WILMETTE, Ill., Sept. 14, 2025 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced that new data on the long-term neurological efficacy and safety of its investigational therapy ALXN1840 (tiomolybdate choline) for Wilson disease will be presented at the 150th American...Read more
Results of the successful phase 3 TETON-2 study of inhaled treprostinil in idiopathic pulmonary fibrosis will be presented in an oral presentation SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Sep 12, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that recent research across its commercial and development portfolio will be presented at the European...Read more
Findings reinforce efficacy and tolerability profile in patients prescribed DAYBUE in the U.S. for as long as 12 months, consistent with the Phase 3 LAVENDER™ trial that supported FDA approval and open-label LILAC, LILAC-2 and DAFFODIL studies SAN DIEGO / Sep 12, 2025 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the journal Developmental Medicine and Child Neurology published interim results from...Read more
Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; and Pioneer Drug Designation in Japan for Stargardt disease Last subject visit completed in the pivotal Phase 3 DRAGON trial of Tinlarebant in Stargardt disease Topline data expected in Q4 2025 SAN DIEGO, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Belite Bio...Read more
Clinical data from Phase 1b prostate cancer trial to be released in Q4/25 Additionally, updated 2-year overall survival data from all 40 patients in the Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma to be released on October 10, 2025 New York, New York--(Newsfile Corp. - September 12, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or...Read more
TORONTO, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (Upstream: QNTM) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development, today...Read more
Dr. Barbara Klencke is an accomplished clinical leader with a distinguished track record in oncology drug development who currently serves on the Company’s Board of Directors and will step down from the Board to join ALX as Interim Chief Medical Officer Alan Sandler, M.D. resigns as Chief Medical Officer and will return to his position serving on the Company’s Board of Directors SOUTH SAN FRANCISCO, Calif., Sept. 12, 2025 (GLOBE...Read more
DURHAM, N.C. / Sep 12, 2025 / Business Wire / Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that the Company presented clinical data from the Phase 1 ELIMINATE-B trial of PBGENE-HBV in patients with chronic Hepatitis B. The data was presented at the International...Read more
$4.7 million upfront with up to an additional approximately $8.3 million of potential aggregate gross proceeds upon the exercise in full of warrants BOTHELL, Wash., Sept. 12, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc., (Nasdaq: COCP) (the “Company” or “Cocrystal”), today announced that it has entered into definitive agreements for the purchase and sale of 2,764,710 shares of its common stock (or common stock equivalents in lieu...Read more
BOTHELL, Wash., Sept. 12, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that President and co-CEO Sam Lee, PhD discussed the scientific foundation and clinical progress with the Company’s lead pan-viral protease inhibitor CDI-988 during a podium presentation at the 9th International Calicivirus Conference, held September 7–11, 2025 in Banff, Alberta. Based on a novel mechanism of action and superior...Read more
Ra’anana, Israel, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced encouraging preclinical results supporting the performance of its PL-14 Allergy Blocker, part of its proprietary Capture & Contain (C&C) platform. The study, conducted in collaboration with the University of Parma...Read more
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announces its unaudited interim results for the six months ended June 30, 2025 which will also be made available on the Company’s website at www.biodexapharma.com. OPERATIONAL HIGHLIGHTS The Company announced the following in the six months ended...Read more
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor 1 Filing based on four Phase 3 studies that met all primary and co-primary endpoints. This unprecedented data package includes head-to-head superiority comparisons versus deucravacitinib, adolescent data, and evaluation of difficult to treat skin sites2,3,4,5,6 Submission underscores that icotrokinra has the potential to...Read more
MORRISVILLE, N.C., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, announced today that the company will present four posters at the Pulmonary Hypertension Professional Association (PHPN) Symposium taking place September 18 – 20, 2025, in Seattle. In a live thematic poster session, Liquidia will...Read more
SAN FRANCISCO and BOSTON, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today announced data from the Phase 2 APEX trial of APG777 for moderate-to-severe atopic dermatitis was accepted for a late-breaker oral presentation at the...Read more
NEW YORK and WALTHAM, Mass., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases (“Dianthus” or the “Company”), today announced that it closed its previously announced underwritten public offering of 7,627,879 shares of its common stock, including the full...Read more
EKTERLY® now approved in the US and UK; first and only oral on-demand therapy for acute attacks of hereditary angioedema Initiated US EKTERLY launch in July; received 460 patient start forms through August European Medicines Agency adopted a positive opinion recommending approval of sebetralstat and confirmed maintenance of orphan designation in EU; decision expected early October $191M in cash, providing runway into 2027 Management...Read more
Presentations collectively highlight pilavapadin’s potential to improve pain management care for patients with diabetic peripheral neuropathic pain (DPNP) Breadth of the data across Phase 2 program to be discussed at Arrowhead’s 19th Annual Pain Summit THE WOODLANDS, Texas, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the presentation of clinical data for its investigational,...Read more
GlyphAgo is an oral prodrug of agomelatine, a medicine with established clinical efficacy in generalized anxiety disorder (GAD) GlyphAgo is designed to overcome a key limitation of agomelatine by shifting absorption toward the intestinal lymphatics, avoiding first-pass liver metabolism, and increasing systemic exposure of the drug Phase 1 proof-of-concept study will evaluate the safety, tolerability, and pharmacokinetics of GlyphAgo and...Read more
Performance and scalability of Oracle Cloud Infrastructure AI infrastructure enables Absci to accelerate biologics design cycles and reduce costs AUSTIN, Texas and VANCOUVER, Washington, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Absci, a clinical-stage biotech company advancing novel therapeutics with generative AI, today announced a collaboration with Oracle Cloud Infrastructure (OCI) and AMD to accelerate generative AI-driven drug...Read more
NEW YORK, Sept. 11, 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 the immediate exercise of warrants, previously issued in January 2025, to purchase up to 19,685,040 shares of its common stock for gross cash proceeds of approximately...Read more
SEATTLE and VANCOUVER, British Columbia, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for treatment of nicotine dependence for smoking cessation, today announced Mark Rubinstein, M.D., will assume the role of Interim Chief Medical Officer (CMO). Dr. Rubinstein will succeed Cindy...Read more
CARMIEL, ISRAEL / ACCESS Newswire / September 11, 2025 / Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that Eyal Rubin, the Company's former Sr. Vice President and Chief Financial Officer, will present at the...Read more
CHICAGO and FORT WORTH, Texas, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced the closing of its $17.25 million underwritten public offering of 2,464,286 shares...Read more
SOUTH SAN FRANCISCO, Calif. / Sep 11, 2025 / Business Wire / Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, today announced that it will host a virtual Investor Day on Thursday, October 2, 2025, from 10:00 a.m. and 12:00 p.m. Eastern Time. Quince’s virtual Investor Day will feature presentations from the company’s...Read more
TORONTO and HAIFA, Israel, Sept. 11, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a pioneering biopharmaceutical company developing exosome-based regenerative therapies, is pleased to provide the following corporate updates. Israeli Patent Grant Expands Global Jurisdiction The Israel Patent Office has granted the Company’s Patent, entitled “Production of...Read more
Dr. Chang led XOLAIR® from invention through FDA approval and commercialization, exceeding $5 billion in sales so far Los Angeles, CA, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Company”, “We” or “Us”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that Nancy T. Chang, former Tanox, Inc. CEO and proven biotechnology...Read more
CHICAGO, Sept. 11, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small...Read more
MOUNTAIN VIEW, Calif., Sept. 11, 2025 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared drug-delivery device, today announced that Shaun Bagai, Chief Executive Officer, will present at the iAccess Alpha Virtual Best Ideas Fall Investment Conference 2025, held on September 16-17,...Read more
Pilot studies underway to advance IND-enabling preclinical development HOUSTON, Sept. 11, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced positive IND-enabling updates...Read more
Event to feature principal investigators from the trial LOS ANGELES / Sep 11, 2025 / Business Wire / Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today announces that it will host a premier KOL event on Thursday, Sept. 18th at 5 p.m. ET / 2 p.m. PT to discuss diverse perspectives on the Company’s interim efficacy results from a Phase 2 trial of its lead...Read more
Supports Clinical Development of CLR 121225, Actinium-Labeled Compound for the Treatment of Solid Tumors FLORHAM PARK, N.J. and GARCHING, Germany and MUNICH, Germany, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB, “Cellectar”), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, and ITM Isotope Technologies Munich SE (ITM), a...Read more
SYDNEY, Sept. 11, 2025 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, today announced new findings from a collaborative research program led by Professor Sudha Rao at QIMR Berghofer. In this ex vivo study, blood samples from Stage IV HER2-positive metastatic breast cancer (mBC) patients were profiled to evaluate the effect of paxalisib, Kazia's investigational PI3K–mTOR inhibitor,...Read more
SAN DIEGO, CA / ACCESS Newswire / September 11, 2025 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life sciences company focused on rebalancing inflammation, announced today the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 4,355,000 shares of common stock, issued by the Company on May 29, 2025 (the "Existing...Read more
New Positive Preclinical Data Shows Succesful Drug Distribution to Liver, Peritoneum, and Lung with Measurable Reductions in Tumor Burden at Clinically Relevant Doses Results Provide Further Validation of the Systemic Component of a Dual-Route Administration Strategy Enabeling Potential Targeting of Both Primary Tumors and Metastatic Disease Silexion Remains on Track for Phase 2/3 Trial Initiation in H1 2026 Following Planned Q4...Read more
SOUTH SAN FRANCISCO, Calif., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with kidney and metabolic diseases, today announced it has entered into a securities purchase agreement for an oversubscribed private placement of its securities for gross proceeds of approximately $150.0 million, before deducting...Read more
Phase 1 data in healthy volunteers exceed expectations and support best-in-class potential, enabling Phase 2 advancement for both intended indications of PKU and CKD Dose-dependent urinary amino acid excretion demonstrated across all SAD and MAD cohorts, including up to a 42-fold increase in urinary phenylalanine (Phe) excretion, a well-validated biomarker for PKU and predictive for CKD Dose-dependent initial eGFR dip similar to SGLT2...Read more
NEW YORK, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Metsera, Inc. (Nasdaq: MTSR), a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, will present clinical and preclinical data from its portfolio of next-generation ultra-long acting, scalable, and combinable therapies at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) held September...Read more
No decline in lung function observed at 6-week interim analysis builds upon positive safety and biomarker data Phase 2a study fully enrolled; Topline data on track for Q3 2025 Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival LA JOLLA, CA, Sept. 11, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI...Read more
24-week data from the Phase 3 STOP-HS clinical trial program of povorcitinib in patients with hidradenitis suppurativa (HS) selected as a late-breaking oral presentation WILMINGTON, Del. / Sep 10, 2025 / Business Wire / Today Incyte (Nasdaq:INCY) announced that it will present new data from its dermatology portfolio at the European Association of Dermatology and Venerology (EADV) 2025 Congress, held from September 17 – 20, in Paris....Read more
Long-term follow-up data for daraxonrasib monotherapy in second line metastatic pancreatic ductal adenocarcinoma reinforces promising clinical activity and durability Highly encouraging initial clinical results for daraxonrasib monotherapy and daraxonrasib plus chemotherapy in first line metastatic pancreatic ductal adenocarcinoma support planned initiation of three-arm Phase 3 trial in Q4 2025 Revolution Medicines to host webcast...Read more
FDA assigns a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026 REDWOOD CITY, Calif. / Sep 10, 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 that the U.S. Food and Drug...Read more
SAN DIEGO, Sept. 10, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that it intends to offer and sell, subject to market and other conditions, $500.0 million of shares of its common stock in an underwritten public offering. In addition, Avidity intends to grant the...Read more
Unprecedented improvement compared to baseline and natural history in multiple functional measures including Time to Rise from Floor (TTR), 4-Stair Climb (4SC), Performance of Upper Limb (PUL) and 10-Meter Walk/Run Test (10mWRT) at approximately one year Unprecedented rapid reduction in creatine kinase (CK) to near normal levels maintained over 16 months of follow-up and 25% increase of normal in dystrophin production, reflecting...Read more
NEW YORK, Sept. 10, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the upcoming schedule of presentations highlighting BRIUMVI® (ublituximab-xiiy) data in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, being held September 24 - 26, 2025 in Barcelona, Spain. Abstracts are now available online...Read more
In preclinical studies presented today at the RNA Leaders USA Congress 2025, investigational ARO-MAPT demonstrated potent and long-lasting MAPT mRNA and Tau protein suppression with uniform distribution throughout the CNS after subcutaneous administration in non-human primates PASADENA, Calif. / Sep 10, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has filed a request for regulatory...Read more
SAN DIEGO / Sep 10, 2025 / Business Wire / Travere Therapeutics, Inc., (Nasdaq: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that following further review of the supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS), an advisory committee is no longer needed. The sNDA remains under review by the FDA with a Prescription Drug User Fee...Read more
FREMONT, Calif. / Sep 10, 2025 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced its collaboration with a leading breast cancer team from Yale Cancer Center for a clinical trial titled “A single arm phase II trial of circulating tumor DNA-guided adjuvant therapy with elacestrant in hormone receptor positive HER2 negative breast cancers at risk for late recurrence...Read more
Company plans to host an investor call at 8 a.m. ET on September 25 Immuneering plans to then share the updated data at the PanCAN Scientific Summit on September 28 Additionally, the Company will present a review of preclinical data on Deep Cyclic Inhibitors at the 7th RAS-Targeted Drug Development Summit CAMBRIDGE, Mass., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage...Read more
CARLSBAD, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today announced the appointment of industry veteran Justin Gover to its Board of Directors, effective immediately. Mr. Gover has more than 25 years of leadership experience in the biotechnology industry. He served as the founding Chief...Read more
SAN MATEO, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that the Company will give two oral presentations and participate in a drug development panel at the 9th Annual MASH Drug Development Summit taking place September 29-October 1, 2025 in...Read more
ORR of 35% in previously treated squamous NSCLC patients with responses across PD-L1 TPS scores Differentiated structure of ‘2510 potentially results in best-in-class monotherapy activity in 2L+ NSCLC for PD-(L)1xVEGF bispecifics DALLAS, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, today announced that...Read more
STAFFORD, Texas, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that FDA has granted Fast Track designation for GLSI-100 in the HLA-A*02 patient population. The designation specifically states...Read more
Second-generation constructs induce robust increases in fecal IgA, which was shown to be correlated with protection against infection in the company’s previous Phase 2b challenge study SOUTH SAN FRANCISCO, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (OTCQX: VXRT), a clinical-stage biotechnology company developing a range of oral recombinant pill vaccines based on its proprietary delivery platform, today reported...Read more
ORLANDO, Fla., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB) (NASDAQ:NTRBW) reported its financial results for the six months ended July 31, 2025. The company reported a strong cash position at quarter end, reinforcing its ability to advance the development of its lead product, AVERSA™ Fentanyl which has been granted a Type C meeting on September 18th. Nutriband is continuing to expand its kinesiology tape contract...Read more
Oversubscribed Financing led by Coastlands Capital with participation from new and existing investors Financing to provide $50 million in upfront proceeds with the potential for up to an additional $50 million of proceeds to fund the Phase 1/2 clinical trial in patients with SYNGAP1-related disorders, expected to initiate as early as 2H 2026 Doug Williams, Ph.D., to become Board Chair, and Dan Tardiff, Ph.D., elevated to Chief...Read more
PYNNACLE Phase 2 pivotal clinical trial interim data include confirmed responses observed in eight tumor types spanning ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma 33% overall response rate (ORR) observed among 97 evaluable patients across all cohorts with a median duration of response of 6.2 months 43% ORR observed among 44 evaluable patients in ovarian cancer cohort with a...Read more
Top-Line Results Anticipated in March 2026 NEWTON, Mass., Sept. 10, 2025 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it has completed enrollment in the Phase 3 SENTRY trial, which is evaluating selinexor in combination with ruxolitinib in JAKi-naïve myelofibrosis patients. "We are excited to announce that we have...Read more
BXCL501 demonstrated a significant mean reduction in mCGI-S score from baseline compared to placebo at 2 hours across 2,433 treated episodes (p<.05) Complete resolution of agitation was significantly higher with BXCL501 compared to placebo across agitation episode severity (p<.0001) BXCL501 showed a similar reduction in agitation symptoms over both the duration of the trial and number of treated episodes, demonstrating continued...Read more
Initial Phase 2 RoAD trial results demonstrate improvements in brain-cell connectivity and health, with a favorable safety profile CAMBRIDGE, Mass., Sept. 10, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced positive initial results from its collaboration with...Read more
Pilot studies have shown encouraging results that are supporting the company’s pre-IND enabling development, marking a critical step toward clinical translation of the Bone Marrow Organoid technology HOUSTON, Sept. 10, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential...Read more
NEW YORK, Sept. 10, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical innovator, today announced it has submitted its Clinical Trial Application (CTA) to the European Medicines Agency (EMA) to expand its ongoing Phase II trial of HT-001, a novel topical therapeutic for skin toxicities associated with Epidermal Growth Factor Receptor inhibitors (EGFRi). The submission marks a major...Read more
A pathological complete response ("pCR") has been observed in the first patient evaluated in Cohort A, where each patient receives two doses of INT230-6 eight days apart, followed by the standard of care immunochemotherapy ("SOC") Safety looks favorable in Cohort A Some INT230-6 patients begin to show localized skin irritation, and new patient enrollment has been paused to implement modifications to resolve the issue Patients being...Read more
SOLANA BEACH, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatologic, or neurological conditions, today announced the publication of new preclinical data on ART12.11, its proprietary cannabidiol:tetramethylpyrazine (CBD:TMP) cocrystal. The...Read more
WINNIPEG, Manitoba, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE) (“Kane Biotech” or “Kane”) today announces that it has enrolled 28 participants in its revyve® Antimicrobial Wound Gel and Spray U.S. Case Series Studies, exceeding its 25-participant target. US FDA 510(k) cleared revyve Antimicrobial Wound Gel For the clinical series, Kane engaged wound care and burn specialists in the U.S. Data is anticipated to be...Read more
Gemini normalized the inflammatory response at the cellular level in stage 3 and 4 CKD patients Gemini could potentially revolutionize the treatment of acute and chronic inflammatory disease Data discussion webcast/conference call will be held at 8:30 am Eastern Time SAN DIEGO, CA / ACCESS Newswire / September 10, 2025 / Revelation Biosciences, Inc. (NASDAQ:REVB) (the "Company" or "Revelation"), a clinical-stage life...Read more
A Phase 2 study for NT219 in combination with immunotherapy is being conducted in collaboration with the University of Colorado REHOVOT, Israel, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. (“Purple Biotech” or “the Company”) (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, today announced that the Examining Division of the...Read more
Type 2 diabetes (T2DM), affecting more than 530 million worldwide, is a metabolic disease often coupled with cardiovascular complications including coronary artery disease, heart failure, and stroke. Cardiovascular complications are a leading cause of disability and death in people with T2DM. People with T2DM are 2 to 4 times more likely to experience cardiovascular events than people without T2DM, and post-event outcomes are often...Read more
CRANFORD, N.J., Sept. 10, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced the closing of its previously announced registered direct offering and concurrent private placement of an...Read more
Late-breaking data from exploratory analyses at WCLC show Libtayo plus chemotherapy demonstrates a more than double five-year overall survival rate of 19.4%, compared to 8.8% with chemotherapy alone In a five-year analysis, consistent efficacy was observed across histologies with especially notable benefit in the squamous patient population where median overall survival was 22.3 months TARRYTOWN, N.Y., Sept. 09, 2025 (GLOBE...Read more
Pivotal Phase 3 REVEAL study enrollment on track to complete in 2026 CARLSBAD, Calif. / Sep 09, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ION582 for the treatment of Angelman syndrome (AS), a rare neurological disease that often presents in infancy and is characterized by profound intellectual...Read more
Modeyso, the first treatment option for this ultra-rare and aggressive brain tumor, is commercially available in the United States For U.S. media and investors only DUBLIN, Sept. 9, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that Modeyso™ (dordaviprone) is recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 2A...Read more
ZUG, Switzerland and BOSTON, Sept. 09, 2025 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced that a late-breaking oral presentation highlighting the Company's Phase 1 clinical data of its investigational CRISPR/Cas9 in vivo gene editing therapy, CTX310™, targeting angiopoietin-related protein 3 (ANGPTL3) for...Read more
Studies leverage company’s Afirma Genomic Resource for Intelligent Discovery (GRID), world’s largest molecular database for thyroid nodules SOUTH SAN FRANCISCO, Calif. / Sep 09, 2025 / Business Wire / Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that 12 Afirma-related abstracts will be presented at the 2025 American Thyroid Association Annual Meeting, taking place September 10-14 at the Westin...Read more
MINNEAPOLIS, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (“Celcuity”), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it has entered into an amendment to its existing senior secured credit facility with an affiliate of Innovatus Capital Partners, LLC (“Innovatus”) and Oxford Finance LLC, and its affiliates (together, “Oxford”). The amendment increases the total...Read more
HAMPTON, N.J., Sept. 09, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced that management will participate in a fireside chat today, September 9th, 2025, at the Morgan Stanley 23rd Annual Global Healthcare Conference at 3:20 pm ET. A live webcast of the presentation will be available on the "Events & Presentations” page of the "Investors" section of the Celldex website. A replay will be available...Read more
Novartis to acquire Tourmaline Bio for $48.00 per share in cash for a total equity value of approximately $1.4 billion Transaction reflects the potential of Tourmaline’s pacibekitug, a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential, for the treatment of cardiovascular diseases Transaction is expected to be completed in the fourth quarter of 2025, subject to customary closing...Read more
CAMBRIDGE, Mass. / Sep 09, 2025 / Business Wire / Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced that it has commenced an underwritten public offering of shares of its common stock. All of the shares of common stock are being offered by Amylyx. In addition, Amylyx intends to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount up to 15% of the shares...Read more
SAN FRANCISCO, Sept. 9, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) announced today that it will present results from the ongoing REZOLVE-AD Phase 2b study at the 2025 European Academy of Dermatology and Venereology (EADV) Congress being held in Paris, France from September 17-20, 2025. The presentation will include Phase 2b results on the primary and secondary endpoints from the 16-week induction phase of the...Read more
New clinical Precision Medicine population 48-week data demonstrates unprecedented cognitive stabilization in early Alzheimer’s disease Cognitive outcomes observed in the oral blarcamesine 30 mg Precision Medicine cohort move toward normal aging profiles across validated clinical scales, supporting its relevance in early-stage Alzheimer’s care 84.7% reduction in decline at 48 weeks of blarcamesine treatment vs placebo on the primary...Read more
Updated efficacy and safety data to be presented from the REZILIENT1 trial of zipalertinib from the cohort of patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who were previously treated with amivantamab Preliminary clinical efficacy and safety data to be presented from the cohort of patients with uncommon non-ex20ins EGFR mutations in the...Read more
Late Breaking Abstract to Present Additional Data from Aclaris’ Phase 2a Trial of ATI-2138 in Atopic Dermatitis WAYNE, Pa., Sept. 09, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that a late-breaking abstract on its open-label Phase 2a trial of ATI-2138, a potent and...Read more
LEXINGTON, Mass. / Sep 09, 2025 / Business Wire / Agenus Inc. (Nasdaq: AGEN), a leader in immuno‑oncology, today announced its investigational combination botensilimab plus balstilimab (BOT/BAL) is now available to eligible patients with refractory microsatellite‑stable (MSS) metastatic colorectal cancer (mCRC) under France’s compassionate access (Accès compassionnel, or AAC) framework. The French National Agency of Medicines and Health...Read more
CHICAGO and FORT WORTH, Texas, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced that it intends to offer and sell shares of its common stock in an underwritten...Read more
Independent prospective analysis validates theta-band inter-trial coherence (ITC) as an important, objective measure to distinguish patients with schizophrenia from healthy individuals A statistically significant correlation was observed between theta ITC and cognitive performance Theta ITC demonstrated greater case-control difference as compared to traditional schizophrenia EEG measures, marking an independent replication...Read more
SOUTH SAN FRANCISCO, Calif. / Sep 09, 2025 / Business Wire / Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced that President and Chief Executive Officer, Shawn Singh, will participate in a fireside chat at the TD Cowen 5th Annual Novel Mechanisms in...Read more
Fifth U.S. Patent Directed to Use of Vidofludimus Calcium in Multiple Sclerosis Comprehensive Intellectual Property Strategy Secures Protection Into 2041 in the U.S., Unless Extended Further NEW YORK, Sept. 9, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases,...Read more
Transaction structured to provide flexible funding to support Phase 1b registrational clinical study program in advanced Parkinson’s under the 505(b)(2) NDA pathway Evaluating complementary funding including strategic equity and non-dilutive alternatives HUNTSVILLE, AL, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ...Read more
New preclinical findings highlight Telomir-1's ability to reverse CDKN2A gene silencing by DNA methylation, reactivating this gene - often called the body's natural "cell cycle brake." These results build on prior STAT1 data, supporting Telomir-1's profile as a potential first-in-class broad-spectrum DNA methylation reset therapy. MIAMI, FLORIDA / ACCESS Newswire / September 9, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), a...Read more
Proprietary safety intelligence creates dual value: faster therapeutic development and biodefense. LOS ANGELES, CALIFORNIA / ACCESS Newswire / September 9, 2025 / Lunai Bioworks Inc. (NASDAQ:RENB), an AI-powered drug discovery and biodefense company, today announced the launch of a transformer-based platform that embeds biological risk intelligence directly into large language model (LLM) pipelines. This breakthrough uses virtual...Read more
| Company | Change | Last Trade |
|---|---|---|
| Bolt Biotherapeutics | 4.62 825.00 | $5.18 |
| Avidity Biosciences | 3.70 9.02 | $44.74 |
| Spruce Biosciences | 3.60 40.45 | $12.50 |
| SIGA Technologies | 2.74 44.34 | $8.92 |
| HCW Biologics | 2.13 64.16 | $5.45 |
| Sonnet BioTherapeutics | 1.89 47.73 | $5.85 |
| Kala Bio | 1.62 9.53 | $18.62 |
| Monopar Therapeutics | 1.55 3.25 | $49.22 |
| Nektar Therapeutics | 1.48 3.14 | $48.68 |
| Quantum BioPharma | 1.21 7.55 | $17.23 |
| NexImmune | 1.01 504,900.00 | $1.01 |
| Belite Bio | 0.93 1.36 | $69.48 |
| MBX Biosciences | 0.90 9.06 | $10.83 |
| LIXTE Biotechnology | 0.87 16.49 | $6.14 |
| Entero Therapeutics | 0.85 36.96 | $3.15 |
Recursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets...
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Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by rare and niche allergic and immunological diseases. Our lead program, STAR-0215, is a monoclonal antibody inhibitor of plasma kallikrein in clinical development...
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