11th quarter in a row of mid-single digit organic revenue growth; Poised to accelerate growth GALWAY, Ireland, Aug. 19, 2025 /CNW/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced financial results for its first quarter (Q1) of fiscal year 2026 (FY26), which ended July 25, 2025. Key Highlights Revenue of $8.6 billion, adjusted revenue of $8.5 billion, increased 8.4% as reported and 4.8%...Read more
Fourth-quarter total net revenue of $262.9 million was better than the company expected (total net revenue excluding Contigo Health* of $258.0 million) Fourth-quarter GAAP net income from continuing operations of $18.0 million, or $0.22 per fully diluted share Fourth-quarter adjusted EPS of $0.46, excluding Contigo Health* contributed to full-year adjusted EPS that was above the high end of the company’s guidance range Full-year net...Read more
U.S. FDA ("FDA") confirms OST-HER2 meets biological definition of Regenerative Medicine Advanced Therapy (RMAT) FDA issues OST-HER2 BLA number in preparation for Accelerated Approval submission following End of Phase 2 Meeting FDA End of Phase 2 Meeting scheduled for August 27, 2025 to review Phase 2b clinical trial in the prevention or delay of recurrent, pulmonary metastatic osteosarcoma Statistically significant 12-month Event...Read more
FDA Approves Genio® System for U.S. Market; Company Begins Commercial Launch Mont-Saint-Guibert, Belgium – August 18, 2025, 10:10pm CET / 4:10 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the second quarter of...Read more
NRx Drug Development Grant of expanded Fast Track Designation for NRX-100 from the FDA for all indications and types of depression and related disorders based on its potential to satisfy an unmet medical need. Represents an approximately 10-fold expansion of the addressable market to 13 million Americans, compared to the original Fast Track Designation issued in 2017 for bipolar depression alone. The Designation letter contains a...Read more
CHICAGO, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Cosmos Health Inc. ("Cosmos Health" or the “Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group, announced today its financial results for the second quarter and six-month period ended June 30, 2025. Financial Highlights for the Three and Six Months Ended June 30, 2025 Income StatementCosmos Health continued its positive trajectory in Q2 2025, delivering...Read more
MIRAMAR, Fla., Aug. 18, 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 second quarter ended June 30, 2025. On May 15,...Read more
CureVac Announces Financial Results for the Second Quarter and First Half of 2025 and Provides Business Updates Entered into a definitive Purchase Agreement pursuant to which BioNTech intends to acquire all shares of CureVac, uniting two highly complementary German companies to bring transformative mRNA-based treatments to patients globally Entered into agreements to resolve and dismiss all pending patent litigation in the U.S....Read more
BEIJING, Aug. 15, 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 second quarter ended June 30, 2025. Second Quarter 2025 Financial Highlights Total revenues were RMB378.7 million (US$52.9 million[1]), compared with...Read more
Patient enrollment for our ongoing Phase-3 clinical trial of SGT-610 for Gorlin Syndrome has been completed; top-line results are expected in the fourth quarter of 2026 Phase-1b proof-of-concept clinical trial of SGT-210 for Darier disease is ongoing Sol-Gel and Mayne Pharma Announce the Purchase of EPSOLAY and TWYNEO in the U.S. for a total consideration of $16 million to be received during 2025 Following recent transactions,...Read more
Successfully initiated enrollment in advanced Phase 2 ovarian cancer trial Expanded global IP protection by securing Australian patent acceptance for the stenoparib DRP® companion diagnostic Secured new service contract with EU biotech for Allarity Medical Laboratory TARPON SPRINGS, Fla., August 15, 2025 -- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company...Read more
Company advanced efforts to secure U.S. FDA 510(k) clearance to advance on path towards planned U.S. market expansion beyond Forensic Use Only settings Fourth quarter sequential and year-on-year revenue growth of 16%, supported by increased demand for drug testing cartridges NEW YORK, Aug. 15, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company...Read more
Strong cash position of $12.1 million expected to fund operations into the second half of 2026 Driving lead program, TPI 287, towards Phase 2 study for treatment of glioblastoma multiforme (GBM) HOUSTON, TX / ACCESS Newswire / August 15, 2025 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the...Read more
BOULDER, CO / ACCESS Newswire / August 15, 2025 / Encision Inc. (OTC PINK:ECIA), a medical device company owning patented Active Electrode Monitoring (AEM®) Technology that prevents dangerous radiant energy burns in minimally invasive surgery, today announced financial results for its fiscal 2025 first quarter that ended June 30, 2025. The Company posted quarterly product net revenue of $1.49 million and service net revenue of $110...Read more
Reported statistically significant and clinically meaningful improvement in both primary endpoints from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial Hazard ratios and improvements in median progression-free survival (“PFS”) are unprecedented in HR+/HER2- advanced breast cancer (“ABC”) Expect to submit a New Drug Application (“NDA”) for gedatolisib, based on data from the PIK3CA wild-type cohort, to the U.S. Food and...Read more
WELL achieved record quarterly revenues of $356.7 million in Q2-2025, an increase of 57% compared to Q2-2024 driven by organic growth and acquisitions. Excluding the impact from Circle Medical’s deferred revenue adjustments or “CM Deferrals”, revenue would have been $347.0 million in Q2-2025, representing 53% year-over-year growth. Results were positively impacted during the quarter by the addition of $40.5 million of revenue from the...Read more
Planned strategic combination with Beckley Psytech expected to solidify position as global leader in transformative, psychedelic-based mental health therapies with a short time in-clinic Reported positive topline data from the core, blinded stage of the Phase 2b clinical trial of BPL-003 (intranasal mebufotenin benzoate) in patients with treatment-resistant depression (TRD) BPL-003 met its primary and all key secondary endpoints, and...Read more
Gained alignment with U.S. Food and Drug Administration (FDA) on the ongoing Phase 2 AQUAx2 randomized double-blind, placebo-controlled pivotal study in Grade 2/3 radiation-induced xerostomia (RIX) to support a potential Biologics License Application (BLA) filing; on track for potential data readout late 2026 FDA Granted Regenerative Medicine Advanced Therapy (RMAT) designation for AAV-GAD for the treatment of Parkinson’s disease In...Read more
Dosed first patient in SURF302 for intermediate risk non-muscle invasive bladder cancer (IR NMIBC) Cash, cash equivalents, and marketable securities of $296.3 million at Q2 2025; runway through at least 2027 CARLSBAD, Calif., Aug. 14, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities...Read more
Adjusted EBITDA grew 21% in Q2 and 29% year-to-date Cash from operations grew 83% in Q2 and 147% year-to-date Made principal repayments on the Company's long-term debt totalling $8.5 million Expanded cardiovascular portfolio by licensing Canadian rights to NEXLETOL® and NEXLIZET® from Esperion Therapeutics TORONTO, Aug. 14, 2025 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company...Read more
Received FDA approval for ZEVASKYN™ (prademagene zamikeracel), 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 on track and first ZEVASKYN patient treatment expected in 3Q 2025, momentum building with strong patient interest at qualified treatment centers and referrals, positive insurance coverage...Read more
Initial data from the 50 mg dose in the open label study and the adolescent PK run-in study planned for program update in September 2025 Adolescent participants from the PK run-in study and patients with FA who have not participated in prior nomlabofusp clinical studies are currently screening and enrolling in the open label study; planning to enroll children (2 to 11 years of age) directly into the open label study FDA recommended...Read more
Presented positive results from the phase 3 randomized, placebo-controlled clinical trial of CAN-2409 (aglatimagene besadenovec) in localized prostate cancer, during an oral presentation at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) Received FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for CAN-2409 for the treatment of prostate cancer Preparations on track for Biologics License...Read more
Conference Call Today at 4:30 p.m. ET SEATTLE / Aug 14, 2025 / Business Wire / Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the second quarter ended June 30, 2025, which include: Net loss for the second quarter of 2025 was $25.4 million, or $0.43 per share, compared to a net loss of $56.0 million, or $0.97 per share for the second quarter of 2024. For the six...Read more
Breakthrough Therapy designation granted for LX2006 based on interim data from Phase I/II trials demonstrating clinically meaningful improvements in cardiac and neurologic measures of Friedreich ataxia LX2006 selected for FDA Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program, created to facilitate CMC registrational readiness and support faster patient access Eight participants dosed in Phase...Read more
Tanruprubart (formerly ANX005) for GBS Advancing Through Regulatory Interactions; MAA Submission in Europe Anticipated in First Quarter of 2026; Ongoing Discussions with FDA Regarding Generalizability Package to Support a BLA Accelerated Completion of Enrollment for Global Phase 3 ARCHER II Trial of Vonaprument (formerly ANX007) for Dry AMD with GA; Selected for EMA PRIME Product Development Candidate Pilot; Topline ARCHER II Data...Read more
NORCROSS, Ga., Aug. 14, 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 and six months ended June 30, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated “We are encouraged by the continued analysis of data from our NAVIGATE trial ,...Read more
Achieved Second Quarter 2025 Total Net Revenues of $9.7 Million Double Digit New Accounts in the Second Quarter of 2025, Including Notable Quarter-Over-Quarter Growth in Both Large Community Practices and Academic Centers, Supported by Targeted Sales Strategy and Enhanced Patient Support Services for PEDMARK® Successful Initial Uptake of PEDMARQSI® in the United Kingdom and Germany with Additional EU Launches...Read more
VALUE Phase III Trial of EscharEx® in Venous Leg Ulcers Continues to Enroll Patients NexoBrid® Manufacturing Expansion on Track; Full Operational Capacity Expected by Year-End 2025 Additional Strategic Research Collaborations Established with Essity and Convatec Second Quarter 2025 Revenue of $5.7 Million, Up 43% from Prior Quarter Conference Call Today, August 14, 2025, at 8:30am Eastern Time YAVNE, Israel, Aug. 14, 2025 (GLOBE...Read more
Updated data from ongoing open-label Phase 1b trial demonstrated a mean 12-month eGFR of approximately 68 mL/min/1.73 m2 post-transplant for patients on tegoprubart Company on track to report topline results from Phase 2 BESTOW trial in kidney transplantation in November 2025 Cash, cash equivalents and short-term investments of $107.6 million as of June 30, 2025 IRVINE, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Eledon...Read more
Three clinical trial readouts for FB102 expected in 2026, including phase 2 in celiac disease and phase 1b in both vitiligo and alopecia areata DALLAS / Aug 14, 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 second quarter 2025 financial results and provided a business update. “I am...Read more
TORONTO, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, AI-powered, incision-free therapies for the ablation of diseased tissue, today reported unaudited financial results for the second quarter ended June 30, 2025. Unless specified otherwise, all amounts in this press release are expressed in...Read more
Announced clinical improvement in progression free survival observed in pivotal Phase 3 Trial of Cylembio® plus KEYTRUDA® (pembrolizumab) for the treatment of first-line advanced melanoma, but statistical significance narrowly missed; company plans to meet with FDA this fall to discuss data and next steps for a potential regulatory submission Ended second quarter with approximately $28.1 million in cash and cash equivalents; the...Read more
Key Highlights ZUNVEYL Launch Momentum: Completed the first quarter of ZUNVEYL commercialization, achieving approximately $2 million in net product revenues year-to-date. Advancing ALPHA-1062: Completed pre-clinical Bomb Blast study in collaboration with the U.S. Department of Defense and the Seattle Institute of Biomedical and Clinical Research. Strong Balance Sheet: Cash and cash equivalents of $39.4 million as of June 30, 2025,...Read more
BOSTON and ATLANTA, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), today reported financial results for the quarter ended June 30, 2025 and highlighted recent developments. “During our second quarter of 2025, we...Read more
First commercial sales of LYTENAVA™ (bevacizumab gamma) achieved in Europe ONS-5010/LYTENAVA™ (bevacizumab-vikg) Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025, in the United States ISELIN, N.J., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today reported...Read more
Following positive preclinical data, simufilam development to advance with a clinical study expected to begin in H1 2026 for the potential treatment of TSC-related epilepsy Recent appointment of experienced neuroscience leaders to guide the clinical development strategy for simufilam Advanced settlement negotiations ongoing to resolve certain securities litigation; $31.25 million estimated loss contingency recorded in Q2 for...Read more
Initiated TibuSHIELD, a global Phase 2 clinical study evaluating tibulizumab in adults with moderate to severe hidradenitis suppurativa (HS) in Q2 2025 Continued progress in the Phase 2 TibuSURE clinical study evaluating tibulizumab in adults with systemic sclerosis (SSc) Appointed new executive and board leadership to support ongoing growth and development Reported $154.5 million in cash and cash equivalents as of June 30, 2025;...Read more
Phase 1 monotherapy expansion study of micvotabart pelidotin (MICVO) for recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients progressing well with preliminary data in second half of 2025 and first half of 2026 Phase 1/2 combination study of MICVO and KEYTRUDA® (pembrolizumab) progressing well with preliminary data in second half of 2025 Received a $2.8 million, net of tax, milestone payment from Simcere...Read more
EluPro™ Q2 revenue up 49% sequentially; Elutia advances next-generation drug-eluting biomatrix for breast reconstruction Conference call today at 5:00 p.m. ET / 2:00 p.m. PT GAITHERSBURG, Md., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today provided a business update and financial results for the second quarter of 2025. Since full...Read more
Conference call to discuss financial and operational results scheduled for Friday, August 15 at 8:30 a.m. U.S. Eastern Time HENDERSON, Nev., Aug. 14, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces financial results and a business update for the second quarter ended June 30, 2025. Volition management will host a conference call tomorrow, August 15 at...Read more
PEMGARDA® (pemivibart) net product revenue of $11.8 million reported for Q2 2025, representing 413% growth year-over-year Invivyd’s target of near-term profitability (1H 2025) was not met but remains possible with the upcoming respiratory virus season Announced alignment with U.S. FDA on rapid pathway to full approval (BLA) of vaccine alternative monoclonal antibody candidate VYD2311 to protect American adults and adolescents from...Read more
Fortress subsidiary Checkpoint Therapeutics acquired by Sun Pharma; Fortress received ~$28 million at closing and is eligible to receive up to an additional $4.8 million under a contingent value right (CVR), plus a 2.5% royalty on future net sales of UNLOXCYT™ (cosibelimab-ipdl) FDA accepted New Drug Application filing for priority review of CUTX-101 to treat Menkes disease; PDUFA goal date of September 30, 2025 Emrosi™ commercial...Read more
WTX-124 Phase 1/1b clinical trial on track for interim data readout in the fourth quarter of 2025, including patients in both the monotherapy and combination expansion arms of cutaneous melanoma and renal cell carcinoma Planning to engage with U.S. Food & Drug Administration (FDA) in the second half of 2025 to discuss potential registrational pathways for WTX-124 in advanced or metastatic cutaneous melanoma Phase 1b/2...Read more
Cash runway extended to deliver clinical program in GVHD and Ph2 results in 2L Gastric Cancer Department of Defense STTR Grant to advance INKTs in GVHD announced; program advancing New clinical grant awarded to launch AgenT-797 in GvHD clinical trial; target initiation 2H2025 NEW YORK, Aug. 14, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic,...Read more
PORTLAND, Maine, Aug. 14, 2025 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that develops, manufactures and markets scientifically proven and practical products that improve the health and productivity of dairy and beef cattle, today announced its unaudited financial results for the quarter ended June 30, 2025. Product Sales Highlights: During the...Read more
- Type A Meeting requested with U.S. Food and Drug Administration (FDA) for resolution of the Complete Response Letter (CRL) for oxylanthanum carbonate (OLC) - OLC pivotal study data, published in the Clinical Journal of the American Society of Nephrology (CJASN), demonstrated OLC was well tolerated and enabled serum phosphate control in over 90% of patients with a low pill burden - Ended Q2 with $22.3 million of cash with expected...Read more
Patient dosing ongoing in CALiPSO-1 trial; on track to report clinical data for CNTY-101 in patients with B-cell-mediated autoimmune diseases by year-end 2025 CNTY-308, a CAR-iT cell therapy functionally comparable to primary T cells, now in IND-enabling studies as a potential treatment for B-cell-mediated diseases; program expected to progress into the clinic in 2026 Dr. Brent Pfeiffenberger, CEO, appointed to Board Chair Cash...Read more
Expands senior leadership team and board of directors to support next phase of growth ROSELAND, N.J., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today provides a business update and reported financial results for the second quarter ended June 30, 2025. Neal Goldman, Chairman of the Board, stated,...Read more
Submitted Investigational New Drug (IND) application to evaluate SL-325 in a Phase 1 clinical trial in healthy volunteers; clearance expected in Q3 2025 On track to dose first participant in Phase 1 clinical trial for SL-325 in Q3 2025 Cash balance of approximately $50.5 million at end of Q2 2025 Aggregate proceeds from recent oversubscribed private placement of up to $103 million, less offering expenses, expected to fund...Read more
CEL-SCI to sign partnership agreement in Saudi Arabia—Potential for patient access and reimbursement/sale of Multikine in Saudi Arabia within approximately 60 days following filing for Breakthrough Medicine Designation VIENNA, Va. / Aug 14, 2025 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the three months ended June 30, 2025, as well as key recent clinical and corporate...Read more
MINNEAPOLIS, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a commercial-stage medical technology company dedicated to transforming care for fluid overload patients, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. Second Quarter 2025 and Recent Business Highlights Nuwellis continued to advance its strategic realignment during the second quarter, sharpening...Read more
Completed Oversubscribed $8.2 Million Capital Raise; Funded Through At Least Fiscal Year 2026 EDEN PRAIRIE, Minn., Aug. 14, 2025 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (“NeuroOne” or the “Company”), a medical technology company dedicated to transforming the surgical diagnosis and treatment of neurological disorders, has reported financial results for the third quarter of fiscal year 2025 ended...Read more
PRT7732, once daily oral SMARCA2 degrader, currently enrolling at the seventh dosing cohort (125 mg); Company to provide an update with preliminary clinical data, including PK/PD, safety and initial clinical activity by year end 2025 Phase 1 study of PRT3789, a once weekly IV SMARCA2 degrader, has been completed; Company to provide final data by year end 2025 Prelude is advancing a development candidate for its oral KAT6A degrader...Read more
Following constructive FDA feedback on its proposed statistical analysis plan, Clene plans to analyze the neurofilament light data from its large NIH-sponsored Early Access Protocol early in the fourth quarter of 2025 A second Type C meeting has been scheduled with the FDA in the third quarter of 2025 to review the survival benefit associated with CNM-Au8 dosing The Company expects to submit a New Drug Application in the fourth...Read more
Presented positive translational data from SYNGAP1-related disorders program showcasing efficacy in a humanized SYNGAP mouse model and increased protein in non-human primates at the 28th American Society of Gene and Cell Therapy (ASGCT) Annual Meeting Initiating GLP toxicology studies evaluating CMP-SYNGAP-01 in Q3 2025 Dosing completed in multiple ascending dose (MAD) cohort 3 of CMP-CPS-001 and data from single ascending dose (SAD)...Read more
MINNEAPOLIS, Aug. 14, 2025 (GLOBE NEWSWIRE) -- OneMedNet Corporation (Nasdaq:ONMD) (“OneMedNet,” the “Company,” “we,” “us” or “our”), a leader in AI-powered Real-World Data (RWD), announced its financial results for the second quarter ended June 30, 2025, including its significantly improved balance sheet. Second Quarter and First Half 2025 Financial Highlights Improved Balance Sheet: Due to the combination of debt conversions, vendor...Read more
Announced updated Phase 2 data at ASCO for vilastobart, a tumor-activated, Fc-enhanced, anti-CTLA-4, demonstrating deep and durable responses and a meaningfully differentiated safety and tolerability profile for an anti-CTLA-4 combination therapy On track with plans to nominate first development candidates for wholly owned masked T cell engager programs in second half of 2025 $121.6 million in cash and cash equivalents as of June 30,...Read more
Generated $1.8 million in cash flow from operations for the second quarter of 2025. Reported gross margin of 16% for the second quarter of 2025, in line with 2025 guidance. Increased cash position at June 30, 2025 to $18.4 million. WIXOM, Mich. / Aug 14, 2025 / Business Wire / Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of...Read more
Well-tolerated safety profile and robust broad-spectrum efficacy sustained over 1-year across all symptom domains including negative symptoms in open label extension (OLE) 1-year trial Successful completion of two large randomized double-blind clinical trials, including one Phase 2 and one Phase 3 trial, a 1-year OLE trial, and clinical pharmacology studies designed to support filing of New Drug Application (NDA) Planned meeting...Read more
Revenues of $3.5 million, Weaker Gross Margin, and Net Loss MISSISSAUGA, Ontario, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, reports results for its third quarter and nine months of fiscal 2025 ended June 30, 2025 (“Q3” and “YTD”). Sales for Q3 were down for both Antigens and QAPs™, while YTD Antigens were up and QAPs were down...Read more
Revenue from RenovoCath® device totaled over $400,000 for the Second Quarter 2025 As of June 30, 2025, the Company had $12.3 million in cash and cash equivalents Management to host conference call today at 4:30 p.m. ET MOUNTAIN VIEW, Calif. / Aug 14, 2025 / Business Wire / RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing...Read more
Announced CNSide® CSF assay platform launch timeline Initiated the REYOBIQ dose optimization trial for patients with leptomeningeal metastases HOUSTON, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announces financial...Read more
LITTLE ELM, Texas / Aug 14, 2025 / Business Wire / Retractable Technologies, Inc. (NYSE American: RVP) reports total net sales of $10.4 million for the second quarter of 2025 and an operating loss of $5.1 million for the period, as compared to total net sales for the same period last year of $6.0 million and an operating loss of $5.8 million. For the first half of the year, net sales were $18.7 million and operating losses were $9.8 million...Read more
Core Business Demonstrates Strength with Flat Medical Cost Trends Despite Industry Inflation $120-$170 Million in Additional EBITDA Opportunities Identified for 2026 Adjusted Full Year Guidance Reflects Prior Period Headwinds Management to Host Conference Call and Webcast August 14, 2025 at 4:30 PM ET HENDERSON, Nev. / Aug 14, 2025 / Business Wire / P3 Health Partners Inc. (“P3” or the “Company”) (NASDAQ: PIII), a patient-centered...Read more
COPENHAGEN, Denmark, August 14, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, provides business update and announces second quarter 2025 financial results. Business highlights (since last quarterly update) Evaxion continues to execute its strategy and plans with a number of significant achievements across the company in recent months. We remain...Read more
Phase 3 Preparations Ongoing as Company Continues to Advance Multiple Partnering Options for Executing the Nebokitug Phase 3 Program Phase 2 SPRING Trial Data Highlighting Nebokitug’s Unique Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Effects in PSC Featured at Multiple Major Scientific Meetings FDA and Chemomab Align on CMC and Non-Clinical Toxicology Regulatory Path Forward for Nebokitug Cash Runway through End of Second...Read more
DARE to PLAY™ Sildenafil Cream on Track for Q4 2025 Launch via 503B Compounding Pathway; Positioned for Product Revenue Beginning in Q4 2025 Positive Interim DSMB Outcome for Ovaprene® Phase 3 Study Supports Continued EnrollmentMultiple Grant-Funded Programs Advance, Including to Address HPV and Long-Acting ContraceptionFour Commercially Available Solutions for Women on the Horizon In addition to DARE to PLAY™ Sildenafil Cream,...Read more
FDA confirms requirement for confirmatory study of roluperidone for the treatment of negative symptoms in schizophrenia Evaluation of strategic alternatives BURLINGTON, Mass., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today provided business updates. FDA Discussions...Read more
PRINCETON, N.J., Aug. 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 today its recent accomplishments and financial results for the quarter ended June 30, 2025. "As we quickly approach the latter part of 2025 into 2026, the Company...Read more
Favorable CDI-988 Phase 1 safety and tolerability reported Challenge study with CDI-988 as a norovirus preventive and treatment planned later this year BOTHELL, Wash., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three and six months ended June 30, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and...Read more
Record second quarter total revenue of $23.6 million, up 25% year-over-year Positive cash flows, with Adjusted EBITDA(1) of $2.2 million, up 69% year-over-year, and our 26th consecutive quarter of positive Adjusted EBITDA Investor webinar scheduled for Thursday, August 21, 2025 at 10:00 AM ET / 7:00 AM PT TORONTO / Aug 14, 2025 / Business Wire / NeuPath Health Inc. (TSXV:NPTH), (“NeuPath” or the “Company”), owner and operator of a...Read more
SARASOTA, Fla., Aug. 14, 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 related businesses and technologies, today announced second quarter 2025 financial results. Q2 2025 Financial Highlights (all metrics compared to Q2...Read more
Reports continued progress in the evaluation of assets for potential pipeline expansion in the areas of oncology and rare disease; transaction targeted for 2025 Provides updated and extended cash runway guidance into H1 2027 Management to host conference call today, August 14th, at 8:30 am EDT TEL AVIV, Israel, Aug. 14, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage...Read more
Intend to Pursue an NDA Submission to the U.S. FDA under Accelerated Approval Pathway for Iopofosine I 131 for the Treatment of Waldenstrom Macroglobulinemia (WM) Subject to Sufficient Funding and Once the Confirmatory Trial is Underway Continue to Work with the EMA Toward a Potential Submission of Iopofosine I 131 for Conditional Approval in the EU; Decision expected late 3Q early 4Q 2025 On track to advance CLR 125 into Phase 1 TNBC...Read more
CAMBRIDGE, Mass., Aug. 14, 2025 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for the second quarter of 2025. Leap Highlights: Board of Directors initiated process of exploring strategic alternatives to maximize shareholder value Strategic restructuring to prioritize corporate development resulting in a...Read more
SALT LAKE CITY, Aug. 14, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced financial results for the quarter ended June 30, 2025. Second Quarter 2025 Financial Results: Revenue of $0.2 million, which declined from $2.7 million during Q2 2024 primarily due to timing of grant revenue...Read more
Conference call today, August 14, 2025, at 4:30 PM ET SAN DIEGO, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today reported financial results for the second quarter ended June 30, 2025. “We continued to execute on our new strategy of focusing on our base of routine users of optical genome mapping (OGM) and VIA™ software as the primary drivers of our revenue and gross profit in the second quarter. These...Read more
Clinical trial advances for INSTASYL siRNA lead product candidate PH-762 5th cohort enrolling patients in on-going clinical study King of Prussia, Pennsylvania--(Newsfile Corp. - August 14, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biopharmaceutical company developing therapeutics using its proprietary INTASYL® siRNA gene silencing technology to eliminate cancer. Phio today reported its financial results...Read more
Achieves record number of ReWalk systems placed for Medicare beneficiaries since fee schedule established Third consecutive quarter of U.S. ReWalk pipeline growth with over 130 qualified leads in process Appoints new CEO and CFO to spearhead strategic change and accelerate growth MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Lifeward Ltd., (Nasdaq: LFWD) (“Lifeward” or the “Company”), a...Read more
Next-generation claudin 18.2 ISAC BDC-4182 now in Phase 1 dose-escalation study Cash balance of $48.5 million as of June 30, 2025 anticipated to fund key milestones through mid-2026 REDWOOD CITY, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today reported financial results for the second...Read more
COSCIENS Board of Directors approves a plan to voluntarily delist from Nasdaq, while retaining the Company’s listing on the TSX TORONTO, ONTARIO, Aug. 14, 2025 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or the “Company”), a life science company focused on natural ingredients and pharmaceutical solutions, today reported its financial and operating results for the second quarter ended June 30,...Read more
Q2 2025 Net Product Sales Increased 47% Year-over-Year to $3.8 Million SOLANA BEACH, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) disorders with an emphasis on GIMOTI® (metoclopramide) nasal spray, today reported financial results for the second quarter ended June 30, 2025, and provided a business update. “This...Read more
New sites accelerate registrational study enrollment - 15 patients have been enrolled in the NEPHRO study which remains on track with completion projected by the end of the year Cash and cash equivalents at June 30, 2025 were $6.8 million Conference call and webcast to be held Thursday, August 14, 2025 at 4:30 pm ET SAN MATEO, Calif., Aug. 14, 2025 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty...Read more
PITTSBURGH, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Predictive Oncology (Nasdaq: POAI), a science-driven company leveraging its proprietary artificial intelligence and machine learning capabilities, extensive biorepository of tumor samples, and CLIA laboratory to accelerate oncologic drug discovery and enable drug development, today reported financial and operating results for the quarter ended June 30, 2025, and provided a corporate...Read more
Advancing novel programs for respiratory viruses that pose pandemic threats or risk of serious illness, including SARS CoV2 (ratutrelvir) and influenza (Tivoxavir marboxil, TXM) Prioritization of ratutrelvir, a ritonavir-free, protease inhibitor regimen in development for Acute and Long COVID, reflects the ongoing infection risk and greater need, with waning vaccine utilization A submitted HREC study will enable initiation of Phase 2...Read more
Lucid processed 2,756 EsoGuard® 2Q25 tests, recognized revenue of $1.2 million, and secured CAC meeting on Medicare LCD for EsoGuard to be held on September 4 Veris Health completed 2Q25 financing, relaunched development of implantable physiological monitor, and initiated integration steps to launch commercial phase with OSU-The James Conference call and webcast to be held today, August 14, at 8:30 AM EDT NEW YORK, Aug. 14, 2025...Read more
CyPath® Lung revenues up 62% year-over-year in first six months of 2025 SAN ANTONIO / Aug 14, 2025 / Business Wire / bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on providing noninvasive, accurate detection of early-stage lung cancer and other lung diseases, today reported financial results for the three months ended June 30, 2025. Key Highlights Increased CyPath® Lung revenues 62%...Read more
Conference call and webcast scheduled for 8:30 a.m. Eastern Time Today, Thursday, August 14, 2025 NEW YORK, Aug. 14, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update. "BrainStorm remains focused on executing our clinical...Read more
GLEN ALLEN, Va., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided a business update and reported its financial results for the second quarter of 2025. Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “We believe we are...Read more
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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