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
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
First presentation of results from Phase 1/2 clinical trial of investigational rinatabart sesutecan (Rina-S®) in patients with recurrent/advanced endometrial cancer Presentation of long-term follow-up data from analysis of Phase 1/2 EPCORE™ NHL-1 study of epcoritamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) COPENHAGEN, Denmark / May 22, 2025 / Business Wire / Genmab A/S (Nasdaq: GMAB) announced...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
An oral presentation at ASCO & EHA Congress from the CARTITUDE-1 study highlighting heavily pre-treated patients that remain alive and progression-free for more than 5 years after a single CARVYKTI® infusion New data at ASCO from the CARTITUDE-4 study to showcase improved progression-free survival and overall survival with CARVYKTI® versus standard of care (SOC) in key subgroups Preliminary results from ongoing Phase 1...Read more
CHATHAM, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals participated in a fireside chat at A.G.P.’s Annual Healthcare Company Showcase. A webcast of the presentation can be found under the IR Events...Read more
REDWOOD CITY, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that Soleno’s Marketing Authorization Application (MAA) seeking regulatory approval of Diazoxide Choline Prolonged-Release Tablets (previously referred to as DCCR) for the treatment of adults and children four years and older...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
Once-daily ZORYVE foam provides powerful clearance and rapid itch relief from head to toe with no limitation on duration of use More than half of the nearly 9 million people in the United States with plaque psoriasis experience scalp involvement Healthcare providers and individuals with plaque psoriasis can now choose ZORYVE foam or cream to treat plaque psoriasis anywhere it appears on the body Fifth FDA approval for ZORYVE in less...Read more
LUPKYNIS Data Presented at LUPUS 2025, the 16th International Congress on SLE, May 21-24 ROCKVILLE, Md. & EDMONTON, Alberta / May 22, 2025 / Business Wire / Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company), today announced that a post-hoc analysis of the 52-week, Phase 3 AURORA 1 study showed that lupus nephritis (LN) patients who received triple immunosuppressive therapy with LUPKYNIS® (voclosporin),...Read more
SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced the pricing of its previously announced underwritten public offering of 2,222,222 shares of its common stock at a public offering price of $9.00 per share. In addition, Gyre has granted the underwriters of the offering an option for a period of 30 days to...Read more
SAN DIEGO, May 22, 2025 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company focused on organ fibrosis, today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, Gyre is expected to grant the underwriters of the offering an option for a period of 30 days to purchase additional shares of its common stock at the public...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
Company to host conference call on Sunday, June 1, 2025 at 3:00 p.m. CT / 4:00 p.m. ET to discuss fulsome dataset BOSTON, May 22, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced the publication of an abstract with updated interim data from the company’s Phase 1/1b...Read more
BOULDER, Colo., May 22, 2025 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced that management will present at the following investor conferences: TD Cowen's 6th Annual Oncology Innovation Summit: Insights from ASCO & EHAFormat: Fireside ChatDate: Tuesday, May 27,...Read more
Partner presentations reinforce ability of proprietary Azymetric™ platform to develop clinically validated therapeutic antibodies Long-term outcomes and survival data for Ziihera® (zanidatamab-hrii), which was developed using Azymetric™, to be presented at ASCO and highlight its potential to transform the treatment landscape for first-line HER2-positive gastroesophageal cancer ZW171 Trial-in-Progress (TiP) poster at ASCO, ZW191 TiP...Read more
BLA priority review of RP1 plus nivolumab in advanced melanoma proceeding on schedule; manufacturing inspections and late cycle review meeting complete Full commercial infrastructure for launch in place ahead of July 22nd PDUFA date Conference call today at 8:00 AM ET WOBURN, Mass., May 22, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel...Read more
CAMBRIDGE, Mass. & SALISBURY, England / May 22, 2025 / Business Wire / KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that it will present new sebetralstat data at two upcoming congresses taking place concurrently from May 29–June 1, 2025: the 14th C1-inhibitor Deficiency & Angioedema Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida. The presentations will include new...Read more
Dr. Read brings >30 years of leadership and scientific expertise in the biopharmaceutical industry Previously served as CEO and Founder of Mariana Oncology until its acquisition by Novartis in 2024 and CSO of Ra Pharma until its acquisition by UCB in 2020 NEW YORK and WALTHAM, Mass., May 22, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next...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
BOTHELL, Wash. / May 22, 2025 / Business Wire / Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced that it will participate in the following investor conferences: TD Cowen 6th Annual Oncology Innovation Summit Presentation Date/Time: May 27, 2025, 6:30 a.m. - 7:00 a.m. PT Goldman Sachs 46th Annual Global Healthcare...Read more
Results from KOMET-001 registration-directed trial of ziftomenib in R/R NPM1-m AML patients selected for oral presentation on Monday, June 2nd Encore presentation planned at EHA 2025 Congress Kura Oncology to host virtual investor event at 7:30pm ET / 4:30pm PT on June 2nd to discuss the trial results SAN DIEGO and TOKYO, May 22, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”)...Read more
CAMBRIDGE, Mass. and TOKYO, Japan and PRINCETON, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), Taiho Pharmaceutical Co., Ltd., and Taiho Oncology, Inc. today announced new positive results from the pivotal Phase 2b cohorts of the REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib monotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth...Read more
BOSTON / May 22, 2025 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that Bharatt Chowrira, PhD, JD, Chief Executive Officer, and Eric Elenko, PhD, Co-founder and President will participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday,...Read more
FREMONT, Calif. / May 22, 2025 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced multiple presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting next week in Chicago, Illinois. The presentations feature new data from clinical studies utilizing the NeXT Personal® ultrasensitive ctDNA assay for residual and recurrent cancer detection. “These studies...Read more
CAMBRIDGE, England, & BOSTON / May 22, 2025 / Business Wire / Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced the poster presentation of two abstracts at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting, taking place May 30-June 3 in Chicago. Poster...Read more
Final data from the GAVRETO® (pralsetinib) Phase 1/2 ARROW study in RET fusion-positive NSCLC and other solid tumors Supportive data for REZLIDHIA® (olutasidenib) utilization in patients with mIDH1 R/R AML SOUTH SAN FRANCISCO, Calif., May 22, 2025 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced...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
NEEDHAM, Mass., May 22, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that results from the Company’s positive phase 3 clinical trial of aglatimagene besadenovec (CAN-2409) in patients with intermediate-to-high-risk localized prostate cancer will...Read more
BOSTON / May 22, 2025 / Business Wire / Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that it will present at the Eastern Allergy Conference (EAC) in Palm Beach, Florida on May 30, 2025. Raffi Tachdjian, M.D., Associate Clinical Professor of Medicine and Pediatrics in the Division of Allergy and Clinical Immunology at...Read more
SOUTH SAN FRANCISCO, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune disease, today announced the publication of two abstracts on the American Society of Clinical Oncology (ASCO) website in advance of the 2025 ASCO Annual Meeting, taking place May 30-June 3 in...Read more
Presentations by leading siRNA CDMOs, Bachem, Nitto Avecia, and ST Pharm, highlight performance and transferability of Codexis double-stranded RNA ligases Management to host conference call today at 8 am Eastern Time to discuss data REDWOOD CITY, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading provider of enzymatic solutions for the efficient and scalable manufacturing of complex therapeutics,...Read more
Phase 2 (Actuate-1801 Part 3B) trial topline results meet primary endpoint of improved survival in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) Oral presentation at the American Society of Clinical Oncology (ASCO) annual meeting to highlight statistically significant improvement in median overall survival and 1-year survival rate in patients treated with the combination of elraglusib and...Read more
MINNEAPOLIS / May 22, 2025 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for preeclampsia and acute ischemic stroke, today announced that Rick Pauls, President and CEO, and Dave Wambeke, Chief Business Officer, will present at the upcoming Jefferies Global Healthcare Conference, being held in New York City, NY, June 3 – 5, 2025. Management...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
WATERTOWN, Mass. / May 22, 2025 / Business Wire / Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced that data from the Company’s Phase 2 study of zelicapavir in young children infected with respiratory syncytial virus (RSV) will be available as an E-Poster at the 43rd Annual Meeting of the European...Read more
SAN MATEO, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced it will host a virtual key opinion leader (KOL) event on Thursday, May 29, 2025 at 1:00 PM ET. To register, click here. The event will feature Rohit Loomba, MD, MHSc (Professor of Medicine, Chief,...Read more
NORWOOD, Mass., May 22, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), today announced that Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, will provide a corporate update and participate in one-on-one investor meetings at the Jefferies Global Healthcare Conference, to be held June 3-5, 2025 in New York, NY. Jefferies Global Healthcare ConferenceFormat: Presentation and...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
CTLA-4 inhibitor ADG126 can be dosed at 20 mg/kg Q6W in combination with pembrolizumab with <20% Grade 3 adverse events In combination with pembrolizumab, ADG126 showed a 29% confirmed overall response rate (ORR) in microsatellite stable colorectal cancer All six responders in the 20 mg/kg cohorts remain on treatment, with four patients on study for over forty weeks Median overall survival (OS) for the 10 mg/kg cohorts was 19.4...Read more
Study CL-QRX003-002 will test whole-body application of QRX003 in conjunction with off-label systemic therapy in approximately 12-15 subjects. Study CL-QRX003-002 complements first whole-body pivotal study, CL-QRX003-003, being led by Dr. Amy Paller at Northwestern University and supported by up to six international sites that are expected to open, where subjects are being tested with QRX003 as monotherapy. Combined data from Studies...Read more
The Clinical Study Is Expected to Randomize 36 Participants in Cleveland Clinic Abu Dhabi (CCAD) and Three Other Clinical Sites in UAE Philadelphia, Pennsylvania--(Newsfile Corp. - May 22, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce that it has received study may proceed approval from the UAE DOH to commence Phase 2 clinical study (SKNJCT-004) to non-invasively treat BCC of the...Read more
Phase 2: Versamune® HPV with pembrolizumab as 1L treatment of r/m HPV16-positive HNSCC Median overall survival for CPS ≥20 is 39.3 months Median overall survival for CPS ≥1 is 30.0 months Phase 3: Versamune® HPV with pembrolizumab as 1L treatment of r/m HPV16-positive HNSCC Trial-in-progress currently enrolling patients Conference call on Friday, May 23 at 8:00 a.m. ET to discuss ASCO abstract data sets PRINCETON, N.J., May 22,...Read more
LOS ALTOS, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that Shalabh Gupta, M.D., Chief Executive Officer will present at two upcoming virtual investment conferences. Event: Lytham Partners Spring 2025 Investor Conference Type: Fireside ChatDate/Time: ...Read more
Renowned neuroscience drug developer joins to support strategic development of long-acting CNS therapeutics HUNTSVILLE, AL, May 22, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing a pipeline of product candidates leveraging its proprietary POZ Platform™ drug optimization technology, today announced the appointment of Stephen (Steve) Brannan,...Read more
LOS ANGELES, May 22, 2025 (GLOBE NEWSWIRE) -- Renovaro Inc. (NASDAQ: RENB), a TechBio leader focused on next-generation diagnostics, drug discovery, and genetically enhanced cancer therapies, today announced that it has received a ruling to expedite a trial in 2025 for the lawsuit it filed on May 9, 2025, in the Delaware Court of Chancery against Predictive Oncology Inc. (NASDAQ: POAI), seeking to enforce a binding merger agreement...Read more
GENEVA, SWITZERLAND / ACCESS Newswire / May 22, 2025 / RELIEF THERAPEUTICS Holding SA (SIX:RLF) (OTCQB:RLFTF) (OTCQB:RLFTY ) (Relief or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to RLF-TD011 for the treatment of...Read more
ISELIN, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has commenced an underwritten public offering of its common stock and accompanying warrants exercisable for shares of its common stock. The offering is subject to market and other conditions, and...Read more
Live webcast on Thursday, May 29th at 2:20 PM ET BOSTON and LONDON, May 22, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), today announced that Abizer Gaslightwala, President and CEO of Akari, will present and discuss recent corporate events at LIVE! with Webull Corporate Connect: Virtual Biotech Investment Webinar on...Read more
POTOMAC, MD / ACCESS Newswire / May 22, 2025 / IGC Pharma, Inc. ("IGC", or the "Company") (NYSE American:IGC) today announced a clinical trial site at Santa Cruz Behavioral in Puerto Rico for its CALMA Phase 2 clinical trial, investigating IGC-AD1 for agitation in Alzheimer's disease. This strategic site directly addresses the significant impact of Alzheimer's in the region. Approximately 12.5% of Puerto Ricans over the age of 65 have...Read more
SALT LAKE CITY, May 22, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that its development candidate LPCN 1148 for men with cirrhosis is featured in the "Hepatology Highlights" section of the June 2025 edition of Hepatology. The article "LPCN 1148: Rebuilding muscle memory in cirrhosis...Read more
Live webcast on Thursday, May 29th at 2:40 PM ET SOUTH SAN FRANCISCO, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced that Timothy Lu, M.D., Ph.D. Co-Founder and Chief Executive Officer of Senti Bio, will present at LIVE!...Read more
Robotic Smell Intelligence Goes Live at Asia's Premier AI Tech Stage SAN DIEGO, CA / ACCESS Newswire / May 22, 2025 / Ainos, Inc. (NASDAQ:AIMD) (Nasdaq:AIMDW) ("Ainos"), a pioneer in AI-driven scent digitization, announced the official debut of its proprietary AI Nose platform at COMPUTEX 2025, alongside ugo, Inc, Japan's top service robotics company. This milestone marks the first public demonstration of real-time robotic...Read more
Istaroxime has previously completed two positive Phase 2 studies in SCAI Stage B cardiogenic shock; the SEISMiC C study in SCAI Stage C cardiogenic shock is another step progressing to the istaroxime cardiogenic shock Phase 3 program WARRINGTON, Pa., May 22, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue-generating company and...Read more
VANCOUVER, British Columbia, May 22, 2025 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian healthcare and clinical stage drug development company, is pleased to announce it has closed the acquisition to acquire 100% of the issued and outstanding shares of NoBrainer Imaging Centers, Inc. (“NIC”) (the “Transaction”) previously announced on May 13, 2025....Read more
TEL AVIV, Israel, May 22, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for cardiometabolic diseases and GI oncological indications, reports financial results for the three months ended March 31, 2025 and recent developments. Key Recent Developments Announced First Time Results in Oncology Studies: Aramchol Significantly Enhances Bayer's...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
Data presented at the 2025 American Thoracic Society (ATS) International Conference Pre-clinical and interim clinical results underscore GRI-0621’s potential to have both anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis Results from 6-week interim analysis (n=24) in ongoing Phase 2a study of GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) anticipated in Q2 2025 LA JOLLA, CA, May 22, 2025 (GLOBE...Read more
ROCKVILLE, Md. and SUZHOU, China, May 22, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma (NASDAQ: AAPG; HKEX: 6855), a global biopharmaceutical company dedicated to addressing unmet medical needs in cancers, today announced that new clinical data from two ongoing investigational studies evaluating lisaftoclax in various blood cancers and alrizomadlin in solid tumors will be presented during an oral presentation and poster presentation,...Read more
Pittsburgh, Pennsylvania and Toronto, Ontario--(Newsfile Corp. - May 22, 2025) - Sharp Therapeutics Corp. (TSXV: SHRX) ("Sharp" or the "Company"), a pre-clinical-stage biotechnology company developing small molecule therapies to treat genetic diseases, announces the release of its condensed interim consolidated financial statements for the three months ended March 31, 2025, and related management discussion and analysis. All dollar...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, MA / ACCESS Newswire / May 21, 2025 / Moderna, Inc. (Nasdaq:MRNA), today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. The Company plans to resubmit the BLA later this year, after vaccine efficacy data from the...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
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
Designation is based on the pivotal Phase 3 DRAGON trial interim analysis results demonstrating Tinlarebant’s efficacy and favorable safety profile Trial completion expected by Q4 2025 (including a three-month follow-up period) Tinlarebant has previously been granted Fast Track and Rare Pediatric Disease Designations in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and the Pioneer Drug Designation in Japan for...Read more
Presentation will highlight the comparable efficacy and safety of taletrectinib across pivotal studies and different ethnicities and world regions The drug is under Priority Review by the U.S. Food and Drug Administration (FDA) and has a Prescription Drug User Fee Act (PDUFA) date of June 23, 2025 NEW YORK / May 21, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the...Read more
Vancouver, British Columbia--(Newsfile Corp. - May 21, 2025) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotechnology company dedicated to developing neuroreparative therapeutics, today announced that topline results from the chronic cohort of the ongoing Phase 1b/2a study of NVG-291 will be presented as an oral presentation at the 52nd American Spinal Injury Association Annual Scientific Meeting being held June...Read more
Vigil’s shareholders to receive up to $10.00 per share in cash, comprised of $8.00 per share in cash at closing and a non-tradeable contingent value right of $2.00 per share in cash following the first commercial sale of VG-3927 Acquisition expected to strengthen development path for the oral small molecule TREM2 agonist program, including VG-3927, a Phase 2-ready clinical candidate for potential treatment of Alzheimer’s...Read more
VALUE Phase III trial of EscharEx® in venous leg ulcers advancing as planned NexoBrid® manufacturing expansion on track; full operational capacity expected by year-end 2025 First quarter revenue of $4 million; full-year 2025 revenue guidance reaffirmed at $24 million Conference call today, May 21 at 8:30am Eastern Time YAVNE, Israel, May 21, 2025 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation...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
VIENNA, Va. / May 21, 2025 / Business Wire / CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a clinical stage cancer immunotherapy company, today announced that it intends to offer to sell shares of its common stock (and/or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof) in an underwritten public offering. All of the shares of common stock (and/or Pre-Funded Warrants) are being offered by the Company. The...Read more
Saudi Arabia’s new Breakthrough Medicine Designation, if granted, would make Multikine available for patient access and commercial use Saudi Food and Drug Authority typically responds to Breakthrough Medicine Designation applications within approximately 60 days Multikine increased the 5-year survival rate of the target patient population in head and neck cancer to 73% vs 45% in patients treated with standard of care alone; The 5-year...Read more
PRINCETON, N.J. / May 21, 2025 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a leading biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, announced the outcome of today’s meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA), which discussed the new drug application (NDA) for investigational drug UGN-102...Read more
SOUTH SAN FRANCISCO, Calif., May 21, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that the Company led oral and poster presentations of clinical and preclinical data this week as part of the American Thoracic Society (ATS) 2025 International Conference, held from May 16-21, 2025. Characterizing the Antifibrotic Activity of Bexotegrast on Distinct Fibroblast Populations in PCLS from Multiple ILD...Read more
Virtual KOL Event Tuesday, June 3, 2025 3:00pm ET Attend the event here: https://lifescievents.com/event/immix-asco LOS ANGELES, CA, May 21, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that it will host a virtual Key Opinion Leader (KOL)...Read more
Investment from largest shareholder strengthens balance sheet, signals insider conviction, and funds Telomir-1's upcoming IND submission for a rare disease indication MIAMI, FLORIDA / ACCESS Newswire / May 21, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), an emerging leader in age-reversal science, today announced it has secured $3 million in equity financing, through a direct investment by The...Read more
SAN FRANCISCO, CA / ACCESS Newswire / May 21, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or "the Company"), today announced that it has entered into definitive agreements for the purchase and sale of 246,306 shares of common stock at a purchase price of $6.09 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company agreed to issue to investors unregistered...Read more
PALM BEACH, Fla., May 21, 2025 /PRNewswire/ -- NRx Pharmaceuticals, Inc. ("NRx" or the "Company") (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, today announced that that Jonathan Javitt, MD, MPH, Founder, Chairman and Chief Executive Officer of NRx Pharmaceuticals and Co-CEO of HOPE Therapeutics, will be presenting a Company update at the upcoming Wall Street Conference, taking place on May 21, 2025 in Palm Beach,...Read more
PHM23 was one of a handful of molecules chosen by the university Bird Flu helping PHM23 gain awareness of broad-spectrum activity at a university level BOSTON, MASSACHUSETTS, May 21, 2025 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company developing breakthrough antiviral treatments, announced that the University of Georgia confirmed the antiviral PHM23 was to be included...Read more
Final CM24 Phase 2 data presented at AACR Annual Meeting 2025, strengthening patient selection strategy for CM24 Phase 2b study planned to be initiated in Second Half of 2025 NT219 data presented at AACR Annual Meeting 2025; NT219 Phase 2 study in head and neck cancer on track to be initiated in First Half of 2025 CAPTN-3 differentiated T-cells and NK cells engagers tri-specific platform advances toward first-in-human clinical...Read more
ZURICH, May 21, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. (NASDAQ: NLSP), a Swiss clinical-stage biopharmaceutical company focused on central nervous system ("CNS") disorders, announces that it will present new preclinical data on Mazindol ER at the 2025 Annual Meeting of the American Society of Clinical Psychopharmacology ("ASCP"). ASCP Annual Meeting will be held at the Fairmont Scottsdale Princess in Scottsdale,...Read more
Study is expected to deliver final device data and documentation needed for planned FDA IND submission SARASOTA, FL, May 21, 2025 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced that it has entered into a service agreement with medical technology provider Resyca BV for a drug-device...Read more
Silexion’s new groundbreaking study explores the potential impact of its next generation RNAI therapeutic candidate beyond pancreatic cancer aiming to address critical unmet needs in additional KRAS-driven tumor types with treatment markets estimated at over $30 Billion Dollars a year GRAND CAYMAN, Cayman Islands, May 21, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp (NASDAQ: SLXN) (“Silexion” or the “Company”), a...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
In a post-hoc analysis of ATTRibute-CM, acoramidis reduced the annual frequency of CVH due to AF/AFL by 43% compared to placebo and reduced the incidence of new-onset AF/AFL by 17% in the subgroup with no prior history of AF compared to placebo In the ATTRibute-CM study, acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date in both ATTRv-CM and ATTRwt-CM patients: In as few as 3 months, the time...Read more
REDWOOD CITY, Calif., May 20, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced data presented from its clinical development program of VYKAT™ XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, at the Pediatric Endocrine Society (PES) Annual Meeting 2025, which was held May 15-18...Read more
ZEVTERA is the first and only U.S. Food and Drug Administration-approved cephalosporin indicated to treat Staphylococcus aureus bacteremia (SAB), including right-sided endocarditis, caused by the methicillin-resistant Staphylococcus aureus (MRSA). WALTHAM, Mass. / May 20, 2025 / Business Wire / Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced the United States commercial availability...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
U.S. FDA clears lung cancer IND for CVHNLC, a proprietary off-the-shelf candidate targeting squamous non-small cell lung cancer (sqNCLC), with clinical study expected to begin H2 2025; Clinical Trial Application filed in Europe with decision expected in Q2 2025 Glioblastoma study fully enrolled with Part B of Phase 1 CVGBM trial completing enrolment in Q1 2025; go/no-go decision on moving to Phase 2 planned for H2 2025 First...Read more
RADNOR, Pa., May 20, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that data from the pivotal Phase 3 Launch-HTN trial evaluating the efficacy and safety of lorundrostat for the treatment...Read more
| Company | Change | Last Trade |
|---|---|---|
| Instil Bio | 8.28 51.05 | $24.50 |
| Vigil Neuroscience | 5.57 241.13 | $7.88 |
| Acadia Pharmaceuticals | 3.98 22.65 | $21.55 |
| Actuate Therapeutics | 3.35 49.63 | $10.10 |
| Alpha Cognition | 3.32 61.82 | $8.69 |
| Ascendis Pharma | 1.95 1.23 | $160.05 |
| Adaptive Biotechnologies | 1.83 26.11 | $8.84 |
| Relief Therapeutics | 1.38 57.02 | $3.80 |
| PureTech Health | 1.09 6.09 | $19.00 |
| Rapport Therapeutics | 1.08 10.76 | $11.12 |
| Bicara Therapeutics | 1.07 7.33 | $15.66 |
| Moderna | 0.92 3.57 | $26.72 |
| ADC Therapeutics | 0.90 74.38 | $2.11 |
| Abeona Therapeutics | 0.86 15.03 | $6.58 |
| Gyre Therapeutics | 0.84 8.10 | $11.21 |
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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Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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