Unprecedented Phase 1 CML efficacy data and potential best-in-disease profile of TERN-701 featured in ASH 2025 abstract Upcoming ASH oral presentation to feature expanded and updated dataset from CARDINAL trial Cash, cash equivalents and marketable securities of $295 million, expected to provide runway into 2028 FOSTER CITY, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”)...Read more
SAN DIEGO, Nov. 10, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that its Phase 2 study evaluating the efficacy, safety and tolerability of investigational compound NBI-1070770 in adults with major depressive disorder did not meet the primary endpoint compared to placebo. NBI-1070770 was generally well tolerated This Phase 2 signal-seeking study enrolled 73 adult patients with a diagnosis of major...Read more
BASEL, Switzerland and LONDON and NEW YORK, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the second quarter ended September 30, 2025, and provided a business update. Brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints in Phase 3 VALOR study in...Read more
Rezdiffra® treatment significantly improved liver stiffness, fibrosis biomarkers, and markers of clinically significant portal hypertension risk in patients with compensated MASH cirrhosis Rezdiffra also improved disease-specific quality of life measures in patients with and without cirrhosis, with sustained effect through two years of treatment New analysis examining effects of Rezdiffra treatment interruption underscores the need...Read more
Announced Novartis agreement to acquire Avidity for total equity value of approximately $12 billion; Avidity expects to separate its early-stage precision cardiology programs into a new public company ("SpinCo") Clear path forward aligned with FDA following pre-BLA meeting for del-zota, with BLA submission planned for 2026 Del-zota one-year data demonstrated sustained muscle protection leading to meaningful improvement and reversal...Read more
Three Late Breaking Science Presentations from MAPLE-HCM Provide Additional Data Including Responder Analyses, Patient Reported Outcomes, and Cardiac Biomarkers SOUTH SAN FRANCISCO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM) were presented in three...Read more
Phase 3 TRANSCEND trial data showed setmelanotide achieved significant BMI reductions in patients with acquired hypothalamic obesity on concomitant treatment with GLP-1 therapy Analysis of data from Phase 3 TRANSCEND trial show clinically meaningful changes in cardiometabolic parameters in patients with acquired hypothalamic obesity treated with setmelanotide for 52 weeks BOSTON, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Rhythm...Read more
Positive Phase 1 data for CTX310® presented in a late-breaking presentation at the American Heart Association (AHA) Scientific Sessions and simultaneously published in The New England Journal of Medicine CASGEVY® momentum accelerating; nearly 300 patients have been referred to Authorized Treatment Centers (ATCs), approximately 165 patients have completed their first cell collection and 39 have received infusions across all regions;...Read more
16.5 months median progression free survival (mPFS) for bezuclastinib plus sunitinib compared to 9.2 months mPFS for sunitinib monotherapy (HR=0.50, CI: 0.39-0.65; p<0.0001) 46% Objective Response Rate (ORR) reported for bezuclastinib combination compared to 26% ORR for sunitinib monotherapy (p<0.0001) Safety profile of bezuclastinib combination was well tolerated with no unique risks observed with the combination when compared...Read more
Completed enrollment with 530 subjects in the pivotal phase 3 PHOENIX trial in geographic atrophy (GA) Completed $15 million registered direct offering and $125 million private placement with potential for up to an additional $165 million upon full warrant exercise Completed pivotal phase 3 DRAGON trial in Stargardt disease (STGD); final topline data expected in Q4 2025 China’s NMPA has agreed to accept New Drug Application with...Read more
Study in uncontrolled Graves’ disease (GD) patients treated for 24 weeks showed first-ever potentially disease-modifying outcome with six-month off-treatment data IMVT-1402 development is progressing with potentially registrational studies in GD, myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), difficult-to-treat rheumatoid arthritis (D2T RA) and Sjögren’s disease (SjD) remains on track Immunovant...Read more
Submission of New Drug Application (NDA) for lorundrostat planned for late-2025/Q1 2026 Completed enrollment in Explore-OSA trial; topline results anticipated in Q1 2026 Conference call today at 4:30 p.m. ET RADNOR, Pa., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related...Read more
Interim Phase 1 results for APG333 exceeded trial objectives, demonstrated a half-life of approximately 55 days, and suppressed key biomarkers for 6 months following a single dose, supporting potential 3- and 6- month dosing Results support development of a quarterly or less frequently dosed co-formulation of APG273 (APG777+APG333) for respiratory indications APG333 was well tolerated across all cohorts with doses of up to 1,000 mg...Read more
Pipeline programs continue to advance, with four clinical data readouts anticipated in 2026; APG777 trial readout timelines accelerated, with Phase 1b in asthma and APEX 52-week Part A data in AD anticipated in Q1 2026, APEX 16-week Part B data in AD in Q2 2026, and APG279 Phase 1b head-to-head readout against DUPIXENT in AD in 2H 2026 Interim Phase 1 results of APG333 in healthy volunteers reported today exceeded trial objectives,...Read more
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & GAITHERSBURG, Md., US, November 10, 2025) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today announced management will participate at the...Read more
MannKind has made the decision to discontinue the ICoN-1 Phase 3 clinical trial evaluating nebulized clofazimine inhalation suspension for nontuberculous mycobacterial (NTM) lung disease, following a futility determination based on medical monitoring data This outcome does not impact the development of MNKD-102, MannKind’s dry powder inhalation (DPI) formulation of clofazimine, which remains under consideration for future clinical...Read more
Announced pivotal topline data from Phase I/II study of AMT-130 in Huntington’s disease met its primary and key secondary endpoints, demonstrating statistically significant slowing of disease progression at 36 months and supportive trends across key clinical and biomarker endpoints Preliminary feedback from FDA at a recent pre-Biologics License Application (BLA) meeting for AMT-130 indicated a key shift from prior regulatory...Read more
Strong execution and continued progress across pipeline Positive Phase 2 barzolvolimab data in Chronic Spontaneous Urticaria (CSU) demonstrating rapid, profound improvement in UCT7 scores with sustained disease control post treatment and strong efficacy regardless of baseline IgE levels Positive Phase 2 barzolvolimab data in Cold Urticaria (ColdU) and Symptomatic Dermographism (SD) demonstrating sustained efficacy and favorable...Read more
Open-label prophylaxis data supporting the long-term safety profile and sustained benefits of deucrictibant, as well as clinical validation data of a kinin biomarker assay were highlighted in two oral presentations Final data from participants in the open-label portion of the CHAPTER-1 study provide further evidence of a well-tolerated safety profile for up to approximately 34 months and an average of 92.4% attack reduction from study...Read more
Dr. Dansey, formerly of Pfizer and Seagen, strengthens the Board’s research, drug development and commercialization expertise SAN FRANCISCO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines in oncology and autoimmune diseases, today announced the appointment of...Read more
VANCOUVER, British Columbia / Nov 10, 2025 / Business Wire / AbCellera (Nasdaq: ABCL) today announced the appointment of Stephen Quake, D.Phil., to its Board of Directors as an independent director. Dr. Quake is a distinguished scientist, inventor, and entrepreneur who has made foundational contributions across diverse fields, including single molecule biophysics, microfluidics, single cell analysis, genomics, molecular diagnostics, and...Read more
A 12 mg dose of BPL-003 (mebufotenin benzoate nasal spray) administered eight weeks after an initial 12 mg, 8 mg or 0.3 mg dose in the core study of the Phase 2b clinical trial produced additional rapid, clinically meaningful antidepressant effects that were sustained for up to eight weeks Patients who received an active dose of BPL-003 in the core study of the Phase 2b clinical trial (either 8 mg or 12 mg) met response and remission...Read more
WVE-007, an INHBE GalNAc-siRNA for obesity designed to drive fat loss while preserving muscle mass, achieved dose-dependent, mean reductions of Activin E of up to 85% in INLIGHT clinical trial, exceeding levels that led to weight loss and prevention of rebound weight gain following cessation of GLP-1 in preclinical models Activin E reduction in lowest single dose cohort of INLIGHT was sustained through six months, supporting once...Read more
One-time treatment of nex-z led to consistently rapid, deep and durable reduction in serum TTR through three years of follow-up Consistent trend in disease stability or improvement in multiple measures of cardiomyopathy, regardless of NYHA Class, at 24 months compared to baseline Longer-term safety data consistent with previously reported Phase 1 data CAMBRIDGE, Mass., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc....Read more
Three-year follow-up data from FIREFLY-1 demonstrates durable responses with evidence of clinical stability off treatment, with the potential for retreatment after progression Treatment-free interval data to also be disclosed for the first time BRISBANE, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a biopharmaceutical company dedicated to developing and...Read more
Oculis accelerates its portfolio development with Privosegtor moving into the PIONEER pivotal program in Acute Optic Neuritis (AON) and Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) following positive FDA meeting OCS-01 DIAMOND Phase 3 trials in diabetic macular edema (DME) remain on track for topline results expected in Q2 2026 Licaminlimab PREDICT-1 registrational trial, the first genotype-based trial to drive precision...Read more
Rosnilimab was safe and well tolerated with similar adverse event rates vs. placebo Observed expected pharmacology, including ~90% depletion of pathogenic T cells, however lack of adequate efficacy at Week 12 does not support further development of rosnilimab in UC and trial will be discontinued, resulting in at least $10 million in savings Will provide update in H1 2026 on advancement of rosnilimab in RA, which would be funded by...Read more
$32.5 million in revenue, including $31.3 million in neffy U.S. net product revenue in third quarter of 2025 Continued U.S. product growth driven by direct-to-consumer (DTC) investments and real-world evidence, expected to accelerate with seamless prescribing experience Strong balance sheet of $288.2 million cash, cash equivalents and short-term investments anticipated to fund operations through cash-flow break-even Conference...Read more
NEW HAVEN, Conn., Nov. 10, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today reported financial results for the third quarter ended September 30, 2025, and provided a review of recent accomplishments and anticipated...Read more
SEP-479 Selected as Next-Generation Oral PTH1R Agonist Development Candidate SEP-631 (MRGPRX2 NAM) Phase 1 Clinical Trial in Healthy Volunteers Ongoing Robust Financial Position of $561.6 Million Expected to Support Operations at Least into 2029 SOUTH SAN FRANCISCO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor...Read more
FREMONT, Calif. / Nov 10, 2025 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced Medicare coverage of its ultrasensitive NeXT Personal® test for surveillance of cancer recurrence in breast cancer patients. This milestone marks an important step forward in cancer surveillance, offering a powerful tool for doctors and breast cancer patients. Medicare beneficiaries with...Read more
Granted FDA Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab in 1L HPV-negative R/M HNSCC Data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly in combination with pembrolizumab in 1L HPV-negative R/M HNSCC patients expected at ESMO Asia 2025 Strong financial position with approximately $408 million in cash, cash equivalents, and investments as of September 30, 2025...Read more
YUPELRI® net sales reached an all-time high of $71.4 million, recognized by Viatris, up 15% year-over-year1, and achieved record brand profitability Open-label portion of the pivotal Phase 3 CYPRESS study of ampreloxetine now complete; topline readout on track for Q1 2026 Company to host an ampreloxetine focused virtual Key Opinion Leader (KOL) event for investors on December 8, 2025 TRELEGY year-to-date sales on track to...Read more
Final Phase 1b results presented at World Lung Conference highlight the potential of firmonertinib to address unmet needs in EGFR PACC mutant NSCLC Received FDA IND clearance for ARR-217, a CDH-17 targeted ADC, with ongoing Phase 1 study in China Establised commercial leadership within excutive team with appointment of Brent S. Rice as Chief Commercial Officer Cash and investments of $305.4 million as of September 30, 2025 expected...Read more
LONDON and NEW YORK, Nov. 10, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced a broad strategic collaboration in the area of ophthalmology with Eli Lilly and Company (“Lilly”). MeiraGTx will grant Lilly worldwide exclusive rights to its AAV-AIPL1 program for treatment of one of the most severe inherited retinopathies, Leber...Read more
Analysis of Patients from CLEAR Outcomes Receiving No Other Background Lipid Lowering Therapies, Bempedoic Acid Alone Reduced MACE-4 by 14% Compared to Placebo An Exploratory Analysis of CLEAR Outcomes Reports Patients Who Took Bempedoic Acid Were 42% Less Likely to Experience Venous Thromboembolism Events Compared to Placebo ANN ARBOR, Mich., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the...Read more
Announced new clinical trial agreement with Pfizer to evaluate palazestrant in combination with atirmociclib in ER+/HER2- metastatic breast cancer Initiated OPERA-02 Phase 3 trial of palazestrant in combination with ribociclib in frontline ER+/HER2- metastatic breast cancer Presented compelling new data from Phase 1b/2 study of palazestrant plus ribociclib at ESMO 2025 Ended the quarter with $329.0 million in cash, cash equivalents,...Read more
Released positive Phase 1b interim results for long-acting helicase-primase inhibitor candidate ABI-5366 showing significant reductions in viral shedding rate and genital lesion rate in recurrent genital herpes Announced Phase 1a interim results for orally bioavailable HDV entry inhibitor candidate ABI-6250 supporting progression into Phase 2 evaluation Additional interim Phase 1b data readouts from HSV program anticipated to...Read more
Entered strategic partnership with Otsuka Pharmaceutical Co., Ltd. for the development and commercialization of 4D-150 in the APAC region; to receive $85 million in upfront cash and expects to receive at least $50 million from cost sharing Announced positive long-term safety and efficacy data with 1.5 to 2 years of follow-up from the Phase 1/2 PRISM clinical trial in wet AMD Completed equity offering providing net proceeds...Read more
Continued progress across LOTIS-7 with updated data anticipated in 2025 and LOTIS-5 with topline data expected in 1H 2026 Updated data from Phase 2 IIT of ZYNLONTA® plus rituximab in patients with r/r follicular lymphoma presented at the 22nd International Workshop on Non-Hodgkin Lymphoma Recent financing supports expansion of ZYNLONTA in anticipation of 2L+ DLBCL launch with strengthened balance sheet relative to previously...Read more
Vafseo® (vadadustat) Q3 2025 net product revenues grew to $14.3 million; Q3 2025 total net product revenues were $56.8 million Operational pilot of Vafseo at DaVita expected to complete in the fourth quarter; Access for 275,000 total patients across customer base expected by year-end Vadadustat post-hoc data analysis presented at ASN Kidney Week demonstrates composite of all-cause mortality and hospitalization outcomes...Read more
Full results from the Phase 2 REGEN-007 study of rilparencel were recently presented as a late-breaking clinical trial at the American Society of Nephrology (ASN) Kidney Week 2025More than half of the patients required for the Phase 3 REGEN-006 (PROACT 1) accelerated approval analysis using estimated glomerular filtration rate (eGFR) slope have been enrolled; topline results anticipated in Q2 2027Ended the third quarter with $272 million in...Read more
LYL273 has demonstrated a 67% overall response rate, an 83% disease control rate, and a manageable safety profile at the highest dose level studied to date in patients with refractory metastatic colorectal cancer enrolled in an ongoing U.S. Phase 1 clinical trial LYL273 is a GCC-targeted CAR T-cell product candidate armed with enhancements designed to improve CAR T-cell expansion and cancer cell killing Lyell management will host an...Read more
New biomarker analyses from the NAVIGATE trial demonstrated consistent antifibrotic effects of belapectin 2 mg/kg Using established criteria for clinically meaningful worsening, a lower proportion of patients treated with belapectin 2 mg/kg experienced ≥30% or ≥5 kPa increases in liver stiffness (LSM) by FibroScan® compared with placebo, indicating slowing of fibrosis progression and stabilization of liver function Across all ELF...Read more
Late-Stage Neuroinflammation Platform Advancing Global Registrational Programs in Guillain-Barré Syndrome (GBS) and Geographic Atrophy (GA) Current Tanruprubart GBS Dossier On Track for MAA Filing in January 2026; Potential to Be the First Approved Targeted and Fast-Acting Therapy for the Treatment of GBS; Continued FDA Discussions Regarding Generalizability Package in Support of BLA Filing Topline ARCHER II Pivotal Data for...Read more
Data from Phase 3 Orbit and Cosmic studies of setrusumab in osteogenesis imperfecta on-track for around the end of 2025 Cash of $48.7 million as of September 30, 2025, expected to support operations into 2027 LONDON, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today announced its financial results for...Read more
EMERYVILLE, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Kyverna, Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced that Warner Biddle, Chief Executive Officer of Kyverna, will present at the Jefferies Global Healthcare Conference in London, United Kingdom on Monday, November 17, 2025 at 1:00 p.m. GMT. A live...Read more
A secondary analysis of FASCINATE-2 Phase 2 trial demonstrated denifanstat improved fibrosis, inflammation and steatosis in advanced qF4 MASH patients as measured by artificial intelligence (AI) digital pathology In a second poster, spatial computational histology relying on baseline fibrosis features was used to predict response to denifanstat SAN MATEO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq:...Read more
Topline results from pivotal HOPE-3 Phase 3 study (n=105) of Deramiocel for the treatment of Duchenne muscular dystrophy expected in the coming weeks (Q4 2025) Pending the results of the topline data from the HOPE-3 study, the Company expects to resubmit its BLA, leveraging the data in support of its application for approval Commercial launch preparations underway to support potential approval and market introduction of Deramiocel in...Read more
The ATEV™ was observed to have superior duration of use over 24 months compared to autogenous fistula in high-need subgroups with historically poor outcomes with AV fistula procedures The significantly longer duration of ATEV use in these high-need patients could greatly reduce reliance on catheters for dialysis access, a major cause of complications, morbidity and cost in dialysis patients DURHAM, N.C., Nov. 10, 2025...Read more
Encouraging CF interim Phase 2 data support continued and expanded trial design 12-week safety and preliminary efficacy study in up to 20 CF participants planned to start H1 2026 Additional cost reductions planned in fourth quarter to extend cash runway Investor conference call at 4:30 p.m. ET today SAN DIEGO / Nov 10, 2025 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial...Read more
CAMBRIDGE, United Kingdom and LEXINGTON, Mass., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Transition Bio, a drug discovery company focused on unlocking traditionally “undruggable” targets by leveraging biomolecular condensates, and Voyager Therapeutics (Nasdaq: VYGR), a biotechnology company dedicated to leveraging genetics to treat neurological diseases, have entered into a drug discovery collaboration and license option agreement. The companies...Read more
Momentum building around tau: expect VY7523 clinical data and VY1706 clinical entry in 2026 Sharpened focus on multi-modality pipeline with introduction of Voyager NeuroShuttle™ discovery program and small molecule collaboration Ended 3Q25 with cash position of $229 million, maintaining runway into 2028 LEXINGTON, Mass., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology...Read more
Presentation of MyPEAK-1 Data and the American Heart Association Scientific Sessions Showed Consistent, Deeper, and Durable Improvement in Measures of Hypertrophy for Cohort 1 Patients Initial TN-201 Cohort 2 Data Demonstrated Early Dose Responsive Increases in TN-201 Transduction and MyBP-C Protein Expression Completed Dosing in Cohort 2 of RIDGE™-1 Trial of TN-401 for PKP2-associated ARVC; Cohort 1 Data On Track for Fourth Quarter...Read more
In vivo preclinical proof-of-concept data presented at AHA and ESGCT demonstrating >90% LDL-C reduction in non-human primates supports EDIT-401’s potential as a best-in-class, one-time therapy Company on track to submit IND/CTA for EDIT-401 by mid-2026 and achieve initial human proof-of-concept data by year-end 2026 Extended cash runway into the third quarter of 2027, enabling progression of EDIT-401 beyond initial human...Read more
LOS ANGELES, Nov. 10, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced that its state-of-the-art current Good Manufacturing Practice ("cGMP") manufacturing...Read more
Rese-cel data presented at multiple medical meetings demonstrated potentially transformative, drug-free clinical responses with a favorable safety profile for autoimmune patients supporting outpatient use All myositis patients in the Phase 1/2 DM/ASyS cohort with sufficient follow-up who would have met key criteria for the registrational cohort met the registrational, 16-week primary endpoint Planned BLA submission for rese-cel in...Read more
The planned confirmatory Phase 3 trial, TELLOMAK 3, aims to demonstrate efficacy of lacutamab in patients with Sézary syndrome (SS) and Mycosis fungoides (MF), who failed at least one prior line of systemic therapy. The Company submitted the confirmatory Phase 3 TELLOMAK 3 protocol to the FDA, which completed its review with no further comments, clearing the study to proceed. The Company is progressing towards the initiation of the...Read more
Secured $147.6 million in proceeds and committed capital following completion of strategic transactions and concurrent public and private equity offerings, led by $71.6 million in committed capital from Medtronic and Ligand, as well as $30 million from TerumoInitiated patient enrollments in the Virtue Trial evaluating Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) trial versus commercially available paclitaxel-coated balloon...Read more
Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia set to launch in November Tonmya is the first new FDA-approved medicine for fibromyalgia in more than 15 years Cash and cash equivalents of $190.1 million reported as of September 30, 2025; current cash runway expected to fund operations into the first quarter of 2027 CHATHAM, N.J., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp....Read more
Results from an interim analysis in the Phase 2 STARBORN-1 trial of TARA-002 in pediatric LMs patients remain on track for 4Q 2025 Expect to present interim analysis from approximately 25 six-month evaluable BCG-Unresponsive NMIBC patients in the ongoing ADVANCED-2 trial in 1Q 2026 Dosing of first patient in THRIVE-3 registrational trial of IV Choline Chloride in patients dependent on parenteral support now expected by year-end...Read more
COM701 Phase 1 data presented at ESMO 2025 characterized patients who derived clinical benefit and informed the design of the ongoing MAIA-ovarian platform trial Enrolling patients in the U.S., Israel and France in the MAIA-ovarian platform trial evaluating COM701 maintenance therapy in patients with platinum sensitive ovarian cancer with interim analysis now estimated in Q1 2027 SITC 2025 – Compugen presented Phase 1 trial design for...Read more
Enrollment now underway in second dose-escalation cohort Deep B-cell depletion observed in all patients treated to date who received NKX019 with lymphodepletion using fludarabine and cyclophosphamide versus partial B-cell depletion in patients receiving only cyclophosphamide Enrollment streamlined across Ntrust-1 and Ntrust-2 under a combined independent Data Safety Monitoring Board (iDSMB) to guide dose escalation Initial...Read more
France grants reimbursed access with patients having commenced treatment Two-year BOT/BAL survival presented at ESMO spanning more than five cancers in over 400 patients Phase 3 on track to commence in fourth quarter 2025 LEXINGTON, Mass. / Nov 10, 2025 / Business Wire / Agenus Inc. (Nasdaq: AGEN) today reported quarterly results for the period ended September 30, 2025, and provided a business update. Highlights include...Read more
BOSTON, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Vor Biopharma Inc. (Nasdaq: VOR) (Vor Bio), a clinical-stage biotechnology company dedicated to transforming the treatment of autoimmune diseases, today announced that it has commenced an underwritten public offering of $100 million of shares of its common stock. In addition, Vor Bio intends to grant the underwriters a 30-day option to purchase up to an additional $15 million of shares of its...Read more
NEWTON, Mass., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS) (“Acumen” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics that target toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced George Golumbeski, Ph.D., has joined its Board of Directors as Chairman. Dr. Golumbeski brings more than 30 years of experience...Read more
Completed rolling Biologics License Application (BLA) submission seeking accelerated approval for lead candidate INO-3107; requested priority review Expect to receive file acceptance by year end 2025 with potential PDUFA date in mid-2026 if request for priority review granted Commercial preparations continuing for potential launch in mid-2026 if INO-3107 is approved by FDA Results from Phase 1 proof-of-concept trial evaluating...Read more
Phase 2a data support oral C5aR inhibitor INF904 as a potentially transformational and best-in-class immunomodulatory agent, indicating strong potential for efficacy and no safety signals of concern In HS, over 4 weeks of therapy, InflaRx observed rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs), robust HiSCR responses that continued to deepen four weeks after the treatment period,...Read more
DENALI Phase 2 trial evaluating azenosertib in patients with Cyclin E1-positive PROC remains on track with topline data anticipated by year end 2026, with the potential to support an accelerated approval, subject to FDA feedback $280.7 million cash, cash equivalents and marketable securities supports runway into late 2027 SAN DIEGO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage...Read more
No safety concerns identified by independent data and safety monitoring board, which recommends continuation of study without any modifications SOUTH SAN FRANCISCO, Calif. / Nov 10, 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 the positive outcome of its pre-planned...Read more
SAN DIEGO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will present at the Piper Sandler 37th Annual Healthcare Conference, which is scheduled to take place December 2 – 4,...Read more
TORONTO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today it has arranged a non-brokered private placement offering of 480,769 common shares priced at $1.04 per common share (the “Common Shares”) for gross proceeds of $500,000 CAD (the “Offering”). The proceeds of the Offering will be used by Arch as general working capital and for certain operating...Read more
Data highlights symptom stability and enhanced efficacy signals in higher dose group Analysis offers valuable insights to guide ongoing development and planning of Phase 3 MELBOURNE, Australia and SAN FRANCISCO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative...Read more
Granted Breakthrough Therapy Designation for Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for the Treatment of Sanfillipo Syndrome Type B (MPS IIIB) Biologics License Application Submission of TA-ERT for the Treatment of MPS IIIB on Track for the First Quarter of 2026 Completed $50.0 Million Private Placement Financing Backed by Dedicated Healthcare Investors SOUTH SAN FRANCISCO, Calif. / Nov 10, 2025 / Business Wire /...Read more
Aligned with U.S Food and Drug Administration (FDA) on design of planned Phase 3 clinical trial of neflamapimod in patients with dementia with Lewy bodies (DLB) Reported 32-week data from Phase 2b RewinD-LB trial showing neflamapimod treatment in patients with DLB had a durable beneficial effect on clinical progression and resulted in substantial reductions in plasma levels of a well-established biomarker of neurodegeneration Meeting...Read more
ONE-D is the first reported protocol to achieve remission from treatment-resistant depression with a single day of treatment, using an FDA-cleared device. HOPE is one of the first Ampa deployments nationwide and is now deployed at multiple HOPE locations in Florida, including Naples, Fort Myers, and Sarasota, with six locations planned by year-end 2025. HOPE Medical Director, Rebecca Cohen, MD, is first Ampa-certified psychiatrist in...Read more
Patent covers brilaroxazine use for treating Pulmonary Fibrosis Similar patents have also been granted in key markets around the world including the United States, China, and Japan Brilaroxazine has a novel mechanism of action for treating the underlying disruption in serotonin signaling implicated in the pathogenesis of Pulmonary Fibrosis CUPERTINO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc....Read more
REDWOOD CITY, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today reported results for the fiscal quarter ended September 30, 2025 and...Read more
On track to submit GraftAssureDx™ for FDA review by year-end On track for commitment to have 20 transplant centers globally engaged with GraftAssure technology by end of 2025 GraftAssure assay’s head-to-head data continue to be favorable Preparing to rapidly expand beyond kidney into heart transplant testing NASHVILLE, Tenn., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Insight Molecular Diagnostics Inc., or iMDx, (Nasdaq: IMDX), today...Read more
Translational study shows that multiple immunological biomarkers predict the clinical activity of PDS0101 combination therapy PDS01ADC reprograms natural killer (NK) cells to possess characteristics that make them more active in killing cancer cells PDS01ADC promotes stem cell-like killer T cells and memory T cells that self-replicate and are therefore capable of potent and long-lasting anti-tumor activity PRINCETON, N.J.,...Read more
Completed the sale of FibroGen China to AstraZeneca for approximately $220 million Initiated the Phase 2 monotherapy trial of FG-3246, a potential first-in-class antibody-drug conjugate (ADC) targeting CD46 in metastatic castration-resistant prostate cancer (mCRPC) Reached agreement with the U.S. Food and Drug Administration (FDA) on important design elements for the pivotal Phase 3 trial for roxadustat for the treatment of anemia in...Read more
Topline nimacimab Phase 2a study data showed clinically meaningful weight loss in nimacimab/semaglutide combination cohort versus semaglutide alone after 26 weeks of treatment; the data demonstrated a clean neuropsychiatric safety profile and no increase in gastrointestinal adverse events. Nimacimab plus semaglutide showed additional reduction in waist circumference of -3.2 cm vs. semaglutide alone. Rebound weight gain was lower in...Read more
Treatment with Auxora significantly reduced IL-17–related inflammation in both kidney and lung, significantly increased glomerular filtration rate (GFR), and decreased renal injury in a rat model of AKI Findings reinforce the mechanistic rationale for Auxora as a potential treatment for severe AKI with respiratory failure, currently being evaluated in the Phase 2 KOURAGE trial LA JOLLA, Calif., Nov. 10, 2025 /PRNewswire/ --...Read more
UTRECHT, The Netherlands and PHILADELPHIA, Nov. 10, 2025 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (“LAVA”) (NASDAQ: LVTX) today announced a reminder to LAVA shareholders related to the proposed transaction with XOMA Royalty Corporation (“XOMA”) (NASDAQ: XOMA). On August 4, 2025, XOMA and LAVA announced they had entered into a share purchase agreement. More recently, on October 17, 2025, XOMA announced it had extended its offer (the...Read more
Oral presentation of 96-week treatment and post-treatment data suggest best-in-class potential of pevifoscorvir sodium SOUTH SAN FRANCISCO, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced positive data from eight presentations, including one...Read more
Exploratory Phase 2 analysis shows Verrica’s novel oncolytic peptide, VP-315, reprograms the tumor microenvironment, increasing cytotoxic T-cell infiltration and reducing immunosuppressive T-regulatory cells Findings provide mechanistic immunologic support for clinical efficacy previously reported, including 97% calculated objective response rate and 51% complete histologic clearance rate Coupled with VP-315’s previously...Read more
JUPITER, Fla. and DUBLIN, Nov. 10, 2025 (GLOBE NEWSWIRE) -- ERS Genomics Limited (‘ERS’), the CRISPR licensing company, and Dyadic Applied BioSolutions, a global biotechnology company producing precision-engineered, animal-free proteins and enzymes for diverse commercial applications, today announced a CRISPR/Cas9 license agreement. This agreement grants Dyadic access to ERS’ CRISPR/Cas9 patent portfolio, enhancing Dyadic’s ability to...Read more
SHELTON, CONNECTICUT / ACCESS Newswire / November 10, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") today reported that it has received approval to Start Phase II Clinical Trial of NV-387 for the Treatment of MPox by the Regulatory Agency ACOREP of the Democratic Republic of Congo (DRC). The proposed Phase II clinical trial to evaluate safety and effectiveness of NV-387 for the treatment of patients with MPox disease...Read more
PONTE VEDRA, Fla., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome current gaps in anticoagulation therapy, today reported its financial results for the third quarter ended September 30, 2025, and provided an update on the clinical development of tecarfarin and the acquisition and development of frunexian. Highlights Progressed...Read more
Actively enrolling Cohort 3 (FTD-GRN) and Cohort 4 (FTD-C9orf72) patients in ongoing upliFT-D study Aligned with the U.S. Food and Drug Administration (FDA) on an analytical approach to establish comparability of a high-productivity, suspension-based PBFT02 manufacturing process On track to obtain regulatory feedback on FTD-GRN registrational trial design in 1H 2026 Cash runway into 1Q 2027 PHILADELPHIA, Nov. 10, 2025 ...Read more
| Company | Change | Last Trade |
|---|---|---|
| Cogent Biosciences | 17.29 116.67 | $32.11 |
| argenx | 15.18 1.78 | $869.83 |
| Vertex Pharmaceuticals | 11.73 2.86 | $421.20 |
| Galecto | 11.35 229.29 | $16.30 |
| Ligand Pharmaceuticals | 6.81 3.36 | $209.29 |
| Madrigal Pharmaceuticals | 6.62 1.35 | $495.88 |
| Mineralys Therapeutics | 6.48 17.04 | $44.50 |
| United Therapeutics | 5.02 1.12 | $453.93 |
| Vera Therapeutics | 4.67 19.31 | $28.86 |
| Tarsus Pharmaceuticals | 4.54 6.65 | $72.79 |
| Bolt Biotherapeutics | 4.36 778.57 | $4.92 |
| Belite Bio | 4.15 3.67 | $117.34 |
| Protagonist Therapeutics | 3.69 4.64 | $83.23 |
| Monopar Therapeutics | 2.96 3.69 | $83.08 |
| Kymera Therapeutics | 2.60 4.43 | $61.26 |
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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Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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