BLA priority review of RP1 plus nivolumab in advanced melanoma proceeding on schedule; manufacturing inspections and late cycle review meeting complete Full commercial infrastructure for launch in place ahead of July 22nd PDUFA date Conference call today at 8:00 AM ET WOBURN, Mass., May 22, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel...Read more
Management to host conference call and webcast on Thursday, May 22, 2025 at 8:30 AM ET PETACH TIKVA, Israel, May 22, 2025 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging technology company, today announced results for the first quarter ended March 31, 2025, and provided a business update. Recent Highlights: Generated $2.8 million in revenue in the first quarter of...Read more
Company to host conference call Today, Thursday, May 22nd at 11am ET/8am PT CARLSBAD, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a leader in spine and interventional spine technology that improves spinal surgery outcomes, today announced its financial results for first quarter ended March 31, 2025. All figures are in U.S. dollars. Financial...Read more
TEL AVIV, Israel, May 22, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological indications, reports financial results for the three months ended March 31, 2025 and recent developments. Key Recent Developments Announced First Time Results in Oncology Studies: Aramchol Significantly Enhances Bayer's...Read more
Pittsburgh, Pennsylvania and Toronto, Ontario--(Newsfile Corp. - May 22, 2025) - Sharp Therapeutics Corp. (TSXV: SHRX) ("Sharp" or the "Company"), a pre-clinical-stage biotechnology company developing small molecule therapies to treat genetic diseases, announces the release of its condensed interim consolidated financial statements for the three months ended March 31, 2025, and related management discussion and analysis. All dollar...Read more
Building momentum in key franchises including Pulsed Field Ablation, TAVR, Cardiac Rhythm Management, Diabetes, Spine, and Neuromodulation GALWAY, Ireland, May 21, 2025 /CNW/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced financial results for its fourth quarter (Q4) and fiscal year 2025 (FY25), which ended April 25, 2025. Q4 Key Highlights Q4 revenue of $8.9 billion increased 3.9% as...Read more
VALUE Phase III trial of EscharEx® in venous leg ulcers advancing as planned NexoBrid® manufacturing expansion on track; full operational capacity expected by year-end 2025 First quarter revenue of $4 million; full-year 2025 revenue guidance reaffirmed at $24 million Conference call today, May 21 at 8:30am Eastern Time YAVNE, Israel, May 21, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation...Read more
WINNIPEG, MB / ACCESS Newswire / May 21, 2025 / Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH) (OTC Pink:MCUJF), a company focused on the development and commercialization of pharmaceuticals and healthcare products for patients and prescribers in the United States market, today reported its results from operations for the quarter ended March 31, 2025. The Company is also pleased to announce the voting results for the election of...Read more
Final CM24 Phase 2 data presented at AACR Annual Meeting 2025, strengthening patient selection strategy for CM24 Phase 2b study planned to be initiated in Second Half of 2025 NT219 data presented at AACR Annual Meeting 2025; NT219 Phase 2 study in head and neck cancer on track to be initiated in First Half of 2025 CAPTN-3 differentiated T-cells and NK cells engagers tri-specific platform advances toward first-in-human clinical...Read more
MONTRÉAL, May 21, 2025 (GLOBE NEWSWIRE) -- Premier Health of America Inc. (TSXV: PHA) (the “Company”), a leading Canadian Healthtech company, announces it has filed its unaudited Quarterly Consolidated Financial Statements and MD&A for its second quarter ended on March 31st, 2025. Highlights Mar. 31, 2025 Mar. 31, 2024 Mar. 31, 2025 Mar. 31,...Read more
Merger Agreement With Vyome Therapeutics and Asset Purchase Agreement with Biorad Medisys Progress Towards Completion IRVINE, Calif., May 21, 2025 (GLOBE NEWSWIRE) -- ReShape Lifesciences Inc. (Nasdaq: RSLS), the premier physician-led weight loss and metabolic health-solutions company, today reported financial results for the first quarter ended March 31, 2025 and provided a corporate strategic update. First Quarter 2025 and...Read more
VANCOUVER – TheNewswire - May 21st, 2025 – Aequus Pharmaceuticals Inc. (TSX-V: AQS) (“Aequus” or the “Company”), a specialty pharmaceutical company focused on bringing healthcare solutions to Canadians through licensing and partnerships, today reports financial results for the quarter ended March 31st, 2025 (“First Quarter 2025”). Unless otherwise noted, all figures are in Canadian currency. Financial Report Highlights Aequus reported...Read more
U.S. FDA clears lung cancer IND for CVHNLC, a proprietary off-the-shelf candidate targeting squamous non-small cell lung cancer (sqNCLC), with clinical study expected to begin H2 2025; Clinical Trial Application filed in Europe with decision expected in Q2 2025 Glioblastoma study fully enrolled with Part B of Phase 1 CVGBM trial completing enrolment in Q1 2025; go/no-go decision on moving to Phase 2 planned for H2 2025 First...Read more
Adjusted EBITDA increases 1% FXN YoY; Peru supports quarterly results, further validating its integrated business model LUXEMBOURG / May 20, 2025 / Business Wire / Auna (NYSE: AUNA) (“Auna” or the “Company”), a leading healthcare platform in Latin America with operations in Mexico, Peru, and Colombia, today announced financial results for the first quarter ended March 31, 2025 (“first quarter 2025” or “1Q25”). Financial results are...Read more
Company now exclusively focused on the growing fertility market following the April 2025 announcement to divest a majority stake in Naya Therapeutics SARASOTA, Fla., May 20, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare services fertility company focused on expanding access to advanced treatment through the establishment, acquisition and operation of fertility clinics and...Read more
Highlights Multiple Significant Potential Liquidity Events Anticipated Within the Next Few Months Completes Significant Reductions in Overhead and Expenses BE-Smart Esophageal Cancer Test Study has been Submitted in the Journal of Clinical Gastrointestinal Hepatology Company to hold a virtual conference call Tuesday, May 20, 2025, at 10:00 AM ET GARDEN CITY, NY, May 20, 2025 (GLOBE NEWSWIRE) -- ProPhase Labs Inc. (NASDAQ: PRPH),...Read more
Q1 Revenue of $2.0 million, down 25% year over year Q1 Operating loss of $(5.9) million, a 37% increase year over year Q1 Adjusted EBITDA of $(4.3) million, a 28% decline year over year Company announces securing a $10.0 million financing commitment from Acuitas Capital LLC Company announces recertification by the National Committee for Quality Assurance (NCQA) as a Credentials Verification Organization (CVO) Company to Host...Read more
Eyenovia and Betaliq continue to negotiate a binding merger agreement consistent with the previously announced signed Letter of Intent Reports continued progress on the development of the user-filled Optejet, and remains on track to file for U.S. device regulatory approval in September 2025 Reduced ongoing cash burn by approximately 70% versus prior year and improved debt repayment terms LAGUNA HILLS, Calif., May 19, 2025 (GLOBE...Read more
Interim Jan-2025 results from three trials of Alpha DaRT® in treating pancreatic cancer shared at prestigious 2025 ASCO GI Symposium and R&D Update Day, showing >90% disease control rate, impressive overall survival in sub-group analyses, and positive safety profile 75% systemic objective response rate (ORR) and 37.5% complete response rate meaningfully higher thus far than historical Keytruda® monotherapy data in Jan-2025...Read more
AUSTIN, TX / ACCESS Newswire / May 19, 2025 / Aspira Women's Health Inc. ("Aspira") (OTCQB:AWHL), an AI enhanced bio-analytics based women's health company focused on delivering leading noninvasive gynecologic disease diagnostic and disease management tools, announced today its results of operations for the three-month period ended March 31, 2025. The Company also reported early progress under its new leadership team. Key financial...Read more
BEIJING, May 16, 2025 /PRNewswire/ -- So-Young International Inc. (Nasdaq: SY) ("So-Young" or the "Company"), the leading aesthetic treatment platform in China connecting consumers with online services and offline treatments, today announced its unaudited financial results for the first quarter ended March 31, 2025. First Quarter 2025 Financial Highlights Total revenues were RMB297.3 million (US$41.0 million[1]),...Read more
Cash expected to fund operations into the second half of 2026 Advancing development strategy for lead program TPI 287 to commence Phase 2 study around year end 2025 for treatment of glioblastoma multiforme (GBM) HOUSTON, TX / ACCESS Newswire / May 16, 2025 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic...Read more
Feedback from Type D FDA Meeting expected by mid-June 2025 to confirm statistical analysis methods to support pending Accelerated Approval, Regenerative Medicine Advanced Therapy & Breakthrough Therapy designation requests Completed Phase 2b trial data analysis using methods agreed to by FDA to be presented at MIB Factor on June 28, 2025 Company remains on track for Q3 2025 BLA filing for OST-HER2 in the prevention of recurrent,...Read more
BEIJING, CN / ACCESS Newswire / May 16, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), ("CASI" or the "Company"), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the quarter ended March 31, 2025. Dr. Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer, commented, "We remained focused...Read more
SHELTON, CT / ACCESS Newswire / May 16, 2025 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), reports that it has filed its Quarterly Report on Form 10-Q for the quarter ending March 31, 2025 with the Securities and Exchange Commission (SEC) on Thursday, May 15, 2025. The report can be accessed at the SEC website (Click Here) . NV-387 - Phase II Clinical Trial to Treat MPox Infection - Unmet Medical Need We reported that we...Read more
WARRINGTON, Pa., May 16, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the first quarter ended March 31, 2025 and provided key business updates. “The first quarter of 2025 was...Read more
Q4 total revenues of $138.3 million, up 17% year-over-year Q4 operating cash flow of $98.5 million, up 54% year-over-year Q4 free cash flow of $97.0 million, up 56% year-over-year Fiscal year 2025 total revenues of $570.4 million, up 20% year-over-year Fiscal year 2025 operating cash flow of $273.3 million, up 48% year-over-year Fiscal year 2025 free cash flow of $266.7 million, up 50% year-over-year SAN FRANCISCO / May 15, 2025 /...Read more
Affirming 2025 guidance Management to Host Conference Call and Webcast May 15, 2025 at 4:30 PM ET HENDERSON, Nev. / May 15, 2025 / Business Wire / P3 Health Partners Inc. (“P3” or the “Company”) (NASDAQ: PIII), a patient-centered and physician-led population health management company, today announced its financial results for the first quarter ended March 31, 2025, and affirmed its 2025 guidance. “Our physician-led care...Read more
Obtained written alignment from the FDA on key elements of TSHA-102 pivotal Part B trial design and next steps on enabling study initiation The FDA advised the Company to submit pivotal Part B trial protocol and associated statistical analysis plan as an amendment to the IND application, eliminating the need for formal end-of-phase meeting and potentially expediting study initiation and registration; IND amendment submission expected...Read more
Announced Global Collaboration with Novo Nordisk to Develop Oral Small Molecules for Metabolic Diseases with Over $2.2 Billion in Potential Milestone Payments On Track to Select a Next-Generation Oral Small Molecule PTH1R Agonist to Accelerate Toward the Clinic Later in 2025 Expect to Initiate Phase 1 Trial for SEP-631, MRGPRX2 NAM Program for Mast Cell Diseases, in Third Quarter of 2025 Ended First Quarter 2025 with $398.2 Million...Read more
Completed last subject, last visit in the chronic cohort, data readout targeted for early June 2025 Vancouver, British Columbia--(Newsfile Corp. - May 15, 2025) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotechnology company dedicated to developing neuro-reparative therapeutics, today reported its financial and operational results for the first quarter ended March 31, 2025. "We continue to make important...Read more
MIRAMAR, Fla., May 15, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its first quarter ended March 31, 2025. On May 15,...Read more
First Patient Enrolled in Multi-Dose Phase 1b/2 Trial of Bel-sar in Non-Muscle-Invasive Bladder Cancer (NMIBC); Initial Data at 3 Months Expected by Year-End 2025 Strengthened Leadership Team with the Appointment of Tony Gibney as Chief Financial and Business Officer BOSTON, May 15, 2025 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors...Read more
Received approval by U.S. Food and Drug Administration (FDA) for ZEVASKYN™ (prademagenezamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) U.S. launch of ZEVASKYN underway with activation of first qualified treatment center (QTC) Entered into sales agreement for priority review voucher (PRV)...Read more
Clinical data builds with CR in testicular cancer, enrollment in Phase 2 gastric trial, and new data in PD-1–resistant tumors Near-term capital transactions poised to bolster liquidity NEW YORK, May 15, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the development of allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced...Read more
Enrollment Completion for Ongoing Registrational PROSERA Phase 3 Study in PAH Expected in Early June; New Patient Screening Closed Topline Results Announcement from PROSERA Phase 3 Expected in February 2026 To Date, Blinded Baseline Characteristics Align with Intended Study Population First Site Activations for Planned Registrational Phase 3 SERANATA Study in PH-ILD Expected in the Fourth Quarter of 2025 Cash,...Read more
Launches and Delivers First Platinum® Pro Units Announces New Library Preparation Development Program BRANFORD, Conn. / May 15, 2025 / Business Wire / Quantum-Si Incorporated (Nasdaq: QSI) (“Quantum-Si,” “QSI” or the “Company”), The Protein Sequencing Company™, today announced financial results for the first quarter ended March 31, 2025. Press Release Highlights First quarter 2025 revenue of $842,000, an 84% increase over the...Read more
Conference Call Today at 4:30 p.m. ET SEATTLE / May 15, 2025 / Business Wire / Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the first quarter ended March 31, 2025, which include: Net loss for the first quarter of 2025 was $33.5 million, or $0.58 per share, compared to a net loss of $37.2 million, or $0.63 per share for the first quarter of 2024. At March 31,...Read more
Plans to file for approval with Breakthrough Therapy Designation in Saudi Arabia based on completed Phase 3 results VIENNA, Va. / May 15, 2025 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the three months ended March 31, 2025, as well as key recent clinical and corporate developments. “We are highly encouraged about the latest development for the commercialization of Multikine in...Read more
Company delivers 42% revenue growth year-over-year and strengthens balance sheet with $22 million gross proceeds from recent private placement Expands commercial footprint, and invests further in new applications for TriNav already in use Updates 2025 guidance to reflect strategic investment in our core liver market and new applications for PEDD Company to Host Conference Call and Webcast today at 8:00am ET DENVER / May 15, 2025 /...Read more
Clinical programs on track, with two major milestones later this year, and cash position, CHF 131 million as of March 31, 2025, expected to provide funding well into 2027 IND filing and initial clinical data on first targeted Radio-DARPin therapy program, MP0712, expected in 2025; strategic partnership with Orano Med expanded from four to ten programs Data from dosing cohort 8 in Phase 1/2a trial of MP0533 demonstrate increased rates...Read more
Launched ZUNVEYL (benzgalantamine) to US market on March 17, 2025 Secured business development licensing revenues of $2.6M for partnership with CMS Pharma Cash and cash equivalents of $45.5 million as of March 31, 2025, compared to $48.6 million as of December 31, 2024. At current cash utilization rates, the Company expects a cash runway of approximately two years. VANCOUVER, British Columbia / May 15, 2025 / Business Wire / Alpha...Read more
MISSISSAUGA, Ontario, May 15, 2025 (GLOBE NEWSWIRE) -- BioSyent Inc. (“BioSyent”, TSX Venture: RX) released today its financial results for the first quarter (Q1) ended March 31, 2025. Key highlights include: (CAD) Q1 2025 % Change vs. Q1 2024 Trailing Twelve Months (TTM) Mar 31, 2025 % Change vs. TTM Mar 31, 2024 Canadian Pharma Sales 9,159,652 +21 % 34,544,657 +13 % International Pharma...Read more
Duchenne (SGT-003): Participant dosing ongoing in the Phase 1/2 INSPIRE DUCHENNE trial; Solid on track to discuss accelerated pathways with U.S. FDA later in 2025 FA (SGT-212): Dosing of first participant anticipated in the second half of 2025 CPVT (SGT-501): FDA IND on track for submission first half of 2025 Cash: Company ended first quarter 2025 with $306.9 million in cash, cash equivalents, investments and...Read more
PEMGARDA™ (pemivibart) net product revenue of $11.3 million reported for Q1 2025, influenced by planned transition (Jan/Feb) from a contracted to an internalized sales force PEMGARDA revenue re-acceleration observed in Q2 2025 to date Invivyd continues to target near-term profitability (1H 2025) with existing cash and cash equivalents, anticipated growth of net product revenue, and continued reduction of operating expenses Since...Read more
Net Income increased 25% to $3.1 million for the quarter ended March 31, 2025 as compared to the quarter ended March 31, 2024. Income from Operations for the quarter ended March 31, 2025 decreased 2% to $3.7 million as compared to the quarter ended March 31, 2024. Diluted Net Income Per Common Share Available to Common Stockholders increased 37% to $0.37 per share for the quarter ended March 31, 2025 as compared to the quarter ended...Read more
Prioritization of givastomig as I-Mab’s lead program positions the Company for clinical progress New givastomig combination data selected for mini-oral presentation at ESMO GI, being held July 2-5 in Barcelona, Spain Strong financial position supported by $168.6 million of cash and cash equivalents, and short-term investments as of March 31, 2025; provides runway into 2027, through expected clinical readouts for...Read more
NORCROSS, Ga., May 15, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three months ended March 31, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated “This quarter, we remained laser-focused on advancing additional analyses for belapectin....Read more
21 SRT systems shipped during the quarter; revenues of $8.3 million 65% increase in treatment volume from FDAs over preceding quarter Profitability forecast for the next three quarters and for the full year Conference call begins at 4:30 p.m. Eastern time today BOCA RATON, Fla. / May 15, 2025 / Business Wire / Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive,...Read more
Reports Increased CompuFlo® Adoption Following Assignment of Favorable Medicare Payment Rates; Expands Federal Outreach Following FSS Contract Award ROSELAND, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today provided a business update and reported financial results for the first quarter ended...Read more
Announced robust preclinical data supporting the unique three-pronged mechanism of action of micvotabart pelidotin (MICVO, formerly PYX-201), driving anti-tumor activity via direct tumor killing, bystander effect and immunogenic cell death On track to report preliminary data from Phase 1 monotherapy expansion cohorts of MICVO for 2L/3L R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor...Read more
Achieved a Record Number of Focal One® Robotic HIFU System Placements for a First Quarter Period Received CE Mark Designation for Focal One for the Treatment of Deep Infiltrating Endometriosis Positive Final Results of FARP Randomized Controlled Trial Presented at American Urology Association Annual Meeting (AUA 2025) Launched the New Focal One i Robotic HIFU System Performed World’s First Remote Transcontinental Focal One Robotic...Read more
The combined net Q1 2025 revenue of approximately $2.2 million for prescription and non-prescription products, including license revenue, decreased approximately 6% versus net Q1 2024 revenue of $2.4 million and 37% versus net Q4 2024 revenue of $3.5 million Mytesi prescription volume increased by approximately 1.8% in Q1 2025 over Q1 2024 and decreased by approximately 13.5% in Q1 2025 over Q4 2024 REMINDER: Today Jaguar to host...Read more
Ongoing screening in CATT1 Phase 3 trial evaluating cadisegliatin in patients with type 1 diabetes (T1D) Topline Phase 3 data for cadisegliatin expected in 2H 2026 HIGH POINT, N.C., May 15, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin being investigated for the...Read more
446 participants completed the brilaroxazine long-term open-label extension (OLE) trial with 156 completing one-year and 301 completing six months of treatment Full data set from RECOVER OLE highlighting clinical response, safety, efficacy, adherence, and biomarker data expected in Q2 2025 Registrational Phase 3 RECOVER-2 trial initiation for brilaroxazine expected mid-2025 CUPERTINO, Calif., May 15, 2025 (GLOBE...Read more
Conference call to discuss financial and operational results scheduled for Friday, May 16 at 8:30 a.m. U.S. Eastern Time HENDERSON, Nev., May 15, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces financial results and a business update for the first quarter ended March 31, 2025. Volition management will host a conference call tomorrow, May 16 at...Read more
Patient dosing initiated in Phase 1 CALiPSO-1 trial evaluating CNTY-101 in autoimmune disease; expanding to additional U.S. and European sites following CTA authorizations in Germany, France, and Italy CNTY-308 expected to enter IND-enabling studies in mid-2025 to support anticipated clinical trials in B-cell-mediated autoimmune diseases and malignancies Presentations at ASGCT 28th Annual Meeting highlight preclinical pipeline...Read more
Updated clinical data from Emi-Le Phase 1 dose escalation and backfill cohorts presented today at ESMO Breast Cancer 2025 ORR increased to 31% across tumor types among evaluable patients with B7-H4 high tumors receiving intermediate doses Encouraging preliminary time-to-event data in triple-negative breast cancer (TNBC) Second, higher dose recently selected for expansion in post-topoisomerase-1 inhibitor ADC (post-topo-1) TNBC;...Read more
DALLAS / May 15, 2025 / Business Wire / Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced its first quarter 2025 financial results and provided a clinical update. “We are looking forward to reading out the topline data from the FB102 celiac disease trial this quarter. FB102 continues to be well-tolerated and there...Read more
Emrosi™ commercial launch initiated for the treatment of inflammatory lesions of rosacea in adults Fortress subsidiary Checkpoint Therapeutics to be acquired by Sun Pharma; special meeting of Checkpoint stockholders to approve the transaction to take place on May 28, 2025 FDA accepted New Drug Application filing for priority review of CUTX-101 to treat Menkes disease; PDUFA goal date of September 30, 2025 MIAMI, May 15, 2025 (GLOBE...Read more
Revenues of $5.3 million, Improved Gross Margin, and Positive Net Income MISSISSAUGA, Ontario, May 15, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, reports results for its second quarter and first half of fiscal 2025 ended March 31, 2025 (“Q2” and “H1”). Sales for Q2 and H1 reflected differential growth between Antigens (up) and QAPs™...Read more
Initiated Phase 2 Seabreeze STAT Asthma and Seabreeze STAT COPD studies evaluating rademikibart as an adjunct treatment for acute exacerbations in Asthma and COPD in May 2025; topline data expected in 1H 2026 Published positive data from its global Phase 2 study supporting potential of rademikibart as a novel biologic treatment for patients with asthma and Type 2 inflammation Strong balance sheet with cash runway into 2027 through key...Read more
RENEW Phase 2 trial evaluating the safety, tolerability, and efficacy of LTI-03 in idiopathic pulmonary fibrosis (IPF) initiated with topline interim data expected in the first half of 2026 Two abstracts accepted to the American Thoracic Society (ATS) 2025 International Conference Cash runway extended following previously announced warrant transactions and private placement AUSTIN, Texas, May 15, 2025 /PRNewswire/...Read more
Atara has transferred all manufacturing responsibility to Pierre Fabre Laboratories, including all costs associated with the manufacturing and supply of tabelecleucel for development and commercialization worldwide Atara expects to reduce its operating expenses year-over-year by approximately 65% in 2025 as a result of implemented cost reduction initiatives Atara has entered into an underwriting agreement for an offering with expected...Read more
LYTENAVA™ (bevacizumab gamma) on track for planned first commercial launches in Germany and the United Kingdom (UK) in Q2 CY2025 Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025 in the United States ISELIN, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of...Read more
Mike Heffernan appointed as Chairman of the Board Topline data from Phase 2 LOTUS trial of AVTX-009 for the treatment of hidradenitis suppurativa expected in 2026 Cash on hand of approximately $125 million as of March 31, 2025 expected to provide runway into 2027, with optionality to extend into 2028 WAYNE, Pa., May 12, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company...Read more
Completion of LP-184 Phase 1a clinical trial enrollment with 62-65 patients across a range of solid tumors expected by end of June 2025. Additional patient data readout from the HARMONIC™ Trial evaluating LP-300 in never-smokers with non-small cell lung cancer (NSCLC) anticipated in Q3 2025, including initial readout for patients from the Asian expansion cohort. Strengthened AI intellectual property portfolio with PCT...Read more
Announced new clinical data for two programs utilizing ARCUS validating safety and efficacy for Precision’s in vivo gene editing approach Announced initial data from first cohort in the ongoing Phase 1 ELIMINATE-B trial evaluating PBGENE-HBV; initial safety data presented at EASL; ongoing clinical updates anticipated throughout 2025 Received regulatory clearance of IND from the U.S. FDA to expand ELIMINATE-B trial and CTA approved by...Read more
Pre-recorded Conference Call to Follow at 1:30 p.m. PDT/4:30 p.m. EDT FREMONT, Calif. / May 15, 2025 / Business Wire / Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company, today announced financial results for the first quarter ended March 31, 2025 and outlined operational highlights based on its newly expanded clinical pipeline. “This is a defining time for the company. During the quarter we initiated...Read more
Advancing development of novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads to treat multiple cancer tumors Rounding out executive team with deep oncology experience by appointing new Head of Business Development - Oncology BOSTON and LONDON, May 15, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biotechnology company developing novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads...Read more
Company has continued to advance its previously announced plan to obtain FDA approval for two new drugs and to develop a network of clinics focused on neuroplastic therapies to treat severe and suicidal depression, PTSD, and related conditions. Clinic acquisition financing is at the HOPE Therapeutics level and non-dilutive to NRXP shareholders In January 2025 completed the third tranche of a convertible note offering and registered...Read more
Therapeutic DNA Production Services Segment (LineaRx) Revenues Up 44% Y/Y, Contributing to a 6% Increase in Total Revenues Intra-Quarter Investor Conference Call and Webcast Scheduled for June 3, 2025, at 4:30 PM ET STONY BROOK, NY / ACCESS Newswire / May 15, 2025 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today reported financial results for...Read more
Q1 2025 RenovoCath® Revenues of ~$200,000, Exceeding Expectations and Anticipated to Continue Growing Sequentially with New Customer Purchase Orders and Reorders Cash on Hand of $14.6 Million Anticipated to Fully Fund both RenovoCath Commercialization Scale-up and Continued Progress Towards the Completion of the Ongoing Phase III TIGeR-PaC Clinical Trial Completion of the TIGeR-PaC Clinical Trial Enrollment and Review of Second Interim...Read more
Ibrexafungerp clinical hold lifted by the FDA. SCYNEXIS working to resolve a disagreement with GSK involving the restart of the MARIO study. GSK remains committed to the commercialization of Brexafemme. Hansoh recently received Chinese (NMPA) approval for ibrexafungerp in the treatment of acute VVC. SCYNEXIS will receive a milestone payment from Hansoh upon commercialization as well as royalties of approximately 10% on China...Read more
Reported Positive 48-Week Data from SPRING Trial-Nebokitug Treatment in PSC Patients with Moderate/Advanced Disease Resulted in Continued Improvements across Key Biomarkers of Liver Injury, Inflammation and Fibrosis Aligned with FDA on Pathway to Potential Regulatory Approval for the Treatment of PSC with a Single, Clinical-Events-Driven Clinical Trial These Major Milestones Support the Advancement of Nebokitug to Phase 3 and Position...Read more
Registration statement for proposed Cullgen merger declared effective by the SEC Proposed merger anticipated to close in June As part of proposed merger, Pulmatrix currently intends to divest its assets including its Phase 2-ready acute migraine candidate, PUR3100, and other development candidates based on its iSPERSE™ technology FRAMINGHAM, Mass., May 15, 2025 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company")...Read more
DUBLIN, May 15, 2025 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB) a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors, today announced results for the quarter ended December 31, 2024 and the fiscal year then ended. Key Highlights and Developments Management continues to make significant progress on the execution of the profitability focused...Read more
LITTLE ELM, Texas / May 15, 2025 / Business Wire / Retractable Technologies, Inc. (NYSE American: RVP) reports total net sales of $8.3 million for the first three months of 2025 and an operating loss of $4.7 million for the period, as compared to total net sales for the same period last year of $7.6 million and an operating loss of nearly $3.0 million. The differences in operating losses are largely due to an increase in tariffs and...Read more
Presented preclinical data for potentially differentiated HER3 ADC, EO-1022, at AACR Annual Meeting Expects to file IND application for EO-1022 in 2026 Cash runway into 2H 2026 BOSTON, May 15, 2025 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with...Read more
TORONTO, May 15, 2025 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, announced financial results for the three months ended March 31, 2025. Summary of Financial Results & Recent Progress: Total revenue for the first quarter of $13.6 million, down 22% year-over-year, reflecting continued difficult market conditions. First quarter operating...Read more
Reports 17% Year over Year First Quarter Revenue Growth Conference Call Scheduled for 12:00 PM ET Today SAN FRANCISCO, May 15, 2025 (GLOBE NEWSWIRE) -- American Shared Hospital Services (NYSE American: AMS) (the "Company"), a leading provider of stereotactic radiosurgery equipment and advanced radiation therapy cancer treatment services through its leasing and direct patient care services segments, today announced financial results...Read more
In vitro testing with CDI-988 demonstrated superior broad-spectrum antiviral activity against major norovirus variants BOTHELL, Wash., May 15, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three months ended March 31, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities. “Our oral pan-viral protease...Read more
U.S. pipeline of ReWalk opportunities continues to build with over 120 qualified leads in process Closure of AlterG sites and resulting consolidation of resources and reduced expenditures yields improved operating expense trend Second consecutive quarter of AlterG revenue growth over 15% reflecting continued sales momentum MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, May 15, 2025 (GLOBE NEWSWIRE) -- Lifeward Ltd.,...Read more
Record total revenue of $19.3 million, up 11% year-over-year Positive cash flows, with Adjusted EBITDA(1) of $1.3 million, up 49% year-over-year, and our 25th consecutive quarter of positive Adjusted EBITDA Secured new credit facilities to drive growth and to refinance existing debt On May 1, Stephen Lemieux assumed the role of President to lead the implementation of NeuPath’s strategic initiatives TORONTO / May 15, 2025 / Business...Read more
Year-over-year product revenue increased 8%, and year-over-year operating expenses decreased 5% as Vivos sets the stage for its Sleep Center of Nevada acquisition and continued advancement of its new marketing and distribution model Management to Host Conference Call today at 5:00 pm ET LITTLETON, Colo., May 15, 2025 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), a leading medical device and...Read more
CHICAGO, May 15, 2025 (GLOBE NEWSWIRE) -- Cosmos Health Inc. ("Cosmos Health" or the “Company”) (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, today reported financial results for the first quarter ended March 31, 2025. First...Read more
In March 2025, BiomX announced positive topline results of the phase 2 trial evaluating BX211 for the treatment of diabetic foot osteomyelitis (DFO) BX004 Phase 2b study in Cystic Fibrosis (CF) on track to report topline results in Q1 2026 In April 2025, shareholders approved exercise of warrants issued in $12 million in financings announced in February 2025; funds expected to provide runway through topline Phase 2b results for BX004...Read more
KUALA LUMPUR, MALAYSIA, May 15, 2025 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines, today announced its first quarter financial results and provided a business update. “As part of the Company’s efforts to reduce operating costs it has determined to focus on the development of the plogosertib (“plogo”) clinical...Read more
Clinical trial advances for INSTASYL siRNA lead product candidate PH-762 4th Cohort enrolling and treating patients in on-going clinical study Marlborough, Massachusetts--(Newsfile Corp. - May 15, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company developing therapeutics that use its INTASYL® siRNA gene silencing technology designed to make the body's immune cells more effective in...Read more
Lucid secured capital to extend runway well past key upcoming reimbursement milestones; ended 1Q25 with over $40 million in proforma cash Veris Health completed 1Q25 financing, resumed development of implantable physiological monitor, and will soon launch first commercial partnership with major cancer center PAVmed seeking to leverage infrastructure and expand into biopharma sector; actively evaluating clinical and late preclinical...Read more
Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
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