4FRONT-1 Phase 3 expected data readout accelerated from H2 2027 to H1 2027 4FRONT-2 Phase 3 trial initiated ahead of schedule Streamlined late-stage clinical and pre-commercial organization aligns with focused pipeline shift, as announced in January 2025 EMERYVILLE, Calif., July 02, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing...Read more
Together, Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven add 30 satellite locations to enroll patients in BriaCell’s pivotal Phase 3 study BriaCell’s Phase 3 study currently has 58 active clinical sites across 15 states, including Smilow Cancer Hospital, Los Angeles Cancer Network, University of Arizona, DHR Health Oncology Institute, Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology...Read more
JERSEY CITY, N.J. / Jul 02, 2025 / Business Wire / Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, today announced that the Phase 2 ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint. OG-6219 is an oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor, which Organon acquired through its acquisition...Read more
500 subjects enrolled across the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia SAN DIEGO, July 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of enrollment in the...Read more
VANCOUVER, British Columbia & DALLAS / Jul 01, 2025 / Business Wire / Alpha Cognition Inc. (Nasdaq: ACOG) (“Alpha Cognition” [ACI], or the “Company”), a biopharmaceutical company developing novel therapies for debilitating neurodegenerative disorders, today announced preclinical data supporting the continued development of ALPHA-1062 for the treatment of mild traumatic brain injury (mTBI). The data provides additional evidence of...Read more
Recruitment initiated into the Phase 2 opaganib plus darolutamide study in patients with advanced prostate cancer, sponsored by ANZUP, and supported by Bayer and Ramsay Hospital Research Foundation Precision medicine approach: The 60-patient Phase 2 study uses the PCPro™ lipid biomarker test to identify patients with poor prognosis most likely to benefit from the combination Led by Professor Lisa Horvath, the study is expected to...Read more
Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival 2- and 6-week interim safety results demonstrated GRI-0621 to be safe and well-tolerated in the first 12 and 24 patients evaluated, respectively Results on track for 6-week interim biomarker analysis (n=24) in July 2025 and topline data in Q3 2025 LA JOLLA, CA,...Read more
PURCHASE, N.Y., July 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the Phase 2 ‘START’ Study surpasses 50% enrollment. The START Study is being conducted with partners at the Alzheimer’s Clinical Trials Consortium (ACTC), with $81 million in grant support from the National Institute of...Read more
DSMB recommended the continuation of trial as planned Topline data expected in Q3 2025 NEW HAVEN, Conn., July 01, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced the second positive recommendation by an independent Data Safety Monitoring Board (DSMB) to continue, without...Read more
Study met its primary and all key secondary endpoints, and BPL-003 demonstrated rapid, robust and durable antidepressant effects with a single dose Both 8 mg and 12 mg single doses of BPL-003 showed statistically significant and clinically meaningful reductions in depressive symptoms at all time points of the study compared to a 0.3 mg low-dose active control out to Week 8 BPL-003 was generally well-tolerated at all doses, with 99% of...Read more
Genitourinary Tumor Study Ongoing with Active Screening and Enrollment MILAN and NEW YORK, July 01, 2025 (GLOBE NEWSWIRE) -- Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology, today announced that a total of 38 patients were enrolled in newly diagnosed glioblastoma multiforme (TEM-GBM) study, with 25 patients receiving Temferon. Two patients have been enrolled in the TEM-LT long-term follow-up study, surviving three years...Read more
SAN DIEGO, June 30, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of investigational compound NBIP-01435 in healthy adult participants. NBIP-01435 is a long-acting corticotropin-releasing factor type 1 receptor antagonist administered as a subcutaneous...Read more
As of June 30th, 16 participants have enrolled in the Phase 1b, ahead of the original goal of at least 15 total participants by 3Q 2025 Analysis of 90-day biomarker activity from cerebrospinal fluid (CSF) in all participants currently enrolled is now expected to also track earlier; available in 4Q 2025 instead of 1Q 2026 Gain will continue screening patients for enrollment through July 31st, 2025, at the request of clinical...Read more
ARCT-810 significantly and consistently reduces biomarker glutamine to levels within normal range 15N-ureagenesis data provide first evidence of an mRNA therapeutic improving urea cycle function Ammonia remained stable and within normal range Multiple administrations of ARCT-810 continue to be safe and well tolerated at all tested dose levels Virtual KOL Presentation at 12:00 p.m. ET Today SAN DIEGO / Jun 30, 2025 / Business Wire /...Read more
Vancouver, Canada, June 30, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced a historic milestone: the first participant has been dosed with CMND-100, its proprietary MEAI-based oral drug candidate, in its...Read more
At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone SHANGHAI & CAMBRIDGE, Mass. / Jun 30, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival...Read more
As recently announced, initial proof-of-concept results from this ongoing investigator-initiated trial (IIT) show crofelemer reduced the required total parenteral nutrition in the first participating microvillus inclusion disease (MVID) patient by up to 27% and in the first participating short bowel syndrome patient by up to 12.5% The first two patients in this IIT were taken off crofelemer after 12 weeks of treatment for a period...Read more
At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone THOUSAND OAKS, Calif., June 30, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim...Read more
The SEISMiC C Study is the third study in the istaroxime cardiogenic shock development program - SEISMiC C is studying more severely ill SCAI Stage C cardiogenic shock patients Windtree has previously reported two positive early cardiogenic shock Phase 2 studies in SCAI Stage B patients The SEISMiC C interim analysis will provide a preliminary assessment of istaroxime safety in treating more severe cardiogenic shock patients who may...Read more
Expansion of study into additional indications doubles the potential addressable market beyond pancreatic cancer pain PoC 2 phase builds on early success and positive results demonstrated in PoC 1 in patients with severe pancreatic cancer pain, supporting multi-indication growth strategy THE WOODLANDS, TX, June 30, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device...Read more
Oral therapy designed to minimize CNS side effects shows dual activity in weight loss and smoking cessation models without muscle loss MIAMI, FLORIDA / ACCESS Newswire / June 30, 2025 / MIRA (NASDAQ:MIRA) today announced new animal study results from SKNY-1, a next-generation oral therapeutic under definitive agreement for acquisition. In a zebrafish model that mimics human obesity and craving behaviors, SKNY-1 demonstrated weight...Read more
No treatment-related neuropsychiatric events seen to date in SAD portion of Phase 1 MAD study on track for completion in Q3 2025 NORWOOD, Mass., June 30, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical-stage company focused on oncology and obesity, today announced the initiation of the multiple ascending dose (MAD) portion of its Phase 1 trial for CRB-913, a highly peripherally restricted CB1...Read more
TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC Initial 3-month complete response (CR) data expected to be reported in 1H 2026 CARLSBAD, Calif., June 30, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor...Read more
SHELTON, Conn., June 30, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, announces that INT230-6 achieved complete responses in a murine models of Malignant Peripheral...Read more
Study will evaluate safety and antiviral activity of ABI-1179 in participants with recurrent genital herpes ABI-1179 IND cleared to support study expansion to sites in United States Phase 1b studies for ABI-1179 and ABI-5366 running concurrently with interim data for both candidates on track for fall 2025 SOUTH SAN FRANCISCO, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a...Read more
First Orally Active Fatty Acid Binding Protein 5 Inhibitor Evaluated in Humans First-in-Class Approach Targets Unmet Need in Multibillion-Dollar Pain Management Market SOLANA BEACH, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological or...Read more
Global Phase 3 PROMINENT study will evaluate the efficacy and safety of felzartamab, as compared to tacrolimus, in adults with primary membranous nephropathy (PMN) There are currently no therapies specifically approved for PMN, a rare immune-mediated disease affecting the kidneys with an estimated prevalence of ~36k patients in the U.S.1 Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potentially differentiated...Read more
Primary objective to determine optimal dosing schedule for a registrational trial Trial builds on recommended Phase 2 dose determined in completed Phase 1 trial Trial benefits from $17.6M award from the Cancer Prevention & Research Institute of Texas HOUSTON, June 30, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics...Read more
In the Phase 2 MINDFuL trial of XPro™ in patients with early Alzheimer’s Disease (AD) with biomarkers of inflammation, the modified intent-to-treat (mITT) population (n=200) did not meet the primary cognitive endpoint (EMACC), however in a predefined population of amyloid-positive early AD patients with two or more biomarkers of inflammation (n=100), a benefit of XPro™ treatment over placebo was observed in cognitive, behavioral and...Read more
In the Phase 1 portion of the CELC-G-201 clinical trial evaluating gedatolisib plus darolutamide in men with metastatic castration resistant prostate cancer (“mCRPC”),the six-month radiographic progression free survival (“rPFS”) rate was 66% In a Phase 2 clinical trial of gedatolisib plus trastuzumab-pkrb as 3L+ therapy in patients with HER2+ metastatic breast cancer (“mBC”), the objective response rate (“ORR”) was 43% No patients...Read more
mRNA-1010 demonstrated superior relative vaccine efficacy that was 26.6% (95% CI; 16.7%, 35.4%) higher than a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older CAMBRIDGE, MA / ACCESS Newswire / June 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive results from a Phase 3 efficacy study (P304) evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010, the...Read more
Single Doses of Aritinercept Led to Robust and Long-Lasting Reductions in Immunoglobulins Pharmacodynamic Effects Supportive of Once-Monthly Dosing Plan to Initiate Clinical Studies in at Least Two Autoimmune Diseases in the Second Half of This Year Aurinia to Host Conference Call Today, June 30, at 8:30 a.m. ET ROCKVILLE, Md. & EDMONTON, Alberta / Jun 30, 2025 / Business Wire / Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today...Read more
TARPON SPRINGS, Fla., June 27, 2025 -- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor today announced that the second patient has been dosed in its new Phase 2 clinical trial protocol evaluating stenoparib in patients with advanced, recurrent, platinum-resistant or...Read more
BOSTON, June 27, 2025 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering the next generation of precision cancer medicines, today announced that the first patient has been dosed in the Phase 1/2 trial of TNG462 and Revolution Medicines’ daraxonrasib (RAS(ON) multi-selective inhibitor) or zoldonrasib (RAS(ON) G12D-selective inhibitor) in patients with MTAP-deleted...Read more
Study demonstrates superiority, showing both statistically significant and clinically meaningful reduction in annualized bleeding rate with a generally well-tolerated safety profile compared to on-demand treatment in patients 12 years and older HYMPAVZI was administered with a straightforward, once-weekly subcutaneous injection that required minimal preparation NEW YORK / Jun 26, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today...Read more
Phase 3 Top Line Results Expected Q2 2026 SALT LAKE CITY, June 26, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the first patient has been dosed in its pivotal Phase 3 clinical trial of LPCN 1154 (oral brexanolone), its investigational oral treatment for postpartum...Read more
The Independent Data Monitoring Committee (“IDMC”) has recommended to continue the study as planned as there are no safety concerns demonstrated in the data reviewed Interim results to date demonstrate GRI-0621 to be safe and well-tolerated in the first 24 patients evaluated 6-week interim biomarker data (n=24) expected in July 2025 and topline data expected in Q3 2025 Currently available treatments for IPF are limited to only two...Read more
Initiation of patient recruitment marks a key milestone in the development of VAR 200, a potential first-in-class treatment for kidney disease addressing renal lipotoxicity. There are no available drugs targeting renal lipotoxicity that damages the kidneys’ filtration system, causing protein leakage into the urine (proteinuria) and disease progression. VAR 200, designed to alleviate renal lipid accumulation, has preclinical data in...Read more
Demonstrated target engagement and response prediction for ALTO-203 by theta/beta ratio, a commonly used EEG index of cortical arousal and attentional control ALTO-203, a non-stimulant compound which demonstrated pro-cognitive and wake-promoting effects, has the potential to address sustained attention abnormalities in EEG biomarker characterized patients Pharmacodynamic activity is aligned with the proposed mechanism of...Read more
Attractive safety profile demonstrated across all dosing cohorts and routes of administration (IV, SC, and IM); all reported adverse events (AEs) deemed unrelated or classified as mild to moderate and largely related to injection site and infusion reactions with no serious or severe adverse events observed Following a single dose, serum concentrations of VYD2311 remained high at six months with an observed half-life of the IM dose...Read more
First product candidate to demonstrate significant MASH effects and weight loss at 24 weeks Trial met its primary endpoint with statistically significant MASH resolution without worsening of fibrosis in up to 59.1% of participants in an ITT analysis Fibrosis improvement without worsening of MASH in up to 34.5% of participants in an ITT analysis Supplemental AI-based analysis demonstrated statistically significant reductions in liver...Read more
New Phase 1 clinical data for CTX310™ continues to demonstrate dose-dependent reductions in triglycerides (TG) and low-density lipoprotein (LDL), with peak reduction of up to 82% in TG and up to 86% in LDL, with a well-tolerated safety profile Complete Phase 1 data presentation for CTX310 anticipated at a medical meeting in the second half of 2025 Data update for CTX320™, targeting the LPA gene, now expected in the first half of...Read more
MR-141 Met Primary And All Secondary Endpoints, Demonstrating Rapid And Sustained Improvement In Near Visual Acuity Without Compromising Distance Vision Safety Profile Consistent With Previous Clinical Trials And No Treatment-Related Serious Adverse Events Reported In This Study Targeting Application To U.S. FDA In Second Half of 2025 PITTSBURGH, June 26, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global...Read more
New open label data in Becker demonstrated sustained disease stabilization up to three years, reinforcing prior clinical findings Ongoing pivotal and FDA Type C meeting provide clear path to potential sevasemten registration as the first ever therapy for Becker Encouraging Phase 2 observations in Duchenne define the dose and inform design for Phase 3 Edgewise leadership to discuss these updates on Thursday, June 26...Read more
Preclinical data demonstrate potent single-agent and combination effects in head and neck squamous cell carcinoma (HNSCC) models, including synergy with anti–PD-1 therapy Initial Phase 1 clinical update shows early disease control in first HPV+ patient treated with APR-1051 DOYLESTOWN, Pa., June 25, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical...Read more
June 25, 2025 - Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce the activation of the first clinical study site for its Serenta trial in patients with familial adenomatous polyposis (FAP). The trial, which is now enrolling, represents a significant...Read more
SAN DIEGO / Jun 25, 2025 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced an update on its Phase 1b positron emission tomography (PET) trial of PIPE-791, a selective antagonist of the lysophosphatidic acid 1 (LPA1)...Read more
MIAMI, FL / ACCESS Newswire / June 25, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced new in vitro preclinical data generated by Eurofins supporting the therapeutic potential of SKNY-1, a next-generation oral drug candidate being developed by SKNY...Read more
Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025 Poised to be among the first wave of biosimilars in the $3.9 billion U.S. omalizumab market and an important growth driver for Amneal BRIDGEWATER, N.J., June 25, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today highlighted positive topline results from a confirmatory clinical efficacy and safety...Read more
Favorable safety and tolerability profile, as well as pharmacokinetics supporting once-daily oral dosing, continued to be observed in final 400 mg cohort Mean plasma HBV DNA reductions of 3.2 logs IU/mL over 28 days of treatment for 400 mg cohort consistent with findings in 150 mg cohort, supporting ability of 150 mg dose to achieve saturated inhibition of viral replication, as anticipated Trial completion triggers opt-in...Read more
Combination cohort initiated following successful review of monotherapy cohort Over 100 participants dosed to-date in monotherapy cohort Priority are Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer Data update on schedule for later this year NORWOOD, Mass., June 25, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage company...Read more
CMND-100 has the potential to provide an innovative and advanced treatment option for hundreds of millions of people around the world afflicted with Alcohol Use Disorder Vancouver, Canada, June 25, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major...Read more
Phio's lead clinical siRNA compound PH-762 demonstrates supportive safety profile in fourth cohort, permitting dose escalation in expected final cohort Marlborough, Massachusetts--(Newsfile Corp. - June 25, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene silencing technology to eliminate cancer. Phio announced today that...Read more
Salanersen (BIIB115/ION306) is a novel antisense oligonucleotide (ASO) with the potential to achieve high efficacy and once yearly dosing in spinal muscular atrophy (SMA) Interim Phase 1 data show children with SMA previously treated with gene therapy experienced a substantial slowing of neurodegeneration and clinically meaningful improvements in motor function following initiation of salanersen Based on these encouraging Phase 1...Read more
VANQUISH-1 and VANQUISH-2 Studies to Evaluate Subcutaneous VK2735 in Obese Adults with and without Type 2 Diabetes SAN DIEGO, June 25, 2025 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the initiation of the VANQUISH Phase 3 clinical program for VK2735, the company's dual...Read more
The first CLARITY patient was enrolled at the Texas Back Institute, a world leader in advancing spine technology, science, and education, as well as patient care CLARITY is a randomized clinical trial designed to demonstrate Nociscan’s ability to improve surgical outcomes for chronic low back pain Nociscan aims to become the gold standard in identifying sources of low back pain through MR Spectroscopy (MRS) and Augmented Intelligence...Read more
Phase 1 dose-escalation study to evaluate VS-7375 in the U.S., with plans to expand as monotherapy into pancreatic cancer and non-small cell lung cancer cohorts, along with colorectal cancer in combination with cetuximab BOSTON / Jun 24, 2025 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that the...Read more
Latest Research Demonstrates Promising Improved Glucose Homeostasis by Reprogramming Alpha Cells AUSTIN, Texas, June 24, 2025 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators presented positive preclinical research from studies of...Read more
Near doubling of 1-year overall survival (OS), increased median OS of 4 months (12.5 vs 8.5 months), and 43% reduction in risk of death in patients treated with at least one cycle (4 weeks) of elraglusib plus gemcitabine/nab-paclitaxel (GnP) vs GnP alone Patients with liver metastases experienced a 2.5x improvement in 1-year OS with a 38% reduction in risk of death when treated with elraglusib plus GnP CHICAGO and FORT WORTH, Texas,...Read more
During the Maintenance Period of 12 weeks after discontinuing semaglutide (GLP-1 receptor agonist), placebo group regained 43% of body weight that was previously lost during Phase 2b QUALITY study; on average, enobosarm 3mg significantly reduced body weight regain by 46% and completely prevented fat regain compared to placebo The enobosarm treated groups showed up to 93% greater fat loss and 100% lean mass preservation compared to the...Read more
STAAR study demonstrated positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study, which U.S. Food and Drug Administration (FDA) has agreed will serve as primary basis of approval Isaralgagene civaparvovec showed a favorable safety and tolerability profile Sangamo intends to submit a Biologics License Application (BLA) in 2026 RICHMOND, Calif. / Jun 24, 2025 /...Read more
Treatment to Evaluate Effect of Food on Overdose Protection of MPAR Grant Funds from NIDA Accelerating Clinical Development Program SAN DIEGO, CALIFORNIA / ACCESS Newswire / June 24, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today...Read more
Achieved statistical significance on primary endpoint at week 16 for mean percent change in EASI score from baseline for all rezpegaldesleukin arms versus placebo Achieved statistical significance for key secondary endpoints at week 16 of disease reduction, including EASI-75, EASI-90, Itch NRS, vIGA-AD and BSA Rapid onset of EASI reduction and magnitude of itch improvement show potential differentiation of this novel regulatory...Read more
A phase 1 study of miroliverELAP for the treatment of acute liver failure is currently underway;1 first patient in the study underwent the procedure at Intermountain Medical Center in Murray, Utah Approximately 30% of acute liver failure (ALF) patients die without access to a liver transplant.2 EDEN PRAIRIE, Minn. & MURRAY, Utah / Jun 24, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit...Read more
MOUNTAIN VIEW, Calif., June 24, 2025 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems, delivery devices, and accessories for the treatment of glaucoma and retinal diseases, announced today that the first patient has been successfully enrolled in the independent, investigator-led DAME Trial to evaluate the clinical efficacy, safety, cost-effectiveness,...Read more
C-FORWARD is the Second Phase 3 Trial in the Global HCV Development Program; the First Phase 3 Trial, C-BEYOND, is Currently Enrolling Patients in the US and Canada Regimen has Potential Best-in-Class Profile with Short Treatment Duration, Low Risk for Drug-Drug Interactions and Convenience with No Food Effect HCV Infection Remains a Significant Global Health Burden, with Approximately 50 Million People...Read more
Intra-patient, double-blind, multicenter, placebo-controlled study with crossover design Repeat administration under compassionate use was previously shown to be well tolerated and associated with full corneal healing by 3 months as well as significant visual acuity improvement from hand motion to 20/25 at 8 months PITTSBURGH, June 24, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced...Read more
Aligned with FDA on NDA submission strategy for TKI pre-treated patients with advanced ROS1-positive NSCLC and participation in Real-Time Oncology Review; the company plans to initiate a rolling NDA submission in July 2025 with target completion in the third quarter of 2025 In 117 ROS1 TKI pre-treated patients, including 50% who had received ≥ 2 prior ROS1 TKIs ± chemotherapy, ORR by BICR was 44% (95% CI: 34, 53) with initial...Read more
At Week 144, 92.3% of Patients Remained Free of 12-Week Confirmed Disability Worsening (CDW) With 92.7% Remaining Free of 24-Week CDW Vidofludimus Calcium Continues to Demonstrate Favorable Safety and Tolerability Profile; Long-Term Data Now Available up to 5.5 Years NEW YORK, June 24, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally...Read more
Top-line trial results are anticipated in the third quarter of 2026, after the final follow-up at 12-months Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated in 2026, if ELPIS II results are positive U.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan drug designation, and Fast track designation Laromestrocel HLHS program addresses...Read more
MariTide, the First Monthly or Less Frequently Dosed Obesity Treatment, Demonstrated Up to ~20% Average Weight Loss Without a Weight Loss Plateau, and Delivered Significant Cardiometabolic Improvements at 52 Weeks In People Living With Obesity With Type 2 Diabetes, MariTide Demonstrated Up to ~17% Average Weight Loss and Robust HbA1c Improvements Dose Escalation With Lower Starting Doses Substantially Improved Gastrointestinal...Read more
Groundbreaking First-in-Human Study Establishes Potential to Treat Type 1 Diabetes by Transplanting Insulin-Secreting Cells Without Immunosuppression Six-Month Patient Follow-up Results Demonstrate that Sana’s Transplanted Pancreatic Islet Cells Modified with its Hypoimmune (HIP) Technology are Safe and Well-tolerated, Survive, Evade Detection by the Immune System, and Continue to Produce Insulin in the Patient Function and...Read more
New pharmacokinetic and cardiac biomarker data further demonstrate ifetroban's potential to protect the heart and reduce cardiac damage in DMD patients NASHVILLE, Tenn., June 23, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company committed to developing new products for rare diseases, shared the latest positive results from its Phase 2 FIGHT DMD trial evaluating ifetroban, a...Read more
Enrollment in company's first-of-its-kind placebo-controlled Phase 2 study to evaluate the efficacy of crofelemer for microvillus inclusion disease (MVID) in pediatric patients has reached approximately 25% As recently announced, initial proof-of-concept results of the ongoing investigator-initiated trial (IIT) show crofelemer reduced the required total parenteral nutrition in patients with intestinal failure due to MVID and short...Read more
POTOMAC, MD / ACCESS Newswire / June 23, 2025 / IGC Pharma, Inc. ("IGC", or the "Company") (NYSE American:IGC) today announced the addition of a new clinical trial site at Tekton Research in Yukon, Oklahoma, for its Phase 2 CALMA study evaluating IGC-AD1 for agitation in Alzheimer's dementia. This expansion into the Oklahoma City metropolitan area underscores IGC's commitment to diversifying its trial population and addressing regional...Read more
SOUTH SAN FRANSCISCO, Calif., June 23, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc. (Nasdaq: CERO) (“CERo” or the “Company”), an immunotherapy company developing the next generation of engineered T cell therapeutics targeting TIM4L with phagocytic mechanisms, today announces the completion of the initial evaluation of the first patient in its Phase 1 clinical trial of lead compound CER-1236. Following an evaluation from the...Read more
Multi-center, multi-national study builds on existing U.S. PE Clearance and CE Mark to assess mechanical thrombectomy treatment and long-term functional outcomes in intermediate-risk PE patients across Europe LATHAM, N.Y. / Jun 23, 2025 / Business Wire / AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer...Read more
Fourth cohort dose is three million CAR positive cells; thirty times higher than the first cohort dose SAN JOSE, Calif., June 23, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that it has dosed its first patient in the fourth dosage cohort in the ongoing Phase 1 clinical trial evaluating its novel...Read more
Initial pharmacological data from placebo-controlled, double-blind Phase I study shows significant T cell suppression and a favourable safety profile at dosing level of 0.9 mg/kg The substantial reduction in T cell activity highlights the potential efficacy of IMP761 in treating autoimmune diseases Single ascending dose levels will continue with 2.5, 7 and 14 mg/kg Additional data from the Phase I to follow in second half of...Read more
Vancouver, Canada, June 23, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced the addition of Tel Aviv Sourasky Medical Center (TASMC), Tel Aviv, Israel, as an additional clinical site for its ongoing Phase...Read more
12 of 13 participants maintained or lost weight at 3 months, with 6 of 13 losing additional weight after stopping GLP-1 therapy and undergoing Revita procedure Median weight remained stable through 3 months (0.46% / ~ 1 pound weight change within the margin of error for daily weight measurement), compared to expected 5–6% weight regain (10–15 pounds) after stopping GLP-1 therapy Revita continued to demonstrate excellent tolerability...Read more
Study completion anticipated in mid-2026 with subsequent data readout and regulatory submissions for treatment of severe hypertriglyceridemia PASADENA, Calif. / Jun 23, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has completed enrollment in SHASTA-3, SHASTA-4, and MUIR-3, the company’s global Phase 3 clinical studies designed to support regulatory submissions for marketing approval of...Read more
Phase 2 Celiac Disease Trial Initiating with Topline Readout Expected in 2026 Forte will be Hosting a Conference Call to Discuss the Results at 8:30 am ET DALLAS / Jun 23, 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 positive data from a Phase 1b trial in celiac disease for lead...Read more
Updated data from DeFianCe study continue to demonstrate statistically significant improvements in PFS among the DKK1-high, VEGF-naïve and liver metastasis subgroups Board of Directors has initiated process to explore strategic alternatives to maximize shareholder value CAMBRIDGE, Mass., June 23, 2025 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and...Read more
Ralinepag has the potential to be the first once-a-day oral prostacyclin agonist for patients with pulmonary arterial hypertension ADVANCE OUTCOMES will continue to accrue clinical worsening events through the end of 2025 and top-line data is expected in the first half of 2026 SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Jun 23, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit...Read more
16.0 months median progression free survival (mPFS) with firmonertinib 240 mg by blinded independent central review (BICR) in first-line patients Robust central nervous system (CNS) activity; 41% (7/17) confirmed complete response (CR) and 53% confirmed overall response (ORR) in CNS evaluable disease patients by BICR in overall cohort Enrollment of first patient in a randomized, global pivotal Phase 3 (ALPACCA) study in first-line...Read more
PBFT02 continued to demonstrate robust, durable elevation in CSF PGRN levels and improvement in plasma NfL, a disease progression biomarker, compared to natural history Dose 2, 50% lower than Dose 1, substantially increased CSF PGRN levels at 30-days, reaching the upper limit of a healthy adult reference range Plan to amend upliFT-D protocol to include a prophylactic course of low dose anticoagulation and modify inclusion criteria to...Read more
The study met its primary and all secondary efficacy endpoints for all dose groups Single doses of 450mg, 300mg and 150mg of CD388 conferred 76%, 61% and 58% protection, respectively, from symptomatic influenza over 24 weeks compared to placebo CD388 was well-tolerated with no safety signals observed End of Phase 2 meeting request has been submitted to the U.S. Food and Drug Administration (FDA) Cidara will host a conference call...Read more
Potential Best-In-Class Bispecific Antibody ATI-052 Targets Both Thymic Stromal Lymphopoietin (TSLP) and Interleukin-4 Receptor (IL-4R) WAYNE, Pa., June 23, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that it has initiated a placebo-controlled Phase 1a/1b program for...Read more
WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy HYPERION, third Phase 3 study to demonstrate significant efficacy in adults with PAH, was previously stopped early based on review of available data from clinical program RAHWAY, N.J. / Jun 23, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United...Read more
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
CLICK TO LEARN MORE