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Latest Phase 2 Clinical Trials Stock News

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Supernus Pharmaceuticals Presents Promising Data from Open-Label Phase 2a Study of SPN-820 Data in Major Depressive Disorder at Psych Congress 2024

October 31
Last Trade: 34.07 -0.80 -2.29

Participants in the Phase 2a study experienced rapid and meaningful decreases in depressive symptoms Suicidal ideation decreased by 80% SPN-820 was well-tolerated with few adverse events SPN-820 is a novel, first-in-class intracellular modulator of mTORC1 for the treatment of depression ROCKVILLE, Md., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing...Read more


Intensity Therapeutics and The Swiss Group for Clinical Cancer Research SAKK Announce the First Patient Dosed in the Randomized, Presurgical Triple Negative Breast Cancer Phase 2 Clinical Trial (INVINCIBLE-4 / SAKK 66/22)

October 31
Last Trade: 3.25 0.20 6.56

Testing the efficacy and safety of Intensity's lead drug candidate, INT230-6, when combined with Standard-of-Care versus Standard-of-Care alone The endpoint is the change in pathological complete response rates SHELTON, Conn. and BERN, Switzerland, Oct. 31, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and...Read more


Acumen Pharmaceuticals Presents Innovative Trial Screening Advancements Utilizing pTau217 Assay in Phase 2 Study of Sabirnetug for Early Alzheimer’s Disease at the 17th Annual Clinical Trials on Alzheimer’s Disease Conference

October 31
Last Trade: 2.88 -0.15 -4.95

Late-breaking presentation highlights the pTau217 assay as an effective and efficient tool to screen participants for ALTITUDE-AD that reduces unnecessary amyloid PET scans and lumbar puncture procedures for those who are not eligible NEWTON, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta...Read more


Atossa Therapeutics Releases Promising Preliminary Analysis Demonstrating (Z)-Endoxifen’s Potential to Rapidly Reduce Ki-67 and Tumor Volume in ER+/HER2- Breast Cancer

October 31
Last Trade: 1.38 -0.03 -2.13

(Z)-endoxifen at 10 mg once daily met the primary endpoint with 19/20 (95%) receiving > 75 % of planned treatment in I-SPY-2 Phase 2 Trial Low dose (Z)-endoxifen was well tolerated and demonstrated promising rapid activity in reducing 3-wk Ki-67 and FTV Biomarkers SEATTLE, Oct. 31, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), today released a preliminary analysis from a phase 2...Read more


Palatin Technologies Completes Enrollment in Phase 2 Clinical Study of Bremelanotide (MC4R Agonist) Co-Administered with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity

October 31
Last Trade: 1.24 -0.02 -1.59

Topline results expected in 1Q calendar year 2025 Study is assessing the co-administration of bremelanotide and tirzepatide on reducing body weight Data will inform and support the Company's obesity programs using novel, long-acting and highly selective MC4R peptide and small molecule compounds for treating general obesity, weight loss management, and rare/orphan MC4R pathway diseases, including hypothalamic obesity CRANBURY, N.J.,...Read more


Windtree Therapeutics Initiates SEISMiC C Study of Istaroxime in SCAI Stage C Cardiogenic Shock for Planned Completion of Phase 2b and Transition to Phase 3

October 30
Last Trade: 0.70 -0.04 -5.36

After successful SEISMiC A and B studies in Early Cardiogenic Shock, SEISMiC C will treat more severe SCAI Stage C cardiogenic shock to complete the assessment of the intended Phase 3 patient population Windtree plans to engage with regulatory authorities in 2025 for Transition to Phase 3 clinical trial WARRINGTON, Pa., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a...Read more


HOOKIPA Pharma Doses First Patients with Eseba-vec as Adjuvant Therapy in Phase 2 Investigator Lead Trial for Head & Neck Cancer

October 30
Last Trade: 3.79 -0.07 -1.81

Study done in collaboration with Memorial Sloan Kettering and led by Dr. Winston Wong, Head and Neck Oncologist and Dr. Alan Ho, Chief of the Head and Neck Oncology Service IIT will evaluate eseba-vec in patients who are HPV16+ after treatment for curative intent Potential to expand the eseba-vec HNSCC opportunity into adjuvant care Initial safety and efficacy data from IIT expected in 2026 NEW YORK and VIENNA, Oct. 30, 2024...Read more


CalciMedica to Present Late-Breaking Positive Data, Including a Win Ratio Analysis, from Phase 2b CARPO Trial of Auxora™ in Acute Pancreatitis (AP) at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting

October 30
Last Trade: 3.70 -1.10 -22.92

Statistically significant 100% reduction (p = 0.0027) in new-onset severe respiratory failure and 64.2% reduction (p = 0.0476) in new-onset persistent respiratory failure in combined high and medium dose Auxora patients versus combined low dose Auxora and placebo patients Statistically significant stratified win ratio of 1.640 (p = 0.0372) for high dose Auxora compared to placebo Clinically meaningful reduction observed for high dose...Read more


Spero Therapeutics Announces SPR720 Phase 2a Interim Results and Provides a Business Update

October 29
Last Trade: 1.23 -0.06 -4.65

Phase 2a proof-of-concept study of SPR720 for the treatment of Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) did not meet its primary endpoint, based on planned interim analysis of 16 patients Phase 3 PIVOT-PO trial of tebipenem HBr remains on track for enrollment completion in 2H 2025 Cash runway extended into mid-2026 following a reduction in workforce and restructuring of operations; Unaudited Q3 2024 ending cash balance...Read more


Shuttle Pharmaceuticals Doses First Patients in Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma

October 29
Last Trade: 1.87 0.07 3.89

GAITHERSBURG, Md., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today that the first three patients in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma have been...Read more


Coya Therapeutics Announces Positive Results of a Double-Blind Study of Subcutaneous Low-Dose Interleukin-2 (LD IL-2) in Alzheimer’s Disease (AD) Presented at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in Madrid (Spain)

October 29
Last Trade: 7.23 0.57 8.56

Study met Primary and Secondary Endpoints for Safety and Regulatory T cell (Treg) Cell Population Enhancement, respectively, with no off-target effects on T effector lymphocytes, providing further evidence of target engagement Exploratory Endpoints demonstrated cognitive stabilization on treatment vs. cognitive declines on placebo for LD IL-2 dosing every 4 weeks (LD IL-2 q4wks), which was associated with significant improvement in...Read more


Shuttle Pharmaceuticals Completes Clinical Trial Site Enrollment for Phase 2 of Ropidoxuridine for Treatment of Patients with Glioblastoma

October 28
Last Trade: 1.87 0.07 3.89

GAITHERSBURG, Md., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today it has finalized agreements with all six of the planned site enrollment locations to administer the Phase 2 clinical trial of Ropidoxuridine for...Read more


EyePoint Pharmaceuticals Announces Positive Interim 16-Week Data for Ongoing Phase 2 VERONA Clinical Trial of DURAVYU™ for Diabetic Macular Edema

October 28
Last Trade: 11.76 0.30 2.62

DURAVYU 2.7mg demonstrated an early and sustained improvement in BCVA with a gain of +8.9 letters compared to baseline  DURAVYU 2.7mg demonstrated an early and sustained anatomical improvement mirroring BCVA results with a 68 micron reduction in CST  Favorable safety profile continues with no DURAVYU-related ocular or systemic SAEs to date  Full topline data anticipated in Q1 2025  WATERTOWN, Mass., Oct. 28,...Read more


Biogen Presents Positive Results from Phase 2 IGNAZ Study of Felzartamab in IgA Nephropathy at American Society of Nephrology (ASN) Kidney Week 2024

October 26
Last Trade: 174.00 -7.18 -3.96

The detailed study results confirmed interim findings, showing stable kidney function and sustained treatment effect more than 18 months after the last dose of felzartamab Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications with planning underway for Phase 3 development IgA Nephropathy (IgAN) is a leading cause of chronic...Read more


Vera Therapeutics Announces 96-week eGFR Stabilization in ORIGIN Phase 2b Study of Atacicept in IgAN in a Late-Breaking Oral Presentation at the American Society of Nephrology Kidney Week 2024

October 26
Last Trade: 40.38 -0.26 -0.64

Long-term improvements observed in the quartet of findings defining disease modification supports atacicept’s potential to prevent kidney failure in patients with IgAN; Long-term results from the ORIGIN Phase 2b study were simultaneously published in the Journal of the American Society of Nephrology; Company will host an investor call and webcast on Monday October 28 at 8:00 AM ET BRISBANE, Calif., Oct. 26, 2024 (GLOBE NEWSWIRE) --...Read more


Celldex Therapeutics Announces Barzolvolimab Met All Primary and Secondary Endpoints with High Statistical Significance in Positive Phase 2 Study in Chronic Inducible Urticaria

October 26
Last Trade: 26.06 -0.27 -1.03

First to demonstrate clinical benefit in patients with chronic inducible urticaria (CIndU) in large, randomized, placebo-controlled study Favorable safety and tolerability Plan to advance CIndU into Phase 3 development Company to host webcast call Monday at 8:00 am ET HAMPTON, N.J., Oct. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive results from the Company’s Phase 2...Read more


NeuroSense Therapeutics: New Analysis Shows PrimeC Significantly Improves Key miRNAs in ALS Patients

October 24
Last Trade: 1.25 -0.05 -3.85

Groundbreaking PARADIGM Trial Offers New Hope for ALS Treatment CAMBRIDGE, Mass., Oct. 24, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced transformative findings from its PARADIGM clinical trial of PrimeC. These results illuminate a new frontier in the treatment of ALS...Read more


Pharvaris Presents Clinical and Non-Clinical Data Supporting HAE Development Program at the 2024 ACAAI Annual Scientific Meeting

October 24
Last Trade: 24.87 0.07 0.28

ZUG, Switzerland, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat hereditary angioedema (HAE) attacks, today announced data from seven posters that will be presented at the 2024 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI). Pharvaris mourns our distinguished...Read more


MindBio Therapeutics Announces Clinical Trial Milestone In Phase 2B Microdosing Trials Targeting Existential Distress, Depression & Anxiety In Advanced Stage Cancer

October 24
Last Trade: 0.04 0.00 0.00

One of two Phase 2B trials currently dosing and underway: Phase 2B trialing MB22001 in patients with Major Depressive Disorder, and;   Phase 2B trialing MB22001 in patients with Advanced Stage Cancer  Vancouver, British Columbia – October 24, 2024 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a leading biopharmaceutical company in psychiatric medicine development,...Read more


OKYO Pharma Announces First Patient Dosed in the First Clinical Trial to Treat Neuropathic Corneal Pain

October 23
Last Trade: 1.18 0.02 1.29

OK-101 is the first drug candidate to enroll patients specifically diagnosed with Neuropathic Corneal Pain (NCP) in a clinical trial The Phase 2 trial is designed as a randomized, placebo-controlled, double-masked study to treat 48 NCP patients OK-101 is the first IND granted by FDA to treat patients with NCP   LONDON and NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), an...Read more


Alto Neuroscience Reports Topline Results from a Phase 2b Trial Evaluating ALTO-100 as a Treatment for Major Depressive Disorder

October 22
Last Trade: 3.89 -0.14 -3.47

Treatment with ALTO-100 did not demonstrate improvement in depressive symptoms compared to placebo in patients with a memory-based cognitive biomarker  ALTO-100 demonstrated a favorable safety and tolerability profile, consistent with previously reported studies  Strong cash position expected to fund Alto’s planned operations through multiple near-term milestones across pipeline of independent programs  MOUNTAIN VIEW,...Read more


Genelux Announces First Patient Dosed in Phase 2 Trial Evaluating Systemic Therapy with Olvi-Vec in Non-Small Cell Lung Cancer

October 22
Last Trade: 3.22 -0.11 -3.30

VIRO-25 trial to assess efficacy & safety of olvimulogene nanivacirepvec (Olvi-Vec) & platinum-doublet + physician's choice of immune checkpoint inhibitor compared to docetaxel in recurrent non-small cell lung cancer  Trial represents second indication in the clinic for Olvi-Vec via systemic administration  Interim readout expected mid-2025  WESTLAKE VILLAGE, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Genelux...Read more


MindBio Therapeutics Completes Final Post Treatment Milestone in Phase 2A Microdosing Depression Clinical Trial. Results to be Reported in the Coming Fortnight

October 22
Last Trade: 0.04 0.00 0.00

Vancouver, British Columbia – TheNewswire - 22 OCTOBER, 2024 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (the “Company” or “MindBio”), is pleased to report that the final milestone in the Company’s Phase 2A Microdosing Depression Clinical Trial, the 6-month post treatment milestone measuring the “severity of depression” has been completed.  The completion of this important milestone comes as the Company progresses more...Read more


Recursion announces first patient dosed in Phase 2 clinical study of REC-3964, a potential first-in-class, oral, non-antibiotic small molecule for recurrent Clostridioides difficile infection

October 22
Last Trade: 6.32 -0.36 -5.39

REC-3964 is Recursion’s first new chemical entity developed using the RecursionOS. REC-3964 represents a novel, non-antibiotic approach with a unique mechanism of action that binds and blocks catalytic activity of the toxin's innate glucosyltransferase in order to inhibit the toxin produced by C. diff. in the gastrointestinal tract. There are up to 175,000 cases of recurrent C. diff. each year and more than 29,000 patients die in the...Read more


Lexicon Pharmaceuticals Announces Completion of Screening in Phase 2B Progress Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP)

October 22
Last Trade: 1.95 0.00 0.00

Top-line Data Now Anticipated in Q1 2025  LX9211 has previously received Fast Track designation from the U.S. Food and Drug Administration (FDA) for DPNP  THE WOODLANDS, Texas, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has closed screening and expects to complete enrollment ahead of schedule in PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind,...Read more


BriaCell Therapeutics Reports Outperforming Metastatic Breast Cancer Patients and Standard-Beating Survival Data

October 22
Last Trade: 0.81 0.04 5.62

55% of BriaCell patients1 remained alive one year since enrollment in BriaCell’s Phase 2 study, markedly exceeding the survival rate of current standard of care for similar patients Multiple outperforming patients with overall survival of over 2 years Survival benefit observed even in heavily pre-treated patients who failed treatment with checkpoint inhibitors (CPIs) and/or antibody-drug conjugates (ADCs) Final median overall...Read more


Annexon Presents Phase 2 Vision Preservation Data with ANX007 in Dry AMD Patients with Less Advanced GA at the American Academy of Ophthalmology 2024 Meeting

October 21
Last Trade: 7.32 -0.22 -2.92

Enhanced protection of vision with ANX007 treatment in healthier eyes Greater preservation of EZ in the central fovea by ANX007 in patients with less advanced GA Pivotal Phase 3 ARCHER II Data Expected Second Half 2026 BRISBANE, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company focused on upstream C1q to advance therapies for neuroinflammatory diseases of the body, brain and eye,...Read more


Trevi Therapeutics Completes Enrollment for Phase 2a RIVER Trial in Refractory Chronic Cough

October 21
Last Trade: 2.95 -0.12 -3.76

Topline results are expected in the first quarter of 2025 NEW HAVEN, Conn., Oct. 21, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that it has completed enrollment in its Phase 2a...Read more


REGENXBIO Presents Positive Data from the Phase II Study of Subretinal ABBV-RGX-314 in Patients with Bilateral Wet AMD at AAO 2024

October 21
Last Trade: 8.59 -0.25 -2.83

97% reduction in treatment burden at nine months after treatment with ABBV-RGX-314 Data consistent with that from multiple previous studies demonstrating favorable safety and efficacy profile Well tolerated with zero cases of intraocular inflammation in a setting of no prophylactic steroids Data highlight the potential of ABBV-RGX-314 to treat both eyes in wet AMD ROCKVILLE, Md., Oct. 21, 2024 /PRNewswire/ -- REGENXBIO...Read more


Acurx Pharmaceuticals Announces New Bile Acid and Microbiome Analyses from Ph2b Trial of Ibezapolstat in CDI Patients Presented at IDWeek Scientific Conference

October 21
Last Trade: 1.88 -0.02 -1.05

The data presented indicate a favorable gut bile acid profile which may contribute to ibezapostat's beneficial anti-recurrence effect in patients with C. difficile Infection (CDI) Ibezapolstat treatment of patients with CDI is associated with the restoration of beneficial bacterial classes in the gut Preparation continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection...Read more


Gilead and Merck Announce Phase 2 Data Showing a Treatment Switch to an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression in Adults at Week 48

October 19
Last Trade: 88.82 0.53 0.60

Novel Investigational Combination Regimen is Advancing to Phase 3 and has the Potential to Become the First Weekly Oral HIV Treatment FOSTER CITY, Calif., & RAHWAY, N.J. / Oct 19, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new results from a Phase 2 clinical study evaluating the investigational combination of islatravir, an...Read more


Supernus Pharmaceuticals Announces Promising Data from Open-Label Phase 2a Study of SPN-820 in Adults with Major Depressive Disorder

October 17
Last Trade: 34.07 -0.80 -2.29

Phase 2a study demonstrated rapid and substantial decrease in depressive symptoms SPN-820 was well-tolerated with few adverse events SPN-820 is a novel, first-in-class intracellular modulator of mTORC1 for the treatment of depression Company to host webcast today at 4:30 p.m. ET to discuss the topline data Topline results from Phase 2b randomized double-blind placebo-controlled study of SPN-820 in adults with treatment-resistant...Read more


Amylyx Pharmaceuticals Announces Positive Topline Results from Phase 2 HELIOS Clinical Trial Demonstrating Sustained Improvements with AMX0035 in People Living with Wolfram Syndrome

October 17
Last Trade: 5.40 0.13 2.47

Improvement observed in pancreatic function, as measured by C-peptide response, following 24 weeks of treatment with AMX0035; worsening is typically expected with disease progression based on natural history studies of Wolfram syndrome Longer-term data for all participants who have completed Week 36 and Week 48 assessments showed sustained improvement over time Improvements or stabilization observed across all secondary endpoints,...Read more


IGC Pharma Announces Patient Enrollment at Toronto's Baycrest in Phase 2 Trial Investigating IGC-AD1

October 17
Last Trade: 0.39 -0.0089 -2.23

Company Expands Phase 2 trial to Canada  POTOMAC, MD / ACCESSWIRE / October 17, 2024 / IGC Pharma, Inc (NYSE American:IGC) ("IGC" or the "Company"), today announced enrollment of patients at the Baycrest Academy for Research and Education in Toronto, Ontario, Canada, as part of the Company's ongoing Phase 2 trial investigating IGC-AD1 as a treatment for agitation in Alzheimer's dementia. Agitation affects between 40-80% of...Read more


Anavex Life Sciences Announces Encouraging Preliminary Biomarker Results from Ongoing Phase 2 Study of ANAVEX®3-71 for the Treatment of Schizophrenia

October 17
Last Trade: 6.62 0.91 15.94

Part A of the placebo-controlled Phase 2 study has been completed ANAVEX®3-71 demonstrates a dose-dependent pharmacodynamic effect on objective EEG biomarkers of schizophrenia Patients are currently being dosed in Part B of the Phase 2 study which will investigate a longer treatment duration NEW YORK, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage...Read more


Verastem Oncology Presents Positive Updated RAMP 201 Data for Avutometinib and Defactinib Combination in Recurrent Low-Grade Serous Ovarian Cancer at the International Gynecologic Cancer Society (IGCS) 2024 Annual Meeting

October 17
Last Trade: 3.76 0.02 0.53

Robust overall response rates observed (31% overall, 44% in KRAS mutant, 17% in KRAS wild-type) in patients whose cancer had progressed despite prior treatment with chemotherapy and/or MEK inhibitors and/or bevacizumab Patients on avutometinib and defactinib achieved a median progression free survival of more than one year (12.9 months); 22 months in KRAS mutant population The Company recently met with the FDA to review the mature data...Read more


Wave Life Sciences Announces First-Ever Therapeutic RNA Editing in Humans Achieved in RestorAATion-2 Trial of WVE-006 in Alpha-1 Antitrypsin Deficiency

October 16
Last Trade: 13.71 -0.61 -4.26

Achieved proof-of-mechanism for Wave’s RNA editing platform; restoring levels of wild-type (edited) M-AAT that are consistent with the heterozygous “MZ” genotype with low risk of AATD lung and liver disease A single subcutaneous dose of WVE-006 in the first two patients with homozygous “ZZ” AATD resulted in mean plasma total AAT levels of ~11 micromolar, with mean wild-type M-AAT representing more than 60% of total AAT; durable editing...Read more


Alzamend Neuro Announces Full Data Set from Phase IIA Multiple Ascending Dose Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s

October 16
Last Trade: 1.57 0.01 0.64

Data confirm the positive topline results announced in June 2023 identifying a maximum tolerated dose as assessed by an independent safety review committee Identified dose is unlikely to require lithium therapeutic drug monitoring Data will guide upcoming “Lithium in Brain” Phase II clinical trials in partnership with Massachusetts General Hospital, which were announced in August 2024 ATLANTA / Oct 16, 2024 / Business Wire / Alzamend...Read more


OKYO Pharma Announces Start of Phase 2 Clinical Trial to Treat Patients with Neuropathic Corneal Pain

October 16
Last Trade: 1.18 0.02 1.29

Neuropathic corneal pain (NCP) is listed in the National Organization for Rare Disorders (NORD) as an orphan disease OKYO is the first company to have an IND application granted by the FDA for NCP The Phase 2 trial is designed as a randomized, placebo-controlled, double-masked study to treat 48 NCP patients OK-101 demonstrated statistically significant pain relief in a recently completed Phase 2 trial of dry eye disease LONDON...Read more


HUTCHMED Announces that TAGRISSO® plus ORPATHYS® demonstrated high, clinically meaningful response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trial

October 16
Last Trade: 18.00 -0.95 -5.01

New data demonstrate efficacy for the oral treatment combination to address MET-driven resistance in EGFR-mutated lung cancer  MET is a common biomarker in this setting for patients who develop resistance to EGFR targeted therapies  HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 16, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces positive high-level...Read more


CervoMed Announces Last Patient Last Visit in Phase 2b RewinD-LB Trial of Neflamapimod for the Treatment of Early-Stage Dementia with Lewy Bodies (DLB)

October 15
Last Trade: 13.65 -0.43 -3.05

On track to report topline data from the Phase 2b trial in December 2024 Neflamapimod has the potential to restore function and improve cognitive and motor functions in DLB patients 96% of patients enrolled in RewinD-LB completed the 16-week portion of the study, of which 98% continued into the open label extension BOSTON, Oct. 15, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical-stage company focused on developing...Read more


Cartesian Therapeutics Announces Presentation of Results from Phase 2b Trial of Descartes-08 in Patients with Myasthenia Gravis at the 2024 MGFA Scientific Session of the AANEM Annual Meeting

October 15
Last Trade: 19.80 -1.34 -6.34

GAITHERSBURG, Md., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced the presentation of data from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG) during the 2024 Myasthenia Gravis Foundation of America (MGFA) Scientific Session of the American...Read more


Clearside Biomedical Announces Positive Topline Results from ODYSSEY Phase 2b Trial of Suprachoroidal CLS-AX in Wet AMD Achieving All Primary and Secondary Outcomes

October 9
Last Trade: 1.02 -0.02 -1.92

Maintained Stable Visual Acuity and Anatomical Control Over 9 Months  Positive Safety Profile with No Ocular or Treatment-Related Serious Adverse Events  67% of CLS-AX Participants Did Not Require Any Additional Treatment up to 6 Months  Reduced Treatment Burden by 84% Over 6 Months  Webcast and Conference Call Today at 8:00 A.M. ET with Management and Key Opinion Leader and Board-Certified Retinal...Read more


MindBio Therapeutics Develops Long Term Shelf-Stable Microdosing Formulation and is Progressing in Multiple Phase 2B Clinical Trials

October 8
Last Trade: 0.04 0.00 0.00

Vancouver, British Columbia – TheNewswire - October 8, 2024 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a leading biopharmaceutical company in psychiatric medicine development using microdoses of psychedelic medicines, is delighted to report its microdosing formulation MB22001 has achieved shelf stability at room temperature for 12 months. MB22001 is a proprietary and self-titratable form of...Read more


Avalo Therapeutics Announces First Patient Dosed in Phase 2 LOTUS Trial of AVTX-009 for the Treatment of Hidradenitis Suppurativa

October 8
Last Trade: 13.01 0.43 3.42

Global study in approximately 180 adults with hidradenitis suppurativa to assess the efficacy and safety of two dose regimens of AVTX-009 compared to placebo Topline data expected in 2026 WAYNE, Pa. and ROCKVILLE, Md., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), today announced that the first patient has been dosed in the Company’s Phase 2 LOTUS trial of AVTX-009 in hidradenitis suppurativa (HS)....Read more


Sage Therapeutics Announces Topline Results from the Phase 2 LIGHTWAVE Study of Dalzanemdor (SAGE-718) in the Treatment of Mild Cognitive Impairment and Mild Dementia in Alzheimer’s Disease

October 8
Last Trade: 6.08 -0.36 -5.59

In the Phase 2 LIGHTWAVE Study, dalzanemdor (SAGE-718) did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the primary endpoint Dalzanemdor was generally well-tolerated and no new safety signals were observed Topline data from the Phase 2 DIMENSION Study of dalzanemdor in Huntington’s Disease expected later this year CAMBRIDGE, Mass. / Oct 08, 2024 /...Read more


Gilead Sciences Presents Additional Efficacy, Safety and Demographic Data From PURPOSE 2 Trial at 5th HIV Research for Prevention Conference

October 7
Last Trade: 88.82 0.53 0.60

Efficacy and Safety Data Demonstrated 96% Reduction in HIV Infections with Lenacapavir Compared to Background HIV Incidence Among a Geographically Diverse Population of Cisgender Men and Gender-Diverse People Gilead to Begin Regulatory Filings for Lenacapavir for PrEP by End of 2024 Gilead Recently Announced Voluntary Licensing Partners to Expand Future Access in High-Incidence, Resource-Limited Countries FOSTER CITY, Calif. / Oct...Read more


Theralase Technologies Provides Update on Bladder Cancer Clinical Study

October 7
Last Trade: 0.25 -0.005 -1.96

TORONTO, ON / ACCESSWIRE / October 7, 2024 / Theralase® Technologies Inc. ("Theralase®" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses, is pleased to announce that it is providing an...Read more


Trevi Therapeutics Provides Update on Haduvio's Clinical Development Program

October 3
Last Trade: 2.95 -0.12 -3.76

Phase 2b CORAL trial in idiopathic pulmonary fibrosis (IPF) chronic cough reaches 50% enrollment milestone; sample size re-estimation results expected in December 2024 Human Abuse Potential (HAP) study dosing complete; topline results expected in December 2024 NEW HAVEN, Conn., Oct. 3, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy...Read more


Abivax Announces First Patient Enrolled in ENHANCE-CD, the Phase 2b Trial of Obefazimod in Crohn’s Disease

October 3
Last Trade: 10.32 -0.17 -1.62

PARIS, France, October 3, 2024 – 10:00 p.m. CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX; Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced the first patient was enrolled in its Phase 2b ENHANCE-CD (NCT06456593)...Read more


OS Therapies Announces Last Patient Enrolled in OST-HER2 Osteosarcoma Phase 2b Clinical Trial Completes Last Patient Visit

October 3
Last Trade: 2.62 -0.10 -3.50

Company to ring Closing Bell at NYSE on Thursday, October 3, 2024 Interviews scheduled with Fintech.TV and Schwab Network NEW YORK / Oct 03, 2024 / Business Wire / OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announces that the last patient (Patient #41) enrolled in the AOST-2121 clinical trial (NCT04974008) of OST-HER2...Read more


Recent clinical data confirms significantly improved predictive power of Evaxion Biotech's AI-Immunology™ platform

October 3
Last Trade: 2.67 -0.09 -3.26

Improved precision of the AI-Immunology™ platform in predicting clinically relevant vaccine targets boosts the potential of its AI-derived vaccine candidates The improvement has been achieved through iterative learning and the integration of advanced bioinformatics and machine learning techniques In the ongoing phase 2 trial with personalized cancer vaccine EVX-01, 79% of the AI-Immunology™ predicted vaccine targets triggered a...Read more


Immutep Completes Patient Enrolment in Randomised Phase II of AIPAC-003 Trial in Metastatic Breast Cancer

October 3
Last Trade: 1.82 -0.14 -6.92

SYDNEY, AUSTRALIA, Oct. 03, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces patient enrolment has been completed in the randomised Phase II portion of the AIPAC-003 (Active Immunotherapy and PAClitaxel) clinical trial. The Phase II enrolled 65 metastatic hormone...Read more


Abivax Reports Positive Interim Efficacy and Safety Analysis of Once-Daily 25mg Obefazimod in Moderate to Severe Ulcerative Colitis Patients After 2-Years of Open-Label Maintenance

October 3
Last Trade: 10.32 -0.17 -1.62

Patients treated with a de-escalated dose of 25 mg of obefazimod once daily demonstrated maintenance of clinical remission at weeks 48 and 96 Efficacy and safety demonstrated out to six years of treatment The treatment was well-tolerated, with a safety profile consistent with previous studies and no new safety signals detected PARIS, France, October 3, 2024, 8:30 a.m. CEST – Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax”...Read more


Processa Pharmaceuticals Announces First Patient Dosed in Phase 2 Clinical Trial of NGC-Cap in Metastatic Breast Cancer

October 2
Last Trade: 1.16 -0.18 -13.16

Phase 2 trial is an adaptive designed randomized study comparing NGC-Cap to monotherapy capecitabine Results from this Phase 2 trial will evaluate NGC-Cap’s safety-efficacy profile and help to define the optimal dosage regimen in patients with metastatic breast cancer HANOVER, Md., Oct. 02, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company...Read more


PDS Biotechnology Announces 36-Month Overall Survival Rate of 84.4% in Locally Advanced Cervical Cancer Patients Treated with Versamune® HPV and Chemoradiation

October 2
Last Trade: 3.19 -0.03 -0.78

100% 36-month overall survival (OS) and progression-free survival (PFS) rates in patients fully treated with Versamune® HPV combined with chemoradiation (N=8) 88% (15/17) of patients had a complete metabolic response IMMUNOCERV Phase 2 clinical trial results presented at ASTRO Annual Meeting 2024 PRINCETON, N.J., Oct. 02, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a...Read more


Barinthus Biotherapeutics Completes Enrollment for Phase 2b HBV003 Clinical Trial in Chronic Hepatitis B and Phase 1 PCA001 Clinical Trial in Prostate Cancer

October 1
Last Trade: 1.49 0.06 4.20

Investigational immunotherapy, VTP-300, is being evaluated as part of a potential functional cure regimen for chronic Hepatitis B. Interim data update for HBV003 anticipated in Q4 2024. Data update for PCA001 anticipated in H1 2025. OXFORD, United Kingdom, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS), a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that...Read more


BriaCell Therapeutics Reports 100% Resolution of Brain Metastasis in Breast Cancer Patient with “Eye-Bulging” Tumor

October 1
Last Trade: 0.81 0.04 5.62

Dramatic anti-tumor response includes complete resolution of right temporal lobe brain metastasis in patient with “Eye-Bulging” metastatic breast cancer Heavily pre-treated patient had failed 8 prior regimens including antibody-drug conjugate (ADC) therapy and continues to receive BriaCell treatment PHILADELPHIA and VANCOUVER, British Columbia, Oct. 01, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX:...Read more


Vaxart Announces Initiation of Sentinel Cohort for Phase 2b Study Evaluating Its COVID-19 Oral Pill Vaccine Candidate

September 30
Last Trade: 0.77 -0.02 -2.50

400 subject sentinel portion of Phase 2b study will evaluate the safety, immunogenicity and efficacy of Vaxart’s next generation oral pill COVID-19 vaccine compared to an approved mRNA vaccine comparator  The sentinel cohort is being funded as part of the Phase 2b NextGen COVID-19 clinical trial, valued at up to $456 million through the Rapid Response Partnership Vehicle under the U.S. government’s Project NextGen  SOUTH...Read more


Gritstone bio Announces Interim Phase 2 Data for GRANITE Individualized Neoantigen Targeting Immunotherapy in Frontline Metastatic Microsatellite Stable Colorectal Cancer

September 30
Last Trade: 0.03 0.00 0.00

Encouraging progression-free survival data in overall population; continued follow-up needed to allow data to mature further, especially in low ctDNA subgroup where events accrue more slowly 21% relative risk reduction of progression or death with GRANITE vs. control in all treated population (HR=0.79 [95% CI, 0.42-1.50]) 38% relative risk reduction of progression or death with GRANITE vs. control in low ctDNA subgroup (HR=0.62 [95%...Read more


Kezar Life Sciences Announces Cessation of Enrollment and Dosing in the Phase 2b PALIZADE Trial of Zetomipzomib in Active Lupus Nephritis Patients

September 30
Last Trade: 7.45 -0.74 -9.04

SOUTH SAN FRANCISCO, Calif. / Sep 30, 2024 / Business Wire / Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company developing a novel small molecule to treat unmet needs in immune-mediated diseases, today announced the voluntary cessation in enrollment of new patients and dosing of ongoing patients in the Phase 2b PALIZADE clinical trial, pending further evaluation. PALIZADE is a global, placebo-controlled,...Read more


Ascendis Pharma: New 3-Year Skeletal Dynamics Data for Adults with Hypoparathyroidism Treated with TransCon™ PTH (Palopegteriparatide) Presented at ASBMR 2024

September 30
Last Trade: 122.82 0.02 0.02

COPENHAGEN, Denmark, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) shared 3-year results from the Company’s ongoing Phase 2 PaTH Forward Trial of 57 adults with hypoparathyroidism showing that long-term treatment with TransCon™ PTH (palopegteriparatide; marketed as YORVIPATH®) through Week 162 drove bone remodeling into the normal range. Deficiency of parathyroid hormone is associated with low rates of bone...Read more


Windtree Therapeutics Announces Positive Phase 2b Topline Clinical Results with Istaroxime Significantly Improving Cardiac Function and Blood Pressure in Heart Failure Patients in Early Cardiogenic Shock

September 30
Last Trade: 0.70 -0.04 -5.36

Istaroxime treatment significantly improved systolic blood pressure as well as cardiac output and renal function without increasing heart rate or clinically significant arrythmias NYHA heart failure classification was improved up to 72 hours with a serious adverse event profile generally similar to placebo WARRINGTON, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) --  Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM:...Read more


INmune Bio Completes Enrollment for Phase 2 Trial in Early Alzheimer's Disease

September 30
Last Trade: 5.85 -0.10 -1.68

Boca Raton, Florida, Sept. 30, 2024 (GLOBE NEWSWIRE) --  INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s Disease (AD), announced today that it closed enrollment for its Phase 2 trial on Friday, 27 September. This global, blinded, randomized Phase 2 trial (the “AD02 trial”) is focused on...Read more


Helius Medical Technologies Announces Positive Preliminary Results of the PoNSTEP Study

September 30
Last Trade: 0.51 -0.04 -7.78

Achieves primary endpoint showing a linear relationship between adherence to PoNS Therapy® in Phase 2 and improvement in DGI scores from Phase 1 to end of treatment at week 14  Confirms the therapeutic benefits of PoNS Therapy for gait deficit improvement in people with MS  NEWTOWN, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company...Read more


Biohaven Initiates Pivotal Trial of Novel Investigational Drug for Treatment of Migraine

September 30
Last Trade: 49.76 -0.70 -1.39

Biohaven initiated a pivotal Phase 2 trial evaluating BHV-2100 in the acute treatment of migraine BHV-2100 is a potential first-in-class, potent, orally administered Transient Receptor Potential Melastatin-3 (TRPM3) antagonist— a novel, highly selective, and non-opioid investigational treatment being developed for migraine and other pain disorders Despite recent treatment advances, migraine remains a leading cause of disability and...Read more


Altimmune Completes Enrollment in Phase 2b IMPACT Trial of Pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis (MASH)

September 30
Last Trade: 6.74 -0.02 -0.30

IMPACT trial is evaluating the safety and efficacy of pemvidutide in approximately 190 subjects with MASH; top-line efficacy data expected in Q2 2025 End-of-Phase 2 Meeting for the obesity program with U.S. Food and Drug Administration (FDA) has been scheduled for early November 2024 Company plans to submit Investigational New Drug (IND) applications for pemvidutide in up to three additional indications beginning in Q4...Read more


Leap Therapeutics Announces Completion of Enrollment in Part B of the DeFianCe Study of DKN-01 for the Treatment of Colorectal Cancer Patients

September 30
Last Trade: 3.74 -0.43 -10.31

CAMBRIDGE, Mass., Sept. 30, 2024 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced that enrollment of 188 patients has been completed in the randomized controlled Part B of the DeFianCe study evaluating DKN-01, Leap's anti-Dickkopf-1 (DKK1) antibody, in combination with standard of care bevacizumab and chemotherapy as a...Read more


Alumis: Late-Breaking Data at EADV of ESK-001, an Oral TYK2 Inhibitor for the Treatment of Psoriasis, Demonstrate Significant Responses with Sustained Increases Over 28 Weeks in Phase 2 OLE Study

September 27
Last Trade: 11.32 0.00 0.00

28-week data show ESK-001 was generally well tolerated and most patients treated with the top dose of 40 mg twice daily achieved PASI 75 Three additional data presentations further support ESK-001’s potential to offer a highly differentiated and best-in-class treatment profile for people with moderate-to-severe plaque psoriasis Full 52-week Phase 2 OLE dataset expected 1H 2025; Phase 3 clinical program ongoing SOUTH SAN FRANCISCO,...Read more


Acurx Pharmaceuticals Announces Additional Ibezapolstat Ph2b Results in CDI as well as Anthrax (B. anthracis) Susceptibility to ACX-375 Analogues

September 26
Last Trade: 1.88 -0.02 -1.05

New analyses extend data on beneficial effects of ibezapolstat on the gut microbiome Confirmed ibezapolstat's favorable pharmacokinetics showing low systemic exposure and high colonic concentrations Selected ACX-375 analogues demonstrated in vitro activity against Anthrax (B. anthracis), a Bioterrorism Category A pathogen, including activity against ciprofloxacin resistant Anthrax. Planning is underway for an Anthrax bioterrorism...Read more


Enanta Pharmaceuticals Announces Positive Topline Results for EDP-323 in a Phase 2a Human Challenge Study of Healthy Adults Infected With Respiratory Syncytial Virus (RSV)

September 26
Last Trade: 11.25 -0.25 -2.18

Treatment With Once-Daily EDP-323 Met Primary and Secondary Endpoints, Achieving Highly Statistically Significant Reductions in Both Viral Load and Clinical Symptoms Compared to Placebo Favorable Safety and Tolerability Observed Conference Call and Webcast to Discuss Data at 8:30 a.m. ET Today WATERTOWN, Mass. / Sep 26, 2024 / Business Wire / Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated...Read more


Celldex Therapeutics Presents Landmark 52 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EADV 2024

September 25
Last Trade: 26.06 -0.27 -1.03

71% of patients (150 mg Q4W) achieved complete response at Week 52 Rapid, profound and durable improvement in UAS7 as early as Week 1 with a deepening of response over 52 weeks Robust improvement across omalizumab-experienced/refractory/naïve disease Well tolerated through 52 weeks Enrollment to Global Phase 3 CSU trials underway Company to host webcast today at 12:00 pm ET/6:00 pm CEST HAMPTON, N.J., Sept. 25, 2024 (GLOBE...Read more


Cyclacel Pharmaceuticals Announces Completion of Enrollment in the Biomarker-Enriched Patient Cohort of Its Phase 2 Study

September 25
Last Trade: 0.65 -0.008 -1.22

Patients are preselected for CDKN2A and/or CDKN2B abnormalities Safety and efficacy data to be reported at an upcoming oncology medical conference BERKELEY HEIGHTS, N.J., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative cancer medicines, today announced that enrollment of 12 patients has been completed as...Read more


Windtree Therapeutics Announces Positive Topline Results from Its Phase 2b SEISMiC Extension Study of Istaroxime in Early Cardiogenic Shock

September 25
Last Trade: 0.70 -0.04 -5.36

Istaroxime significantly improved primary endpoint of the systolic blood pressure profile over six hours and showed significant improvements in many secondary endpoint assessments Study results to be presented at the Heart Failure Society of America Medical Conference on September 30, 2024 WARRINGTON, Pa., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a...Read more


Mineralys Therapeutics Completes Target Enrollment in Pivotal Advance-HTN Trial of Lorundrostat for the Treatment of Hypertension

September 25
Last Trade: 13.38 -0.40 -2.90

On track to announce topline data in Q1 2025  Virtual KOL event scheduled on October 30th to discuss the unmet need in hypertension, as well as a review of the ongoing pivotal clinical program for lorundrostat in hypertension  RADNOR, Pa., Sept. 25, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic...Read more


Lipella Pharmaceuticals Reports Encouraging Early Tolerability Results in Phase 2a Trial of LP-310 for Oral Lichen Planus

September 24
Last Trade: 0.39 -0.02 -5.22

PITTSBURGH, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on addressing serious diseases with significant unmet needs, today announced an update on its ongoing multi-center Phase 2a clinical trial evaluating LP-310 for the treatment of Oral Lichen Planus (OLP). The Company reported that three participants have completed the...Read more


Wave Life Sciences Announces Positive Interim Data from FORWARD-53 Clinical Trial Evaluating WVE-N531 in Boys with Duchenne Muscular Dystrophy Amenable to Exon 53 Skipping

September 24
Last Trade: 13.71 -0.61 -4.26

Mean muscle content-adjusted dystrophin expression of 9.0% and unadjusted dystrophin of 5.5%, with high consistency across participants, in a prespecified analysis; dystrophin was comprised of two isoforms consistent with Becker muscular dystrophy patients who display milder disease Data demonstrated meaningful improvement in serum biomarkers for muscle health, with localization of WVE-N531 in myogenic stem cells and regeneration of...Read more


Cardiol Therapeutics Achieves Target Patient Enrollment in its Phase II ARCHER Trial Investigating CardiolRx(TM) for Acute Myocarditis

September 24
Last Trade: 1.80 -0.02 -1.10

Toronto, Ontario--(Newsfile Corp. - September 24, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced it has achieved the target patient enrollment of 100 patients in "ARCHER", its Phase II randomized,...Read more


MindBio Therapeutics Enrols 25th Participant into Landmark Take-Home Microdosing Depression Trial

September 23
Last Trade: 0.04 0.00 0.00

Vancouver, British Columbia – TheNewswire - September 23, 2024 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), a leading biopharmaceutical company in psychiatric medicine development, is delighted to report it has enrolled its 25th participant into its landmark clinical trial of MB22001 in patients with Major Depressive Disorder. The Company has entered multiple Phase 2B trials with confidence,...Read more


Cidara Therapeutics Announces First Subjects Dosed in Phase 2b NAVIGATE Trial Evaluating CD388 for the Prevention of Seasonal Influenza

September 23
Last Trade: 13.00 0.17 1.33

SAN DIEGO, Sept. 23, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the first subjects dosed in the Phase 2b NAVIGATE trial to evaluate the efficacy and safety of CD388 for the pre-exposure...Read more


Theriva Biologics Achieves Target Patient Enrollment in the VIRAGE Phase 2b Trial of VCN-01 with Gemcitabine/nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer

September 23
Last Trade: 1.46 -0.02 -1.35

Target of 92 evaluable patients (46 in each of the control and VCN-01 treatment arms) enrolled across 15 sites in Spain and the USA within 21 months  ROCKVILLE, Md., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today...Read more


Black Diamond Therapeutics Announces Initial Phase 2 Data Demonstrating Robust Anti-tumor Activity of BDTX-1535 in Patients with Recurrent EGFRm NSCLC who Present with a Broad Spectrum of Classical, Non-classical, and C797S Resistance Mutations

September 23
Last Trade: 2.74 -0.13 -4.53

BDTX-1535 dose of 200 mg daily selected for pivotal development; favorable tolerability profile and no new safety signals observed Preliminary ORR of 42% in 19 patients at 200 mg with on-target resistance EGFR mutations Encouraging durability with DOR of approximately 8 months or more for first 3 patients with a PR; 14 of 19 patients remain on treatment Regulatory feedback on registration path anticipated in Q1 2025 Initial results...Read more


IDEAYA Biosciences Announces Positive Interim Phase 2 Data for Darovasertib and Successful FDA Type C Meeting on Registrational Trial Design for Regulatory Approval in Neoadjuvant Uveal Melanoma

September 23
Last Trade: 28.15 -1.31 -4.45

Phase 2 company-sponsored and IST neoadjuvant uveal melanoma (UM) clinical data update in 49 evaluable patients, demonstrates ~49% of patients with >30% tumor shrinkage by product of diameters, and ~61% eye preservation rate for enucleation patients Targeting to initiate Phase 3 randomized registrational trial in neoadjuvant UM following finalization of the clinical protocol with FDA Clinical endpoints supportive of full approval...Read more


Novo Nordisk: Monlunabant phase 2a trial in obesity successfully completed

September 20
Last Trade: 111.95 -1.29 -1.14

Bagsværd, Denmark, 20 September 2024 – Novo Nordisk today announced headline results from a phase 2a clinical trial with monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist. Monlunabant, formerly INV-202, was part of the acquisition of Inversago Pharmaceuticals Inc. announced in August 2023 [Link]. The trial investigated the efficacy and safety of a once-daily 10 mg, 20 mg and 50 mg dose of monlunabant...Read more


Kiromic BioPharma Advances Deltacel-01 Into Expansion Phase Following Safety Monitoring Committee’s Unanimous Recommendation

September 19
Last Trade: 1.15 0.14 13.86

HOUSTON / Sep 19, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announced today that the Deltacel-01 Safety Monitoring Committee (SMC) has unanimously voted in favor of proceeding with the expansion phase of the Deltacel-01 clinical trial. This trial is evaluating Deltacel™ (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic...Read more


Aligos Therapeutics Announces Positive Topline Results from the Phase 2a HERALD Study of ALG-055009 for the Treatment of MASH

September 19
Last Trade: 9.78 0.01 0.10

ALG-055009 dose groups met the primary endpoint with statistically significant reductions in liver fat at Week 12 as measured by MRI-PDFF Placebo-adjusted median relative reductions in liver fat were up to 46.2% with a clear dose response ALG-055009 was well-tolerated with no serious adverse events or dose reductions. Importantly, ALG-055009 dose groups had a similar incidence of gastrointestinal-related adverse events with less...Read more


Oncolytics Biotech® Reports Favorable Results for BRACELET-1 Breast Cancer Study Reinforcing Path to Funding of a Registration-Enabling Study

September 19
Last Trade: 1.15 -0.04 -3.36

Overall survival (OS) results from BRACELET-1 corroborate results of previous randomized IND-213 breast cancer study Together, these two studies support the compelling potential of pelareorep-based combination therapy to benefit patients with advanced or metastatic HR+/HER2- breast cancer Oncolytics Biotech is moving forward to secure funding for a registration-enabling study of pelareorep-based therapy in advanced or metastatic...Read more


Edgewise Therapeutics Announces Positive Top-Line Data from Phase 1 Trial in Healthy Subjects and Phase 2 CIRRUS-HCM Trial in Patients with Obstructive Hypertrophic Cardiomyopathy (HCM)

September 19
Last Trade: 33.57 0.25 0.75

In a Phase 1 in healthy subjects, EDG-7500 was well-tolerated without meaningful changes in left ventricle ejection fraction (LVEF)  CIRRUS-HCM single-dose trial of EDG-7500 in obstructive HCM demonstrated robust left ventricular outflow tract (LVOT) gradient reductions without meaningful changes in LVEF  Company announced dosing of first patients in CIRRUS-HCM 28-day trial  Edgewise to host webcast event on Thursday,...Read more


Kyverna Therapeutics Presents Patient Data Reinforcing Potential of KYV-101 for Treatment of Neuroinflammatory Diseases in Symposium at ECTRIMS 2024

September 18
Last Trade: 4.78 -0.54 -10.15

Company symposium to highlight case reports from 11 patients with stiff-person syndrome, myasthenia gravis and multiple sclerosis reinforcing KYV-101's initial efficacy and safety profile and broad potential in B cell-driven neuroinflammatory diseases Key biomarkers indicate potential for KYV-101 to durably modify neuroinflammatory diseases with immune system reset Kyverna to present posters on design and methods for...Read more


Immunic Presents Key Vidofludimus Calcium Data at the 40th Congress of ECTRIMS, Highlighting Its Therapeutic Potential in Multiple Sclerosis

September 18
Last Trade: 1.21 -0.03 -2.42

Vidofludimus Calcium Consistently Reduced Neurofilament Light Chain Levels, Compared to Placebo, in the Interim Analysis of the Phase 2 CALLIPER Trial, Across Age and Disability Levels at Baseline For All Progressive Multiple Sclerosis Subtypes  Clinical Signal Shown for Vidofludimus Calcium on Post COVID Fatigue May Be Related to Epstein-Barr Virus Reactivation; Preventing This Reactivation May Contribute to Fatigue...Read more


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