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
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
The Independent Data Monitoring Committee (IDMC) has recommended to continue the study as planned as there are no safety concerns seen in the data reviewed Continued momentum with completed patient enrollment for the 6-week interim analysis (N=24) and over two-thirds enrollment completed for the overall trial Results on track for interim data in Q2 2025 and topline data in Q3 2025 Management releases “What This Means” segment...Read more
Zervimesine treatment slowed the rate of GA lesion growth by 28.6% compared to placebo Observed GA lesion area was reduced by 28.2% at 18 months compared to placebo Dry AMD results validate zervimesine’s potential across degenerative disease indications PURCHASE, N.Y., May 08, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders,...Read more
Enrollment completed for the 6-week interim analysis with 24 of the 36 planned patients now enrolled Company on track to report interim biomarker data from the first 12 patients imminently Completion of patient enrollment and topline results expected Q3 2025 LA JOLLA, CA, May 07, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of...Read more
Patients treated with VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy had increased overall survival, progression free survival, and duration of response compared to patients treated with gemcitabine/nab-paclitaxel SoC VCN-01 was well-tolerated, with transient and reversible adverse events (AEs), meeting primary safety endpoint Greater differences between the treatment...Read more
Topline data shows statistically significant improvement in overall survival in elraglusib plus GnP combination arm versus GnP control arm Elraglusib/GnP combination arm demonstrated substantial improvement in median overall survival since the last data analysis Clinical trial meets primary endpoint for overall survival and confirms significant 1-year survival rate Elraglusib/GnP combination arm demonstrated a favorable risk-benefit...Read more
Topline results expected H2 2025 REDWOOD CITY, Calif. / May 05, 2025 / Business Wire / Exicure, Inc. (Nasdaq: XCUR), a clinical-stage biotechnology company developing therapeutics for hematologic diseases, today announced it has completed patient enrollment in its ongoing Phase 2 clinical trial (NCT05561751) evaluating the safety and efficacy of GPC-100 (burixafor) in combination with propranolol and G-CSF in multiple myeloma patients...Read more
UBX1325 demonstrated vision gains that were comparable and statistically non-inferior to aflibercept at week 36 in a difficult-to-treat DME patient population UBX1325 generally outperformed aflibercept in a pre-specified subgroup of patients entering the study with CST <400 microns (60% of enrolled patients) Company to explore strategic alternatives to advance UBX1325, Tie2/anti-VEGF bispecific, and Tie2 agonistic antibody...Read more
Study met primary endpoint with dose-dependent blood HTT protein lowering at Week 12 Favorable dose-dependent trends across clinical scales in Stage 2 patients at Month 12 Signals of dose-dependent clinical benefit relative to matched natural history cohort as well as dose-dependent lowering of NfL in Stage 2 patients at Month 24 Continued favorable safety and tolerability profile with no treatment-related NfL...Read more
MaGic trial exceeded enrollment target of 60 patients Top-line results anticipated this September will be the first of three DNTH103 catalysts by YE'26 Building a neuromuscular franchise with DNTH103 in gMG, CIDP and MMN with a potential best-in-class, potent classical pathway inhibitor intended as a self-administered autoinjector dosed once every two weeks NEW YORK and WALTHAM, Mass., May 05, 2025 (GLOBE NEWSWIRE) --...Read more
Study ANAVEX3-71-SZ-001 successfully completes enrollment with a total of 71 participants Both Part A (16 participants) and Part B (55 participants) of the placebo-controlled Phase 2 study fully enrolled Top line data expected in the second half of 2025 NEW YORK, May 01, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing...Read more
Reduced Relative Risk of 24-Week Confirmed Disability Worsening Events by 20% in Overall Study Population Compared to Placebo; Even More Prominent 30% Reduction in High Unmet Need Population of Primary Progressive Multiple Sclerosis Showed Consistent Reduction of Disability Worsening in Subpopulations Without Inflammatory Lesions at Baseline in Overall Study Population; Reduced Relative Risk of 24-Week Confirmed Disability...Read more
Statistically significant efficacy in biomarker subgroup analyses was observed: 78% reduction in risk of death and 81% reduction in risk of progression or death in defined pretreatment ranges of serum or tumor CEACAM1 subgroup 61% reduction is risk of death and 72% reduction in risk of progression or death in defined pretreatment ranges of serum CEACAM1 or myeloperoxidase (MPO) subgroup 90% reduction is risk of death and...Read more
90% of patients achieved high grade disease-free status at any time point with NDV-01, demonstrating strong proof-of-concept for sustained-release “GEM/DOCE” formulation* NDV-01 showed promising clinical activity in BCG-naïve and BCG-unresponsive patients, with favorable overall tolerability Data to be reviewed at Investor Event on April 28, 2025 at 4:30 PM ET CORAL GABLES, Fla., April 28, 2025 (GLOBE NEWSWIRE) -- Relmada...Read more
Phase 2 registration-intent trial enrolling Part 2a dose confirmation arms Topline data from DENALI Part 2 anticipated by year end 2026 with the potential to support an accelerated approval, subject to FDA feedback SAN DIEGO, April 28, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class and best-in-class WEE1 inhibitor for...Read more
Data Presented at the American Urological Association 2025 Annual Meeting in Las Vegas, Nevada PRINCETON, N.J. / Apr 27, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced new data from the OPTIMA II Phase 2b study of UGN‑102 (mitomycin) for intravesical solution demonstrate clinically...Read more
First results from SunRISe-1 (Cohort 4) show strong disease-free survival rates across high-grade papillary tumors, demonstrating the potential for bladder preservation with 94 percent of patients avoiding radical cystectomy 95 percent progression-free survival rate at 9-months signals the promise of TAR-200 in this high-risk patient population LAS VEGAS, April 26, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today...Read more
Phase 2b SunRISe-1 study shows more than 82 percent of patients achieved complete response (CR) with more than half of responders remaining cancer-free at one year after CR Results reinforce potential of TAR-200 to transform outcomes for certain types of BCG-unresponsive, high-risk non-muscle invasive bladder cancer LAS VEGAS, April 26, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced new data from Cohort...Read more
TARA-002 demonstrates 100% complete response rate at any time and 67% 12-month landmark complete response rate in BCG-Unresponsive patients TARA-002 demonstrates 76% complete response rate at any time and 43% 12-month landmark complete response rate in BCG-Naïve patients Favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse events On track to present updated interim data from approximately 25...Read more
In ASPEN-03 and ASPEN-04 trials, efficacy data do not support advancing evorpacept in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), into a registrational study Company remains confident in continuing to pursue evorpacept in multiple clinical trials, based on the different mechanism of evorpacept in combination with anti-cancer antibodies, as evidenced by durable clinical response and consistent safety data in...Read more
NEW YORK, April 23, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that dosing has commenced at the fourth clinical site in its ongoing Phase 2 trial evaluating intranasal foralumab in patients...Read more
Second Cohort Results Highlight Efficacy Across All Key Measures and Reinforce Safety of Twice-Daily Oral Rinse Phase 2a Study Now Fully Enrolled Across All Three Dose Cohorts Advancing Toward Phase 2b IND Submission and Broader Regulatory Engagement PITTSBURGH, April 22, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “our,” “us,” or the “Company”), a clinical-stage biotechnology company addressing...Read more
HONG KONG and FLORHAM PARK, N.J., April 22, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has completed enrollment of the registration phase of its Phase II trial of savolitinib in gastric cancer patients with MET amplification. This clinical trial is a single-arm, multi-center, open-label, Phase II registration study to evaluate the efficacy, safety and...Read more
The Institutional Review Board Has Approved the Increase in Number of Patients from Sixty (60) to Ninety (90). The Company to Expand the Study into Additional Trial Sites in Europe Philadelphia, Pennsylvania--(Newsfile Corp. - April 21, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce that Institutional Review Board (IRB) has approved the increase in number of patients from sixty (60) to...Read more
76-week trial is evaluating the safety and efficacy of a progranulin-elevating candidate in slowing disease progression Enrollment completed ahead of schedule SOUTH SAN FRANCISCO, Calif., April 17, 2025 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, today announced the completion of...Read more
Co-administered bremelanotide + tirzepatide, bremelanotide alone, and tirzepatide alone arms showed improvement in appetite suppression, fullness, and satiety Bremelanotide matched or exceeded tirzepatide in appetite suppression Low-dose bremelanotide helped prevent appetite rebound after tirzepatide cessation CRANBURY, N.J., April 17, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company...Read more
SUNRISE-PD evaluating the Company’s anti-inflammatory, insulin-sensitizing candidate bezisterim in patients with Parkinson’s disease who have not been treated with carbidopa/levodopa SUNRISE-PD is one of very few clinical trials for a Parkinson’s disease treatment to incorporate a decentralized approach option to allow for remote participation Patient enrollment has commenced, with recruitment being supported by The Michael J. Fox...Read more
Median overall survival of 17.3 months in Bria-IMT™ treated patients with hormone receptor positive (HR+) metastatic breast cancer markedly exceeds historical data of 14.4 months in TRODELVY® (sacituzumab govitecan-hziy) in similar heavily pre-treated patients Survival data in triple negative breast cancer patients treated with the BriaCell regimen was comparable to TRODELVY® No Bria-IMT related discontinuations reported to...Read more
SIGNAL-AA Part B topline data readout on-track for 1H'26 WALTHAM, Mass., April 16, 2025 /PRNewswire/ -- Q32 Bio Inc. (Nasdaq: QTTB) ("Q32 Bio" or the "Company"), a clinical stage biotechnology company focused on developing innovative therapies for alopecia areata and other autoimmune and inflammatory diseases, today announced that the Company has dosed the first patients in both the Part A open-label extension (OLE) and...Read more
MELBOURNE, Australia and INDIANAPOLIS, April 16, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces preliminary results from the Phase 2 IPAX-Linz study of TLX101 (131I-iodofalan1) in recurrent high-grade glioma (brain cancer), substantiating the patient benefit seen in the IPAX-1 study2. IPAX-Linz is a single-arm Phase 2 investigator-initiated trial (IIT). IPAX-Linz...Read more
Initial results from randomized Phase 2 CRDF-004 trial in RAS-mut mCRC were released in December 2024 Additional clinical data from CRDF-004 trial expected in 1H 2025 SAN DIEGO, April 15, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced completion of patient enrollment in...Read more
JERUSALEM, April 15, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, announced highlights from Dr. Rachel B Wagman’s oral presentation at the 2025 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) Congress in Rome entitled “EFFECTS OF EB613 TABLETS [ORAL PTH(1-34)] ON TRABECULAR AND CORTICAL BONE USING...Read more
Reports 50% Reduction in Pruritus (Mean Score Dropped from 1.6 to 0.8) by Day 21 in Open-Label Portion of CLEER HT-001 Phase 2a clinical Trial for Cancer EGFR Inhibitor- Induced Skin Toxicities Key Interim Results (Day 1–21): Patients experienced a 50% reduction in pruritus severity, with mean scores dropping from 1.6 on Day 1 to 0.8 by Day 21. Rapid symptom relief was observed, with mean scores improving to 1.0 by Day 7. Some...Read more
Interim Results from FDA-Funded Study Reinforces HyBryte's™ Rapid Response and Strong Safety Profile PRINCETON, N.J., April 14, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today interim results from the ongoing open-label,...Read more
REDWOOD CITY, Calif. / Apr 14, 2025 / Business Wire / Exicure, Inc. (Nasdaq: XCUR) today announced that GPCR Therapeutics USA, a subsidiary of Exicure Inc., has dosed the 19th patient in its ongoing Phase 2 clinical trial evaluating GPC-100 (burixafor), a small molecule CXCR4 inhibitor, for the mobilization of stem cells in multiple myeloma (MM) patients undergoing autologous stem cell transplant (ASCT) (NCT05561751). The study is an...Read more
New miRNA findings unveiled at the AAN, reveal key biological mechanisms behind PrimeC's clinical benefit in ALS. CAMBRIDGE, Mass., April 9, 2025 /PRNewswire/ -- NeuroSense Therapeutics, Ltd. (NASDAQ: NRSN), a leading clinical-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, today announced promising new findings from its Phase 2b PARADIGM clinical trial. The data highlights the...Read more
POTOMAC, MARYLAND / ACCESS Newswire / April 8, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") today announced the expansion of its ongoing Phase 2 CALMA clinical trial with the addition of Butler Hospital's Memory and Aging Program, a nationally recognized research center affiliated with the Warren Alpert Medical School of Brown University, in Providence, Rhode Island. The site will support enrollment for the...Read more
8.9 Months Median Overall Survival (mOS) in Patients with AML-Myelodysplasia-Related Changes (AML-MRC) and 8.8 mOS in All Relapsed or Refractory to Venetoclax-Based Regimens Patients; Surpassing Historical Benchmark of 2.5 Months Overall Response Rate (ORR) of 67% Achieved in Patients with AML-MRC (Target Patient Population of SLS009 in r/r AML) – Exceeding Targeted 20% ORR Trial Continues with Full Data and FDA Regulatory...Read more
After a single course of therapy, Descartes-08-treated participants were observed to sustain deep responses through long-term follow-up, with an average 4.8-point reduction in MG-ADL at Month 12 Deepest and most compelling sustained responses observed in Descartes-08-treated participants who did not have prior exposure to biologic therapies, with an average 7.1-point reduction in MG-ADL and 57% of patients in this subgroup maintaining...Read more
PITTSBURGH, April 08, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on developing innovative therapies for unmet medical needs, today announced the completion of enrollment in its Phase 2a multicenter, dose-ranging trial evaluating LP-310, a liposomal tacrolimus oral rinse for the treatment of oral lichen planus (OLP). The Phase 2a trial...Read more
REDWOOD CITY, Calif. / Apr 07, 2025 / Business Wire / Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced the start of BELLA, a Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab evaluating efficacy and...Read more
NEW YORK, April 02, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced dosing has commenced at Johns Hopkins University (JHU) Autoimmunity Center of Excellence, the third clinical site in its Phase 2...Read more
Phase 2 trial of EDG-7500 demonstrated rapid and clinically meaningful reductions in LVOT gradients in participants with obstructive HCM Four-week treatment with EDG-7500 demonstrated substantial improvements in measures of feel and function, reductions in key cardiac biomarkers and positive trends in measures of diastolic function EDG-7500 was generally well-tolerated; clinical activity was observed without meaningful...Read more
Active immunotherapy with ACI-7104.056 induces high anti-a-synuclein (a-syn) antibody levels on average over 20-fold higher than placebo after 4 immunizations Repeated immunizations amplify the anti-a-syn antibody response, supporting boostability and the potential to further increase antibody titers ACI-7104.056 is well tolerated with no safety issues reported to date Lausanne, Switzerland, April 2, 2025 – AC Immune SA (NASDAQ:...Read more
POTOMAC, MARYLAND / ACCESS Newswire / April 1, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the expansion of its Phase 2 clinical trial, CALMA, evaluating IGC-AD1 for the treatment of agitation in Alzheimer's dementia, to MIND Institute at Miami Jewish Health in Miami, Florida. This addition further advances the company's efforts to accelerate the trial's completion and builds on promising interim data suggesting the...Read more
The Independent Data Monitoring Committee (IDMC) has recommended to continue study as planned as there are no safety concerns seen in the data reviewed Interim results demonstrate GRI-0621 to be safe and well-tolerated in the first 12 patients evaluated Interim biomarker data on track for Q2 2025 and topline results expected Q3 2025 Currently available treatments for IPF are limited to only two approved drugs that come with...Read more
DUBLIN, April 1, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the initiation of Vibrance-3, a phase 2 clinical study evaluating the safety and efficacy of ALKS 2680 compared to placebo in adults with idiopathic hypersomnia (IH). ALKS 2680 is the company's novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy type 1, narcolepsy type 2 and IH...Read more
New late-breaking clinical trial data presented at ACC and published simultaneously in JACC show benefit of investigational medicine AZD0780 on top of standard of care WILMINGTON, Del. / Mar 31, 2025 / Business Wire / Positive results from the PURSUIT Phase IIb trial for AstraZeneca’s AZD0780 demonstrated a statistically significant low-density lipoprotein cholesterol (LDL-C) reduction when administered on top of standard-of-care...Read more
ROCKVILLE, Md., March 31, 2025 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that a second Independent Data Monitoring Committee (IDMC) review of data from the VIRAGE Phase 2b clinical trial in newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) found that...Read more
Primary endpoint met in the 8-week treatment study (highly statistically significant). Co-administered group had a 4.4% reduction in weight compared to 1.6% for the placebo group (p<0.0001). Primary analysis for the co-administered group in the 8-week treatment study showed: 40% of patients achieved 5% reduction in weight (p<0.05). 27% achieved 6% reduction in weight (p<0.05). 19% achieved 7% reduction in...Read more
At All Doses Evaluated, VAX-24 Was Well-Tolerated and Demonstrated a Safety and Tolerability Profile Similar to Prevnar 20® (PCV20) At All Doses Evaluated, VAX-24 Elicited Substantial Immune Responses Following Primary Three-Dose Immunization Series; Topline Results Also Include Interim Booster Dose IgG Data Showing Robust Memory Responses Across All Doses Dose-Dependent Immune Responses Consistently Demonstrated and...Read more
Company expects safety data readout in 2025 as Randomized Arm continues enrollment at key medical centers LOS ANGELES / Mar 31, 2025 / Business Wire / Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company (the “Company’”), announces the completion of the safety lead-in of its Phase 2 clinical trial of ENV105 for the treatment of metastatic, castration-resistant prostate cancer. The trial, titled, “Phase...Read more
BX211 was safe and well-tolerated BX211 produced sustained and statistically significant1 Percent Area Reduction (PAR) of ulcer size (p = 0.046 at week 12; p=0.052 at week 13), with a separation from placebo starting at week 7 and a difference greater than 40% by week 10 Compared to placebo, BX211 also produced statistically significant1 improvements in both ulcer depth at week 13 (in patients with ulcer depth defined as bone at...Read more
In Phase 2 ALPACA results, lepodisiran significantly reduced levels of genetically inherited cardiovascular risk factor, with some patients sustaining reductions for nearly 1.5 years These data were presented at the American College of Cardiology 2025 Scientific Sessions and simultaneously published in the New England Journal of Medicine (NEJM) INDIANAPOLIS, March 30, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today...Read more
Lorundrostat 50 mg dose achieved a 15.4 mmHg absolute reduction and 7.9 mmHg placebo-adjusted reduction (p=0.001), assessed by 24hr ABPM at week 12, with favorable safety and tolerability profile Lorundrostat is a highly selective aldosterone synthase inhibitor that disrupts aldosterone biosynthesis rather than blocking the mineralocorticoid receptor Data from Advance-HTN support the potential of lorundrostat as a best-in-class...Read more
Clinical Remission: Achieved in 33% of PL8177-treated patients versus 0% on placebo after eight weeks of treatment. Clinical Response (statistically significant): Demonstrated in 78% of PL8177-treated patients versus 33% on placebo after eight weeks of treatment (p<0.005). Symptomatic Remission: Achieved in 56% of PL8177-treated patients versus 33% on placebo after eight weeks of treatment. Safety and Tolerability: Excellent, with...Read more
Reinforces potential of nebokitug to become the first approved drug with disease-modifying activity for PSC--a deadly disorder that currently has no effective treatments Treatment in PSC patients with moderate/advanced disease for 48 weeks resulted in continued improvements across key biomarkers of liver injury, inflammation and fibrosis, including ELF score, fibrosis-related ELF score components and PRO-C3 Patients treated with...Read more
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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