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HUTCHMED and Innovent Jointly Announce that the FRUSICA-2 Phase II/III Study of Fruquintinib and Sintilimab Combination Has Met its Primary Endpoint in Advanced Renal Cell Carcinoma in China

March 18
Last Trade: 14.95 -0.19 -1.25

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 19, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) and Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), today jointly announce that the FRUSICA-2 Phase II/III clinical trial evaluating fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China has met its...Read more


Biofrontera Announces Completion of Patient Enrollment in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% for the Treatment of Actinic Keratoses on the Extremities, Neck and Trunk

March 18
Last Trade: 1.05 0.04 3.96

First US Phase 3 study of Photodynamic Therapy (PDT) to include neck, trunk and extremities Protocol involves one or two PDT treatments using 1-3 tubes of Ameluz® or vehicle gel over a surface area of up to 240 cm2 Treatment phase expected to be complete by Q3 2025 WOBURN, Mass., March 18, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the...Read more


Hoth Therapeutics Announces Positive Preclinical Results for HT-KIT in Aggressive Cancer Gastrointestinal Stromal Tumors (GIST). HT-KIT Triggered Significant Tumor Cell Death as Early as 24 Hours Post-treatment

March 18
Last Trade: 1.09 -0.08 -6.84

New Data Demonstrates Significant Reduction in Tumor Growth and KIT Expression in Preclinical GIST Models Induction of Tumor Cell Death – HT-KIT triggered significant tumor cell death as early as 24 hours post-treatment, while the lower dose led to delayed but substantial cell death at 72 hours. Decreased Tumor Cell Proliferation – HT-KIT treatment inhibited cell growth and proliferation in GIST-T1 cells, as confirmed by cell...Read more


Ocugen: Data and Safety Monitoring Board Reviews Cohort 1 Safety Data and Approves Dosing Cohort 2 in the Clinical Trial of OCU200—a Novel Fusion Protein for Diabetic Macular Edema

March 18
Last Trade: 0.52 -0.06 -9.88

OCU200 has a very favorable safety and tolerability profile No serious adverse events related to the study drug have been reported Dosing of the second cohort has been approved MALVERN, Pa., March 18, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Data and Safety Monitoring Board (DSMB) for the...Read more


Alzamend Neuro Announces Initiation Date of Phase II Clinical Trial of AL001 for Treatment of Major Depressive Disorder to take Place at Massachusetts General Hospital

March 18
Last Trade: 0.94 0.05 5.04

Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in MDD subjects ATLANTA, March 18, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder...Read more


Actinium Pharmaceuticals Announces Clinical Trial Program in Solid Tumors Combining Actimab-A with PD-1 Checkpoint Inhibitors KEYTRUDA® and OPDIVO®

March 18
Last Trade: 1.19 -0.11 -8.46

Trials are designed to demonstrate whether the addition of Actimab-A to either KEYTRUDA® or OPDIVO® can result in improved patient outcomes MDSCs – Myeloid Derived Suppressor Cells in the tumor microenvironment are believed to reduce effectiveness of PD-1 inhibitors like KEYTRUDA® and OPDIVO® Trials supported by preclinical data showing Actimab-A can selectively target and deplete MDSCs which express CD33 Clinical proof of concept...Read more


Indaptus Therapeutics Initiates Phase 1 Combination Study of Decoy20 with PD-1 Checkpoint Inhibitor Tislelizumab

March 18
Last Trade: 0.81 -0.0023 -0.28

NEW YORK, March 18, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical-stage biotechnology company dedicated to developing novel treatments for cancer and viral infections, today announced that it has advanced to a new expansion arm of its Phase 1b/2 clinical trial of Decoy20. This expansion will evaluate the combination of Decoy20 with BeiGene’s PD-1 checkpoint inhibitor, tislelizumab, with a focus on...Read more


Clearmind Medicine Announces Initiation of First in Human Clinical Trial with CMND-100 in Alcohol Use Disorder Patients

March 18
Last Trade: 1.14 0.00 0.00

Study represents the first clinical application of CMND-100, the Company’s proprietary drug platform Vancouver, Canada, March 18, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announces today that it initiated its...Read more


Virax Biolabs Enrolls First Patients in Clinical Study Assessing T cell Dysfunction in Post-acute Infection Syndromes

March 18
Last Trade: 1.26 -0.02 -1.56

LONDON, March 18, 2025 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company"), an innovative biotechnology company focused on the detection of immune responses and diagnosis of viral diseases, announced today that it has started enrolling patients into its United Kingdom based, multi-center clinical study (NCT06731179). Conducted in collaboration with the United Kingdom's National Health Service,...Read more


Bio-Path Announces Pre-Clinical Results Signaling Increased Potential for BP1001-A as Treatment for Obesity in Type 2 Diabetes Patients

March 18
Last Trade: 0.16 -0.05 -23.81

HOUSTON, March 18, 2025 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (OTCQB:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer and obesity drugs, today reported results from recent preclinical studies of BP1001-A that support its potential as a treatment for obesity. In these studies, BP1001-A attenuated fatty acid-induced...Read more


Genmab: Investigational Rinatabart Sesutecan (Rina-S®) Continues to Show Encouraging Antitumor Activity in Patients with Advanced Ovarian Cancer

March 17
Last Trade: 20.20 -0.60 -2.88

Results from Phase 2 RAINFOLTM-01 trial (B1 cohort) showed that with a median on-study follow-up of 48 weeks, Rina-S 120 mg/m2 led to a confirmed objective response rate (ORR) of 55.6% and median duration of response (mDOR) was not reached Phase 2 RAINFOLTM-01 and Phase 3 RAINFOLTM-02 trials evaluating the safety and efficacy of Rina-S at 120 mg/m2 in patients with platinum resistant ovarian cancer (PROC) are actively...Read more


IGC Pharma Expands CALMA Trial with Addition of BayCare Health System in Florida

March 17
Last Trade: 0.33 0.006 1.88

POTOMAC, MARYLAND / ACCESS Newswire / March 17, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") today announced the addition of a new trial site at BayCare's St. Anthony's Hospital in St. Petersburg, Florida as part of its ongoing Phase 2 CALMA trial evaluating IGC-AD1, the Company's lead therapeutic candidate, for the treatment of agitation in Alzheimer's dementia. IGC-AD1 is a combination therapy designed to...Read more


Pliant Therapeutics Announces Interim Phase 1 Data for PLN-101095 in Patients with Immune Checkpoint Inhibitor-Refractory Advanced Solid Tumors

March 17
Last Trade: 1.69 -0.01 -0.59

Antitumor activity observed with confirmed partial responses in 50% of patients at highest dose tested to date, across multiple tumor types PLN-101095 was generally well tolerated across all doses SOUTH SAN FRANCISCO, Calif., March 17, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced data from the first three of five potential cohorts of its ongoing Phase 1 dose escalation clinical trial evaluating...Read more


Incyte Announces Positive Topline Results From Two Phase 3 Clinical Trials of Povorcitinib in Patients With Hidradenitis Suppurativa

March 17
Last Trade: 60.00 -2.01 -3.24

- Statistically significant results for primary endpoints in both STOP-HS1 and STOP-HS2 Phase 3 studies for both doses tested - Favorable safety profile, with no safety concerns - Data will support planned regulatory submission for povorcitinib in hidradenitis suppurativa (HS) worldwide - Incyte to hold an analyst and investor call on Monday, March 17, 2025 from 8:00-9:00 a.m. ET WILMINGTON, Del. / Mar 17, 2025 / Business Wire /...Read more


Filament Health Announces Positive Data From Phase 2 Study Of PEX010 In Patients With Alcohol Use Disorder

March 17
Last Trade: 0.02 0.00 0.00

Open-label study at Psychiatric Centre Copenhagen found that alcohol consumption significantly decreased amongst participants dosed with Filament's botanical psilocybin drug candidate After a single dose of PEX010, the mean percentage of heavy drinking days was reduced by more than 50% over the 12-week observation period VANCOUVER, BC, March 17, 2025 /CNW/ - Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) (FSE: 7QS)...Read more


Avidity Biosciences Announces Positive Topline Del-zota Data Demonstrating Consistent, Statistically Significant Improvements in Dystrophin, Exon Skipping and Creatine Kinase in People Living with Duchenne Muscular Dystrophy Amenable to Exon 44...

March 17
Last Trade: 30.48 -3.35 -9.90

On track for year end 2025 BLA submission for accelerated approval of 5 mg/kg every six weeks of del-zota in DMD44 Consistent favorable safety and tolerability across del-zota dose cohorts  Plan to present functional data in fourth quarter of 2025 Investor and analyst webcast event today at 8:00 a.m. ET SAN DIEGO, March 17, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company...Read more


Perspective Therapeutics Announces First Patient Dosed with [212Pb]VMT01 in Combination with Nivolumab in a Phase 1/2a Study of MC1R-Positive Metastatic Melanoma

March 17
Last Trade: 2.43 -0.17 -6.54

SEATTLE, March 17, 2025 (GLOBE NEWSWIRE) -- Perspective, Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, announced today that the first patient was dosed in a new cohort of a Phase 1/2a trial evaluating the safety of [212Pb]VMT01, a targeted alpha-particle therapy (TAT), in patients with...Read more


Greenwich LifeSciences Provides Update on Open Label Safety Data from FLAMINGO-01

March 17
Last Trade: 11.61 -0.60 -4.91

STAFFORD, Texas, March 17, 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 the following update on FLAMINGO-01 open label safety data. FLAMINGO-01 Data Safety Monitoring Board (DSMB) The FLAMINGO-01 DSMB...Read more


Revelation Biosciences: Gemini Priming Attenuates Inflammation in Human Peripheral Blood Mononuclear Cells

March 17
Last Trade: 2.76 -0.24 -8.00

Observed response is excellent surrogate of the potential of Gemini in target indications  Equivalent response anticipated in Phase 1b study CKD patients  SAN DIEGO / Mar 17, 2025 / Business Wire / Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on rebalancing inflammation to optimize health, announced Gemini priming attenuates the...Read more


Scholar Rock Presents New Phase 3 SAPPHIRE Data at the 2025 Muscular Dystrophy Association Clinical & Scientific Conference

March 16
Last Trade: 33.88 -0.84 -2.42

Primary endpoint showed clinically meaningful improvement in patients with SMA receiving apitegromab as measured by gold standard Hammersmith Functional Motor Scale Expanded (HFMSE) versus placebo (p=0.0192), with consistent outcomes across all major sub-groups including age, SMN-targeted background therapy, and age at initiation of SMN-targeted therapy Pre-specified secondary endpoint showed that 30.4% of patients receiving apitegromab...Read more


Dyne Therapeutics Announces New Long-Term Clinical Data from Phase 1/2 DELIVER Trial of DYNE-251 in Duchenne Muscular Dystrophy Demonstrating Unprecedented and Sustained Functional Improvement Through 18 Months

March 16
Last Trade: 12.58 0.27 2.19

Continued favorable safety profile for DYNE-251  DELIVER Registrational Expansion Cohort is fully enrolled; data from this cohort planned for late 2025  Potential for Biologics License Application submission for U.S. accelerated approval in early 2026  WALTHAM, Mass., March 16, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on advancing life-transforming...Read more


Zentalis Pharmaceuticals Presents Updated Clinical Data at the Society of Gynecologic Oncology 2025 Annual Meeting on Women’s Cancer

March 15
Last Trade: 1.77 -0.12 -6.35

Azenosertib median duration of response (mDOR) updated to 6.3 months in the ongoing DENALI Part 1b clinical trial in patients with platinum-resistant ovarian cancer (PROC) and continues to demonstrate an objective response rate (ORR) of ~35% in response-evaluable patients On track to initiate Part 2 of the ongoing DENALI clinical trial in 1H 2025, with registration-intent topline data anticipated by year end 2026 Company also presents...Read more


AbbVie: ELAHERE® (mirvetuximab soravtansine-gynx) Shows Consistent Survival Benefit in Long-Term Analysis for Certain Ovarian Cancer Patients

March 15
Last Trade: 213.85 9.77 4.79

Final data analysis from Phase 3 MIRASOL trial after 30.5-month median follow-up demonstrated 32% reduction in risk of death with ELAHERE compared to chemotherapy in folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) Data presented in a late-breaking oral presentation at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer in Seattle NORTH CHICAGO, Ill., March 15, 2025 /PRNewswire/ --...Read more


NurExone Biologic: ExoPTEN Preclinical Study Demonstrates Significant Potential for Enhancing Motor Function, Blood Flow, and Spinal Cord Injury Recovery

March 14
Last Trade: 0.75 0.01 1.35

TORONTO and HAIFA, Israel, March 14, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) is pleased to announce that it has successfully completed an important preclinical study towards its Investigational New Drug (“IND”) submission. The new study, which advances the Company’s path towards first-in-human trials, demonstrated that ExoPTEN treatment with different dose...Read more


Palisade Bio Commences Dosing in First Ulcerative Colitis Patient Cohort in Ongoing Phase 1a/b Study of PALI-2108

March 14
Last Trade: 0.80 -0.06 -6.67

Positive preliminary data from all five single ascending dose (SAD) cohorts and first three completed multiple ascending dose (MAD) cohorts support safety and tolerability of PALI-2108 No serious adverse events (SAEs) and no treatment-emergent adverse events (TEAEs) related to laboratory values or EKGs seen to date On track to report topline data in first half of 2025 Carlsbad, CA, March 14, 2025 (GLOBE NEWSWIRE) -- Palisade Bio,...Read more


Gain Therapeutics Doses First Participant in Phase 1b Clinical Trial of GT-02287 in Parkinson’s Disease

March 14
Last Trade: 2.38 -0.02 -0.83

BETHESDA, Md., March 14, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced the dosing of the first participant with Parkinson’s disease (PD) in its Phase 1b clinical trial of GT-02287, the Company’s lead allosteric small molecule in development...Read more


INOVIO Announces Promising Interim Results from Ongoing Proof-of-Concept Clinical Trial of DNA-Encoded Monoclonal Antibodies (DMAbs) for COVID-19

March 13
Last Trade: 2.10 -0.01 -0.47

Long-lasting in vivo antibody production: DMAb levels remained stable for 72 weeks in all participants (n=24) who have reached that timepoint No anti-drug antibodies (ADA): no immune rejection of the DMAbs was detected across ~1,000 blood samples, unlike other gene-based antibody delivery approaches where ADA formation has been a challenge Well-tolerated: most common side effects were mild, temporary injection site reactions...Read more


Amgen: UPLIZNA (inebilizumab-cdon) Significantly Improves Generalized Myasthenia Gravis Symptoms In Acetylcholine Receptor Autoantibody-Positive Patients Over 52 Weeks

March 13
Last Trade: 318.65 1.48 0.47

Patients Reported Improvement in Ability to Conduct Daily Activities with Twice-Yearly Dosing* Late-Breaking Data to be Presented at AAN 2025 THOUSAND OAKS, Calif., March 13, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data from the Phase 3, registrational MINT trial evaluating the efficacy and safety of UPLIZNA® (inebilizumab-cdon) in adults living with generalized myasthenia gravis (gMG). The results...Read more


Vir Biotechnology Enrolls First Patient in Phase 3 ECLIPSE Registrational Program for Chronic Hepatitis Delta

March 13
Last Trade: 6.93 -0.07 -1.00

First patient enrolled in ECLIPSE 1 Phase 3 clinical trial evaluating combination of tobevibart and elebsiran for chronic suppressive treatment ECLIPSE program designed to enable regulatory submissions and support reimbursement and access Rapid study start indicative of significant unmet need for chronic hepatitis delta treatment SAN FRANCISCO / Mar 13, 2025 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the...Read more


COSCIENS Biopharma Announces Successful Phase 1 Results Supporting Initiation of Phase 2a Clinical Efficacy Trial with Avenanthramides as a Potential Anti-Inflammatory Product

March 13
Last Trade: 3.33 0.15 4.72

No significant clinical adverse event observed in Phase 1clinical study Pharmacokinetic profile established and range of doses selected for Phase 2a Clinical Efficacy Study First patient expected to be treated in the Phase 2a Clinical Efficacy Study on March 14, 2025 at the Montreal Heart Institute TORONTO, ONTARIO, March 13, 2025 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or the “Company”),...Read more


TransCode Therapeutics Announces Safety Review Committee Approval to Open Fourth Cohort in Phase I/II Clinical Trial

March 13
Last Trade: 0.78 0.00 0.00

Clinical trial Safety Review Committee (SRC) approved opening of Cohort 4 based on favorable safety data from the three patients comprising Cohort 3 No significant safety or dose limiting toxicities reported in Cohorts 1, 2, or 3 Patients currently being evaluated for Cohort 4 eligibility PK and PD data from patients in Cohort 1 and Cohort 2 consistent with preclinical results and results from Phase 0 clinical trial BOSTON, March...Read more


Vivani Medical Achieves First Implant and Full Enrollment in the First-in-Human Clinical Trial of GLP-1 Implant NPM-115 in Obese or Overweight Adults

March 13
Last Trade: 1.09 -0.01 -0.91

Miniature, twice-yearly GLP-1 (exenatide) implant under development for chronic weight management NPM-115 has demonstrated comparable preclinical weight loss to injections of semaglutide, the active ingredient in Ozempic®/Wegovy® Rapid full study enrollment with all 24 subjects initiating the 8-week run-in period within four weeks; top-line study results expected in mid-2025 ALAMEDA, Calif. / Mar 13, 2025 / Business Wire / Vivani...Read more


Marvel Biosciences Announces First of Two Final Data Sets from Rett Syndrome Study: MB-204 Significantly Outperforms Trofinetide

March 13
Last Trade: 0.14 0.00 0.00

Calgary, Alberta--(Newsfile Corp. - March 13, 2025) - Marvel Biosciences Corp. (TSXV: MRVL) (OTCQB: MBCOF) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the "Company" or "Marvel"), is pleased to share part of the final data from its preclinical Rett syndrome study conducted in collaboration with the iBraiN Institute. The study evaluated MB-204, Marvel's lead compound (10 mg/kg oral once daily), in...Read more


Merck Announces Positive Data from Phase 3 Trials that Show the Investigational, Once-Daily, Oral, Two-Drug Regimen of Doravirine/Islatravir (DOR/ISL) Maintained HIV-1 Viral Suppression at Week 48

March 12
Last Trade: 94.72 -0.07 -0.07

DOR/ISL demonstrated non-inferiority and a similar safety profile to comparator antiretroviral therapies in adults with virologically suppressed HIV-1 RAHWAY, N.J. / Mar 12, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of positive results from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir...Read more


Portage Biotech Resumes Enrollment in Final Cohort of Dose Escalation for Port-6 in ADPORT-601 Trial

March 12
Last Trade: 4.20 -0.05 -1.18

DOVER, Del., March 12, 2025 (GLOBE NEWSWIRE) -- Portage Biotech Inc. (“Portage” or the “Company”) (NASDAQ: PRTG), a clinical-stage immuno-oncology company with a portfolio of innovative therapeutics, today announced the resumption of patient enrollment in the fourth and final cohort of the dose escalation stage for PORT-6, a highly selective A2A antagonist, within its ADPORT-601 Phase 1b clinical trial. Portage had previously...Read more


Clene Demonstrates Strengthened ALS Survival Benefit with CNM-Au8® Treatment

March 12
Last Trade: 4.46 -0.10 -2.19

SALT LAKE CITY, March 12, 2025 (GLOBE NEWSWIRE) -- Clene, Inc. (Nasdaq: CLNN) and its subsidiary, Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced new evidence from a cross-regimen, post hoc analysis of long-term survival in HEALEY ALS Platform Trial...Read more


Corvus Pharmaceuticals Announces Initiation of Phase 2 Clinical Trial of Soquelitinib for Patients with Autoimmune Lymphoproliferative Syndrome (ALPS)

March 12
Last Trade: 4.69 -0.03 -0.64

Trial for this rare genetic disease to be conducted by NIH/NIAID in partnership with Corvus ITK inhibition intended to address dysregulation of T cells that causes ALPS and has been shown to be effective at treating the disease in preclinical models BURLINGAME, Calif., March 12, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that the National...Read more


Gilead Sciences: First Clinical Data for Gilead’s Investigational Once-Yearly Lenacapavir for HIV Prevention Presented at CROI 2025 and Published in The Lancet

March 11
Last Trade: 110.23 -2.03 -1.81

Phase 1 Data Indicate Potential for Use of Once-Yearly Lenacapavir for HIV Prevention, with Plans to Launch a Phase 3 Trial in 2H 2025 Also at CROI: New PURPOSE 1 Data Showcasing Preference for Twice-Yearly Lenacapavir vs. Once-Daily Orals and In-Depth Look at Adolescent Pharmacokinetic, Safety and Efficacy Data FOSTER CITY, Calif. / Mar 11, 2025 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today presented the first data...Read more


VolitionRx Announces First Patient Enrolled in NTU Hospital's Prospective Validation Study of Nu.Q® Lung Cancer Test

March 11
Last Trade: 0.55 -0.02 -3.88

Published study shows Nu.Q® Lung Cancer Test differentiated malignant and benign nodules found by Low Dose CT screening. The study is expected to be completed by the end of 2025 HENDERSON, Nev., March 11, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, announces first patient enrollment in a clinical study evaluating the company's proprietary Nu.Q® Cancer...Read more


Actinium Pharmaceuticals Announces Initiation of Actimab-A Triplet Combination Frontline Trial Under NCI CRADA with Venetoclax and Taiho Oncology's Hypomethylating Agent ASTX-727 in Patients with Newly Diagnosed AML

March 11
Last Trade: 1.19 -0.11 -8.46

Represents first ever triplet combination using targeted radiotherapy as a backbone therapy in AML with initial clinical data expected in 2H:2025 Expansion into frontline setting greatly expands potential addressable patient opportunity for Actimab-A Triplet combination supported by previously completed Phase 1 trials of Actimab-A + Venetoclax and Actimab-A + CLAG-M demonstrating Actimab-A's mutation agnostic and...Read more


Vaxart Announces Clinical Trial Initiation of Norovirus Oral Pill Vaccine Candidate

March 11
Last Trade: 0.57 -0.0054 -0.94

Topline data expected as early as mid-2025  SOUTH SAN FRANCISCO, Calif., March 11, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced the initiation of a Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. “We are pleased to initiate a Phase 1 trial for our oral bivalent norovirus vaccine,...Read more


Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Late Antibody-Mediated Rejection (AMR) in Kidney Transplant Patients

March 11
Last Trade: 143.09 -0.45 -0.31

Global Phase 3 TRANSCEND study will evaluate the efficacy and safety of felzartamab, as compared to placebo, in adults with late AMR AMR is a leading cause of kidney transplant loss, with approximately ~23k patients living with all forms of AMR in the U.S1 Felzartamab, with demonstrated proof of concept in multiple immune-mediated diseases, represents a key asset in Biogen’s late-stage immunology portfolio CAMBRIDGE, Mass., March...Read more


PolyPid Announces Successful Completion of Enrollment in Phase 3 SHIELD II Trial of D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections

March 11
Last Trade: 2.96 -0.11 -3.58

PETACH TIKVA, Israel, March 11, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced the successful completion of enrollment in the SHIELD II Phase 3 trial for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery. This milestone follows recommendation by the...Read more


atai Life Sciences Announces First Patient Dosed in Elumina, the Phase 2 Clinical Trial of VLS-01 for Treatment-Resistant Depression

March 11
Last Trade: 1.35 -0.11 -7.53

Elumina is a Phase 2, multicenter, double-blind, randomized, placebo-controlled, clinical trial to assess the efficacy, safety and tolerability of VLS-01 (buccal film DMT) in people suffering from treatment-resistant depression VLS-01 is being developed as a rapid-acting, robust and durable antidepressant for people suffering from treatment-resistant depression, which affects approximately 100 million people globally VLS-01 is...Read more


Arvinas and Pfizer Announce Positive Topline Results from Phase 3 VERITAC-2 Clinical Trial

March 11
Last Trade: 8.42 -0.28 -3.22

VERITAC-2 achieved its primary endpoint in the estrogen receptor 1-mutant population, demonstrating statistically significant and clinically meaningful improvement in progression-free survival  Vepdegestrant is the first PROTAC degrader to demonstrate clinical benefit in a Phase 3 trial  NEW HAVEN, Conn. and NEW YORK, March 11, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today...Read more


Kodiak Sciences Completes Enrollment in Second Registrational Trial of Tarcocimab in Patients with Diabetic Retinopathy

March 10
Last Trade: 3.24 -0.21 -6.09

Topline clinical data of the confirmatory registrational study GLOW2 expected in 1Q 2026. GLOW2 study design mirrors GLOW1 study, which met primary endpoint and all key secondary endpoints with high statistical significance PALO ALTO, Calif., March 10, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today announced that it has completed enrollment in its GLOW2 Phase 3 clinical trial of tarcocimab tedromer in patients with...Read more


CervoMed Announces Positive Results from the Extension Phase of its Phase 2b Clinical Study of Neflamapimod in Patients with Dementia with Lewy Bodies

March 10
Last Trade: 9.34 0.29 3.20

A new batch of neflamapimod capsules led to increased plasma drug concentrations and demonstrated improvement (p<0.001 vs. old capsules; p=0.003 vs. placebo) on the primary outcome measure, change from baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Improvement (p=0.035 against either old capsules or placebo) also demonstrated on the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change...Read more


Novo Nordisk: CagriSema demonstrates superior weight loss in adults with obesity or overweight and type 2 diabetes in the REDEFINE 2 trial

March 10
Last Trade: 80.90 0.75 0.94

Bagsværd, Denmark, 10 March 2025 – Today, Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo. The trial included 1,206 randomised people with obesity or overweight and type 2...Read more


Protagonist Therapeutics Reports Positive Top Line Results From Phase 2b Study of Icotrokinra Showing Potential to Transform the Treatment Paradigm for Patients With Ulcerative Colitis

March 10
Last Trade: 54.52 1.51 2.85

Clinical response rate of 63.5% and clinical remission rate of 30.2% achieved at Week 12 with the highest dose, which continued to improve through Week 28 All three doses met the primary endpoint of clinical response at Week 12, with a favorable safety profile These results in ulcerative colitis build on strong data recently reported for the plaque psoriasis Phase 3 program NEWARK, CALIFORNIA / ACCESS Newswire / March 10, 2025 /...Read more


Natera Announces Enrollment of First Patients in the HEROES Clinical Trial in Metastatic HER2+ Breast Cancer

March 10
Last Trade: 146.28 -2.97 -1.99

HEROES is Natera’s first clinical trial using Signatera™ to guide de-escalation of therapy in patients with metastatic HER2+ breast cancer Approximately 170 patients are expected to enroll in up to 35 sites in France AUSTIN, Texas / Mar 10, 2025 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced the enrollment of the first patients in the HEROES clinical trial. HEROES...Read more


Corcept Therapeutics Initiates MOMENTUM Trial to Determine Prevalence of Hypercortisolism in Patients with Resistant Hypertension

March 10
Last Trade: 56.50 -1.38 -2.38

REDWOOD CITY, Calif. / Mar 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 the initiation of MOMENTUM, a clinical trial examining the prevalence of endogenous hypercortisolism (Cushing’s...Read more


Johnson & Johnson: Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients

March 10
Last Trade: 164.79 1.95 1.20

Topline results also show investigational targeted oral peptide icotrokinra achieved clinical remission rates up to 30.2% at Week 12 and a favorable safety profile in Phase 2b ANTHEM-UC study Clinical response and remission rates continued to improve through Week 28, building on strong data recently reported for the plaque psoriasis Phase 3 program Icotrokinra demonstrates potential to offer therapeutic benefit and...Read more


4D Molecular Therapeutics Announces First Patients Enrolled in 4FRONT-1 Phase 3 Clinical Trial Evaluating 4D-150 in Wet AMD

March 10
Last Trade: 3.82 -0.36 -8.61

EMERYVILLE, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced that the first patients have been enrolled across multiple sites in the 4FRONT-1 Phase 3 clinical trial evaluating...Read more


Calidi Biotherapeutics Announces Demonstrated Ability To Deliver Transient Gene Therapy (Payload) To Tumors Using Systemic Platform

March 10
Last Trade: 0.83 -0.04 -5.06

SAN DIEGO, March 10, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced promising preclinical results for its systemic RTNova platform. The platform has successfully delivered transient gene therapy payloads to targeted tumors. Additionally, Calidi's tumor-specific virotherapy has...Read more


Polyrizon Initiates Preclinical Studies for Intranasal Naloxone Targeting Opioid Overdose Based on Its Innovative T&T Platform

March 10
Last Trade: 0.59 -0.05 -7.81

Raanana, Israel, March 10, 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 today the initiation of preclinical studies for intranasal Naloxone, a life-saving opioid overdose treatment. The study will be conducted in collaboration with Professor Fabio Sonvico, Associate Professor at the...Read more


Immunome Doses First Patient in Phase 1 Trial of IM-1021, a ROR1-Targeted ADC

March 10
Last Trade: 8.36 -0.68 -7.52

BOTHELL, Wash. / Mar 10, 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 the first patient has been dosed in the Phase 1, first-in-human trial of IM-1021, a ROR1-targeted ADC. “Immunome is developing differentiated ADCs that we believe can greatly benefit cancer patients,” said Bob Lechleider, M.D., Chief...Read more


Arrowhead Pharmaceuticals Announces Topline Results from Part 2 of Phase 1/2 Study of ARO-C3 in Patients with IgA Nephropathy

March 10
Last Trade: 15.10 -0.50 -3.21

ARO-C3 achieved deep and sustained reductions in alternative pathway complement activity and proteinuria Mean sustained reductions in C3 of ≥87%, AH50 of ≥76%, Wieslab AP of ≥89% through week 24 Mean reduction in spot urine protein-to-creatinine ratio (UPCR) of 41% by week 24 PASADENA, Calif. / Mar 10, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced topline results from Part 2 of a Phase 1/2...Read more


Aurora Spine Announces Completion of Enrollment in Groundbreaking REFINE Study: First Prospective, Multi-Center, Multi-Specialty Study on Lumbar Interlaminar Fusion 

March 10
Last Trade: 0.33 0.03 10.00

CARLSBAD, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- Aurora Spine Corporation ("Aurora Spine" or the "Company") (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, today announced the completion of patient enrollment in its REFINE study of its ZIP™ Interspinous Fixation device for patients suffering from back pain due to symptomatic degenerative disc disease . This...Read more


Theralase Technologies Therapy Improves Motor and Non-Motor Function in Parkinson's Patients

March 10
Last Trade: 0.21 -0.005 -2.38

Parkinson's Patients Have Improved Motor and Non-Motor Function After Treatment with Theralase(R) Cool Laser Therapy Toronto, Ontario--(Newsfile Corp. - March 10, 2025) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations,...Read more


Mineralys Therapeutics Announces Positive Topline Results from Launch-HTN and Advance-HTN Pivotal Trials of Lorundrostat for the Treatment of Uncontrolled or Resistant Hypertension

March 10
Last Trade: 15.43 1.21 8.51

Launch-HTN met its primary endpoint with lorundrostat 50 mg dose achieving a 16.9 mmHg reduction in systolic blood pressure, and a 9.1 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office blood pressure at week 6 Launch-HTN met a predefined endpoint with lorundrostat 50 mg dose achieving a 19.0 mmHg reduction in systolic blood pressure, and an 11.7 mmHg placebo-adjusted reduction (p-value < 0.0001)...Read more


Trevi Therapeutics Announces Positive Topline Results from the Phase 2a RIVER Trial of Haduvio in Patients with Refractory Chronic Cough

March 10
Last Trade: 6.56 0.02 0.31

Haduvio met the primary endpoint with a statistically-significant reduction (p<0.0001) in 24-hour cough frequency with a 57% placebo-adjusted change from baseline Haduvio showed similar efficacy in patients with moderate or severe cough counts (p<0.0001) Haduvio is the first and only therapy to show a statistically-significant reduction in chronic cough across both RCC and IPF patients Patient reported and other secondary...Read more


Beam Therapeutics Announces Positive Initial Data for BEAM-302 in the Phase 1/2 Trial in Alpha-1 Antitrypsin Deficiency (AATD), Demonstrating First Ever Clinical Genetic Correction of a Disease-causing Mutation

March 10
Last Trade: 22.59 -1.93 -7.87

Single Dose of BEAM-302 Led to Durable, Dose-dependent Increases in Total and Functional Alpha-1 Antitrypsin (AAT), Production of Corrected M-AAT, and Decreases in Mutant Z-AAT in Circulation Across Initial Three Dose Levels Third Dose Level of BEAM-302 (60 mg, N=3) Achieved Mean Total AAT of 12.4µM at Day 28, Exceeding Protective Therapeutic Threshold, and Reduced Mutant Z-AAT up to 78% Initial Safety Findings Demonstrated BEAM-302...Read more


Eli Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS study

March 8
Last Trade: 822.51 -2.25 -0.27

Late-breaking results presented at AAD show 80% or more scalp hair coverage at Week 36 in 42.4% of adolescents receiving baricitinib 4 mg Patients treated with baricitinib 4 mg saw significant regrowth of eyebrows and eyelashes at Week 36 compared to placebo Positive data underscore Lilly's continued expansion across dermatologic conditions, with treatments that can improve outcomes for patients with the greatest...Read more


Regeneron Pharmaceuticals: Dupixent® (dupilumab) Late-Breaking Positive Pivotal Data in Bullous Pemphigoid Presented at AAD

March 8
Last Trade: 664.96 -13.46 -1.98

Five times more adults on Dupixent achieved sustained disease remission at 36 weeks compared to placebo; significant reductions were also seen in disease severity and itch Dupixent also significantly reduced oral corticosteroid and rescue medicine use compared to placebo Data support the potential of Dupixent to be the first and only targeted medicine to treat bullous pemphigoid, a skin disease with underlying type 2 inflammation;...Read more


Q32 Bio Presents Results from SIGNAL-AA Part A Clinical Trial Evaluating Bempikibart in Patients with Alopecia Areata at the 2025 American Academy of Dermatology Meeting

March 8
Last Trade: 32.95 0.00 0.00

Results presented in AAD late-breaker demonstrate bempikibart's encouraging improvement on SALT reduction at week 24 and continued effects after dosing cessation in patients with severe and very severe alopecia areata (AA) Durable, ongoing responses in multiple patients through week 36 follow-up period and beyond to week 55, despite only 24 weeks of dosing, suggestive of potential for remittive effect; multiple inbound patient requests...Read more


Protagonist Therapeutics: Icotrokinra Clinical Study Results Demonstrate Its Potential to Shift Treatment Paradigm and Set a New Standard for Treatment in Plaque Psoriasis

March 8
Last Trade: 54.52 1.51 2.85

Nearly half of patients with moderate-to-severe plaque psoriasis (PsO) treated with icotrokinra achieved completely clear skin (IGA 0) at Week 24 in Phase 3 ICONIC-LEAD study Topline results from Phase 3 ICONIC-ADVANCE 1&2studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe PsO Results pave the way to initiate the first-ever head-to-head study (ICONIC-ASCEND)...Read more


Bristol Myers Squibb Presents Late-Breaking Data from Phase 3 POETYK PsA-2 Trial Demonstrating Superiority of Sotyktu (deucravacitinib) Compared with Placebo in Adults with Psoriatic Arthritis

March 8
Last Trade: 59.90 -0.09 -0.15

Significantly more patients treated with Sotyktu achieved ACR and PASI response rates and had greater improvements in patient-reported quality of life compared with placebo at Week 16 Sotyktu was well-tolerated in comparison with placebo and apremilast, demonstrating safety consistent with its established clinical profile PRINCETON, N.J. / Mar 08, 2025 / Business Wire / Bristol Myers Squibb (NYSE:BMY) today announced positive data...Read more


New Analysis of Organon’s VTAMA® (tapinarof) cream, 1% Phase 3 Data Shows Atopic Dermatitis Disease Activity Remained Low After Treatment-Free Interval in Adults and Children 2 Years of Age and Older

March 8
Last Trade: 15.70 0.08 0.51

Low disease activity was observed after a mean duration of 80 consecutive days off-treatment following success with VTAMA cream, with a mean weekly Peak Pruritus Numerical Rating Scale (PP-NRS) score of 2.9 at the end of the treatment-free interval Data presented as late breaker at 2025 American Academy of Dermatology (AAD) Annual Meeting JERSEY CITY, N.J. / Mar 08, 2025 / Business Wire / Organon (NYSE: OGN), a global healthcare...Read more


Alumis: Late-Breaking ESK-001 Phase 2 OLE Data Presented at 2025 AAD Annual Meeting Demonstrate Robust Clinical Responses Over 52-Weeks in Psoriasis

March 8
Last Trade: 4.48 0.15 3.46

ESK-001 is a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor currently under development in moderate-to-severe plaque psoriasis and systemic lupus Phase 2 OLE data of ESK-001 at 40 mg BID demonstrated sustained or increasing clinical responses through week 52 on PASI 90, PASI 100, and sPGA 0 ESK-001 was generally well-tolerated at one year, with no new safety findings Data further support ESK-001’s potential...Read more


Amgen and Kyowa Kirin Provide Top-Line Results from Rocatinlimab Phase 3 Ignite Study in Adults with Moderate to Severe Atopic Dermatitis

March 8
Last Trade: 318.65 1.48 0.47

Ongoing Studies are Evaluating Long-Term Maintenance and Durability THOUSAND OAKS, Calif., and TOKYO, March 8, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) today announced new results from the ongoing ROCKET Phase 3 clinical trial program evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in moderate to severe atopic dermatitis (AD). The...Read more


Incyte Announces Results of Phase 3 Clinical Trials Evaluating Ruxolitinib Cream 1.5% (Opzelura®) in Patients with Prurigo Nodularis (PN) at 2025 American Academy of Dermatology Annual Meeting

March 8
Last Trade: 60.00 -2.01 -3.24

Full data from the Phase 3 TRuE-PN1 study, presented today in a late-breaking oral presentation, showed the study met all primary and key secondary endpoints Topline data from a separate Phase 3 study, TRuE-PN2, showed that while the primary endpoint did not reach statistical significance, the primary and all key secondary endpoints were in favor of ruxolitinib cream 1.5% versus vehicle These Phase 3 data will inform planned discussions...Read more


Johnson & Johnson: Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis

March 8
Last Trade: 164.79 1.95 1.20

Standout combination of complete skin clearance and favorable safety profile in a once daily pill could shift treatment paradigm Nearly half of patients with moderate-to-severe plaque psoriasis (PsO) treated with investigational icotrokinra achieved completely clear skin (IGA 0) at Week 24 in Phase 3 ICONIC-LEAD Topline results from Phase 3 ICONIC-ADVANCE 1&2 studies show icotrokinra achieved co-primary endpoints and showed...Read more


PDS Biotechnology Initiates VERSATILE-003 Phase 3 Clinical Trial Evaluating Versamune® HPV in HPV16-Positive Head and Neck Cancer

March 7
Last Trade: 1.39 0.05 3.73

PRINCETON, N.J., March 07, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced the initiation of the VERSATILE-003 Phase 3 clinical trial. The trial is now open to patient enrollment. “We are thrilled to share that the first trial site has been initiated and...Read more


AstraZeneca: IMFINZI® (durvalumab)-based regimen demonstrated statistically significant and clinically meaningful improvement in event-free survival in resectable early-stage gastric and gastroesophageal junction cancers

March 7
Last Trade: 77.07 -0.30 -0.39

MATTERHORN is first global, randomized Phase III trial to demonstrate superior event-free survival with an immunotherapy combination over standard of care in this setting IMFINZI plus chemotherapy more than doubled pathologic complete response rate in previously reported analysis of this trial in 2023 WILMINGTON, Del. / Mar 07, 2025 / Business Wire / Positive high-level results from the MATTERHORN Phase III trial showed perioperative...Read more


I-Mab Announces Accelerated Givastomig Phase 1b Study Progress

March 7
Last Trade: 0.85 0.00 0.00

Enrollment completed ahead of schedule in the first dose expansion cohort Momentum continues with first patient dosed in the second expansion cohort Topline results from the 40-patient dose expansion study expected in 1H 2026 Phase 1b dose escalation data expected to be presented in 2H 2025 ROCKVILLE, Md., March 07, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, global biotech company, focused on...Read more


BioXcel Therapeutics Announces 33% Enrollment in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

March 7
Last Trade: 2.20 -0.08 -3.51

Data to support potential sNDA submission for label expansion of IGALMI® in the home setting Topline data expected in second half of 2025 NEW HAVEN, Conn., March 07, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced it has reached 33% enrollment in its 200-patient SERENITY At-Home...Read more


aTyr Pharma Announces Fourth Positive DSMB Review for Efzofitimod in Phase 3 EFZO-FIT™ Study in Pulmonary Sarcoidosis

March 6
Last Trade: 3.88 -0.13 -3.24

SAN DIEGO, March 06, 2025 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: ATYR) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced the outcome of a fourth, pre-planned interim safety analysis conducted by an independent data and safety monitoring board (DSMB) for the ongoing Phase 3 EFZO-FIT™...Read more


Arrowhead Pharmaceuticals Showcases Two Clinical-Stage RNAi-Based Candidates to Treat Obesity and Metabolic Diseases

March 6
Last Trade: 15.10 -0.50 -3.21

ARO-INHBE and ARO-ALK7 both target a known pathway that signals the body to store fat in adipose tissue with a novel mechanism of action that may better preserve lean muscle mass compared to currently approved obesity therapies Data highlight Arrowhead’s leadership in the use of RNA interference to potentially treat Obesity PASADENA, Calif. / Mar 06, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced...Read more


Medicus Pharma Announces Positively Trending Interim Analysis for SKNJCT-003 Phase 2 Clinical Study to Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC)

March 6
Last Trade: 5.69 0.00 0.00

PHILADELPHIA, March 06, 2025 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce a positively trending interim analysis for SKNJCT-003 Phase 2 clinical study to non-invasively treat basal cell carcinoma of the skin (BCC). The SKNJCT-003 clinical study is currently underway in nine (9) clinical sites in United States and is expected to randomize 60 patients. The interim analysis was...Read more


HUTCHMED Announces that it has Completed Enrollment of a Phase II Registration Study of Fanregratinib (HMPL-453) for Intrahepatic Cholangiocarcinoma in China

March 6
Last Trade: 14.95 -0.19 -1.25

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 06, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that it has completed enrollment of its a Phase II trial of fanregratinib (HMPL-453) for intrahepatic cholangiocarcinoma (“IHCC”) patients with fibroblast growth factor receptor (“FGFR”)2 fusion/rearrangement.  The study is a single-arm, multi-center, open-label, Phase II...Read more


Tenax Therapeutics Expands Phase 3 LEVEL Program, Advancing Two TNX-103 (Oral Levosimendan) Registrational Studies for the Treatment of PH-HFpEF

March 5
Last Trade: 6.25 0.02 0.32

Amendment to Enlarge Phase 3 LEVEL Study, Increasing Statistical Powering, Accepted by FDA, Expected to be Fully Enrolled Around Year End 2025 Agreement by FDA to Initiate Second Global Phase 3 Study, LEVEL-2, with First Patient Expected to be Enrolled this Year CHAPEL HILL, N.C., March 05, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax Therapeutics” or the “Company”), a Phase 3, development-stage...Read more


Phio Pharmaceuticals Announces Completion of Enrollment in Third Safety Cohort in PH-762 Phase 1b Dose-Escalation Study

March 5
Last Trade: 1.39 0.03 2.21

Marlborough, Massachusetts--(Newsfile Corp. - March 5, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage biotechnology company developing therapeutics that use its INTASYL® siRNA gene silencing technology designed to make the body's immune cells more effective in killing cancer cells. Phio announced today that it has fulfilled the required enrollment for safety in its third dose cohort in its Phase 1b dose escalating...Read more


atai Life Sciences Announces Completion of Enrollment in Phase 2b Clinical Trial Evaluating BPL-003 for Treatment-Resistant Depression

March 5
Last Trade: 1.35 -0.11 -7.53

The eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial is evaluating the efficacy and safety of a single dose of BPL-003 (mebufotenin benzoate) in patients with treatment-resistant depression The open-label extension stage of the Phase 2b clinical trial continues to enroll patients to evaluate the safety and efficacy of a second dose of BPL-003 As previously reported, the Phase 2a study of BPL-003...Read more


Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating NBI-1140675, a Second-Generation VMAT2 Inhibitor, in Healthy Adults

March 5
Last Trade: 109.70 -1.80 -1.61

SAN DIEGO, March 5, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of investigational compound NBI-1140675 in healthy adult participants. NBI-1140675 is an investigational, oral, selective second-generation small molecule inhibitor of the vesicular monoamine transporter 2 (VMAT2) in...Read more


Contineum Therapeutics Initiates Patient Dosing in Phase 1b Chronic Pain Trial of PIPE-791

March 4
Last Trade: 7.49 0.43 6.09

Exploratory phase 1b trial will evaluate safety, tolerability and effect on pain intensit Topline data readout planned for early 2026 SAN DIEGO / Mar 04, 2025 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today initiated patient...Read more


Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: On Track to File for FDA Approval Mid-2025

March 4
Last Trade: 3.67 -0.03 -0.81

Results Have Been Submitted Ahead of In-Person Meeting with FDA Set for April 2 CTx-1301 is the First, True, Once-Daily Stimulant Medication to Treat ADHD Over the Entire Active Day KANSAS CITY, Kan., March 04, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of...Read more


PepGen Announces Update to Phase 2 CONNECT2-EDO51 Study in Patients with DMD

March 4
Last Trade: 2.18 -0.17 -7.23

Company will temporarily pause CONNECT2 and focus efforts on ongoing CONNECT1-EDO51 study of PGN-EDO51 in DMD, with 10 mg/kg results expected in the third quarter of 2025 No new safety issues have been observed in PGN-EDO51 program BOSTON / Mar 04, 2025 / Business Wire / PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the...Read more


Alzamend Neuro Announces Initiation Date of Phase II Clinical Trial of AL001 for Treatment of Bipolar Disorder to take Place at Massachusetts General Hospital

March 4
Last Trade: 0.94 0.05 5.04

ATLANTA, March 04, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment...Read more


MIRA Pharmaceuticals Announces Approval and Initiation of Phase 1 Clinical Trial for Ketamir-2 in Neuropathic Pain

March 4
Last Trade: 1.17 0.09 8.33

MIAMI, FL / ACCESS Newswire / March 4, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), a preclinical-stage pharmaceutical company focused on developing therapies for neurological and neuropsychiatric disorders, today announced the approval and upcoming initiation of its Phase 1 clinical trial for Ketamir-2, the Company's novel oral ketamine analog in development for neuropathic pain, with subject recruitment scheduled to begin in Q1...Read more


Adverum Biotechnologies Initiates ARTEMIS Phase 3 Study Evaluating Ixo-vec for Wet AMD

March 3
Last Trade: 4.90 0.17 3.59

Ixo-vec is a potential best-in-class one-time gene therapy designed to deliver long-term efficacy, reduce the burden of frequent anti-VEGF and improve vision outcomes for patients with wet AMD ARTEMIS is the first-ever initiation of a registrational intravitreal gene therapy trial in patients with wet AMD Non-inferiority study to evaluate a single Ixo-vec injection compared to on-label aflibercept 2mg in both treatment-naïve and...Read more


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