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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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
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
Topline ATTENTION-AD trial: Patients showed improved cognition and function over three years Delayed-start analysis of treatment with oral blarcamesine was significant reflecting importance of early treatment initiation Blarcamesine exhibited a favorable safety profile with no treatment-related deaths NEW YORK, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage...Read more
VANCOUVER, British Columbia / Jan 13, 2025 / Business Wire / AbCellera (Nasdaq: ABCL) announced today that it has expanded its existing collaboration with AbbVie Inc. (NYSE: ABBV) to include the discovery of T-cell engagers (TCE) in oncology. The expansion builds upon the successful partnership established in December 2022 and includes access to AbCellera’s TCE platform to develop therapeutic antibodies for tumor targets. “We are pleased...Read more
Updated topline Phase 1 combination data for zelenectide pevedotin plus pembrolizumab continue to show promising anti-tumor activity and a differentiated safety profile in first-line cisplatin-ineligible metastatic urothelial cancer NECTIN4 gene amplification development strategy underway for zelenectide pevedotin in breast cancer, lung cancer and multiple tumors, with several Phase 1/2 trials planned to start in 2025 Emerging...Read more
Announces encouraging early safety and efficacy data in ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with mCRPC Entered into clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate ORIC-114 in combination with subcutaneous amivantamab for the first-line treatment of NSCLC patients with EGFR exon 20 insertion mutations Expects to report seven data readouts...Read more
SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Jan. 13, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that the company has entered into a supply agreement with Janssen Research & Development, LLC, a Johnson & Johnson company, to evaluate ORIC-114, a brain penetrant, orally...Read more
Symvess is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for use in arterial replacement and repair Highly experienced sales team onboard and trained in preparation for commercial launch Budget Impact Model supports pricing of Symvess DURHAM, N.C., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing...Read more
Results demonstrate the importance of ultra-sensitive ctDNA detection in lung cancer FREMONT, Calif. / Jan 13, 2025 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), in collaboration with Professor Charles Swanton and his colleagues at London’s Francis Crick Institute and University College London, published new results from their TRACERx lung cancer study in Nature Medicine. In this groundbreaking study funded by Cancer Research UK,...Read more
Single Pivotal Trial Designed to Demonstrate Efficacy and Safety of Every 3- and Every 6-Month Administration in a 6-Month Treatment Period Pioneering Patient-Centric Dosing Flexibility in HAE with Potential Market-Leading First-Choice Profile Phase 3 Initiation On-Track, Expected in Q1 2025 Strong Financial Position, Funded Through Expected Top-Line Phase 3 Results BOSTON / Jan 13, 2025 / Business Wire / Astria...Read more
Collaboration leverages Ginkgo's cell engineering and screening platform to enhance the potency and persistence of Universal Cells' iPSC-derived immune cell therapeutics BOSTON, Jan. 13, 2025 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, today announced a research collaboration with Universal Cells, an Astellas company, to optimize next-generation...Read more
KRRO-110 is the first product candidate from Korro’s proprietary RNA editing OPERATM platform Interim readout from REWRITE expected in the second half of 2025 Korro to advance additional pipeline programs towards clinical development CAMBRIDGE, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a clinical-stage biopharmaceutical company focused on developing a new class of genetic medicines based on...Read more
BURLINGAME, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new interim data from the randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The data, which include previously reported results from cohort 1 of the trial and new data covering...Read more
Preliminary Full-Year 2024 Product Revenues Total $180.3 million, 15% Over 2023 Results and Exceed Prior Product Revenue Guidance 2025 Product Revenues Expected to be Between $194-$200 million, Reflecting 8%-11% Growth Year-Over-Year CONCORD, Calif. / Jan 13, 2025 / Business Wire / Cerus Corporation (Nasdaq: CERS) today announced preliminary product revenue for the fourth quarter and full-year 2024 and provided product revenue...Read more
PRGN-2012 has potential to be first FDA-approved therapeutic for treatment of RRP, a rare and devastating chronic disease Company completed BLA submission for PRGN-2012 for treatment of adults with RRP Commercial readiness activities underway in anticipation of potential launch of PRGN-2012; Company started 2025 with approximately $100 million cash on-hand* with cash runway well into 2026, beyond the anticipated launch in...Read more
DURHAM, N.C., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, announced today that Dr. Joshua E. Allen, Chief Scientific Officer at Chimerix, will speak at the Biden Cancer Moonshot Mission Report 2024 – And Beyond. Dr. Allen’s remarks will cover the program’s impact on...Read more
Global Phase 3 HCV Program Expected to Initiate in 1Q 2025 Potential Best-in-Class Profile of Bemnifosbuvir + Ruzasvir Regimen Supports Opportunity to Disrupt and Expand Global HCV Market of Approximately $3 Billion in Annual Net Sales The Regimen, if Approved, Should Play an Important Role in Efforts to Reduce the Continuing High Disease Burden of HCV BOSTON, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq:...Read more
100% (9/9) of treated evaluable subjects demonstrated improvement or preservation in visual function compared to untreated eyes at both one and two years 100% (9/9) of treated evaluable subjects demonstrated improvement or stabilization in mobility testing, which was only performed up to one year Improvement in visual function was statistically significant (p=0.01, treated vs untreated eyes), regardless of mutation at two...Read more
Independent Data Safety Monitoring Board (DSMB) recommends study to proceed without modifications based on initial safety assessment of 400 participant 30-day data The company plans to progress the trial to enrollment of 10,000 participants, upon favorable review from the U.S. Food and Drug Administration (FDA) and upon Biomedical Advanced Research and Development Authority (BARDA) approval SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025...Read more
STAFFORD, Texas, Jan. 13, 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 activation of clinical sites in France. According to the latest data collected by the European Cancer Information System (click...Read more
The Company will present at the Annual J.P. Morgan Healthcare Conference, providing business updates on its sarcoma franchise and other cell therapy pipeline assets Adaptimmune Allo-T program to be featured at the Biotech ShowCase(TM) and the Wuxi Global Forum 2025 Philadelphia, Pennsylvania and Oxford, United Kingdom--(Newsfile Corp. - January 13, 2025) - Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine...Read more
Extending Company's leadership position in autoimmune CAR T with prioritized indication strategy; pivoting to late-stage development and commercialization First-to-market opportunity with KYV-101 in stiff person syndrome; 40% enrolled in pivotal Phase 2 trial with first BLA filing targeted for 2026; fast-follow indications in myasthenia gravis and lupus nephritis Efficiently expanding into broader autoimmune indications and increasing...Read more
Company also announces strong enrollment progress for REMAIN-1 weight maintenance pivotal study High demand from patients and physicians indicates significant interest in REMAIN-1 study and GLP-1 discontinuation; mid-point analysis on-track and anticipated in Q2 2025 BURLINGTON, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering pattern...Read more
X4 to receive a €28.5 million upfront payment and up to €226 million in potential regulatory and commercial milestone payments in addition to tiered, double-digit royalties up to the mid-twenties Upfront non-dilutive funds strengthen X4’s balance sheet as enrollment ramps up in the company’s global Phase 3 clinical trial in chronic neutropenia Agreement underscores Norgine’s commitment to bring transformative therapies to patients in...Read more
Opportunity to Define a New Myelofibrosis Treatment Paradigm with Top-Line Data Readout from Phase 3 SENTRY Trial Evaluating Selinexor in Combination with Ruxolitinib in Patients with JAKi-Naïve Myelofibrosis Anticipated in 2H 2025; Company On Track to Complete Enrollment in 1H 2025 Recently Announced Key Leadership Changes, including the Appointment of Lori Macomber as Chief Financial Officer and Brendan Strong as SVP of...Read more
Mr. Pasternak brings decades of global pharmaceutical leadership experience Transition further highlights transformation of the Board to lead Context into next phase of growth PHILADELPHIA, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing T cell engagers for solid tumors, today announced the appointment of Andy Pasternak as Chairman of its...Read more
CAMBRIDGE, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- CAMP4 Therapeutics Corporation (“CAMP4”) (Nasdaq: CAMP), a clinical-stage biotechnology company developing regRNA-targeting antisense oligonucleotide (ASO) therapies to upregulate gene expression to restore healthy protein levels, today announced that Josh Mandel-Brehm, President & CEO, will present a corporate update at the 43rd Annual J.P. Morgan Healthcare Conference taking place...Read more
Two new partial responses (PRs) reported in Phase 2a arm studying IMM-1-104 in combination with modified FOLFIRINOX (mFFX) in first-line pancreatic cancer Overall Response Rate (ORR) of 50%; historic benchmark of 32% for FOLFIRINOX alone Nearly $14M in net proceeds raised in January 2025 through utilization of Company’s ATM CAMBRIDGE, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX),...Read more
Halifax, Nova Scotia--(Newsfile Corp. - January 13, 2025) - Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona") is pleased to announce that the now complete findings from our previously announced pre-clinical breast cancer and melanoma efficacy studies have been published in the peer-reviewed scientific journal, Frontiers in Immunology. This research article includes new follow-up data which provides a comprehensive...Read more
VANCOUVER, British Columbia, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV), a biopharmaceutical company dedicated to advancing new cancer therapies based on novel DNA-damage response technologies, is pleased to announce the successful achievement of a shortlist of AI-generated molecules targeting ATR (Ataxia Telangiectasia and Rad3-related protein) with specific designs for central nervous system (CNS)...Read more
SHELTON, CT / ACCESSWIRE / January 13, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, announced today that it is presenting at Biotech Showcase™ 2025 in San Fransisco, being held in parallel to the JP Morgan Life Sciences Conference. Event Information: Event NanoViricides Presentation at the...Read more
SAN DIEGO, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced that its abstract, titled "Development of a Systemic Enveloped Virotherapy for Targeting All Metastatic Sites", has been accepted for presentation at the American Association for Cancer Research (AACR) Annual...Read more
NEW YORK, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announced that it has entered into securities purchase agreements with investors for the issuance and sale in a private placement priced at-the-market under Nasdaq rules of an aggregate of 2,109,383 of its shares of common...Read more
Ainos invites robotics and humanoid companies to join Ainos Alliance and digitize smell Ainos is now inviting robotics and humanoid companies worldwide to join its Ainos Alliance, leveraging nearly a decade of research, development, and success in this field. With multiple patents secured, AI Nose represents the culmination of years of innovation and is poised to lead the next wave of advancements in robotics. This is the perfect...Read more
Pathologic Complete Response reported for 2 patients with cutaneous Squamous Cell Carcinoma Marlborough, Massachusetts--(Newsfile Corp. - January 13, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL® siRNA gene silencing technology designed to make the body's immune cells more effective in killing cancer cells. Phio today announced pathologic...Read more
The first selective Fatty Acid Binding Protein 5 inhibitor safely administered to human subjects Initial safety and pharmacokinetic data expected during the first half 2025 SOLANA BEACH, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, or dermatologic and...Read more
Decoy’s proprietary IMP3ACT™ peptide conjugate drug design and manufacturing platform leverages machine learning (ML) and artificial intelligence (AI) tools Decoy is leveraging non-dilutive funding and equivalents from federal governments, corporations and The Bill & Melinda Gates Foundation totaling approximately $7 million Combined company expects to accelerate clinical development of novel peptide conjugate therapeutics for the...Read more
EDINBURGH, Scotland, Jan. 13, 2025 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP), a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced that CEO Bryan Kobel will be presenting a corporate overview at the upcoming Sequire Investor Summit 2025. The conference is scheduled for January...Read more
WARRINGTON, Pa., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced the appointment of Leanne Kelly to its board of directors (“Board”). Ms. Kelly has significant public company executive experience and joins the Board as an independent...Read more
BOSTON / Jan 12, 2025 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced multiple program updates ahead of upcoming investor meetings in January, including the company’s scheduled webcast from the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 10:30 a.m. ET/7:30 a.m. PT. “2024 marked another year of excellent progress for Vertex, as we reached more people with CF than ever...Read more
Full Year 2024 Preliminary Net Product Revenues of $1,646 Million for ONPATTRO®, AMVUTTRA®, GIVLAARI®, and OXLUMO®, Representing 33% Annual Growth 2025 Combined Net Product Revenue Guidance** of $2,050 Million to $2,250 Million Positions Company to Achieve Alnylam P5x25 Goal of Non-GAAP Profitability Robust Clinical Pipeline with Multi-Billion-Dollar Opportunities for Sustainable Growth CAMBRIDGE, Mass. / Jan 12, 2025 / Business Wire...Read more
Cabozantinib franchise achieves approximately $1.805 billion in preliminary U.S. net product revenues for fiscal year 2024 Fiscal year 2025 net product revenues guidance of $1.95 billion - $2.05 billion Presentation and webcast at 43rd Annual J.P. Morgan Healthcare Conference tomorrow, Monday, January 13th at 5:15 p.m. PT / 8:15 p.m. ET ALAMEDA, Calif. / Jan 12, 2025 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced its...Read more
Ascendis positioned to drive rapid revenue growth COPENHAGEN, Denmark, Jan. 12, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today provided a business and strategic roadmap update, including planned 2025 key corporate milestones. Ascendis President and CEO Jan Mikkelsen will present this update tomorrow, January 13, during the 43rd Annual J.P. Morgan Healthcare Conference. “Ascendis is well-positioned for rapid...Read more
Updating peak systemic mastocytosis franchise revenue opportunity to $4 billion, catalyzed by strong AYVAKIT® (avapritinib) launch and evolving SM prevalence estimates Expect to achieve $2 billion in AYVAKIT revenue by 2030 BLU-808 demonstrates wide therapeutic window with rapid, robust and sustained tryptase reductions exceeding 80% in Phase 1 healthy volunteer study Kate Haviland, CEO, to present at J.P. Morgan conference...Read more
Preliminary 2024 total revenue of $555 million to $560 million, exceeding top end of guidance, including Crysvita® revenue of $405 million to $410 million, and Dojolvi® revenue of $87 million to $89 million 2025 expected total revenue guidance of $640 million to $670 millionUX143 (setrusumab) Phase 3 Orbit study for osteogenesis imperfecta progressing to second interim analysis in mid-2025 GTX-102 Phase 3 Aspire study for...Read more
2024 Total Revenue of $528M, Representing Significant Growth of 32% Year-Over-Year1 Strong and Growing Demand for Galafold® and Pombiliti® + Opfolda® Total Revenue Growth of 17-24% at CER Expected in 2025 >3,000 People Treated with an Amicus Therapy Today2 PRINCETON, N.J., Jan. 12, 2025 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and...Read more
NEW HAVEN, Conn. and UTRECHT, The Netherlands and CAMBRIDGE, Mass., Jan. 12, 2025 (GLOBE NEWSWIRE) -- Biohaven Ltd. (NYSE: BHVN) and Merus N.V. (Nasdaq:MRUS), today announced a research collaboration and license agreement to co-develop three novel bispecific antibody drug conjugates (ADCs), leveraging Merus’ leading Biclonics® technology platform, and Biohaven’s next-generation ADC conjugation and payload platform...Read more
SOUTH SAN FRANCISCO, Calif., Jan. 12, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation at the 43rd Annual J.P. Morgan Healthcare Conference and provided 2025 corporate guidance and program updates. 43rd Annual J.P. Morgan Healthcare ConferenceMonday, January 13th, 2025, at 5:15 PM PT (8:15 PM...Read more
| Company | Change | Last Trade |
|---|---|---|
| Finch Therapeutics | 8.80 488.89 | $10.60 |
| Evaxion Biotech | 2.72 320.00 | $3.57 |
| Sarepta Therapeutics | 2.66 2.25 | $121.09 |
| Kymera Therapeutics | 2.38 6.39 | $39.61 |
| TG Therapeutics | 2.35 8.49 | $30.02 |
| Verona Pharma | 2.30 4.93 | $49.00 |
| Praxis Precision Medicines | 2.19 3.42 | $66.21 |
| BioNTech | 1.70 1.49 | $115.44 |
| BridgeBio Pharma | 1.57 4.65 | $35.30 |
| Instil Bio | 1.20 6.31 | $20.22 |
| United Therapeutics | 1.17 0.32 | $364.05 |
| ORIC Pharmaceuticals | 0.83 9.65 | $9.43 |
| Immunovant | 0.81 3.56 | $23.56 |
| Exicure | 0.80 10.13 | $8.71 |
| MoonLake Immunotherapeutics | 0.63 1.39 | $45.89 |
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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Recursion Pharmaceuticals is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest....
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