 (ranibizumab) in Europe The partnership broadens Teva's biosimilars portfolio, in line with its Pivot to Growth strategy TEL AVIV, Israel, Jan. 13, 2025 (GLOBE NEWSWIRE)...Read more
Collaboration combines Illumina's sequencing technologies and Illumina Connected Software with NVIDIA tools to develop biological foundation models SAN DIEGO, Jan. 13, 2025 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN), a global leader in genomic sequencing and analysis, today announced it is collaborating with NVIDIA to advance technology platforms for the analysis and interpretation of multiomic data, accelerating progress in...Read more
Study will generate a key reference data set with Illumina Protein Prep solution SAN DIEGO, Jan. 13, 2025 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced a pilot proteomics program to analyze 50,000 UK Biobank samples in collaboration with deCODE Genetics, Standard BioTools, Tecan, GSK, Johnson & Johnson, and Novartis. The pilot program is based on...Read more
LEQEMBI is the only FDA-approved anti-amyloid therapy that potentially could offer the convenience of a subcutaneous injection with at-home administration option TOKYO and CAMBRIDGE, Mass., Jan. 13, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S....Read more
The Omnipod 5 Automated Insulin Delivery System is now commercially available in Italy, Denmark, Finland, Norway, and Sweden with Abbott’s FreeStyle Libre 2 Plus and Dexcom G6 ACTON, Mass. / Jan 13, 2025 / Business Wire / Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced the Omnipod 5 Automated Insulin Delivery System...Read more
WALTHAM, Mass. & SAN DIEGO / Jan 13, 2025 / Business Wire / Revvity, Inc. (NYSE: RVTY), today announced a strategic agreement to commercialize an in vitro diagnostic (IVD) workflow solution for neonatal sequencing, co-developed with Element Biosciences, Inc., a life science company democratizing access to advanced DNA and multi-omic sequencing solutions. This initiative builds upon Revvity's recent introduction of an automated...Read more
2025 will be a transformational year for Incyte with multiple significant milestones, including four potential launches, four pivotal trial readouts, seven proof of concept data readouts and at least three Phase 3 study initiations Well-positioned for long-term growth, the Company has the potential to deliver more than 10 high impact launches across its portfolio by 2030 WILMINGTON, Del. / Jan 13, 2025 / Business Wire / Incyte...Read more
Achieved 2024 product sales of $3.0 to 3.1 billion (unaudited) and an ending cash balance of approximately $9.5 billion (unaudited) Updates 2025 expected revenue range to $1.5 to 2.5 billion Expects to reduce 2025 cash cost expenses by $1.0 billion with a plan for additional 2026 cost reductions of $0.5 billion Updates 2025 expected ending cash balance to approximately $6.0 billion Anticipates milestones across 10 prioritized...Read more
Preliminary total net product revenue of $638.2 million for the fourth quarter and $1.79 billion for full-year 2024, exceeding full-year guidance by over $100 million Preliminary ELEVIDYS net product revenue totaled $384.2 million for the fourth quarter, exceeding guidance by over $60 million, and $820.8 million for full-year 2024 Preliminary RNA-based PMO net product revenue for the fourth quarter and full-year of 2024 totaled $254.0...Read more
WILMINGTON, Mass. / Jan 13, 2025 / Business Wire / Charles River Laboratories International, Inc. (NYSE: CRL) announced today that it will present at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14th, at 2:15 p.m. PT (5:15 p.m. ET). Management will present an overview of Charles River’s strategic focus, business developments, and recent trends. A live webcast of the presentation will be available through a link...Read more
DRAPER, Utah, Jan. 13, 2025 (GLOBE NEWSWIRE) -- HealthEquity, Inc. (NASDAQ: HQY) (“HealthEquity” or the “Company”), the nation’s largest health savings account (“HSA") custodian, today announced estimates of HSAs, HSA Assets and Total Accounts for its fiscal year ending January 31, 2025, reflecting a strong sales year with record New HSAs from Sales and strong custodial HSA Asset growth. Estimated HSAs to be approximately 9.8 million...Read more
Remarkable early Attruby demand: 430 scripts written by 248 unique HCPs since FDA approval with broad uptake across academic centers and community centers in all patient types Fully enrolled three major market Phase 3 clinical trials: FORTIFY (BBP-418 for LGMD2I/R9); CALIBRATE (encaleret for ADH1); and PROPEL 3 (infigratinib for Achondroplasia) Well-financed to launch Attruby and read out major market Phase 3 trials: $406M in...Read more
Enhances Lantheus’ growth profile with Neuraceq®, a globally approved F-18 PET imaging agent used to detect beta-amyloid plaques in patients evaluated for Alzheimer’s Disease Advances Lantheus’ radiopharmaceutical leadership with addition of Alzheimer’s radiodiagnostic commercial infrastructure, expanded pipeline, and enhanced R&D capabilities Transaction expected to be accretive to adjusted EPS within the first 12 months Company...Read more
Healthcare providers gain access to first-of-its-kind generative AI technology, leading to faster and more accurate payments LEHI, Utah, and LOUISVILLE, Ky., Jan. 13, 2025 /PRNewswire/ -- Waystar (Nasdaq: WAY), a provider of leading healthcare payment software, today announced the launch of Waystar AltitudeAI™, a comprehensive set of AI capabilities for providers, including AltitudeCreate™, a new generative AI innovation focused on...Read more
Preliminary fourth-quarter and full-year 2024 Rezdiffra™ (resmetirom) net sales ranges of $100 million to $103 million and $177 million to $180 million, respectively Preliminary year-end 2024 cash, cash equivalents, restricted cash and marketable securities of approximately $931 million As of year-end 2024, more than 11,800 patients on Rezdiffra Madrigal to present at the 43rd Annual J.P. Morgan Healthcare Conference at 2:15 p.m. PST...Read more
VAUGHAN, Ontario / Jan 13, 2025 / Business Wire / Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced the commercial launch of the enVista Aspire monofocal and toric intraocular lenses (IOLs) in the European Union after receiving a CE Mark late last year. enVista Aspire combines novel Intermediate Optimized optics, which are designed for a...Read more
VAUGHAN, Ontario / Jan 13, 2025 / Business Wire / Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced an affiliate has acquired Whitecap Biosciences, LLC, which is currently developing two innovative therapies for potential use in glaucoma and geographic atrophy (GA). The acquisition strengthens Bausch + Lomb’s expanding clinical-stage...Read more
2024 preliminary unaudited revenue in the range of approximately $1.355 billion - $1.357 billion, up approximately 7.7% - 7.9% year-over-year 2024 preliminary constant currency revenue* increased in the range of approximately 8.4% - 8.6% year over year 2024 financial results and 2025 guidance to be released February 25, 2025 * Constant currency revenue is a non-GAAP financial measure. A reconciliation of this financial measure...Read more
MELBOURNE, Australia and INDIANAPOLIS, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today provides an update on its commercial and operational performance for the quarter ended 31 December 2024 (Q4 2024). Sustained revenue growth Q4 2024 unaudited revenue of approximately US$142 million (AU$218 million)1, represents an increase of 46% over the prior year corresponding...Read more
MELBOURNE, Australia and INDIANAPOLIS, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today advises that Dr. Christian Behrenbruch, Managing Director and Group CEO, will be presenting this week at the 43rd Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA (U.S.A.). The presentation will take place this Wednesday, 15 January at 2:15 pm PST (5:15 pm...Read more
MINNEAPOLIS, Minn, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (“Inspire”, or the “Company”), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea, today announced certain preliminary, unaudited results for the fourth quarter and full year ended December 31, 2024, and provided its initial full...Read more
CHICAGO / Jan 13, 2025 / Business Wire / Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced select, preliminary, unaudited results for the fourth quarter and full year ended December 31, 2024. Full Year 2024 Select, Preliminary, Unaudited Financial Results Revenue of approximately $693 million, representing approximately 30% growth...Read more
CHICAGO / Jan 13, 2025 / Business Wire / Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced the company is developing its first whole-genome sequencing test, xH. This test marks Tempus’ first foray into adopting whole-genome sequencing (WGS) as a platform, supporting clinicians with detection of all clinically-relevant variants and advancing the...Read more
BANNOCKBURN, Ill., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Option Care Health, Inc. (the “Company” or “Option Care Health”) (Nasdaq: OPCH), the nation’s largest independent provider of home and alternate site infusion services, announced today preliminary unaudited financial results for the fourth quarter and full year ended December 31, 2024. For the fourth quarter 2024, Option Care Health expects to report: Net revenue of...Read more
Full year revenue growth of 31% driven by strong clinical and biopharma volume and Guardant360 ASP tailwinds PALO ALTO, Calif. / Jan 13, 2025 / Business Wire / Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced preliminary, unaudited results for the quarter and full year ended December 31, 2024. Fourth quarter 2024 preliminary unaudited financial results For the three-month period ended December...Read more
Auvelity preliminary 4Q and full year 2024 net product sales of $92.6 million and $291.4 million, respectively Sunosi preliminary 4Q and full year 2024 net product revenue of $25.7 million and $93.8 million, respectively NEW YORK, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced...Read more
FY 2024 Preliminary Unaudited Total Revenue of Approximately $417-425 Million, Exceeding Previous Guidance of $415 Million YE 2024 Total Cash Grew to More than $100 Million, an Increase of Approximately $45 Million Q-o-Q, Notwithstanding $30 Million of Debt Organically Discharged During 4Q 2024 Newly Executed High Titer Plasma Supply Contracts Expected to Provide Foundation for Durable ASCENIV Revenue Growth Through Late 2030s PAS...Read more
Presents progress and new anticipated milestones across portfolio of more than 10 assets and 6 therapeutic areas. Announces multiple advancements across the MoDETM (molecular degraders of extracellular proteins) platform and the next generation TRAPTM (targeted removal of aberrant protein) degraders, including: IgA Nephropathy (IgAN) program: First-in-human dosing with BHV-1400, a next generation TRAP degrader, achieved rapid,...Read more
Reports $709 million in preliminary1 full-year 2024 U.S. net product revenues $611 million in SYFOVRE® U.S. net product revenues, including $167 million in 4Q 2024 $98 million in EMPAVELI® U.S. net product revenues, including $23 million in 4Q 2024 Expects submission of EMPAVELI sNDA for C3G and primary IC-MPGN in early 2025; U.S. launch anticipated in 2H 2025, if approved Plans initiation of Phase 3 studies of...Read more
NEW YORK, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced that it has agreed to sell an aggregate of 22,500,000 shares of common stock at a purchase price of $20.00 per share to three institutional accredited investors in a private investment in public equity (PIPE). Immunovant anticipates...Read more
Preliminary full year 2024 net revenues of $605 million and fourth quarter net revenues of $161 million Novocure to present at the 43rd Annual J.P. Morgan Healthcare Conference at 9:00 a.m. PST on Wednesday, January 15, 2025 BAAR, Switzerland / Jan 13, 2025 / Business Wire / Novocure (NASDAQ: NVCR) today reported preliminary unaudited financial and operational results for the quarter and full year ended December 31, 2024. Novocure is...Read more
Top-line Results In Line with Expectations; Company Expects to Report Fourth Quarter and Full Year 2024 Financial Results on February 12, 2025 SAN DIEGO / Jan 13, 2025 / Business Wire / QuidelOrtho Corporation (Nasdaq: QDEL) (the “Company” or “QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, today announced preliminary unaudited...Read more
Indication expands to include treatment-naïve patients The 2021 conditional approval in previously treated patients converted to full approval HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 14, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the supplemental New Drug Application for ORPATHYS® (savolitinib) has been granted approval by the China...Read more
BRENTWOOD, Tenn., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Surgery Partners, Inc. (NASDAQ:SGRY) (“Surgery Partners” or the “Company”) today announced that Dr. Laura L. Forese has been appointed to serve as an independent director on its Board of Directors. Dr. Forese’s appointment, which is effective January 10, 2025, will increase the size of Surgery Partners’ Board to eleven members. Dr. Forese joins the Surgery Partners Board with...Read more
Achieves 35% year-over-year growth to 209,900 members on Jan. 1, showing how Medicare Advantage can be done right Announces year-end 2025 health plan membership of 225,000 to 231,000 and reiterates confidence in achieving consensus adjusted EBITDA of $40 million in 2025 ORANGE, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Alignment Healthcare, Inc. (NASDAQ: ALHC), an award-winning Medicare Advantage (MA) company, today announced Jan....Read more
Achieved $61.5 million and $172.0 million in preliminary fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively Ended 2024 with approximately $462 million in cash, cash equivalents, and marketable securities Additional updates across Company’s commercial portfolio and investigational pipeline to be provided during J.P. Morgan Healthcare conference presentation today at 11:15 a.m....Read more
BRISBANE, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic...Read more
2024 net product sales of approximately $336 million exceeds upper end of guidance range; preliminary and unaudited estimate 2025 expected global net product sales of $420 million to $435 million VISTAS study of volixibat in primary sclerosing cholangitis expected to complete enrollment in second half 2025; topline data expected 2026 FOSTER CITY, Calif. / Jan 13, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today...Read more
WAKIX® (pitolisant) Preliminary Net Revenue of ~$201 Million for Fourth Quarter and ~$714 Million for Full Year 2024; Representing Growth of ~23% in Year-Five of Launch 2025 WAKIX Net Revenue Guidance Between $820 - $860 Million; On Track to a Potential $1 Billion+ Opportunity Value-Creating Catalysts Anticipated Every Quarter in 2025: - Q1 – FDA Decision on File Acceptance of Pitolisant sNDA...Read more
Expects to exceed guidance with full year 2024 revenues1 of at least $299 million Expects fourth quarter 2024 revenues1 of at least $92 million Expects to exceed guidance with full year 2024 adjusted gross margin1 of at least 64% Expects fourth quarter 2024 adjusted gross margin1 of at least 68% STAMFORD, Conn. / Jan 13, 2025 / Business Wire / GeneDx Holdings Corp. (Nasdaq: WGS), a leader in delivering improved health outcomes...Read more
BLOOMFIELD, Conn., Jan. 13, 2025 /PRNewswire/ -- Cigna Healthcare, the health benefits division of The Cigna Group (NYSE: CI), today announced a new offering in collaboration with Progyny, Inc (Nasdaq: PGNY) that makes best-in-class fertility and family-building services accessible and equitable for more employers. This new and comprehensive benefit will enable employers to offer expanded coverage throughout the entire fertility journey,...Read more
MASON, Ohio / Jan 13, 2025 / Business Wire / AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management, today announced preliminary financial results for the fourth quarter and full year 2024 and provided 2025 financial guidance. Additionally, AtriCure announced that it will host an Analyst & Investor...Read more
PURCHASE, NY, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Teladoc Health (NYSE: TDOC), the global leader in virtual care, today announced a new collaboration with Amazon to expand access to Teladoc’s industry-leading chronic condition programs. Customers of Amazon that are eligible for Teladoc Health’s diabetes, hypertension, pre-diabetes and weight management programs can now seamlessly discover and enroll in these benefits directly through...Read more
Preliminary 2024 HEPLISAV-B® net product revenue grew 26% year-over-year to approximately $268 million Enrollment completed in Phase 1/2 shingles trial; top line results expected in Q3 2025 New $30 million contract with U.S. Department of Defense to advance plague vaccine program Cash, cash equivalents and marketable securities were approximately $714 million as of December 31, 2024 EMERYVILLE, Calif., Jan. 13, 2025 /PRNewswire/...Read more
Full-year 2024 total revenue grew 27% to approximately $611 million Expect full-year 2025 total revenue of $732 million and positive free cash flow CARLSBAD, Calif. / Jan 13, 2025 / Business Wire / Alphatec Holdings, Inc. (Nasdaq: ATEC), a provider of innovative solutions dedicated to revolutionizing the approach to spine surgery, announced today preliminary financial results for the fourth quarter and full-year ended December 31,...Read more
601 patients have been enrolled in the double-blind portion of the SYNCHRONY Real-World study since initiation in November 2023 Data from SYNCHRONY Real-World study anticipated in the first half of 2026 SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked...Read more
Fourth Quarter Revenue is Expected to Increase 30% Year-Over-Year Expects Full Year 2024 Revenue of $332 Million to $333 Million BRISBANE, Calif. / Jan 13, 2025 / Business Wire / CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – today reported preliminary, unaudited financial results for the fourth quarter and full year ended December 31, 2024. Preliminary Fourth Quarter 2024 Financial Results Revenue is expected to be...Read more
Fourth quarter Cell Processing revenue increased 7% sequentially to $20.3 million Unaudited revenue for FY2024 from Cell Processing of $73.5 million, exceeded the high end of previously raised guidance BOTHELL, Wash., Jan. 13, 2025 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS) ("BioLife" or the "Company"), a leading developer and supplier of bioproduction products and services for the cell and gene therapy (CGT)...Read more
Preliminary 2024 OJEMDA™ (tovorafenib) net product revenue of approximately $57.2 million (unaudited) First dose cohort cleared in Phase 1a/b clinical trial of DAY301 (PTK7-targeted ADC) Ended 2024 with approximately $531.7 million in cash, cash equivalents and short-term investments (unaudited) Company to present at 43rd Annual J.P. Morgan Healthcare Conference today at 3:45 p.m. Pacific Time (6:45 p.m. Eastern Time)...Read more
For full year 2024, the Company expects total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS to be at or above the guidance ranges provided on November 8, 2024 Rare Disease Segment performed in line with expectations, with Purified Cortrophin Gel net revenues of $197.8 million to $198.4 million for the full year 2024 and ILUVIEN and YUTIQ net revenues of $30.4 million to $31.0 million for the post-acquisition...Read more
Preliminary fourth quarter neffy® net product revenue of approximately $6.5 million Preliminary cash, cash equivalents and short-term investments of $314.0 million at year-end 2024 to support an operating runway of at least three years Company to present at 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025 at 7:30am PT SAN DIEGO, Jan. 13, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY),...Read more
Assertio is a leading commercial pharmaceutical company bringing differentiated products to patients. The Company has a robust portfolio of branded prescription products in three areas: neurology, hospital, and pain and inflammation. Assertio has grown through...
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Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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