First patient dosed with CUE-102 for recurrent glioblastoma multiforme (rGBM) at Dana-Farber Cancer Institute (DFCI) BOSTON, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, announced today the initiation of...Read more
Ivonescimab to be Featured at WCLC Presidential Symposium for Second Consecutive Year MIAMI / Aug 14, 2025 / Business Wire / Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today announced that data from the Phase III HARMONi trial featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented as part of the Presidential Symposium at the International...Read more
CAMBRIDGE, Mass., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to BEAM-101, an investigational genetically modified cell therapy for the treatment of sickle cell disease...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
Anaphylm launch funding of $75 million committed by RTW, subject to FDA approval of Anaphylm and other conditions Strategic financing will further strengthen the Company’s balance sheet in advance of potential commercialization of Anaphylm for the emergency treatment of allergic reactions, including anaphylaxis WARREN, N.J., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the...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
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 I/II...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
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 epilepsyRecent appointment of experienced neuroscience leaders to guide the clinical development strategy for simufilamAdvanced settlement negotiations ongoing to resolve certain securities litigation; $31.25 million estimated loss contingency recorded in Q2 for resolution$112.4...Read more
Cash runway extended to deliver clinical program in GVHD and Ph2 results in 2L Gastric CancerDepartment of Defense STTR Grant to advance INKTs in GVHD announced; program advancingNew 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, off-the-shelf...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
- 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
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 June...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
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
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
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
CNSide® can quantify leptomeningeal metastases (LM) over time and monitor changes in the expression of multiple targetable mutations CNSide® may catalyze LM treatment initiation, allow physicians to adapt treatment with real time shifts in tumor biology, and enable personalized cancer therapy HOUSTON, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical...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 on...Read more
BOTHELL, Wash., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a clinical stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, presented results from its Phase 1 clinical trial of ATH-1105 in healthy volunteers at the ALS Nexus 2025 conference in Dallas, Texas. ALS Nexus convenes leading experts from the ALS community, including researchers,...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
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...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
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
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
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
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...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
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
Approval is based on KEYNOTE-689 Phase III Clinical Trial Results KIRKLAND, QC, Aug. 13, 2025 /CNW/ -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumours express...Read more
Program Designed to Increase Use of Recommended Medication Therapy by Connecting with Providers in Workflow LOUISVILLE, Ky. and ARLINGTON, Va., Aug. 13, 2025 /PRNewswire/ -- Humana Inc. (NYSE: HUM), one of the nation's leading health and well-being companies, and health technology pioneer DrFirst today announced the launch of a program designed to close gaps in care for patients with chronic health conditions like diabetes and...Read more
IRVING, Texas, Aug. 13, 2025 /PRNewswire/ -- Caris Life Sciences® (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, published results in Breast Cancer Research comparing the effectiveness and optimal sequencing of two antibody-drug conjugates, trastuzumab deruxtecan (T-DXd) and sacituzumab govitecan (SG), in HER2-negative breast cancer patients. The study found that the...Read more
CAMBRIDGE, Mass., Aug. 13, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC)...Read more
Newly formed Advisory Board comprises world-class leaders in oncology to support advancement of Zai Lab’s robust oncology products and pipeline SHANGHAI & CAMBRIDGE, Mass. / Aug 13, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the creation of its Oncology Scientific Advisory Board (SAB). The newly formed Oncology SAB is comprised of distinguished oncology leaders and will support the advancement...Read more
Strong performance driven by over 200% growth in product revenues year-on-year Best quarter in Alvotech’s history in terms of operating cash flows Continued expansion of commercial partnerships for pipeline assets Alvotech listed on Nasdaq Stockholm Market Conference call and live webcast on Thursday August 14, 2025, 8:00 am ET (12:00pm GMT) REYKJAVIK, Iceland, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the...Read more
Single-agent CD19 CAR-NK cell therapy achieved a complete response in third-line Waldenstrom macroglobulinemia (WM), a type of non-Hodgkin lymphoma Second patient maintains an ongoing complete response at six months with CD19 CAR-NK in combination with rituximab and a third WM patient has been enrolled in the study First study to demonstrate the potential for complete responses with a chemotherapy-free immunotherapy in late-stage WM...Read more
Safety review leading to dose escalation and achievement of first predetermined enrollment target in Phase 1/2 study of SRP-1003 for DM1 triggers $100 million milestone payment Sarepta sells at least $174 million of Arrowhead common stock for cash proceeds, Arrowhead will redeem $50 million of stock from Sarepta to prefund half of $100 million milestone payment due to Arrowhead CAMBRIDGE, Mass. / Aug 13, 2025 / Business Wire / Sarepta...Read more
Initiative to expand testing access to underserved U.S. communities SAN DIEGO, Aug. 13, 2025 /PRNewswire/ -- QuidelOrtho Corporation has launched a Certified Analyzer Program, an innovative initiative designed to expand access to high-quality diagnostic testing in rural and community hospitals across the United States. Tailored for clinics, physician office labs and small hospitals with fewer than 100 beds, the program...Read more
$15.7 million in revenue, including $12.8 million in neffy U.S. net product revenue in second quarter of 2025 Growth for neffy in the U.S. driven by increased payor access with additional near-term growth anticipated from national direct-to-consumer (DTC) campaign and pediatric co-promote partnership 93% commercial coverage achieved with streamlined prior authorization process with approval rates at the pharmacy benefit manager (PBM)...Read more
Announced positive data from the Phase 1 clinical trial of ELVN-001 in CML, reporting a cumulative MMR rate of 47% with 32% of patients achieving MMR by 24 weeks and demonstrating a favorable safety and tolerability profile across all dose levels Strong balance sheet with $491 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into the first half of 2029 BOULDER, Colo., Aug. 13,...Read more
TORONTO, Aug. 13, 2025 /CNW/ - VitalHub Corp. (the "Company" or "VitalHub") (TSX: VHI) is pleased to announce that it has entered into an agreement with Cormark Securities Inc. and National Bank Financial Inc. acting as co-lead underwriters, on behalf of a syndicate of underwriters (collectively, the "Underwriters") pursuant to which the Underwriters have agreed to purchase 5,118,111 Common Shares (the "Common Shares") from the...Read more
Anzu-cel (anzutresgene autoleucel, IMA203) PRAME Cell Therapy: One-time infusion continues to show favorable tolerability as well as strong anti-tumor activity and durability in 33 heavily pretreated patients with metastatic melanoma in data from a Phase 1b trial presented at the 2025 ASCO Annual Meeting: 56% cORR, 12.1 months mDOR at 13.4 months mFU, 6.1 months mPFS and 15.9 months mOS Anzu-cel (IMA203) PRAME Cell Therapy: Global,...Read more
Reported positive topline results from the ongoing Phase 2 TRANQUILITY trial of pacibekitug in May 2025, demonstrating rapid, deep, and durable reductions in high-sensitivity C-reactive protein with quarterly dosing Additional data from the ongoing Phase 2 TRANQUILITY trial to be presented at the European Society of Cardiology Congress in August 2025 On track to initiate Phase 2 proof-of-concept trial in abdominal aortic...Read more
Reached Alignment with the U.S. Food and Drug Administration (FDA) on Information Needed for Resubmission of the Biologics License Application (BLA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Plan to Resubmit the BLA in December with FUJIFILM Biotechnologies (Fujifilm) as the Drug Substance Manufacturer and Will Request Priority Review Anticipate Submitting the MOLBREEVI...Read more
PALO ALTO, Calif., Aug. 13, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today reported recent business highlights and financial results for the second quarter ended June 30, 2025. "Our July 16 Investor R&D Day brought forward compelling new data along with a clear commercial vision for our three late-stage clinical assets –tarcocimab, KSI-501 and KSI-101– underscoring their transformative potential in retinal disease...Read more
Continued Clinical Program Execution in the Phase 3 CoMpass Trial in Early Choroidal Melanoma and the Phase 1b/2 Trial in Non-Muscle Invasive Bladder Cancer (NMIBC) Strengthened Balance Sheet with $75 Million Equity Financing; Cash Position Expected to Fund Operations into the First Half of 2027 BOSTON, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing...Read more
GFH375 demonstrated an overall response rate (ORR) of 68.8% in non-small cell lung cancer (NSCLC) at the recommended Phase 2 dose of 600 mg QD GFH375 demonstrated an ORR of 57.7% in efficacy evaluable patients with NSCLC across all dose levels Mini oral presentation on Sunday, September 7, 2025 from 12:00 to 1:15 pm (CEST) BOSTON / Aug 13, 2025 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed...Read more
First Half 2025 Total Revenues were $88.8 Million, up 11% Year-over-Year; Revenues for 2025 Second Quarter were $44.8 Million, up 5% Year-over-Year First Half 2025 Adjusted EBITDA of $22.5 Million, up 35% Year-over-Year and Representing 25% Margin of Revenues; Second Quarter Adjusted EBITDA of $10.9 Million, up 20% Year-over-Year Robust First Half Results and Positive Outlook for Remainder of 2025 Support Increased Adjusted EBITDA...Read more
Completed enrollment in Phase 3 ONWARD clinical trials for envudeucitinib in moderate-to-severe plaque psoriasis; topline readout expected in early Q1 2026 Completed enrollment in Phase 2b LUMUS clinical trial for envudeucitinib in systemic lupus erythematosus (SLE); topline readout expected in Q3 2026 Completed merger with ACELYRIN, Inc. to strengthen financial position and support advancement of late-stage immunology pipeline Cash,...Read more
HEALWELL achieved quarterly revenue from continuing operations of $40.5 million in Q2-2025, 645% higher than the $5.4 million generated in Q2-2024. Revenue growth in the quarter was largely driven by the Orion Health acquisition, resulting in a record 1,064% year-over-year increase in the Company's Healthcare Software business compared to Q2-2024. During Q2-2025, HEALWELL reported positive Adjusted EBITDA of $1.9 million, compared to...Read more
Richard Barasch to Retire; Anne McGeorge Brings Extensive Financial Experience to Role as New Chairman CERRITOS, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- The Oncology Institute, Inc. (“TOI”) (NASDAQ: TOI), one of the largest value-based oncology groups in the United States, today announced that Richard Barasch will retire from his role as Chairman of the Board, effective August 12, 2025. Anne McGeorge, who currently serves as a...Read more
CERRITOS, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- The Oncology Institute, Inc. (NASDAQ: TOI) (“TOI” or the “Company”), one of the largest value-based community oncology groups in the United States, today reported financial results for its three months ended June 30, 2025. Daniel Virnich, CEO of TOI, commented, "We delivered another strong quarter with over 20% year-over-year revenue growth. This was driven by exceptional...Read more
Business development: Purchased mezagitamab royalty and milestone rights held by BioInvent International and will secure royalty economic interests in two early-stage partnered assets through XOMA Royalty’s recently announced acquisition of LAVA Therapeutics. Company acquisitions: Announced XOMA Royalty’s acquisitions of Turnstone Biologics, LAVA Therapeutics, and HilleVax; acted as structuring agent and provided financing for...Read more
SAN DIEGO, Aug. 13, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") today reported financial results for the second quarter of 2025. Following the completion of the sale of INBRX-101 (the "101 Transaction") by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. and the Former Parent's concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs...Read more
MALVERN, Pa., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the ongoing pivotal confirmatory OCU410ST Phase 2/3 GARDian3 clinical...Read more
Denifanstat met all primary and secondary endpoints in Phase 3 clinical trial in moderate to severe acne conducted by license partner Ascletis in China Initiated first-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 being developed for acne in the U.S. Phase 1 clinical trial to evaluate the pharmacokinetics (PK) of a combination of denifanstat and resmetirom expected to initiate in 2H 2025; data readout expected...Read more
Net Revenue Increased 28% Year-Over-Year in Q2; Increased 27% Year-Over-Year in First Six Months of 2025 Announces Process to Evaluate Strategic Alternatives for its Tissue Health Plus, LLC Subsidiary FORT WORTH, TX, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Sanara MedTech Inc. (“Sanara,” the “Company,” “we,” “our” or “us”) (Nasdaq: SMTI), a medical technology company focused on developing and commercializing transformative...Read more
[212Pb]VMT-α-NET study update presented at the 2025 ASCO Annual Meeting, based on updated interim results from a Phase 1/2a study in neuroendocrine tumors. As of the April 30, 2025 data cut-off date: Four of the initial seven patients enrolled in Cohort 2 experienced objective responses as defined by RECIST v1.1. Three of those patients experienced confirmed response and remained in response. One new first response was subject to...Read more
The CTMX-2051-101 study has enrolled 73 colorectal cancer patients to-date, aligned with the Company’s goal of providing a Phase 1 data update in Q1 2026 The CTMX-2051-101 study remains active and patients continue to be dosed with CX-2051 across all expansion doses SOUTH SAN FRANCISCO, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally...Read more
Announces revenue of $15.3M vs $14.1M analyst consensus estimate Six presentations featured ECO Synthesis® platform at 2025 TIDES USA annual meeting, including three from leading CDMO collaborators $27.3M raised via ATM facility and Innovatus loan to support expansion of ECO Synthesis REDWOOD CITY, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading provider of enzymatic solutions for the efficient and...Read more
Phase 3 results position telitacicept as potential best-in-disease profile in primary Sjögren's disease Telitacicept demonstrated a favorable safety profile Vor evaluating timing of global Phase 3 clinical study in primary Sjögren's disease Data anticipated to be presented at an upcoming medical conference CAMBRIDGE, Mass., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming...Read more
Achieved record quarterly revenue of $12.6 million in Q2 2025, an increase of 26% compared to Q2 2024 Operating profit totaled $0.6 million and Adjusted EBITDA rose to $1.5 million, Raised full-year 2025 Revenue and EBITDA guidance Remaining performance obligations increased by 25% YOY to $62 million Conference call to be held today at 8:30 AM ET BURLINGTON, Mass. and JERUSALEM, Aug. 13, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd....Read more
BEIJING, Aug. 13, 2025 /PRNewswire/ -- Shineco Inc. ("Shineco" or the "Company"; NASDAQ: SISI), a manufacturer of induced pluripotent stem cell (iPSC) technology platforms, today announced the establishment of a Biological Cell Digital Business Division (the "Division"), and the appointment of Mr. Lin Hongguang as General Manager, to advance the integration of its biological cell assets and blockchain technology. Through a new...Read more
Pivotal Phase 2 ALPHA3 Trial with Cemacabtagene Ansegedleucel (Cema-Cel) in First Line (1L) Consolidation in Large B-Cell Lymphoma (LBCL) ALPHA3 Proceeding as a Two-Arm Randomized Trial Comparing Cema-cel After Standard Fludarabine and Cyclophosphamide (FC) Lymphodepletion vs. Observation More than 50 sites Activated Across the U.S. and Canada, with Additional International Expansion Underway; Scheduled Futility Analysis Remains on...Read more
MediWound Announces New EscharEx® Phase II Data Demonstrating Strong Link Between Wound Bed Preparation and Wound Closure in Venous Leg Ulcers Post hoc analysis published in Advances in Wound Care, provides clinical evidence supporting wound bed preparation as a critical step in the healing process YAVNE, Israel, August 13, 2025 (GLOBE NEWSWIRE) – MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic...Read more
Cybin continues to make significant progress on its journey to bring breakthrough therapies to patients by delivering on the following key milestones Received European and United Kingdom Medical and Healthcare Products Regulatory Agency (“MHRA”) approval for EMBRACE, the Company’s second pivotal study evaluating CYB003 for the adjunctive treatment of Major Depressive Disorder (“MDD”) on schedule EMBRACE study to enroll 330 participants...Read more
With the clearance of the U.S. IND, initiation of the U.S. clinical trial of AXN-2510/IMM2510 (“‘2510”) anticipated before the end of 2025 Updated ‘2510 monotherapy data in squamous-NSCLC to be presented at IASLC’s 2025 World Conference on Lung Cancer (WCLC) by ImmuneOnco DALLAS, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of...Read more
STAFFORD, Texas, Aug. 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 addition of clinical sites in Romania. The Company's application to expand Flamingo-01 into Romania has been formally approved...Read more
Strong Service Growth; Debt Refinancing Complete; Company Issues FY26 Guidance MADISON, Wis., Aug. 13, 2025 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) today reported financial results for the fourth quarter and fiscal 2025, ended June 30, 2025. Key Fiscal Fourth Quarter Highlights Net revenue was $127.5 million, a decrease of 5 percent from the prior year period. Net income was $1.1 million compared to net income...Read more
Initiated Phase 2 Seabreeze STAT asthma and COPD studies evaluating rademikibart as an adjunct treatment for acute exacerbations – Presented positive data at ATS 2025 and EAACI 2025 supporting the potential of rademikibart to deliver differentiated efficacy and safety in patients with eosinophilic-driven type 2 asthma and COPD New drug application for rademikibart for the treatment of AD submitted to China’s NMPA by Simcere, the...Read more
Company now plans to share updated OS and PFS data from first-line pancreatic cancer patients (N = 34) treated with atebimetinib + mGnP in Q3 2025, earlier than prior guidance Exceptional 94% overall survival (OS) observed at 6 months in ongoing Phase 2a trial of atebimetinib plus modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N = 34) Newly issued U.S. composition of matter patent for...Read more
Processed 2,756 EsoGuard® tests and recognized 2Q25 revenue of $1.2 million, ending quarter with over $30 million in proforma cash and extending runway well past upcoming reimbursement milestones Multi-Jurisdictional Contractor Advisory Committee (CAC) meeting on Medicare Local Coverage Determination (LCD) for EsoGuard to be held on September 4 Conference call and webcast to be held today, August 13, at 8:30 AM EDT NEW YORK, Aug....Read more
ROCKVILLE, MD, Aug. 13, 2025 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company developing innovative antibody-based therapeutics for the treatment of cancer, today announced that effective as of August 13, 2025, Eric Risser has been appointed President, Chief Executive Officer and to the Board of Directors. Mr. Risser has served as Chief Operating Officer at MacroGenics...Read more
Reported positive Phase 1b data in five adults with Duchenne muscular dystrophy (DMD) after 28 days of treatment Demonstrated safety, tolerability and an approximate doubling in grip strength On track to initiate a follow-up of the Phase 1b study in adults with DMD in Q3 2025 Expected to report 3-month interim data this year Preparing submissions to enable initiation of a global Phase 2 randomized, placebo-controlled...Read more
Reported positive topline data from Phase 1 clinical trial evaluating Company’s second-generation oral norovirus vaccine constructs, supporting potential for improved protection against infection Enrolled approximately 5,000 participants in COVID-19 Phase 2b trial prior to stop work order; Follow-up for all participants dosed, including 400-person sentinel cohort continues Cash, cash equivalents and investments of $26.3...Read more
Acquisition of potentially best-in-class dopamine agonist combination product candidates, including ALTO-207, expands precision psychiatry pipeline; guided by compelling PAX-D study results published in The Lancet Psychiatry ALTO-207 adds expected late-stage readout in treatment resistant depression within current cash runway; planned Phase 2b trial, designed to be a potentially pivotal study expected to initiate by...Read more
MOUNTAIN VIEW, Calif. / Aug 13, 2025 / Business Wire / Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO) a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced the appointment of Raymond Sanchez, M.D., to its Board of Directors, effective August 12, 2025. Dr. Sanchez is a highly accomplished executive with a strong background in medicine and over 20...Read more
Toronto, Ontario – TheNewswire - 13 August 2025 – Helix BioPharma Corp. (TSX: “HBP”, OTC PINK: “HBPCD”, FRANKFURT: “HBP0”) (“Helix” or the “Company”), a clinical-stage oncology company shaping a near future where today’s hard-to-treat cancers are vincible, announced today the publication of a peer-reviewed article in Frontiers in Oncology titled “Safety of unconventional antibody-drug conjugate L-DOS47 in a Phase I/II monotherapy study...Read more
ASCO 2025 presentation: First-in-class agent Plinabulin drives immune re-sensitization in NSCLC patients progressed to PD-1/L1 therapies Med (Cell Press) Publication with MD Anderson Collaboration highlights Plinabulin’s rapid dendritic cell activation in responding patients across eight cancer types who failed prior immunotherapy SEED Therapeutics’ RBM39 degrader ST-01156 clears FDA IND and advances toward Phase 1 trials New...Read more
GUILFORD, Conn., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced second quarter 2025 financial results and provided a business update. “In the second quarter, we executed across our key growth drivers. We received FDA...Read more
Company plans rapid advancement of semaglutide implant NPM-139, following positive weight loss data from an ongoing preclinical study of NPM-139 and promising results from the LIBERATE-1 Phase 1 clinical study of NPM-115 New $10M equity financing to enable accelerated development of NPM-139 while securing financial position into the second half of 2026 Vivani to spin off Cortigent, Inc., a division of the Company that develops brain...Read more
CMT-SORD program advances; meeting scheduled with the FDA in Q3 2025 to discuss govorestat for the treatment of CMT-SORD Presented full 12-month clinical results and new topline data from INSPIRE Phase 2/3 trial of govorestat for the treatment of CMT-SORD at PNS 2025 Annual Meeting highlighting slowed progression of disease observed via MRI at 24 months Launched new sponsored Sorbitol Assay to support identification of patients...Read more
Topline results from the OV329 Phase 1 safety, tolerability and biomarker study remain on track for a readout in Q3 2025 $7.0 million royalty monetization agreement signed with Immedica Pharma AB for future ganaxolone royalties, delivering capital to the Company from a non-pipeline asset OV4071, the first ever oral KCC2 direct activator, is completing an IND-enabling package; Ovid anticipates first-in-human studies in Q2 2026 Cash,...Read more
$10 million two-times over-subscribed rights offering creates cash runway to anticipated FDA marketing authorization decision for ProSense® in women aged 70+ with early-stage low risk breast cancer Conference call to be held today at 11:00 am Eastern Time CAESAREA, Israel, Aug. 13, 2025 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation...Read more
Positive Phase 3 SHIELD II Trial Results - D-PLEX₁₀₀ successfully met its primary efficacy endpoint and demonstrated 58% reduction in SSI NDA submission expected in Q1 2026 Unveiled a Long-Acting GLP-1 Receptor Agonists Delivery Platform Targeting the Obesity and Diabetes Market Successful Warrant Exercise Significantly Strengthened Balance Sheet with Cash Runway into 2026 Conference Call Scheduled for Today at 8:30 AM ET PETACH...Read more
Multiple Abstracts Presented at the 2025 American Society of Clinical Oncology Annual Meeting Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., Aug. 13, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today provided a business update and...Read more
Major milestone achieved with successful completion of enrollment for LP-184 Phase 1a clinical trial, with 65 patients enrolled across a range of solid tumors including glioblastoma (GBM); LP-184 is a potential blockbuster drug-candidate with market potential of $10-12 billion USD in annual revenue. Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) established for LP-184, enabling advancement to upcoming Phase 1b/2 trials...Read more
REDWOOD CITY, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today reported results for the fiscal quarter ended June 30, 2025 and provided...Read more
Memorandum of Understanding (MOU) signed with a leading Saudi Arabian pharma company which submitted the Breakthrough Medicine Designation to the Saudi Food and Drug Authority (SFDA) Increasing interest in CEL-SCI from Saudi investment funds as Multikine advances through regulatory and drug distribution channels VIENNA, Va. / Aug 13, 2025 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today announced that a Breakthrough...Read more
Continued advancement of two clinical-stage assets, both with clinically demonstrated single-agent anti-tumor activity -- ACR-368 in a registrational-intent Phase 2 study in endometrial cancer and ACR-2316 in a Phase 1 study in AP3-predicted tumor types New paradigm for accelerated design and development of novel compounds, like ACR-2316, based on optimal intracellular pathway selectivity, uniquely enabled by AI-driven AP3 Generative...Read more
SOUTH SAN FRANCISCO, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that dosing in the Phase 2 B-SUPREME study of its investigational compound ALG-000184 has been initiated in subjects with chronic hepatitis B virus (HBV)...Read more
Executing on Commercial Readiness Plans in Anticipation of FDA 510(k) Clearance for Groundbreaking 12-lead Electrocardiogram (ECG) Synthesis Software Engaged in Ongoing Productive Discussions with FDA Related to the 510(k) Application Increased Business Development Resources to Match Inbound Interest from Industry Partners Management to Host Webcast and Conference Call Today at 4:30 p.m. ET SANTA CLARA, Calif. / Aug 13, 2025 /...Read more
Announced entry into an agreement to be acquired by XOMA Royalty Corporation for between $1.16 and $1.24 per share in cash, plus a contingent value right related to LAVA’s two partnered assets and unpartnered programs Consummation of acquisition expected to occur in the fourth quarter of 2025, subject to customary closing conditions and an extraordinary general meeting of shareholders Announced decision to discontinue development of...Read more
More than 45 patients enrolled in Emi-Le Phase 1 dose expansion cohorts in post-topoisomerase-1 inhibitor ADC (post-topo-1) triple-negative breast cancer (TNBC) Plan to report initial clinical data from Emi-Le expansion cohorts in second half of 2025 Conference call today at 8:00 a.m. ET CAMBRIDGE, Mass., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused...Read more
First new patient dosed in Phase 3 MARIO study following the lifting of the FDA clinical hold, triggering a $10M milestone payment from GSK. An additional $20M milestone will be triggered upon the six month anniversary of the new patient dosing; as previously disclosed GSK disputes these milestone payments. SCYNEXIS vigorously disagrees with GSK’s position and is working towards resolving this disagreement; SCYNEXIS is...Read more
Completed Strategic Leadership and Operational Transformation from R&D to Commercial Operations Rebranded as Dyadic Applied BioSolutions to Reflect Our New Operational Priorities Full Redesign of Corporate Website to Prioritize Commercial Execution and Long-term Value Creation Completed $5.3 million Equity Offering to Strengthen Liquidity and Help Fund Pipeline and Commercial Growth Achieved Key Development and Commercial...Read more
COMMACK, NY, Aug. 13, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce the shipment of launch quantities of Arbli™ (losartan potassium)...Read more
Announced FDA removal of partial clinical hold on PORTOLA Phase 2a trial evaluating zetomipzomib for the treatment of patients with autoimmune hepatitis Submitted Type C meeting request to the FDA to meet during the fourth quarter of 2025 to discuss the development plan for zetomipzomib in autoimmune hepatitis PORTOLA Phase 2a data selected for oral presentation at The Liver Meeting® 2025 Cash, cash equivalents and marketable...Read more
Phase 3 LEVEL Study Ongoing, Enrollment Completion (230 Patients) Expected in First Half of 2026, with Topline Data Expected in Second Half of 2026 On Track to Initiate Second Phase 3 Study, LEVEL-2, in 2025 CHAPEL HILL, N.C., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to...Read more
U.S. FDA Grants Fast Track Designation for PMN310 in Alzheimer’s Disease, enhancing program’s potential for priority review PRECISE-AD Phase 1b Trial in Alzheimer’s Disease Progressing on Schedule: Over 50% enrolled, no cases of ARIA and no patient dropouts to date Strengthened Financial Position with $21.6 Million in Gross Proceeds Raised in July 2025 Cambridge, Massachusetts, Aug. 13, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences...Read more
Conference call to follow tomorrow, August 14 at 5 PM EST NEW HAVEN, Conn., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), filed its 10-Q report today. The following are the highlights of the Company’s financial performance and outlook for 2025. “Yet another quarter of revenue growth in both company divisions, along with overall gross margin improvement, has led to an...Read more
Marpai Slashes Losses by Two-Thirds in Q2 2025, Paving the Way to Profitability. Operating Expenses Cut 70% as Turnaround Gains Traction TAMPA, Fla., Aug. 13, 2025 /PRNewswire/ -- Marpai, Inc. ("Marpai" or the "Company") (OTCQX: MRAI), a leader in innovative healthcare technology and Third-Party Administration (TPA) services, today announced second quarter 2025 results that mark a decisive step forward in its turnaround...Read more
BOSTON, Aug. 13, 2025 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today closed an upsized private placement of 11,040,776 shares of common stock and pre-funded warrants to purchase 48,852,772 shares of common stock for total offering proceeds of $85 million. The originally announced offering of $60 million was increased to allow for the...Read more
Q2 Tecelra sales of $11.1m with 16 patients invoiced represents >150% growth vs Q1 2025 Entered into a definitive agreement for the sale of TECELRA, lete-cel, afami-cel, and uza-cel cell therapies to US WorldMeds for $55 million upfront with up to $30 million in future milestone payments Following the transaction, Adaptimmune has repaid its debt and is restructuring to maximize value from remaining assets, including PRAME and CD70...Read more
Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
CLICK TO LEARN 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...
CLICK TO LEARN MORE