Immix Biopharma today reported ASCO abstract results from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201 demonstrating strong efficacy and favorable safety. NXC-201 demonstrated a complete response (CR) rate of 71% (5/7 patients) No relapses recorded to-date; no safety signals identified Updated results with a later data cutoff, including endpoint analysis, will be presented at ASCO by lead...Read more
One-time Amtagvi Treatment Demonstrated Durable Responses and a Five-year Overall Survival Rate of 20% Five-year Follow Up is Unprecedented for Any Therapy in Patients with Advanced Melanoma Previously Treated with Immune Checkpoint Inhibitor SAN CARLOS, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel...Read more
- 63% response rate observed among 43 evaluable patients - 79% overall survival rate at 12-months; 9 months median progression-free survival - Conference Call on Thursday, May 22 at 5:30 p.m. ET UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 22, 2025 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific antibodies...Read more
Zanzalintinib in combination with nivolumab demonstrated an objective response rate of 63% and a disease control rate of 90% Additional results from dose-finding cohorts will also be presented ALAMEDA, Calif. / May 22, 2025 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced results from an expansion cohort of the phase 1b/2 STELLAR-002 trial evaluating zanzalintinib in combination with either nivolumab...Read more
Selected recommended Phase 2 dose: Dose level 1 demonstrated an ORR of 83% (10/12) in frontline metastatic pancreatic ductal adenocarcinoma Plans for registrational Phase 3 study underway in frontline metastatic pancreatic ductal adenocarcinoma Company will host an R&D investor webcast on Monday, June 2 at 11:00 am CDT to review the updated RAMP 205 data as well as updated data on VS-7375 presented at ASCO BOSTON / May 22, 2025 /...Read more
Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30% After a median follow-up of 61.4 months, treatment with XTANDI (enzalutamide) plus ADT was associated with a 66% probability of survival at five years compared to 53% probability of survival with placebo plus ADT XTANDI (enzalutamide) is the first and only androgen receptor...Read more
First results to be presented in two ASCO oral presentations Data in both combinations demonstrate high response rates TARRYTOWN, N.Y., May 22, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced initial results from two cohorts of the Phase 1b LINKER-MM2 trial evaluating linvoseltamab in combination with two different proteasome inhibitors (PI) – carfilzomib or bortezomib – in patients with...Read more
Achieved statistically significant ≥1-stage fibrosis regression at Week 52 vs. placebo (52.85% vs. 29.84%, P=0.0002). Demonstrated favorable safety and tolerability profile: 4.88% serious adverse events vs. 6.45% for placebo; zero discontinuations due to adverse events. Breakthrough Therapy Designation granted by China’s National Medical Products Administration (“NMPA”) in 2021 supports potential first-in-class approval in...Read more
Generation of additional clinical data allows for a more comprehensive assessment of the full potential of EVX-01, while strengthening the already strong clinical data package Will provide insights into the durability of immune and clinical responses up to three years Extension phase enables exploration of EVX-01 as monotherapy, following initial combination with standard of care Minimal costs are associated with the extension as...Read more
Phase 1b data shows treatment with SAT-3247 was safe and well-tolerated Pharmacokinetic (PK) profile of SAT-3247 translated as expected to Duchenne Muscular Dystrophy (DMD) patients taking concurrent steroids Potential trend to improved grip strength observed, with average strength across the study participants doubling from ~2kg to ~4kg Study participants will have the option to enroll into an 11-month, long-term follow-up...Read more
Purified Cortrophin Gel is the only ACTH therapy approved by the FDA for the treatment of acute gout flares Trial to be conducted by Dr. Hyon Choi at Massachusetts General Hospital and will compare the safety and efficacy of two dose levels of Purified Cortrophin Gel for the treatment of acute gout flares PRINCETON, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today...Read more
Phase 3 trial of ‘2510 in combination with chemotherapy in first-line NSCLC anticipated to start in mid-2026 in China, subject to regulatory discussions Monotherapy US dose optimization Phase 1b/2 trial of ‘2510 in relapsed/refractory solid tumors, intended to bridge the doses to the ongoing China trials, replaces the previously planned US trial DALLAS and SHANGHAI, May 22, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (Nasdaq: TIL,...Read more
Insmed Presented 11 Abstracts at ATS 2025 from Across Its Respiratory Portfolio, Including Data on ARIKAYCE®, TPIP and Health Economics and Outcomes Research BRIDGEWATER, N.J., May 21, 2025 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, presented 11 new...Read more
CAMBRIDGE, Mass. / May 21, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, shared the following update related to ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for patients with Duchenne muscular dystrophy. We have received feedback from the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.)...Read more
The Company demonstrated strong mucoadhesion and broad surface coverage in ex vivo nasal tissue models Raanana, Israel, May 21, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (the “Company” or “Polyrizon”), a development stage biotech company specializing in the development of innovative intranasal hydrogels, announced compelling results from recent ex vivo studies demonstrating the mucoadhesive strength and extensive nasal...Read more
Investigator-initiated Phase 2 trial to evaluate TNX-102 SL’s potential to reduce severity of acute stress reaction (ASR) and frequency of acute stress disorder (ASD) Trial is sponsored by the University of North Carolina (UNC) and supported by a grant from the U.S. Department of Defense Topline results from the trial are expected in the second half of 2026 CHATHAM, N.J., May 21, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals...Read more
BOSTON, May 21, 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 TNG456 Phase 1/2 trial in patients with MTAP-deleted solid tumors, with a focus on glioblastoma (GBM). TNG456 is a next-generation, brain-penetrant, MTA-cooperative PRMT5...Read more
There are nearly 40,000 U.S. cases of cutaneous squamous cell carcinoma each year that advance to stages that are difficult to treat and life-threatening Skin Cancer Awareness Month in May shines a spotlight on the growing burden of advanced skin cancers The investigational drug is designed to be activated in the tumor microenvironment, including in cutaneous squamous cell carcinoma SCOTTSDALE, Ariz., May 20, 2025 (GLOBE NEWSWIRE)...Read more
As announced, initial proof-of-concept (POC) results from distinct ongoing investigator-initiated trial (IIT) in Abu Dhabi show crofelemer reduced total parenteral support in a pediatric MVID patient with intestinal failure by up to 27%; per the IIT protocol, patient was taken off crofelemer after 12 weeks of treatment for a period of 30 days, but was restarted on daily crofelemer treatment after just 8 days, as patient's symptoms were...Read more
Subjects Demonstrated Marked Improvement of ADHD Symptoms at Week 5 New Drug Application on Schedule for this Summer CING CEO Shares Insights and Strategic Outlook on “Unboxing Biotech” Podcast KANSAS CITY, Kan., May 20, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a...Read more
Preconditioning with lymphodepletion linked to stronger MAR-T cells response and suggests enhanced anti-tumor activity Highest enrollment since study launch underscores momentum and signals a positive trial trajectory Clinical data readout from Phase 1 APOLLO study expected later this year HOUSTON, May 20, 2025 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on...Read more
Rapid, deep, and durable reductions in high-sensitivity C-reactive protein (hs-CRP) through Day 90 achieved across all pacibekitug arms with high statistical significance as compared to placebo (p<0.0001 for all arms) Pacibekitug becomes the first and only IL-6 inhibitor known to demonstrate deep hs-CRP reductions with quarterly dosing in a clinical trial, achieving >85% hs-CRP reductions from baseline in the 50 mg...Read more
Results of analyses presented at an investor meeting during the American Thoracic Society 2025 International Conference NEW HAVEN, Conn., May 20, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with...Read more
70% of patients treated with veligrotug in THRIVE who were proptosis responders at week 15 maintained their response at week 52 Veligrotug recently received Breakthrough Therapy Designation (BTD), supporting eligibility for Priority Review; the BTD request was based on veligrotug’s (i) consistent and robust improvement and resolution of diplopia in chronic TED, and (ii) rapid onset of proptosis response Biologics License...Read more
Demonstrates PAS-004’s potential as a differentiated MEK inhibitor for immune-mediated inflammatory diseases such as IBD and ankylosing spondylitis Positions PAS-004 for potential expansion beyond MAPK pathway driven tumors into inflammatory diseases PAS-004 outperforms FDA-approved MEK inhibitor selumetinib in targeting ETS2 pathway Study conducted at Francis Crick Institute by lead author of 2024 Nature paper that...Read more
Positive results show that a single dose of BPL-003, administered adjunctively to SSRIs, produced a rapid and durable antidepressant effect for up to three months after dosing BPL-003 was well-tolerated and patients were able to be discharged within an average time of less than two hours after dosing Data from the eight-week core, randomized stage of Beckley Psytech’s Phase 2b study of BPL-003 for treatment-resistant depression is...Read more
TibuSHIELD has launched with the activation of its first clinical site This study is the first to evaluate dual inhibition of B-cell activating factor (BAFF) and interleukin-17A (IL-17A) pathways in adults with moderate to severe hidradenitis suppurativa (HS) TibuSHIELD will assess tibulizumab over a 28-week study period, comprising a 16-week primary efficacy assessment and a 12-week safety follow-up, conducted at clinical sites across...Read more
A Brighter Future for Mental Health Vancouver, British Columbia – May 19, 2025 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (“MindBio”), (the “Company”), a clinical-stage biopharmaceutical company dedicated to developing novel and effective mental health treatments, is pleased to announce the enrolment of the 80th participant in its landmark Phase 2B clinical trial evaluating MB22001 for Major Depressive Disorder (MDD)....Read more
AIRSUPRA demonstrated a 47% reduction in the risk of severe exacerbations in mild asthma compared with albuterol alone Full results published in the New England Journal of Medicine and presented at ATS 2025 International Conference WILMINGTON, Del. / May 19, 2025 / Business Wire / Positive full results from the BATURA Phase IIIb trial showed AstraZeneca’s anti-inflammatory reliever rescue therapy, AIRSUPRA (albuterol/budesonide),...Read more
For each 5-mg/dL increase in serum TTR level within 28 days of starting treatment, the relative risk reduction of mortality was up to 31.6% through Month 30, confirming the hypothesis that ever better levels of stabilization achieved by treatment with acoramidis, a near-complete (≥90%) TTR stabilizer, lead to ever better clinical outcomes ATTRibute-CM is the only study to demonstrate a direct association between a prompt, sustained...Read more
KT-621, a potent, selective, oral STAT6 degrader, demonstrated comparable or superior activity to dupilumab in a newly disclosed preclinical chronic asthma model reversing disease progression KT-621 Phase 1 healthy volunteer SAD/MAD trial completed with data to be reported in June 2025 KT-621 BroADen Phase 1b trial in moderate to severe atopic dermatitis (AD) ongoing with data expected in 4Q25 Two parallel Phase 2b trials in AD and...Read more
Following the formal safety review of Cohort 1, no safety or tolerability issues were observed, allowing the company to move forward with Cohort 2. The company plans on releasing more detailed results from Phase 1 later in 2025 following completion of additional dose cohorts. SAN FRANCISCO, CALIFORNIA, May 19, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused...Read more
First ever clinical data supporting safety and efficacy of Prime Editing in humans Initial data from first patient dosed in Phase 1/2 trial finds single dose of PM359 led to 58% DHR positivity by Day 15 and 66% by Day 30, well above levels believed to be potentially curative Rapid engraftment observed in both neutrophils and platelets Encouraging safety profile; no serious adverse events related to...Read more
Early results show steroid-free remission, opening pathway into $13B global pet dental health market VELDONA delivers consistent anti-inflammatory effects, strengthening Ainos' positioning in companion animal immunotherapy SAN DIEGO, CALIFORNIA / ACCESS Newswire / May 19, 2025 / Ainos, Inc. (Nasdaq:AIMD) (Nasdaq:AIMDW) ("Ainos"), a pioneer of low-dose oral interferon therapeutics, today announced compelling interim results from its...Read more
SOUTH SAN FRANCISCO, Calif., May 19, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced that the first patient has been dosed with CX-801 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in the ongoing Phase 1 dose escalation study (NCT06462794) evaluating safety and initial clinical activity in patients with...Read more
Topline data expected by year end Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in healthy subjects ATLANTA, May 19, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease...Read more
GAITHERSBURG, Md., May 19, 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 enrolled the first subject in the RECLAIM Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol Use Disorder (AUD). Pemvidutide is a novel, investigational...Read more
Olezarsen met the primary endpoint with a statistically significant mean reduction in triglycerides versus placebo at 80 mg and 50 mg doses Olezarsen met all key secondary endpoints Olezarsen demonstrated a favorable safety and tolerability profile Nearly 1,500-person Phase 3 study supports the exposure database for olezarsen Data from pivotal Phase 3 CORE and CORE2 studies of olezarsen in severe hypertriglyceridemia (sHTG)...Read more
All primary endpoints for safety, tolerability, and clinical response in the intent-to-treat population met AP-SA02 arm significantly improved clinical outcomes and prevented relapse compared to best available antibiotic therapy No treatment-related serious adverse events were observed with repetitive intravenous dosing LOS ANGELES, May 19, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the...Read more
BASKING RIDGE, N.J. & RAHWAY, N.J. / May 19, 2025 / Business Wire / The first patient has been dosed in the IDeate-Esophageal01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus investigator’s choice of chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with disease progression following treatment with a platinum-containing...Read more
LANGHORNE, Pa. / May 18, 2025 / Business Wire / Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced new data in two poster presentations at the ATS International Conference 2025. Data presented were from the Phase 3 IMPALA-2 clinical trial of molgramostim in aPAP and demonstrated that molgramostim reduces surfactant burden and improves health-related...Read more
Slowing of progression of disease observed via MRI at 24 months Improvements in outcomes and reduction in sorbitol maintained through 24 months Statistically significant correlation between absolute reduction in sorbitol and change in 10MWRT and CMT-FOM Lower Limb domain at 12 months, though the primary endpoint of 10MWRT at 12 months was not statistically significant (the measure has since been removed from the CMT-FOM clinical...Read more
Treatment with ELEVIDYS for Duchenne muscular dystrophy resulted in mean protein expression of 93.87% as measured by western blot in study participants (n=6) Safety profile consistent with prior studies of ELEVIDYS and real-world experience CAMBRIDGE, Mass. / May 16, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today reported new results from Study...Read more
RP-A601 was generally well-tolerated at a dose of 8.0E13 GC/kg with no dose-limiting toxicities in all three patients with up to 12 months follow-up RP-A601 promoted increased protein expression and desmosomal localization of Plakophilin-2 (PKP2), Desmocollin-2, and Cadherin-2 in all three patients Improvement or stabilization observed in arrhythmia burden, heart function, and quality of life in all patients No further dose escalation...Read more
Topline CATT1 Phase 3 data is expected in 2H 2026 Protocol amendment shortens trial duration from 12 to 6 months, expediting time to topline data HIGH POINT, N.C., May 15, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced that screening has been reinitiated in the Company’s CATT1...Read more
First ASXL1 Pediatric Acute Myeloid Leukemia (AML) Patient Dosed at MD Anderson Cancer Center: Program Supported by Rare Pediatric Disease Designation (RPDD) NEW YORK, May 15, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the...Read more
Company’s PlaCCine® technology platform demonstrates better durability and other advantages compared to mRNA vaccines Results further validate PlaCCine as a novel vaccine platform with potential applications in COVID-19 and other infectious diseases with epidemic implications LAWRENCEVILLE, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated...Read more
Novel combination achieves 60.8% response rate and 90.2% disease control rate in first-line non-small cell lung cancer (1L NSCLC) Notably, ~92% of all evaluable patients have PD-L1 TPS <50%, including 43% with PD-L1 below 1 (TPS <1%), who represent an area of high unmet need Data demonstrates significant improvement in response rates compared to historical controls, and safety continues to be favourable Multi-centre INSIGHT-003...Read more
Despite growing recognition of long COVID as a serious condition, diagnosed patients have no approved treatment options, with many suffering from debilitating fatigue and brain fog Evidence suggests sustained inflammation plays a central role in the pathogenesis of long COVID, particularly in the associated cognitive dysfunction and other neurological symptoms1 Bezisterim targets key underlying mechanisms of neuroinflammation, and has...Read more
SOUTH SAN FRANCISCO, Calif., May 15, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it has received approval from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), to initiate dosing in the 10,000-participant portion of its ongoing Phase 2b clinical trial...Read more
Study also met secondary endpoint of overall survival (OS) for patients whose tumors express PD-L1 KEYTRUDA® (pembrolizumab) plus chemotherapy (paclitaxel) with or without bevacizumab is the first immune checkpoint inhibitor-based regimen to show a statistically significant improvement in OS for ovarian cancer RAHWAY, N.J. / May 15, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today...Read more
Reported cumulative MMR rate of 44% (16 of 36) by 24 weeks with 26% (7 of 27) of patients achieving MMR by 24 weeks, which continues to compare favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs ELVN-001 continues to demonstrate a favorable safety and tolerability profile across all dose levels with 74 patients enrolled and a median treatment duration of ~26 weeks at cutoff Presentation at EHA will include updated data...Read more
Results from all 117 patients dosed in the pivotal Phase 2 iMMagine-1 study of anito-cel demonstrated 97% ORR and 68% CR/sCR at a median follow-up of 12.6 months No delayed neurotoxicities including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barré syndrome, and no immune-mediated enterocolitis have been observed to date with anito-cel iMMagine-1 data to be presented during an oral presentation at EHA2025 on Saturday,...Read more
San Diego, California--(Newsfile Corp. - May 14, 2025) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQX: TTIPF) ("Thiogenesis" or the "Company") a clinical-stage biotechnology company developing disulfides that drive the production of critically important intracellular antioxidants and other therapeutic compounds, today announced that it has dosed its first two patients in its Phase 2 clinical trial of TTI-0102, Thiogenesis' lead...Read more
Expect to report topline data from the Seabreeze STAT COPD study in 1H 2026 SAN DIEGO, May 14, 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 obstructive pulmonary disease (COPD), today announced the initiation of its Phase 2 Seabreeze STAT COPD...Read more
Feasibility endpoint achieved; rapid Ki‑67 suppression and substantial MRI‑confirmed tumor shrinkage observed with favorable safety profile SEATTLE, May 14, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today reported full results from the Phase 2 Endocrine Optimization Pilot (EOP)...Read more
Global Chronic Ocular Pain Market Valued at US$ 7.2 Billion in 2023 and Is Projected To Reach US$ 12.44 Billion by 2032 at a CAGR of 6.6% During Forecast Period 2024–2032 FREEHOLD, N.J., May 14, 2025 (GLOBE NEWSWIRE) -- Channel Therapeutics Corporation, (“Channel” or the “Company”), (NYSE American: CHRO), a pioneer in the development of non-opioid pain treatment therapeutics, today announced that it has achieved its predefined...Read more
REDWOOD CITY, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the first patient has been dosed in RASolve 301, a global, randomized, open-label Phase 3 clinical trial. RASolve 301 will evaluate the safety and efficacy of daraxonrasib (RMC-6236), a RAS(ON) multi-selective...Read more
Patient dosing completed in Phase 2 portion of Phase 2/3 RePOSA study evaluating IHL-42X oral treatment for OSA. End-of-study follow-up assessments on track for completion by May 17, 2025. Topline results expected in July 2025. NEW YORK and MELBOURNE, Australia, May 14, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing oral...Read more
Clear Improvement in Patient’s Skin Appearance Observed in Study after 12 weeks Compared to Baseline Key endpoints including Investigator’s Global Assessment (IGA), Modified Ichthyosis Area Severity (M-IASI) and Children’s Dermatology Life Quality Index (CDLQI) all demonstrated improvement from baseline QRX003 is being well tolerated and no adverse events have been reported Patient is expected to continue to be treated with QRX003...Read more
First patient expected to be dosed during Q2 2025 Trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in both plexiform neurofibromas and cutaneous neurofibromas Starting dose of 4mg tablet QD (once daily) First trial site in Australia. Four additional sites planned for Australia, South Korea, and U.S. Australian R&D Tax Incentive refund of up to 48.5% of...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
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
White Bear Lake, Minnesota--(Newsfile Corp. - May 13, 2025) - Envoy Medical®, Inc. (NASDAQ: COCH) ("Envoy Medical"), a revolutionary hearing health company focused on fully implanted hearing devices that leverage the ear's natural anatomy, today announces achieving the important milestone of successful activation of all 10 study participants' fully implanted Acclaim® cochlear implants in the first stage of the Company's pivotal clinical...Read more
MELVILLE, N.Y., May 13, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage regenerative medicine innovator focused on stem cell-based therapies and products, is pleased to announce that preliminary 26-, 52- and 104-week blinded preliminary data from the first 15 patients with chronic lumbar disc disease (“cLDD”) enrolled in the ongoing Phase 2 clinical trial...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
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
Indication Has Been Granted FDA Breakthrough Device Designation for Potential PMA Filing DENVER, May 13, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that it has successfully reached the halfway point in the NEUTRALIZE-AKI pivotal clinical...Read more
Topline data expected by year end Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in healthy subjects ATLANTA, May 13, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease...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
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
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
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
Long term follow-up in this curative setting demonstrated clinically meaningful survival benefit when adding adjuvant Perjeta® (pertuzumab) to Herceptin® (trastuzumab) and chemotherapy 21% reduction in the risk of death was seen in the pre-specified subgroup of people with lymph node-positive disease Data to be presented as a late-breaking abstract at the 2025 European Society for Medical Oncology (ESMO) Breast Cancer...Read more
COPENHAGEN, Denmark, May 12, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new data from Week 214 of its Phase 2 PaTH Forward Trial showing that long-term treatment with TransCon PTH (palopegteriparatide) continued to provide a durable response in adults with hypoparathyroidism. Results were shared in an oral presentation today by Andrea Palermo, M.D., from the Campus Bio-Medico University (Rome), during ESPE...Read more
BOSTON, MASSACHUSETTS, May 12, 2025 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company developing novel antiviral therapies, today announced the successful completion of the dose optimization of its antiviral drug ProLectin-M in a randomized double-blind placebo-controlled trial. Preliminary results are expected, with full data submission to the FDA under Bioxytran’s active...Read more
HT-KIT dramatically suppresses tumor growth in preclinical models of GIST and systemic mastocytosis. Treatment shows potent downregulation of oncogenic KIT mutations with no observed systemic toxicity. IND filing expected early 2026, opening pathway to first-in-human trials. Preclinical Milestones: Over 80% reduction in KIT expression in vitro using cancer cell lines harboring activating KIT mutations. Significant...Read more
The RENEW Phase 2 trial will enroll up to 120 IPF patients with topline data expected in the first half of 2026 In the previously reported Phase 1b study, LTI-03 showed a positive trend in seven out of eight biomarkers evaluated in Cohort 2, with five showing dose dependence and four showing statistically significant improvement in the combined Cohort 1 and 2 data set AUSTIN, Texas, May 12, 2025 /PRNewswire/ -- Rein Therapeutics...Read more
Data at Week 48 demonstrated that treatment with AMX0035 led to sustained stabilization or improvement in multiple outcomes related to disease progression, including pancreatic function, glycemic control, vision, and overall symptom burden AMX0035 continued to be generally well-tolerated in all participants Week 48 data and discussions with FDA will inform the design of a Phase 3 trial of AMX0035 in Wolfram syndrome Amylyx continues...Read more
28% confirmed response rate (5/18) per RECIST v1.1 in unselected patients across doses prioritized for expansion (7.2, 8.6 and 10 mg/kg Q3W) 3 of 7 evaluable patients (43%) with confirmed responses at upper expansion dose (10 mg/kg Q3W) Median progression free survival of 5.8 months as of April 7th 2025 data cutoff Encouraging initial safety profile with no dose limiting toxicities at data cutoff Planning...Read more
Multiple doses of APG808 resulted in rapid suppression of FeNO, a biomarker of Type 2 inflammation associated with exacerbations in asthma, with a robust maximal FeNO decrease from baseline of 53% APG808 demonstrated the potential for durable disease control in asthma with sustained FeNO decrease from baseline of 50% at 12 weeks APG808's optimized formulation and potential best-in-class pharmacokinetic (PK) profile, combined with...Read more
Participants achieved an average weight loss of 20.2% with Zepbound vs. 13.7% with Wegovy In key secondary endpoints, Zepbound was superior to Wegovy across all weight reduction targets and waist circumference reduction INDIANAPOLIS, May 11, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from SURMOUNT-5, a Phase 3b open-label clinical trial, evaluating the safety and efficacy of Zepbound...Read more
Analysis of EFX results with AI-based digital pathology underscores the potential value in evaluating histopathology response Data contribute to growing body of support around the anti-fibrotic activity of EFX in patients with pre-cirrhotic MASH SOUTH SAN FRANCISCO, Calif., May 10, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with...Read more
Late-breaking results from the open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial presented at the EASL Congress 65% of patients with clinically significant portal hypertension (CSPH) at baseline moved into lower risk categories by year two Patients achieved a mean 6.7 kPa reduction in liver stiffness, which was statistically significant compared to baseline CONSHOHOCKEN, Pa., May 10, 2025 (GLOBE...Read more
Data from icotrokinra ICONIC-TOTAL show 66% of patients with scalp psoriasis and 77% with genital psoriasis achieved site-specific clear or almost clear skin at Week 16 Icotrokinra continues to demonstrate a standout combination of significant skin clearance (IGA 0/1) and a favorable safety profile in a once daily pill PN-881, a first-in-class oral peptide targeting the IL-17 pathway, potently and selectively binds IL-17A and -17F,...Read more
Patients lived significantly longer without high-risk disease recurrence or progression after one year of IMFINZI treatment plus Bacillus Calmette-Guérin (BCG) induction and maintenance therapy vs. BCG alone WILMINGTON, Del. / May 09, 2025 / Business Wire / Positive high-level results from the POTOMAC Phase III trial showed one year of treatment with AstraZeneca’s IMFINZI® (durvalumab) plus standard-of-care BCG induction and...Read more
SOUTH SAN FRANCISCO, Calif., May 09, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, presented results from the Phase 2b SYMMETRY trial demonstrating the potential of efruxifermin (EFX) to improve fibrosis in compensated cirrhosis (F4) caused by metabolic...Read more
HBsAg loss 24 weeks post-end of treatment achieved in 17% and 21% of participants with low baseline HBsAg receiving tobevibart + elebsiran without or with PEG-IFNα, respectively As previously announced, Phase 3 development in chronic hepatitis B to occur only with a global development and commercialization partner, which has not been secured Vir Biotechnology to streamline the final stages of MARCH Phase 2 study to ensure continued...Read more
GAITHERSBURG, Md., May 08, 2025 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma” or the “Company”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today that it has nearly achieved 50% enrollment in the initial randomized portion of its Phase 2 clinical trial of Ropidoxuridine for...Read more
Data continue to demonstrate favorable safety and efficacy profile, including earlier and deeper responses in cohort 3 compared to cohorts 1-2 Data to be presented in an oral session and poster at the Society for Investigative Dermatology 2025 Annual Meeting Company to discuss data today on its first quarter 2025 business update conference call and webcast at 4:30 pm ET / 1:30 pm PT SOUTH SAN FRANCISCO, Calif., May 08, 2025 (GLOBE...Read more
Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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