ALPHA-ORBIT Pivotal Phase 3 Trial Evaluating Every 3- and Every 6-Month Administration of Navenibart (STAR-0215) in Hereditary Angioedema is Enrolling Patients Upcoming Navenibart and STAR-0310 Data: ALPHA-SOLAR Long-Term Extension Trial Results Expected Mid-2025 and Phase 1a STAR-0310 Healthy Subject Results Expected in Q3 2025 BOSTON / May 13, 2025 / Business Wire / Astria Therapeutics, Inc. (NASDAQ:ATXS), a...Read more
NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) today announced that it will participate in the following upcoming investor conferences during the month of May: BofA Securities 2025 Healthcare Conference on Wednesday, May 14 at 5:20 p.m. ET / 2:20 p.m. PT RBC Capital Markets 2025 Global Healthcare Conference on Tuesday, May 20 at 4:05 p.m. ET The webcasts will be accessible from Royalty Pharma’s...Read more
Total Revenues of $555.4 million, Cabozantinib Franchise U.S. Net Product Revenues of $513.3 million GAAP Diluted EPS of $0.55, Non-GAAP Diluted EPS of $0.62 Increasing 2025 Full Year Net Product Revenues and Total Revenues Guidance by $100 million Conference Call and Webcast Today at 5:00 PM Eastern Time ALAMEDA, Calif. / May 13, 2025 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today reported financial...Read more
COPENHAGEN, Denmark, May 13, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new data showing improvements in growth and bone morphometry from Week 52 of its pivotal ApproaCH Trial of TransCon CNP (navepegritide) in children with achondroplasia. TransCon CNP is an investigational prodrug of C-type natriuretic peptide (CNP) administered once weekly providing continuous exposure of active CNP to receptors on...Read more
ATTRibute-CM, BridgeBio’s Phase 3 clinical trial of acoramidis in patients with ATTR-CM, achieved statistical significance in reducing the risk of ACM or first CVH versus placebo in ATTRv-CM patients (59.1% risk reduction), establishing the mechanistic hypothesis that stabilizing TTR may delay or prevent ATTRv-CM ACT-EARLY is a registrational, randomized, double blind, placebo controlled, event driven prevention study that will enroll...Read more
CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) net trade sales of approximately $369 million Over 6,000 patients treated to date Initiated CARVYKTI® clinical production at the Tech Lane facility Received positive CHMP opinion to add statistically significant improvement in overall survival from CARTITUDE-4 study to CARVYKTI® label Australia’s TGA approved CARVYKTI® in second-line plus settings for multiple myeloma patients Cash...Read more
Previous term loan facility retired NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a $570 million term loan and revolving credit facility with funds managed by Blackstone Life Sciences and Blackstone Credit & Insurance (“Blackstone”). Concurrent...Read more
Trial Demonstrates Superiority of Aficamten to Standard of Care Beta Blocker in Improving Peak Exercise Capacity in Patients with Obstructive Hypertrophic Cardiomyopathy SOUTH SAN FRANCISCO, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced positive topline results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), a Phase 3 clinical...Read more
Approval based on efficacy and safety results from clinical studies, including longer-term functional outcomes from EMBARK global phase 3 study Company is eligible to receive up to $103.5M in near-term regulatory and commercial milestone payments CAMBRIDGE, Mass. / May 13, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the Japanese...Read more
REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it will present data on the burden of Prader-Willi syndrome (PWS) and findings from its clinical development program of VYKAT™ XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for...Read more
Updated BOND-003 clinical results presented at AUA showing best-in-disease durability and tolerability data for Cohort C with 24-month complete response rate of 42.3% by K-M Promising early signal in Cohort P with 90.5% high-grade recurrence free survival at 3 and 9 months by K-M New enrollment completion date for Phase 3 PIVOT-006 in intermediate-risk non-muscle invasive bladder cancer (NMIBC) expected in the second half of...Read more
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced its participation at the upcoming investor conferences. MannKind’s Chief Executive Officer Michael Castagna, PharmD, and Chief Financial...Read more
Enrollment underway in CHAPTER-3, a pivotal Phase 3 study of deucrictibant for prophylaxis of HAE attacks; topline data expected in 2H2026 Attack dataset continues to accumulate in RAPIDe-3, a pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, strengthening confidence in clinical timelines TQT study waivers received from FDA for both deucrictibant extended-release formulation and deucrictibant...Read more
NEW YORK / May 13, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that new data from a matching-adjusted indirect comparison study evaluating taletrectinib versus entrectinib in ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) will be presented in a poster session at ISPOR 2025, the Professional Society for...Read more
Updated data from ongoing Phase 1/1b trial in 1L R/M HNSCC to be presented at 2025 ASCO Annual Meeting Enrollment ongoing in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in 1L R/M HNSCC Strong financial position with approximately $462 million in cash and cash equivalents expected to fund operations into the first half of 2029 BOSTON, May 13, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a...Read more
Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous...Read more
CAMBRIDGE, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that John Butler, Chief Executive Officer, and Nik Grund, Chief Commercial Officer, will participate in a Fireside Chat at the H.C. Wainwright 3rd Annual BioConnect Investor Conference on Tuesday, May 20 at 2:30 PM EDT. A...Read more
IMA203 PRAME Cell Therapy: Randomized-controlled Phase 3 trial, SUPRAME, in previously treated advanced melanoma ongoing and expected to complete enrollment in 2026 IMA203 PRAME Cell Therapy: Phase 1b clinical trial ongoing with updated data in metastatic melanoma with substantially longer follow-up and additional uveal melanoma patients to be presented in an oral presentation at the 2025 ASCO Annual Meeting IMA203CD8 PRAME Cell...Read more
Completed Submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) and Requested Priority Review Company Remains on Track to Submit the MOLBREEVI Marketing Authorization Application (MAA) for Autoimmune PAP to the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory...Read more
Regulatory alignment achieved for Phase 3 EMPEROR study of zorevunersen, a potential first-in-class disease-modifying medicine for Dravet syndrome; Study start anticipated in 2Q 2025 Zorevunersen collaboration with Biogen brings leading capabilities for commercializing high value, disease-modifying medicines for rare genetic diseases; Stoke retains full rights in the United States, Canada, and Mexico As of March 31, 2025,...Read more
NEW YORK / May 13, 2025 / Business Wire / Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or “MindMed”), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that members of the Company’s management team will present at the 2025 RBC Capital Markets Global Healthcare Conference: 2025 RBC Capital Markets Global Healthcare Conference Format:...Read more
Addresses key challenges for CAR-T therapies Potential to significantly reduce costs and improve clinical efficacy of engineered effector T cells Data Shared at 2025 Annual Meeting of American Association of Immunologists MIRAMAR, Fla., May 13, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (“HCWB” or the “Company”) (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing innovative...Read more
Q1 2025 revenue of $17.3 million, with product sales of $14.0 million, representing 76% growth over Q1 2024 and the 17th straight quarter of sequential product sales growth Q1 2025 basic and fully diluted GAAP EPS of $(0.06), Non-GAAP fully diluted EPS of $0.07, and Adjusted EBITDA of $3.7 million Relaunched pediatric endocrinology biologic INCRELEX® in the U.S. and out-licensed international rights Established Wilson disease...Read more
Q1 2025 net revenue of $20.4 million, driven by product net revenue of $17.2 million Completed sale of PRV for gross proceeds of $150 million, positioning balance sheet to drive the Company’s commercial launches and development programs Company to host conference call and webcast today, May 13, 2025, at 4:30 p.m. ET CELEBRATION, Fla., May 13, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the...Read more
Top-line data from IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) expected in Q2 2025 Phase 2 trials in Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD), expected to initiate in Q2 and Q3 2025, respectively Cash, cash equivalents and short-term investments of $150 million as of March 31, 2025 $100 million credit facility secured with Hercules Capital, adding balance sheet...Read more
Term loan adds balance sheet strength and provides financial flexibility to support continued development of pemvidutide GAITHERSBURG, Md., May 13, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it has entered into an agreement with Hercules Capital, Inc. (NYSE: HTGC), a...Read more
FDA assigns PDUFA target action date of November 9, 2025 RGX-121 on track to be the first gene therapy and one-time treatment for MPS II Partner Nippon Shinyaku to lead commercialization upon potential approval REGENXBIO to lead commercial manufacturing and supply chain ROCKVILLE, Md., May 13, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the U.S. Food and Drug Administration (FDA) has...Read more
Multiple Poster Presentations Highlight the Depth and Novelty of MeiraGTx’s Technology Platforms for Gene and Cell Therapy LONDON and NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced the Company will exhibit four poster presentations at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual...Read more
Announced strategic collaboration with Hologen AI, including a $200 million cash upfront payment to MeiraGTx and the formation of a joint venture, Hologen Neuro AI Ltd, with a further $230 million in capital committed to initially focus on expediting Phase 3 clinical development of AAV-GAD for Parkinson’s disease U.S. Food and Drug Administration (FDA) Granted Regenerative Medicine Advanced Therapy (RMAT) designation for AAV-GAD for...Read more
Early entry of RAS-targeting franchise into clinic enabled by strong execution Initial Phase 1 monotherapy data for pan-RAS molecular glue ERAS-0015 and pan-KRAS inhibitor ERAS-4001 expected in 2026 Robust balance sheet with cash, cash equivalents, and marketable securities of $411 million as of March 31, 2025 with cash runway guidance extended to H2 2028 SAN DIEGO, May 13, 2025 (GLOBE NEWSWIRE) -- Erasca, Inc....Read more
Progress continues in Phase 3 Orbit study of setrusumab in osteogenesis imperfecta (OI) Cash of $62.5 million as of March 31, 2025, expected to fund operations into 2027 LONDON, May 13, 2025 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced its financial results for the first quarter ended March 31, 2025, and...Read more
Pivotal Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in frontline metastatic breast cancer on track for initiation in 2025, supported by promising updated efficacy data from ongoing Phase 1b/2 study Pivotal Phase 3 OPERA-01 trial of palazestrant monotherapy in 2/3L metastatic breast cancer continues to advance with top-line data anticipated in 2026; trial-in-progress poster to be highlighted at ASCO Annual...Read more
Initiated dosing of participants in the first-in-human study of ABS-101 (anti-TL1A antibody), with interim data expected in the second half of 2025 ABS-201 (anti-PRLR) non-human primate (NHP) data demonstrate extended half life and high subcutaneous bioavailability; anticipate Phase 1 initiation in early 2026 Cash, cash equivalents, and short-term investments sufficient to fund operations into the first half of 2027 VANCOUVER,...Read more
Absci becomes clinical stage company with ABS-101, first AI-designed biologic for IBD, beginning Phase 1 trial Preclinical data for ABS-101 demonstrates high potency and potential for quarterly dosing, an improvement in efficacy and convenience over first-generation anti-TL1As Interim data anticipated in the second half of 2025 VANCOUVER, Wash., May 13, 2025 (GLOBE NEWSWIRE) -- Absci Corporation (NASDAQ: ABSI) a clinical-stage...Read more
AVMAPKI™ FAKZYNJA™ CO-PACK launch underway following accelerated approval on May 8, 2025, for adult patients with KRAS-mutated recurrent LGSOC U.S. IND cleared for VS-7375, oral KRAS G12D (ON/OFF) inhibitor; expect to initiate Phase 1/2a study in mid-2025 Initial safety and efficacy results from the trial of VS-7375 by partner GenFleet Therapeutics to be presented at the 2025 ASCO Annual Meeting Updated safety and efficacy results from...Read more
Biologics License Application (BLA) for deramiocel in the treatment of Duchenne muscular dystrophy (DMD) remains under priority review by the U.S. FDA, with a target Prescription Drug User Fee Act (PDUFA) date slated for August 31, 2025 Recently completed mid-cycle review meeting with FDA with no significant deficiencies identified; late cycle meeting scheduled for June FDA has indicated intent to convene advisory committee...Read more
Pipeline advancements: The Marketing Authorization Application (MAA) for Day One Biopharmaceuticals and Ipsen’s tovorafenib was accepted for review by the European Marketing Authority (EMA) and Takeda initiated its Phase 3 trial exploring mezagitamab for the treatment of chronic primary immune thrombocytopenia Business development: Acquired an economic interest in Castle Creek Biosciences’ D-Fi (FCX-007) through participation in a...Read more
Presented new amezalpat mechanism-of-action data reinforcing its potential as a novel cancer treatment at the 2025 AACR Annual Meeting Granted Orphan Drug designation by FDA for TPST-1495 for the treatment of familial adenomatous polyposis (FAP) Received FDA “Study May Proceed” letter for Phase 2 trial of TPST-1495 for the treatment of FAP Granted both Orphan Drug & Fast Track designations by FDA for Amezalpat (TPST-1120) for the...Read more
GALAXIES Lung-201 did not meet established criteria for clinically meaningful improvements in progression free survival Based on totality of data, iTeos and GSK have agreed to terminate the belrestotug development program iTeos has initiated a targeted review of strategic alternatives to maximize shareholder value WATERTOWN, Mass. and GOSSELIES, Belgium, May 13, 2025 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq:...Read more
SOUTH SAN FRANCISCO, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing therapies using a precision approach to optimize clinical outcomes and significantly improve the lives of patients with immune-mediated diseases, today announced that its stockholders voted to approve all proposals required to be approved in connection with the pending merger with ACELYRIN, INC....Read more
Announced accepted oral presentation of positive phase 3 randomized placebo controlled clinical trial results of CAN-2409 (aglatimagene besadenovec) in localized prostate cancer at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting Preparations on track for Biologics License Application (BLA) for CAN-2409 in intermediate-to-high-risk localized prostate cancer, with submission expected in Q4 2026 Recently announced...Read more
Pivotal Phase 2 ALPHA3 Trial with Cemacabtagene Ansegedleucel (Cema-Cel) in First Line (1L) Consolidation in Large B-Cell Lymphoma (LBCL) Nearly 50 Sites Activated Across U.S. with Strong Enthusiasm from Investigators Lymphodepletion Selection and Futility Analysis Shifted to 1H 2026 in Part Due to Site-Related Factors that Impacted Expected Pace of Screening Immediately Following Site Activation Over 250 Patients Consented for MRD...Read more
In a Phase 1 study, EMP-01 (oral R-MDMA) demonstrated a unique, dose-dependent subjective effect profile that was generally found to be more similar to classical psychedelics than to racemic MDMA The exploratory, randomized, double-blind, placebo-controlled Phase 2 study will assess the safety, tolerability and efficacy of EMP-01 in adults with social anxiety disorder Topline data anticipated in the first quarter of 2026 NEW YORK...Read more
BMB-101 demonstrated a complete elimination of drop attacks in the DBA/2 mouse model The DBA/2 model is highly predictive of sudden unexpected death in epilepsy (SUDEP) Findings highlight BMB-101’s potential to address critical gaps in SUDEP prevention NEW YORK and VANCOUVER, British Columbia, May 13, 2025 (GLOBE NEWSWIRE) -- Bright Minds Biosciences Inc. (CSE: DRUG) (NASDAQ: DRUG) (“Bright Minds” or the...Read more
Company had a strong start to 2025, emerging as an R&D-focused organization Exclusive license agreement with Novo Nordisk for LX9851 executed; IND-enabling studies on track for completion in 2025 Phase 2b PROGRESS study confirmed 10 mg pilavapadin as appropriate dose for advancement into Phase 3 development for diabetic peripheral neuropathic pain Conference call and webcast at 5:00 pm ET THE WOODLANDS, Texas, May 13, 2025...Read more
Commenced market launch and first commercial sales of Symvess™ (acellular tissue engineered vessel-tyod) for the treatment of extremity vascular trauma Total revenues of $517,000 for quarter from sales and collaborative research agreement Completed public offering raising $46.7 million in net proceeds Implemented cost reduction to extend cash runway Conference call today at 8:30am ET DURHAM, N.C.,...Read more
Post hoc analysis published in the peer-reviewed journal Wounds highlights EscharEx®’s superior clinical performance and comparable safety profile to SANTYL® YAVNE, Israel, May 13, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced the publication of a peer-reviewed post hoc analysis in Wounds. The analysis is based on data from the...Read more
sunRIZE enrollment on track including U.S. sites and expected to be completed in May 2025; topline data anticipated in December 2025 U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy Designation to ersodetug for hypoglycemia due to tumor hyperinsulinism REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on...Read more
LOS ANGELES, May 13, 2025 (GLOBE NEWSWIRE) -- ACELYRIN, Inc. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that at the Company’s special meeting of stockholders held earlier today, its stockholders voted to approve the adoption of the Company’s merger agreement with Alumis Inc. (Nasdaq: ALMS). As previously announced,...Read more
WILMETTE, Illinois, May 13, 2025 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs, today announced first quarter 2025 financial results and recent developments. Recent Developments ALXN1840 for Wilson Disease On May 7, 2025, Monopar presented long-term efficacy and...Read more
UNLOXCYT™ (cosibelimab-ipdl) approved by U.S. FDA in December 2024 as first and only anti-PD-L1 treatment for advanced cutaneous squamous cell carcinoma Special meeting of stockholders to vote on Merger to take place on May 28, 2025 WALTHAM, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a commercial-stage immunotherapy and targeted oncology company, today announced...Read more
Reported Net Product Revenues of $20.9 million for the first quarter of 2025, a year-over-year increase of approximately 8% National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Neuroblastoma updated to include naxitamab-gqgk (DANYELZA®) Dosed first patient in Phase 1 clinical trial evaluating CD38-SADA pretargeted radioimmunotherapy in patients with Relapsed/Refractory non-Hodgkin Lymphoma...Read more
Achieved First Quarter 2025 Total Net Revenues of $8.8 Million, Up 18% Year Over Year Positive Momentum from Company’s Refined, Targeted Sales Strategy and Enhanced Patient Support Services PEDMARQSI Now Commercially Available in Germany and the United Kingdom Management to Host Conference Call Today at 8:30 a.m. ET RESEARCH TRIANGLE PARK, N.C., May 13, 2025 (GLOBE NEWSWIRE) -- Fennec...Read more
Conference Call and Webcast May 14 at 8:00 AM Eastern Time / 7:00 AM Central Time Topline DM199 Preeclampsia Phase 2 Part 1A Proof of Concept Results Expected in Near Term and Phase 2 Part 1B Expected to Initiate in Q3 2025 KOL Event Scheduled for May 28, 2025 to Discuss the Disease of Preeclampsia and the Ongoing DM199 Phase 2 Study Design Acute Ischemic Stroke Phase 2/3 Program Enrollment Progressing as Planned Cash Runway into Q3...Read more
xPloration Maximizes Impact for OmniAb’s Partners through Efficient and Precise Mining of Immunized Antibody Repertoires EMERYVILLE, Calif. / May 13, 2025 / Business Wire / OmniAb, Inc. (NASDAQ: OABI) today announced its participation in the 21st Annual PEGS Boston – The Essential Protein & Antibody Engineering Summit underway at the Omni Hotel. Earlier today, the company showcased case studies utilizing xPloration, a...Read more
€15 million investment by Sanofi, in addition to the ongoing partnership including the development of BCMA targeting ANKET® program in autoimmune indications First patient dosed in a Phase 1 study for IPH4502, Nectin-4 ADC in patients with selected advanced solid tumors. Presentations at AACR Annual Meeting 2025 and ASCO 2025 Annual Meeting FDA Breakthrough Therapy Designation granted to lacutamab for relapsed or refractory Sézary...Read more
In vivo CRISPR Editing Results in Functional Upregulation of a Liver Target Protein and Meaningful Reduction of Disease-Associated Biomarker in Mice CAMBRIDGE, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a pioneering gene editing company, today shared in vivo proof of concept data supporting the development of a potentially first-in-class treatment for an undisclosed liver target in a poster...Read more
Presenting new clinical data from Phase 1/2 multi-center clinical trial of LYL314, a next-generation dual‑targeting CD19/CD20 CAR T-cell product candidate for the treatment of relapsed and/or refractory large B‑cell lymphoma at the 18th International Conference on Malignant Lymphoma. Received Regenerative Medicine Advanced Therapy (RMAT) designation from the United States Food and Drug Administration (FDA) for LYL314 for the treatment...Read more
Additional Phase 1 Data for FT819 Off-the-Shelf CAR T-cell Product Candidate in Moderate-to-Severe Systemic Lupus Erythematosus to be Featured in Oral Presentation at EULAR 2025 Congress in June Regenerative Medicine Advanced Therapy Designation Granted by the FDA for FT819 in Moderate-to-Severe Systemic Lupus Erythematosus Expanding FT819 Phase 1 Study to Include Treatment of Multiple Additional B Cell-mediated Autoimmune Diseases...Read more
Announced strategic plan to advance (Z)-endoxifen for metastatic breast cancer indication Enhanced (Z)-endoxifen intellectual property portfolio with three new U.S. patents, expanding IP portfolio to more than 200 patent claims related to (Z)-endoxifen Ended first quarter 2025 with $65.1 million in cash and cash equivalents and no debt SEATTLE, May 13, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa...Read more
Revenue grew 37%, driven by increased product sales and service revenue REDWOOD CITY, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Seer, Inc. (Nasdaq: SEER), a leading life sciences company commercializing a disruptive new platform for proteomics, today reported financial results for the first quarter ended March 31, 2025. Recent Highlights Achieved revenue of $4.2 million for the first quarter of 2025 Secured a significant contract...Read more
RG6501 (OpRegen®) Phase 1/2a Clinical Study 36 Month Results to be featured June 21st at Clinical Trials at the Summit 2025 Initiated Clinical Study of OPC1 Delivery Device for Patients with Subacute and Chronic Spinal Cord Injury Announced 3rd Annual SCI Investor Symposium with Christopher & Dana Reeve Foundation CARLSBAD, Calif. / May 13, 2025 / Business Wire / Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a...Read more
Enrollment complete in registrational Phase 2 KYV-101 trial in stiff person syndrome (SPS); on track for topline data in 1H 2026; biologics license application (BLA) filing now anticipated in 1H 2026 Advancing into registrational Phase 3 KYV-101 trial in myasthenia gravis (MG) following successful end-of-Phase 2 meeting with U.S. Food and Drug Administration (FDA); Phase 2 MG data anticipated in 2H 2025 Company to host KOL event...Read more
Announced Positive Overall Survival in Cohort 3 from the Ongoing Phase 2 Trial of SLS009 (tambiciclib) in Relapsed/Refractory (r/r) Acute Myeloid Leukemia (AML) Demonstrating 8.9 mOS in AML-MRC and 8.8 mOS in All r/r to Venetoclax-Based Regimens Patients SLS009 Shows Promising Efficacy in Pediatric Acute Lymphoblastic Leukemia (ALL) Xenograft Models Final Analysis of Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in...Read more
First patient dosed in LINNET Phase 2 study of lorigerlimab in ovarian and other gynecologic cancers Clinical update on LORIKEET, a randomized 150-patient Phase 2 study of lorigerlimab in combination with docetaxel in patients with mCRPC, expected in second half of 2025 Advancement in portfolio of innovative ADC product candidates, including MGC026, MGC028 and MGC030 Cash, cash equivalents and marketable securities of $154.1...Read more
HOUSTON / May 13, 2025 / Business Wire / Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the quarter ended March 31, 2025. Recent Corporate Highlights Announced positive interim results of an investigator-initiated proof of concept...Read more
Actively screening for the 10,000 participant portion of COVID-19 Phase 2b trial; Dosing expected to begin in second quarter of 2025 Completed enrollment of Phase 1 clinical trial evaluating Company’s second-generation oral norovirus vaccine constructs, with topline data expected in mid-2025 New avian influenza vaccine candidate was 100% protective in a ferret challenge model, compared with 0% survival in placebo-treated...Read more
Reiterates Planned Submission of an NDA for Cytisinicline to FDA in June 2025 Company to Host Conference Call at 8:30 AM EDT Today, Tuesday, May 13, 2025 SEATTLE and VANCOUVER, British Columbia, May 13, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for...Read more
REVEAL-1 Cohort 3-month open-label data update expected in June 2025; early clinical signals reinforce Revita’s potential to maintain weight loss after GLP-1 discontinuation in the real world REMAIN-1 Midpoint Cohort data expected in Q3 2025; first randomized data on post-GLP-1 weight maintenance REMAIN-1 Pivotal Cohort has completed enrollment ahead of schedule; 6-month primary endpoint data anticipated in H2 2026 Rejuva gene...Read more
Enrollment of 1L NSCLC patients in China trial of AXN-2510/IMM2510 in combination with chemotherapy is ongoing with initial clinical data by ImmuneOnco expected in 2H 2025 Initiation of U.S. clinical study of AXN-2510/IMM2510 in combination with chemotherapy in 1L NSCLC anticipated before the end of 2025, assuming receipt of necessary regulatory approvals DALLAS, May 13, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (Nasdaq:...Read more
Company advancing plans to develop TPI 287, a novel, late stage abeotaxane that appears to cross the blood-brain barrier and has published clinical efficacy data in glioblastoma multiforme (GBM) Management releases "What This Means" segment discussing the receipt of Orphan Drug Designations for TPI 287; Access here HOUSTON, TX / ACCESS Newswire / May 13, 2025 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a...Read more
Completed enrollment in the Phase 1b trial in adult patients with Duchenne muscular dystrophy (DMD); data analysis and reporting expected in Q2 2025 Received regulatory approval, allowing initiation of a long-term follow-up study to treat DMD patients from the Phase 1b for 11 additional months Profile of SAT-3247, presented at the Muscular Dystrophy Association (MDA) Conference, demonstrated the drug to be safe and well tolerated with a...Read more
On track to begin rolling submission of Biologics License Application (BLA) for INO-3107 as a potential treatment for recurrent respiratory papillomatosis (RRP) in mid-2025 Device design verification (DV) testing of CELLECTRA device required for BLA submission is underway, anticipated completion in 1H25 Clinical and immunological results from Phase 1/2 trial of INO-3107 published in Nature Communications in February...Read more
Expect to report topline results for ALTITUDE-AD, a Phase 2 study to investigate sabirnetug (ACU193) for the treatment of early Alzheimer’s disease, in late 2026 Cash, cash equivalents and marketable securities of $197.9 million as of March 31, 2025, expected to support current clinical and operational activities into early 2027 Company to host conference call and webcast today at 8:00 a.m. ET NEWTON, Mass., May 13,...Read more
TECELRA® launch 2025 YTD metrics: 28 ATCs available; 21 patients aphresed; and 14 doses invoiced $4.0 million Tecelra net sales in Q1 2025 Instituting 2025 Tecelra full year sales guidance of $35-$45 million Lete-cel on track to initiate rolling BLA submission late 2025; approval anticipated in 2026 Adaptimmune had Total Liquidity1 of $60 million as of March 31, 2025; call at 8 a.m. EDT today Philadelphia, Pennsylvania and...Read more
Interim analysis focused on disease-free survival (“DFS”) in randomized Phase 2 AMPLIFY-7P clinical trial expected in Q3 2025 Company has alignment with U.S. Food and Drug Administration (“FDA”) on key design elements of planned Phase 3 study of ELI-002 Current cash position expected to support operations beyond anticipated AMPLIFY-7P Phase 2 interim analysis BOSTON, May 13, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics,...Read more
Exploring strategic alternatives to advance clinical stage pipeline and maximize shareholder value $124.2 million in cash and cash equivalents and marketable securities provides runway as of March 31, 2025 CAMBRIDGE, Mass. & MONTREAL / May 13, 2025 / Business Wire / Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a clinical-stage precision oncology company, today reported financial results for the first...Read more
Nonhuman primate (NHP) study in hemophilia A demonstrated therapeutically relevant factor VIII (FVIII) activity with durable response through approximately 19 months with an encouraging safety profile Well capitalized with $226.0 million in cash, cash equivalents and available-for-sale marketable securities as of March 31, 2025 with runway anticipated to support operations into 2027 EMERYVILLE, Calif., May 13, 2025 (GLOBE NEWSWIRE)...Read more
This model demonstrates that central inhibition of CB1 is not required for weight loss Anti-CB1 inhibiting antibody, nimacimab, showed greatest peripheral restriction compared with monlunabant and rimonabant, small molecule-based CB1 inhibitors, which both exhibited increasing dose-dependent brain penetration This model predicts nimacimab’s potentially superior therapeutic index, which is dependent on minimal brain exposure...Read more
LOS ANGELES, May 13, 2025 (GLOBE NEWSWIRE) -- Renovaro Inc. (NASDAQ: RENB), a TechBio leader focused on next-generation diagnostics, drug discovery, and genetically enhanced cancer therapies, today agreed on terms for an exclusive collaboration agreement with Amsterdam University Medical Center (“Amsterdam UMC”) to jointly evaluate and develop blood platelet RNA diagnostics. This partnership marks an important step forward in the clinical...Read more
Continued Progress in Ongoing Late-Stage Netherton Syndrome Studies Announced Positive Clinical Data for Adult and Pediatric Netherton Patients Provided Clear Visual Evidence of QRX003 Mechanism of Action Patent Portfolio Expanded to Support Pipeline Growth Launch of NETHERTON NOW Advocacy Initiative ASHBURN, Va., May 13, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late...Read more
Company to present full 12-month clinical data and new topline 18-month and 24-month data from INSPIRE registrational Phase 3 trial of govorestat in CMT-SORD Deficiency at the Peripheral Nerve Society 2025 Annual Meeting Review of govorestat development programs for Classic Galactosemia and CMT-SORD Deficiency ongoing NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT) (the “Company”), a...Read more
Company reports $3.4 million in YCANTH revenue, reflective of increasing demand, following the dispensing of more than 10,000 applicator units in the quarter, the most in company history and a 16.7% growth over Q4’24 Late-stage pipeline continues to advance with completion of end-of-Phase 2 meeting with Food and Drug Administration for VP-315, Verrica’s candidate for basal cell carcinoma, and continued advancement towards...Read more
64% (9/14) complete response rate with AlloNK + rituximab in heavily pretreated patients that were naïve to prior CAR-T cell therapy, in line with approved auto-CAR-T therapies in aggressive B-NHL Median duration of response for AlloNK + rituximab not yet reached and is at least 19.4 months, in line with approved auto-CAR-T therapies in aggressive B-NHL AlloNK’s activity and well-tolerated safety profile in aggressive B-NHL patients...Read more
Pilot Program for Qualifying Clinical Labs to Diagnose Bacterial Vaginosis MISSISSAUGA, Ontario and HELSINKI, Finland, May 13, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, and Aurevia Oy via its Labquality EQAS affiliate (Aurevia), announce a pilot external quality assessment (“EQA”) program to help clinical laboratories establish their...Read more
Expect to report topline data from the Seabreeze STAT Asthma study in 1H 2026 On track to initiate similarly-designed Phase 2 study in patients with COPD imminently SAN DIEGO, May 13, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic...Read more
Plan to potentially conclude enrollment early for Phase 3 NEAT clinical trial in Ataxia-Telangiectasia (A-T) to align topline results with existing cash runway SOUTH SAN FRANCISCO, Calif. / May 13, 2025 / Business Wire / Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, today provided an update on the company’s...Read more
Phase 1 clinical trial of CMP-CPS-001 in Urea Cycle Disorders (UCDs) ongoing, with dosing completed in multiple ascending dose (MAD) cohort 3; safety, pharmacokinetic, and pharmacodynamic data expected Q4 2025 CTA successfully submitted in Europe for Phase 1b clinical trial in female OTC heterozygotes Nominated development candidate, CMP-SYNGAP-01, to address SYNGAP1-related disorders; GLP toxicology studies expected to be initiated...Read more
AUSTIN, Texas / May 13, 2025 / Business Wire / Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage pharmaceutical company developing novel solutions for people suffering from acute cannabis-induced toxic effects (the “Company” or “Anebulo”), today announced financial results for the three months ended March 31, 2025, and recent updates. Third Quarter Fiscal Year 2025 and Subsequent Highlights: Anebulo is prioritizing the...Read more
Pre-specified interim analysis of the ongoing Phase 3 PIVOT-PO clinical trial of tebipenem HBr in complicated urinary tract infection (cUTI), including acute pyelonephritis (AP), on track to be completed in Q2 2025 Existing cash, together with earned development milestones from GSK, provide runway to fund operating expenses and capital expenditures into Q2 2026 CAMBRIDGE, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics,...Read more
| Company | Change | Last Trade |
|---|---|---|
| Ascendis Pharma | 7.09 4.59 | $161.52 |
| HCW Biologics | 5.21 100.00 | $10.42 |
| Cardio Diagnostics | 5.19 3,301.14 | $5.35 |
| Actuate Therapeutics | 2.89 42.81 | $9.64 |
| XOMA | 2.70 10.89 | $27.49 |
| Adaptive Biotechnologies | 2.28 32.52 | $9.29 |
| Galapagos | 1.77 7.06 | $26.84 |
| Alpha Cognition | 1.54 28.68 | $6.91 |
| Cadrenal Therapeutics | 1.41 10.54 | $14.79 |
| Arrowhead Pharmaceuticals | 1.31 9.38 | $15.28 |
| Tonix Pharmaceuticals | 1.30 6.77 | $20.49 |
| MediWound | 1.27 6.81 | $19.92 |
| ABVC BioPharma | 1.10 189.06 | $1.68 |
| ZIVO Bioscience | 1.04 6.52 | $17.00 |
| Enliven Therapeutics | 1.02 5.37 | $20.03 |
Assertio is a leading commercial pharmaceutical company bringing differentiated products to patients. The Company has a robust portfolio of branded prescription products in three areas: neurology, hospital, and pain and inflammation. Assertio has grown through...
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Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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