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Latest Phase 2 Clinical Trials Stock News

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G1 Therapeutics: Trilaciclib Increases Pool of Memory T Cells in the Tumor Microenvironment Responsible for Long Term Immune Surveillance and Efficacy

June 4
Last Trade: 2.62 0.09 3.56

Phase 2 Mechanism of Action Trial Results Demonstrate the Immunomodulatory Effects of Trilaciclib in the Tumor Microenvironment Trilaciclib Enhances Expression of Genes Associated with Memory T Cells Trilaciclib Increases Multiple Surrogate Immune Markers for Memory CD8+ T Cell Differentiation, Infiltration,and Function RESEARCH TRIANGLE PARK, N.C., June 04, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a...Read more

Day One Biopharmaceuticals Announces New FIREFLY-1 Data for Tovorafenib (DAY101) and Initiation of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma

June 4
Last Trade: 13.60 -0.05 -0.37

Overall response rate (ORR) of 67% and clinical benefit rate (CBR) of 93% in 69 heavily pretreated RANO-HGG evaluable patients The Company expects to complete rolling NDA submission in October 2023 Conference call and webcast today at 6:00 p.m. CT BRISBANE, Calif., June 04, 2023 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals (Nasdaq: DAWN) (“Day One” or the “Company”), a clinical-stage biopharmaceutical Company dedicated to...Read more

Puma Biotechnology Announces Presentation of Biomarker Findings from a Phase II Study of Alisertib with Paclitaxel versus Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer at the 2023 ASCO Annual Meeting

June 4
Last Trade: 3.55 0.11 3.20

LOS ANGELES / Jun 04, 2023 / Business Wire / Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of biomarker findings from a Phase II study of alisertib plus paclitaxel versus paclitaxel alone ( identifier NCT02187991) in metastatic hormone receptor positive (HR+) and triple negative (TN) breast cancer at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting held...Read more

NewAmsterdam Pharma Presents Full Data from Phase 2 ROSE2 Trial Evaluating Obicetrapib in Combination with Ezetimibe as an Adjunct to High-Intensity Statin Therapy at NLA Scientific Sessions 2023

June 3
Last Trade: 13.78 -0.01 -0.07

Met Primary Endpoint with 63.4% Median Reduction in LDL-C (p<0.0001) 87.1% of Patients Treated with Combination of Obicetrapib and Ezetimibe Met Guideline-Recommended LDL-C Goal of <55 mg/dL compared to 0% of Patients Treated with Placebo (p<0.05) New Data Demonstrate Statistically Significant and Clinically Meaningful Improvements in Additional Lipid and Lipoprotein Parameters Predictive of Cardiovascular Disease Risk, Such...Read more

Apexigen Announces Phase 2 Data Evaluating Sotigalimab, its CD40 Agonist Antibody, in Combination with Doxorubicin in Patients with Advanced Soft Tissue Sarcoma Presented at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting

June 3
Last Trade: 0.56 0.0099 1.80

Marked increases in overall survival observed across soft tissue sarcoma patients Demonstrated improvement of median progression free survival in patients with dedifferentiated liposarcoma (DDLPS) DDLPS expansion cohort enrolling to inform a potential Phase 3 registration trial SAN CARLOS, Calif., June 03, 2023 (GLOBE NEWSWIRE) -- Apexigen, Inc. (Nasdaq: APGN) a clinical-stage company focused on developing innovative antibody-based...Read more

Zevra Therapeutics Presents Design of Phase 2 Clinical Trial Investigating KP1077 for the Treatment of Idiopathic Hypersomnia (IH) at Beyond Sleepy 2023

June 3
Last Trade: 5.04 -0.08 -1.56

Zevra is a corporate sponsor of the Hypersomnia Foundation and Beyond Sleepy Conference CELEBRATION, Fla., June 03, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company, formerly Zevra.), a rare disease therapeutics company, today announced that an oral presentation featuring the Phase 2 clinical trial design evaluating KP1077 as a treatment for idiopathic hypersomnia (IH), a rare neurological...Read more

Jazz Pharmaceuticals and Zymeworks Present Positive Pivotal Phase 2b Trial Data at ASCO 2023 Evaluating Zanidatamab in HER2-Amplified Biliary Tract Cancers

June 2
Last Trade: 128.34 -0.78 -0.60

Results presented today at ASCO 2023 and concurrently published in The Lancet Oncology demonstrate meaningful clinical benefit including antitumor activity, confirmed objective response rate (cORR) of 41.3%, median duration of response (DOR) of 12.9 months, and median progression-free survival (PFS) of 5.5 months (median study follow-up time of 12.4 months) Biliary tract cancers (BTC) are an aggressive group of cancers with no...Read more

Autolus Therapeutics Presents Positive Results from Pivotal Phase 2 FELIX study in adult r/r B-ALL at ASCO

June 2
Last Trade: 2.90 -0.23 -7.35

76% of patients treated with obe-cel in the FELIX study achieved a response (CR/CRi), primary endpoint has been met based on previously communicated interim analysis Potential best in class tolerability, with very low levels of high-grade CRS and ICANS Robust and reliable manufacturing and logistics, with 84% of enrolled patients receiving obe-cel Analyst call to be held today, June 2, 2023 at 4.00 pm ET/9.00 pm BST LONDON, June...Read more

SciSparc Announces Successful Final Phase IIa Results, Meeting End Points of its Phase IIa Alzheimer Disease Patients with Agitation Trial

June 2
Last Trade: 0.62 -0.21 -24.95

Tel-Aviv, June 02, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (NASDAQ: SPRC), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (the “Company” or “SciSparc”), today announced positive topline results from its investigator-initiated Phase IIa trial at the Sophie & Abraham Stuchynski Israeli Alzheimer’s Medical Center (“IMCA”), which suggest that the...Read more

Patient Enrollment Begins in Third and Final Cohort of the Phase 2 MATRICS-1 Clinical Study Evaluating Athersys’ MultiStem® Following Hemorrhagic Trauma

June 1
Last Trade: 0.97 -0.0059 -0.60

CLEVELAND / Jun 01, 2023 / Business Wire / Athersys, Inc. (NASDAQ: ATHX), a regenerative medicine company developing MultiStem® (invimestrocel) cell therapy for critical care indications, announces patient enrollment has begun in the third and final cohort in MATRICS-1, the Phase 2 clinical study evaluating MultiStem® in patients following resuscitation from hemorrhagic trauma. This study is being conducted at The University of Texas Health...Read more

Connect Biopharma Announces Positive Long-Term Data from the Maintenance Period Through Week 48 of CN002 Phase 2 Icanbelimod Trial in Patients with Moderate-to-Severe Ulcerative Colitis

June 1
Last Trade: 1.22 0.11 9.91

Icanbelimod demonstrated sustained clinical remission, a regulatory relevant efficacy endpoint, through Week 48 in 80% of patients who achieved clinical remission at Week 12 of the induction period. Icanbelimod continued to be well-tolerated, consistent with observed induction period safety data. SAN DIEGO, CA and TAICANG, China, June 01, 2023 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma”...Read more

Ionis Pharmaceuticals announces positive donidalorsen late-stage clinical progress in HAE

June 1
Last Trade: 41.75 -1.19 -2.77

Two-year treatment with donidalorsen in the Phase 2 open label study resulted in consistent, sustained protection from HAE attacks Completed enrollment in the Phase 3 OASIS-HAE study Topline Phase 3 results expected in H1 2024 CARLSBAD, Calif., June 1, 2023 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive clinical progress with donidalorsen, its late-stage investigational prophylactic therapy for...Read more

Aurinia Pharmaceuticals: LUPKYNIS® (voclosporin) Achieved Significantly Higher Renal Response in Lupus Nephritis Patients with High Proteinuria Compared to Patients Treated with MMF and Low Dose Steroids Alone

June 1
Last Trade: 9.54 0.42 4.61

EDMONTON, Alberta / Jun 01, 2023 / Business Wire / Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced the results of a post-hoc, pooled analysis of the Phase 2 AURA-LV (NCT02141672) and Phase 3 AURORA 1 (NCT03021499) studies, which found that LUPKYNIS® with mycophenolate mofetil (MMF) and low-dose steroids resulted in earlier and greater reductions in proteinuria in lupus nephritis (LN) patients with high...Read more

Clearside Biomedical Opens Enrollment in ODYSSEY Phase 2b Clinical Trial of CLS-AX (axitinib injectable suspension) in Wet AMD

June 1
Last Trade: 1.15 0.03 2.68

U.S. Clinical Sites Screening Treatment-Experienced Participants with Wet AMD  ODYSSEY Topline Results Expected in Q3 2024  ALPHARETTA, Ga., June 01, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that enrollment has opened in ODYSSEY, its Phase 2b...Read more

HOOKIPA Pharma Announces Positive Preliminary Phase 2 Data on HB-200 in Combination with Pembrolizumab in Patients with HPV16+ Head and Neck Cancers

May 31
Last Trade: 1.13 0.01 0.89

HB-200 in combination with pembrolizumab doubled the objective response rate of 1st-line pembrolizumab for patients with recurrent/metastatic head and neck cancer HOOKIPA is preparing to start a pivotal trial of HB-200 in combination with pembrolizumab as 1st-line treatment of recurrent/metastatic HPV16+ head and neck cancer in 2024 Initial cohort of heavily pre-treated patients who received HB-200 monotherapy showed preliminary...Read more

AbbVie: Phase 2 Study of Upadacitinib (RINVOQ®) Alone or as a Combination Therapy Meets Primary and Key Secondary Endpoints in Patients with Systemic Lupus Erythematosus

May 31
Last Trade: 136.87 3.43 2.57

At week 24, upadacitinib 30 mg given alone or as a combination therapy (ABBV-599 high dose [elsubrutinib 60 mg and upadacitinib 30 mg]) met the primary endpoint of systemic lupus erythematosus (SLE) Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day in patients with moderately to severely active SLE receiving standard lupus therapies1 Upadacitinib maintained greater improvements...Read more

Alterity Therapeutics Initiates Second Phase 2 Study in Rare Parkinsonian Disorder

May 30
Last Trade: 2.85 0.13 4.60

ATH434 now being evaluated in early and more advanced Multiple System Atrophy  New trial expected to generate data before ongoing Phase 2 trial  MELBOURNE, Australia and SAN FRANCISCO, May 30, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced it...Read more

SpringWorks Therapeutics Announces Full Enrollment of Phase 2 Trial Evaluating Nirogacestat in Patients with Ovarian Granulosa Cell Tumors

May 30
Last Trade: 27.34 -0.35 -1.26

STAMFORD, Conn., May 30, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that it has achieved full enrollment in its Phase 2 trial evaluating nirogacestat, an investigational gamma secretase inhibitor, as a monotherapy in patients with recurrent ovarian...Read more

Genprex Receives Safety Review Committee Approval to Advance to Phase 2 Expansion Portion of Acclaim-1 Clinical Trial of REQORSA® in Combination with Tagrisso® in Advanced Non-Small Cell Lung Cancer

May 30
Last Trade: 1.04 0.11 11.35

Results from Phase 1 Portion Indicate Favorable Safety Profile of Novel Gene Therapy in Solid Tumor Cancer AUSTIN, Texas, May 30, 2023 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that it has completed the Phase 1 portion of the Acclaim-1 Phase 1/2 clinical trial...Read more

Silo Pharma Commences Study of Novel Joint Homing Peptide SPU-21

May 30
Last Trade: 2.21 0.04 1.84

Phase 2 of study will further investigate the peptides’ method, optimization, and binding affinity in human tissue ENGLEWOOD CLIFFS, NJ, May 30, 2023 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced its entry into a research agreement expanding the study of its novel joint...Read more

Immuron Initiates Recruitment of Travelan® Clinical Study

May 30
Last Trade: 1.91 -0.09 -4.26

Highlights: Immuron receives approval from U.S. Army Medical Research and Development Command Recruitment and screening of healthy volunteers for Travelan® Controlled Human Infection Model (CHIM) Clinical Trial is in progress Clinical Trial to examine a dosing regimen for Travelan® more suited to the US military will commence shortly Travelan® is known to protect against the onset of Travelers diarrhea (TD), the most common illness...Read more

Structure Therapeutics Initiates Phase 2a Study of Oral GLP-1 agonist GSBR-1290 for the Treatment of Type 2 Diabetes and Obesity

May 25
Last Trade: 31.93 -0.14 -0.44

12-week Phase 2a and Phase 1b multiple ascending dose (MAD) topline results expected to be announced in latter half of fourth quarter 2023 Ethnobridging study initiated in Japanese individuals and formulation bridging study planned to evaluate tablet formulation in preparation for global Phase 2b study of GSBR-1290 in 2024 SAN FRANCISCO and SHANGHAI, China, May 25, 2023 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ:...Read more

Apellis Pharmaceuticals Reports Top-Line Results from Phase 2 MERIDIAN Study in ALS

May 25
Last Trade: 87.96 0.65 0.74

WALTHAM, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Phase 2 MERIDIAN study investigating systemic pegcetacoplan for the treatment of amyotrophic lateral sclerosis (ALS) did not meet its primary endpoint of the Combined Assessment of Function and Survival (CAFS) rank score at Week 52. The study also did not meet key secondary efficacy endpoints. Systemic pegcetacoplan was...Read more

Onconova Therapeutics Announces Dosing of First Participant in Investigator-Sponsored Phase 2 Trial of Rigosertib Plus Pembrolizumab in Metastatic Melanoma Patients Refractory to Immune Checkpoint Blockade

May 25
Last Trade: 1.20 0.02 1.69

NEWTOWN, Pa., May 25, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the first participant has been dosed in an investigator-sponsored Phase 2 trial of oral rigosertib plus the PD-1 inhibitor pembrolizumab in patients with metastatic melanoma who have progressed...Read more

Eupraxia Pharmaceuticals Announces Last Patient Last Visit in Phase 2 Osteoarthritis Clinical Trial of EP-104IAR

May 25
Last Trade: 6.93 -0.07 -1.00

VICTORIA, BC, May 25, 2023 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced that it has reached the last patient last visit in its Phase 2 clinical trial of EP-104IAR for osteoarthritis ("OA"). Dr. James Helliwell, CEO of Eupraxia, commented, "Our team has worked effectively to rapidly...Read more

Annexon Topline Data from ARCHER Phase 2 Trial of ANX007 in Geographic Atrophy Demonstrated Statistically Significant, Dose-Dependent Preservation of Visual Function

May 24
Last Trade: 2.98 -0.02 -0.67

ARCHER data support ANX007 as the first complement therapy to preserve visual acuity, achieving statistically significant protection against vision loss in both foveal and non-foveal patients through 12 months Reduction in rate of geographic atrophy lesion growth did not reach statistical significance ARCHER results support ANX007’s neuroprotective mechanism of protecting photoreceptor cells, synapses and function Company plans to...Read more

Eloxx Pharmaceuticals Intends to Advance ELX-02 into Pivotal Trial for the Treatment of Alport Syndrome with Nonsense Mutations Following Achievement of Remission in Patient in Phase 2 Study

May 24
Last Trade: 6.97 -0.03 -0.43

Patient treated in trial achieved a remission after eight weeks of treatment, demonstrating a significant reduction in proteinuria ELX-02 well-tolerated in study, with no discontinuations to date WATERTOWN, Mass., May 24, 2023 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today announced that the company intends to advance ELX-02 into a...Read more

Palisade Bio’s LB1148 Two Ongoing Clinical Trials Expecting Topline Data Readouts

May 24
Last Trade: 1.39 -0.05 -3.47

Company approaching Phase 2 topline data readout for prevention of post-surgical abdominal adhesions Continued momentum with execution of ongoing dose optimization study with 25% enrollment complete Carlsbad, CA, May 24, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today...Read more

Lisata Therapeutics Announces Enhancements to Ongoing Phase 2b ASCEND Trial of LSTA1

May 24
Last Trade: 4.21 -0.04 -0.84

Target enrollment increased to 155 subjects with the addition of a cohort testing a second dose of LSTA1 Results to be used to explore possible conditional approvals globally Futility analysis results expected in the third quarter of 2023 BASKING RIDGE, N.J., May 24, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative...Read more

Phase 2 Data from “ASTRAEUS” Trial of Mereo BioPharma’s Alvelestat in Alpha-1 Antitrypsin Deficiency-associated Lung Disease Presented at the 2023 American Thoracic Society International Conference

May 23
Last Trade: 1.06 0.05 4.95

LONDON, May 23, 2023 (GLOBE NEWSWIRE) -- Mereo BioPharma Group plc (NASDAQ: MREO), (“Mereo” or “the Company”), a clinical-stage biopharmaceutical company focused on rare diseases today announced that data from the Phase 2 “ASTRAEUS” trial of alvelestat for the treatment of Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD), as well as post-hoc analyses demonstrating the association between biomarker reductions with...Read more

Arrowhead Pharmaceuticals Presents Interim Data from ARO-ANG3 Phase 2 GATEWAY Study in Patients with HoFH

May 23
Last Trade: 36.05 1.38 3.98

44-48% Mean Reductions in LDL-C Achieved on Top of Continued Standard of Care Phase 3 Planning is Ongoing PASADENA, Calif. / May 23, 2023 / Business Wire / Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today presented interim data from the ongoing Phase 2 GATEWAY clinical study of ARO-ANG3, the company’s investigational RNAi therapeutic designed to reduce expression of angiopoietin-like protein 3 (ANGPTL3), in patients with homozygous...Read more

Galecto Completes Dosing in 52-Week Phase 2b GALACTIC-1 Trial of GB0139 in Idiopathic Pulmonary Fibrosis

May 23
Last Trade: 2.19 0.05 2.34

BOSTON, May 23, 2023 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical-stage biotechnology company and world leader in galectin biology focused on the development of novel treatments for fibrosis and cancer, today announced the last dosing of the last patient in the GALACTIC-1 Phase 2b trial of its most advanced product candidate, GB0139, for the treatment of idiopathic pulmonary fibrosis (IPF). GALACTIC-1 is a randomized,...Read more

MindBio Therapeutics Ethics Approval for Landmark World First Phase 2 Clinical Trial of Take-Home LSD-Microdosing for Major Depressive Disorder

May 23
Last Trade: 0.07 -0.005 -6.67

Ethics approval received for take-home LSD-Microdosing clinical trial in depressed patients Clinical trial has been approved by the Clinical Trials Registry One of two approved take home Phase 2 LSD-Microdosing Clinical Trials running in 2023 VANCOUVER, BC / ACCESSWIRE / May 23, 2023 / MindBio Therapeutics Corp. (CSE:MBIO) (Frankfurt:WF6), (the "Company" or "MindBio") is pleased to announce that ethics approval has been received...Read more

Trevi Therapeutics Announces Publication of Positive Data from the CANAL Trial in IPF Chronic Cough in NEJM Evidence

May 22
Last Trade: 2.24 0.08 3.70

Nalbuphine ER resulted in a rapid and marked reduction in recorded daytime cough among patients suffering from IPF-related cough The mean change in 24-hour objective cough frequency was similar in patients with concomitant anti-fibrotic therapy and without concomitant anti-fibrotic therapy NEW HAVEN, Conn., May 22, 2023 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company...Read more

Bristol Myers Squibb’s Investigational LPA1 Antagonist Reduces the Rate of Lung Function Decline in Patients with Idiopathic Pulmonary Fibrosis

May 22
Last Trade: 65.66 0.98 1.52

Phase 2 study shows 26 weeks of treatment with twice-daily 60 mg dose of BMS-986278 resulted in a 62% relative reduction in the rate of decline in percent predicted forced vital capacity (ppFVC) versus placebo BMS-986278 was well tolerated with rates of adverse events and treatment discontinuation comparable to placebo Data demonstrate potential of BMS-986278 in pulmonary fibrosis and support progression into Phase 3 PRINCETON, N.J....Read more

Hepion Pharmaceuticals’ Phase 2 ‘ALTITUDE-NASH’ Trial Achieves Primary and Secondary Endpoints, Including Improvement in Liver Function and Multiple NASH Biomarkers

May 22
Last Trade: 10.70 1.22 12.87

 Improvements in physiologic liver function and key NASH biomarkers including ALT, ProC3, PIIINP and ELF  Results reinforce rencofilstat’s direct antifibrotic mode of action; increases confidence for reductions in fibrosis in ongoing Phase 2b ‘ASCEND-NASH’ paired biopsy trial  EDISON, N.J., May 22, 2023 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused...Read more

Inari Medical Announces PEERLESS II, a Randomized Controlled Trial Evaluating Clinical Outcomes of the FlowTriever® System vs. Anticoagulation in Pulmonary Embolism Patients

May 22
Last Trade: 62.23 -0.09 -0.14

IRVINE, Calif., May 22, 2023 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, announced planned enrollment of the PEERLESS II trial, Inari’s third randomized controlled trial (RCT) in venous thromboembolism (VTE). The trial design was presented at the Society for Cardiovascular Angiography &...Read more

ABVC BioPharma Vitargus® Phase II Study Received Ethical Approval at Sydney Eye Hospital in Australia

May 22
Last Trade: 0.67 -0.0052 -0.77

FREMONT, CA, May 22, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, central nervous system (CNS) disorders, and ophthalmology, today announced that the Vitrargus® Phase II study at the Sydney Eye Hospital in New South Wales, Australia received ethical approval from the St. Vincent’s Hospital Melbourne...Read more

Cytokinetics Presents New Data in Patients With Non-Obstructive HCM From Cohort 4 of REDWOOD-HCM in Late-Breaking Clinical Trial Session at The European Society of Cardiology Heart Failure 2023 Congress

May 20
Last Trade: 38.63 0.67 1.77

Treatment of Aficamten was Well-Tolerated and Associated with Statistically Significant Improvements in KCCQ, Angina Frequency, NYHA Class, NTpro-BNP and High-Sensitivity Troponin I Phase 3 Clinical Trial in Non-Obstructive HCM To Begin in 2H 2023 SOUTH SAN FRANCISCO, May 20, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data from Cohort 4 of REDWOOD-HCM (Randomized Evaluation of...Read more

ASLAN Pharmaceuticals Doses First Patient in Phase 2a Trial of Farudodstat in Alopecia Areata

May 18
Last Trade: 4.20 0.00 0.00

The Phase 2a, proof-of-concept study, called FAST-AA (FArudodstat STudy in Alopecia Areata), will enroll approximately 60 adult patients in the US; interim topline readout is expected in 1Q 2024 Farudodstat is a potent, oral DHODH inhibitor with the potential to be a novel, first-in-class treatment for alopecia areata (AA) SAN MATEO, Calif. and SINGAPORE, May 18, 2023 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (NASDAQ: ASLN), a...Read more

PDS Biotechnology Completes Enrollment in Immune Checkpoint Inhibitor Naïve Arm of VERSATILE-002 Phase 2 Clinical Trial in Advanced HPV16 Positive Head and Neck Cancer

May 18
Last Trade: 9.42 -0.48 -4.85

FLORHAM PARK, N.J., May 18, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced the completion of enrollment in the immune checkpoint inhibitor naïve group (ICI naïve) of its VERSATILE-002 Phase 2 trial for the treatment of recurrent or metastatic human papillomavirus...Read more

Genentech’s BTK Inhibitor Fenebrutinib Significantly Reduced Brain Lesions in People With Relapsing Forms of Multiple Sclerosis

May 17
Last Trade: 40.39 0.80 2.02

Fenebrutinib is an investigational, potent and highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor, the only reversible BTK inhibitor currently in Phase III multiple sclerosis (MS) trials Phase II study met its primary and secondary endpoints by reducing the total number of new gadolinium-enhancing T1 brain lesions and significantly reducing the total number of new or enlarging T2 brain lesions compared to placebo The safety...Read more

MindMed Announces Enrollment Milestone in Phase 2b Trial of MM-120 in Generalized Anxiety Disorder (GAD)

May 17
Last Trade: 3.46 -0.10 -2.68

 Over 50% of patients dosed across 20 active clinical sites   On Track for Topline Results in late 2023  NEW YORK / May 17, 2023 / Business Wire / Mind Medicine (MindMed) Inc (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that the company’s Phase 2b study evaluating MM-120...Read more

Immutep’s Efti in Combination with Pembrolizumab Achieves Excellent Initial Overall Survival Benefit in 1st Line Non-Small Cell Lung Cancer

May 17
Last Trade: 2.07 0.06 2.99

Immuno-oncology combination of eftilagimod alpha (efti) and the leading anti-PD-1 therapy generates meaningful long-term survival in non-small cell lung cancer patients in Phase II TACTI-002 trial Initial median Overall Survival of 25 months in non-small cell lung cancer patients with >1% PD-L1 expression, a key area of focus for future development of efti Result is above reported rates of anti-PD-1 monotherapy and various immune...Read more

Tonix Pharmaceuticals Announces Pharmacology and Medicinal Chemistry Results that Reveal the Molecular Mechanism of Action of Tianeptine, the Active Ingredient of TNX-601 ER, in Treating Depression

May 17
Last Trade: 1.88 0.00 0.00

Research Supports Direct Role for Restoring Neuroplasticity and Upsets Previously Held Beliefs About the Significance of Neurotransmitters in Treating Depression Findings Explain Why Tianeptine Is Not Associated with Sexual Dysfunction and Weight Gain Mechanism Supports Development of TNX-601 ER for a Broad Range of Neurodegenerative Diseases and Psychiatric Disorders CHATHAM, N.J., May 17, 2023 (GLOBE NEWSWIRE) -- Tonix...Read more

Viking Therapeutics Announces Positive Top-Line Results from Phase 2b VOYAGE Study of VK2809 in Patients with Biopsy-Confirmed Non-Alcoholic Steatohepatitis (NASH)

May 16
Last Trade: 22.28 0.31 1.41

Study Achieves Primary Endpoint, Demonstrating Statistically Significant Reductions in Liver Fat from Baseline to Week 12 in Patients Receiving VK2809 as Compared to Placebo Up to 52% Mean Liver Fat Reduction Observed in VK2809-Treated Patients Up to 85% of Patients Experienced at Least a 30% Relative Reduction in Liver Fat Statistically Significant Reductions in LDL-C, Triglycerides, and Atherogenic Lipoproteins Observed Adverse...Read more

Inhibikase Therapeutics Announces Dosing of First Patient in its Phase 2 '201' Clinical Trial of IkT-148009 to Treat Parkinson's Disease

May 16
Last Trade: 0.71 0.0054 0.77

BOSTON and ATLANTA, May 16, 2023 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced that the first patient has been dosed in its Phase 2 '201' trial evaluating IkT-148009, the Company's novel Abelson Tyrosine Kinase, or c-Abl, inhibitor for the treatment of Parkinson's...Read more

Devonian Health Announces Presentation of Thykamine™ Efficacy Results in Atopic Dermatitis at the World Congress of Dermatology and Provides Thykamine™ Clinical Development Program Update.

May 16
Last Trade: 0.28 0.10 52.78

QUEBEC CITY / May 16, 2023 / Business Wire / Devonian Health Group Inc. (“Devonian” or the “Corporation”) (TSXv: GSD; OTCQB : DVHGF), a clinical late stage botanical pharmaceutical corporation, focused on developing a unique portfolio of botanical pharmaceutical and cosmeceutical products, today announced that results from phase 2 clinical study in mild-to-moderate atopic dermatitis (‘‘AD’’) will be presented at the upcoming 25th World...Read more

NeuroSense Therapeutics Completes Enrollment in Phase 2b ALS Clinical Trial

May 15
Last Trade: 1.88 0.31 19.75

96% of participants who completed the trial opted to receive treatment with PrimeC in a 12-month open label extension Topline results expected Q4 2023 CAMBRIDGE, Mass., May 15, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced the completion of enrollment in PARADIGM, a multinational, randomized, double-blind,...Read more

Vir Biotechnology Announces First Patient Dosed in New Phase 2 Chronic Hepatitis B Virus Trial Evaluating Combinations of VIR-2218, VIR-3434, PEG-IFNα and an NRTI

May 11
Last Trade: 27.29 0.40 1.49

STRIVE is the first Phase 2 sub-protocol trial initiated under Vir’s new PREVAIL platform trial investigating the Company’s novel therapies in two chronic hepatitis B virus patient populations  SAN FRANCISCO, May 11, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first participant has been dosed in the Phase 2 STRIVE sub-protocol clinical trial evaluating the safety and efficacy of...Read more

Mirum Pharmaceuticals Announces Enrollment Completion in Phase 2b EMBARK Biliary Atresia Study

May 11
Last Trade: 26.33 0.22 0.84

Topline data are expected in second half of 2023. EMBARK will be the first completed randomized study of an IBAT inhibitor for the treatment of biliary atresia. FOSTER CITY, Calif. / May 11, 2023 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced it has completed enrollment of its Phase 2b EMBARK study for pediatric patients with biliary atresia, the most common indication for pediatric liver transplant. The...Read more

First Wave BioPharma Completes Patient Screening For Phase 2 Span Adrulipase Clinical Trial in Cystic Fibrosis

May 11
Last Trade: 1.95 0.01 0.52

Top line data read-out on track for July 2023 BOCA RATON, Fla., May 11, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. ("First Wave BioPharma" or the “Company”) (NASDAQ: FWBI), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that it has completed patient screening in its ongoing Phase 2 SPAN clinical trial...Read more

MindBio Therapeutics Phase 2 Clinical Trial Has Received Ethics Approval for World First Take-Home LSD-Microdosing Trials in Cancer Patients Experiencing Emotional Distress

May 11
Last Trade: 0.07 -0.005 -6.67

Ethics approval granted The clinical trial protocol has been submitted for publication and the trial registered A Phase 2 clinical trial assessing the effectiveness of psychedelic (LSD) Microdosing and Meaning Centred Psychotherapy in advanced stage cancer patients One of two Phase 2 LSD-Microdosing Clinical Trials running in 2023 VANCOUVER, BC / ACCESSWIRE / May 11, 2023 / MindBio Therapeutics Corp. (CSE:MBIO); (the "Company" or...Read more

Palisade Bio Announces Enrollment and Dosing of First Patient in LB1148 Dose Optimization Study

May 11
Last Trade: 1.39 -0.05 -3.47

Study designed to determine if a different dosing protocol for all indications might enhance the risk profile of LB1148 while simultaneously providing efficacy Company expects enrollment to be completed in Q3 2023 Carlsbad, CA, May 11, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today...Read more

Theralase Technologies Provides Update on Phase II Bladder Cancer Study

May 10
Last Trade: 0.25 0.00 0.00

For the primary objective, 65% of Evaluable Patients (Patients evaluated by a Principal Investigator ("PI")) achieved a Complete Response ("CR") at any assessment date post primary Study Treatment and 30% of Evaluable Patients achieved a CR at 450 days. TORONTO, ON / ACCESSWIRE / May 10, 2023 / Theralase® Technologies Inc. ("Theralase®" or the "Company") (TSXV:TLT) (OTCQB:TLTFF), a clinical stage pharmaceutical company focused on the...Read more

G1 Therapeutics: New Results from Phase 2 Trial Confirm Benefit of Trilaciclib in Reducing Adverse Events Related to an Antibody Drug Conjugate (ADC)

May 10
Last Trade: 2.62 0.09 3.56

On-Target Effect of Trilaciclib Reduces Rates of Multiple Adverse Events Associated with Sacituzumab Govitecan-Hziy by Over 50% Including Neutropenia, Anemia, and Diarrhea  Most Enrolled Patients Received Prior PD-(L)1 Inhibitor Treatment; Initial Objective Response Rate (ORR) in Overall Study Population Consistent with ORR in Checkpoint Inhibitor Pretreated Population in ASCENT Trial  Initial ORR Higher in Patients with...Read more

Alterity Therapeutics Enrolls First Patient in Australia in ATH434 Global Phase 2 Clinical Trial in Multiple System Atrophy

May 10
Last Trade: 2.85 0.13 4.60

MELBOURNE, Australia and SAN FRANCISCO, May 10, 2023 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the first participant in Australia has been treated in the Company’s Phase 2 clinical trial of ATH434 in Multiple System Atrophy (MSA), a rare and highly debilitating...Read more

Moleculin Biotech Provides Update on Ongoing Clinical Trials and Outlines Expected Upcoming Milestones

May 10
Last Trade: 0.61 0.04 6.48

Actively recruiting in three Phase 1b/2 clinical trials (one of which is in Phase 2) Recently completed first cohort in Phase 1b/2 trial evaluating Annamycin in combination with cytarabine (Ara-C) for the treatment of acute myeloid leukemia (AML); Preliminary results show a durable complete response at starting dose level in an elderly subject Multiple expected milestones and interim data readouts expected in 2023 HOUSTON, May...Read more

Eli Lilly Discloses First-in-Class, Interim Phase 2 Data in Pediatric Patients and New Analysis from Phase 3 Program in Adult Patients for Mirikizumab in Ulcerative Colitis

May 9
Last Trade: 442.33 5.84 1.34

First interim Phase 2 data of an IL-23p19 antagonist in pediatric patients New analysis from the pivotal Phase 3 LUCENT-1 and LUCENT-2 studies INDIANAPOLIS, May 9, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today new investigational data for mirikizumab in patients with moderately to severely active ulcerative colitis (UC) that further support the efficacy and safety seen in previous pivotal...Read more

ALX Oncology Announces First Patient Dosed in Phase 2 Investigator-Sponsored Trial of Evorpacept in Patients with Ovarian Cancer

May 9
Last Trade: 8.32 0.94 12.74

SOUTH SAN FRANCISCO, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced the initiation of a Phase 2 investigator-sponsored trial of evorpacept, a next generation CD47 blocker, in combination with liposomal doxorubicin and KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1...Read more

Positive Phase 2 Topline Results Show Novavax's COVID-Influenza Combination, Stand-alone Influenza and High-dose COVID Vaccine Candidates Demonstrate Robust Immune Responses

May 9
Last Trade: 7.62 -0.10 -1.30

This Phase 2 trial is evaluating three vaccine candidates: COVID-Influenza Combination, stand-alone influenza and high-dose COVID Preliminary topline immune responses for all three vaccine candidates were robust versus authorized comparators For the stand-alone influenza vaccine candidate, HAI responses were 31 to 56% higher for all four influenza strains compared to Fluad®, and were 44 to 89% higher for A strains compared to Fluzone...Read more

Galmed Pharmaceuticals Announces Initiation of a Clinical Development Program to Evaluate Aramchol meglumine for the Treatment of Primary Sclerosing Cholangitis (PSC)

May 9
Last Trade: 4.74 0.11 2.38

The clinical research and development program will be conducted in collaboration with the Stravitz–Sanyal Institute for Liver Disease and Metabolic Health Virginia Commonwealth University.    TEL AVIV, Israel, May 9, 2023 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases, today announced the initiation...Read more

Can-Fite BioPharma to Initiate Exploratory Phase 2 Trial with Namodenoson in Pancreatic Cancer Patients

May 9
Last Trade: 2.79 0.11 4.10

Exploratory, small, open-label study aims to assess potential efficacy of Namodenoson following strong preclinical results in pancreatic cancer Namodenoson, now in a pivotal Phase 3 liver cancer study, has completely cleared liver cancer in a patient who remains cancer-free 6 years after starting treatment PETACH TIKVA, Israel / May 09, 2023 / Business Wire / Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology...Read more

Enanta Pharmaceuticals Reports Positive Topline Results from Phase 2 SPRINT Trial Evaluating EDP-235 in Standard Risk Patients with COVID-19

May 8
Last Trade: 25.93 1.18 4.77

Study Met Primary Endpoints of Safety and Tolerability Dose-Dependent Improvement in Total Symptom Score Observed with EDP-235 Treatment Compared to Placebo, Achieving Statistical Significance as Early as One Day After First Dose No Difference in Viral Load Reduction; Rapid Decline Observed in All Study Arms Conference Call and Webcast Today at 4:30 p.m. ET WATERTOWN, Mass. / May 08, 2023 / Business Wire / Enanta Pharmaceuticals,...Read more

BioRestorative Therapies and Northwell Health Enter into Agreement to Participate in the Company’s Phase 2 Clinical Trial

May 8
Last Trade: 5.35 0.00 0.00

New York State’s largest health care provider will participate in BRTX’s clinical trial  Expansive universe of patients and clinical sites from which to recruit high quality subjects Leverage Northwell’s “Center for Regenerative Orthopedic Medicine” Potential future collaborations to be explored in connection with basic science research MELVILLE, N.Y., May 08, 2023 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc....Read more

Pieris Pharmaceuticals Announces Successful Completion of Safety Review for 10 mg Dose of Phase 2a Trial of Elarekibep (PRS-060/AZD1402)

May 4
Last Trade: 0.90 0.05 5.35

BOSTON, MA / ACCESSWIRE / May 4, 2023 / Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, today announced the successful safety review of the 10 mg dry powder dose safety cohort from the ongoing multi-center, placebo-controlled phase 2a study of dry powder...Read more

Scilex Announces Complete Enrollment of a Phase 2 Study to Evaluate the Safety and Efficacy of SP-103 (lidocaine topical system) 5.4%, Triple Strength Formulation of ZTlido®, for the Treatment of Acute Low Back Pain

May 4
Last Trade: 6.41 0.51 8.64

Scilex Holding Company, an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced complete enrollment of its SP-103 Phase 2 study to evaluate the safety and efficacy in subjects with acute low back pain. Top-line data from the Phase 2 study is expected in Q3-2023. The Phase 2, randomized, double-blind,...Read more

Karyopharm Therapeutics Announces Presentation of Interim Data from Phase 2 Study of Single-Agent Eltanexor in Relapsed/Refractory (R/R) Higher-Risk Myelodysplastic Neoplasms (MDS) at 17th International Congress on MDS

May 3
Last Trade: 2.26 0.06 2.73

Relapsed/Refractory MDS Patients Achieved Median Overall Survival of 8.7 months  Historically, Median Overall Survival in this Hard to Treat Patient Population is Only 4-6 Months1,2 Results Indicate Potential Single Agent Activity of Eltanexor in Patients with R/R MDS NEWTON, Mass., May 3, 2023 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer...Read more

Horizon Therapeutics Announces First Patient Enrolled in Phase 2 Trial Evaluating Daxdilimab for the Treatment of Lupus Nephritis

May 2
Last Trade: 99.93 -0.47 -0.47

DUBLIN / May 02, 2023 / Business Wire / Horizon Therapeutics plc (Nasdaq: HZNP) today announced the first patient has enrolled in a Phase 2 randomized placebo-controlled trial to evaluate its development-stage medicine daxdilimab, a potentially first-in-class, fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7) that depletes certain dendritic cells, to treat people with active proliferative lupus nephritis...Read more

AnaptysBio Announces British Journal of Dermatology Publication of Imsidolimab (IL-36R) Previously Reported Phase 2 GALLOP Data in Generalized Pustular Psoriasis (GPP)

May 2
Last Trade: 18.72 0.24 1.30

Rapid and sustained efficacy demonstrated in GPP patients after only a single dose, achieving primary endpoint at Week 4 Flare control sustained on monthly subcutaneous doses through Week 16 Imsidolimab was generally safe and well tolerated with low overall ADA incidence Top-line GEMINI-1 Phase 3 trial data expected in Q4 2023 SAN DIEGO, May 02, 2023 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage...Read more

NeuroSense Therapeutics Reports Positive Preliminary Results in Parkinson's Biomarker Study

May 2
Last Trade: 1.88 0.31 19.75

Statistically significant decreased levels of novel biomarker AGO2 (p= 0.002) observed in newly diagnosed people living with Parkinson's disease (PD) compared to healthy individuals NeuroSense's combination platform has been observed in a clinical trial to induce an increase of AGO2 in ALS patients, indicating therapeutic potential in PD NeuroSense is exploring co-development of PD asset with potential collaborators CAMBRIDGE,...Read more

SciSparc Completed Treatment of Last Patient Enrolled for its Phase IIa Clinical Trial for Alzheimer's Disease and Agitation

May 2
Last Trade: 0.62 -0.21 -24.95

The Company previously announced positive interim results from the trial meeting its primary endpoints TEL AVIV, Israel, May 02, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced that the last patient enrolled in the Company's Phase IIa trial of...Read more

OKYO Pharma Announces First-Patient First-Visit for Phase 2 Trial Evaluating Efficacy and Safety of OK-101 in Patients with Dry Eye Disease

May 2
Last Trade: 1.63 0.09 5.79

Trial designed with pre-specified primary efficacy endpoints discussed previously with FDA If successful, this phase 2 trial may serve as one of the two required phase 3 studies necessary to support FDA approval Top-line data from trial anticipated before end of 2023 LONDON and NEW YORK, May 02, 2023 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is...Read more

Incyte Announces Results from SCRATCH-AD Trial Demonstrating Substantial and Rapid Itch Reduction in Patients with Mild-Moderate Atopic Dermatitis Treated with Opzelura® (ruxolitinib) Cream

May 1
Last Trade: 62.54 1.03 1.67

Adult patients with atopic dermatitis treated with Opzelura experienced rapid and substantial improvement in itch, which was sustained through Day 28 WILMINGTON, Del. / May 01, 2023 / Business Wire / Incyte (Nasdaq:INCY) today announced new data from the Phase 2 SCRATCH-AD trial evaluating the short-term clinical benefits of Opzelura® (ruxolitinib) cream 1.5% to control pruritus (itching) and reduce disease severity in adult patients...Read more

Bristol Myers Squibb’s TRANSCEND FL and TRANSCEND NHL 001 Studies of Breyanzi (lisocabtagene maraleucel) in Relapsed or Refractory Follicular Lymphoma and Mantle Cell Lymphoma Meet Primary Endpoint of Overall Response Rate

May 1
Last Trade: 65.66 0.98 1.52

With these results, Breyanzi has now demonstrated clinically meaningful benefit across the broadest array of B-cell malignancies of any CD19-directed CAR T cell therapy, underscoring the company’s leadership in advancing innovative therapies for many types of hematological malignancies PRINCETON, N.J. / May 01, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced positive topline results from two studies, TRANSCEND...Read more

Pliant Therapeutics Announces Positive Long-Term Data from the INTEGRIS-IPF Phase 2a Trial Demonstrating Bexotegrast was Well Tolerated at 320 mg with Durable Improvement Shown in FVC and Across Multiple Measures

April 30
Last Trade: 22.21 0.46 2.11

Bexotegrast was well tolerated up to 40 weeks of treatment with no drug-related serious adverse events Combination of bexotegrast with standard of care reduced FVC decline by 80% relative to standard of care alone at Week 24 89% of bexotegrast-treated patients with an increase in FVC from baseline at Week 12 maintained an increase at Week 24 Stabilization of fibrosis as measured by QLF imaging was observed in the...Read more

Bionomics Announces the Completion of Enrollment in Phase 2b ATTUNE Clinical Trial of BNC210 in Patients with Post-Traumatic Stress Disorder (PTSD)

April 27
Last Trade: 2.16 -0.04 -1.82

ADELAIDE, Australia, April 27, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (Bionomics or Company), a clinical-stage biopharmaceutical company developing novel allosteric ion channel modulators for serious central nervous system (CNS) disorders with high unmet medical need, today announced that the Company has completed target enrollment of approximately 200 participants in its randomized, double-blind,...Read more

Allarity Therapeutics Accelerates Trial Enrollment To Bring FDA-Approved Breast Cancer Treatment To European Market - Interim Results Could Be Released In Second Half Of 2023

April 27
Last Trade: 0.27 0.01 4.29

CAMBRIDGE, MA / ACCESSWIRE / April 27, 2023 / Recently, Allarity Therapeutics, Inc. (NASDAQ:ALLR) announced plans to speed up its Phase 2 clinical trial for IXEMPRA®, the clinical-stage pharma company's metastatic breast cancer treatment. Already approved by the Food and Drug Administration (FDA) for patients in the United States, the company is sponsoring this current trial as part of its work to get IXEMPRA® and IXEMPRA-DRP® the...Read more

New Data from Interim Analysis of Verastem Oncology’s RAMP 201 Trial Evaluating Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer to be Presented at the American Society of Clinical Oncology Annual Meeting

April 26
Last Trade: 11.96 -0.10 -0.83

Registration-Directed RAMP-201 Trial Designed to Address High Unmet Need in Low-Grade Serous Ovarian Cancer, a Unique and Distinct Type of Ovarian Cancer with Limited Treatment Options BOSTON / Apr 26, 2023 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that an abstract highlighting updated interim results from Part A...Read more

AlloVir Announces Positive Results Including Long-Term Mortality Data in Phase 2 Posoleucel Multi-Virus Prevention Study in Oral Presentation at EBMT 2023

April 26
Last Trade: 3.96 0.24 6.45

Day 400 non-relapse mortality was 0% Previously reported data from the 14-week primary endpoint showed low rates of clinically significant viral infections and diseases in this high-risk patient population despite the expected high rates of viral reactivation Global Phase 3 pivotal posoleucel trials continue to progress with robust patient enrollment in the US, Europe and Asia with data readouts on track for 2024 WALTHAM, Mass. / Apr...Read more

ABVC BioPharma Announces Completion of Phase II Part 2 Clinical Study Site Initiation Visit at UCSF

April 26
Last Trade: 0.67 -0.0052 -0.77

Fremont, CA, April 26, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that the site initiation visits (SIV) at the University of California San Francisco (UCSF) Medical Center was conducted on March 29, 2023. The UCSF site, led by Professor Keith McBurnett, PhD, at...Read more

Inhibikase Therapeutics Provides Safety and Functional Update on its Phase 1/1b 101 Trial and its Phase 2 IkT-148009 201 Trial in Parkinson's Disease

April 26
Last Trade: 0.71 0.0054 0.77

State-of-the-art biomarker analyses a hallmark of the 201 study BOSTON and ATLANTA, April 26, 2023 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease ("PD"), Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today reported updates in...Read more

Evelo Biosciences Provides Clinical Updates

April 26
Last Trade: 0.13 0.01 11.59

Topline Data from fourth cohort of EDP1815 Phase 2 trial in atopic dermatitis did not meet primary endpoint  Company will focus on development of extracellular vesicles (EVs)  First EV candidate, EDP2939, in Phase 2 moderate psoriasis study fully enrolled; data anticipated in early Q4 2023  Management to host conference call today at 8:30 a.m. ET  CAMBRIDGE, Mass., April 26, 2023 (GLOBE NEWSWIRE) -- Evelo...Read more

Belite Bio Presented 18-Month Interim Data from a 24-Month Phase 2 Study of Tinlarebant in Adolescent Stargardt Disease at the 2023 ARVO Meeting

April 25
Last Trade: 17.15 0.13 0.76

Tinlarebant (aka LBS-008) continues to be safe and well tolerated in adolescent Stargardt Disease (STGD1) subjects at the 18-month time point A continued trend of slowing expansion of autofluorescence was observed The growth rate of incident atrophic retinal lesions was reduced compared to a natural history study of the disease (“ProgStar”) Visual acuity was stabilized with no significant loss, and no clinically significant changes...Read more

Biomind Labs Announces Start of First-Ever Clinical Trial Targeting Depression and Anxiety in Alzheimer’s Disease With Proprietary Formulation Based on 5-MeO-DMT

April 25
Last Trade: 0.45 0.00 0.00

TORONTO / Apr 25, 2023 / Business Wire / Biomind Labs Inc. (“Biomind Labs” or the “Company”) (NEO: BMND) (OTC: BMNDF) (FSE: 3XI), a leading biotech company focused on developing the next generation of pharmaceuticals to treat patients suffering from neurological disorders by targeting the drivers of disease, is pleased to announce that it has commenced a Phase II clinical trial for its proprietary 5-Metoxi-N,N-dimethyltryptamine...Read more

Morphic Therapeutic Reports Positive Topline Results of the EMERALD-1 UC Main Cohort; Orally Administered MORF-057 Achieves Primary Endpoint and Demonstrates Clinically Meaningful Improvements Across Secondary and Exploratory Measures

April 25
Last Trade: 57.04 0.57 1.01

MORF-057 demonstrates statistically significant reduction of 6.4 points (p=0.002) from baseline at Week 12 in the Robarts Histopathology Index (RHI) Score MORF-057 achieves 25.7% clinical remission by Modified Mayo Clinic Score (mMCS) MORF-057 generally well tolerated with no safety signal observed MORF-057 achieves saturation of α4β7 receptor and demonstrates changes in α4β7 lymphocyte subsets that are consistent with Phase 1...Read more

Baudax Bio Announces Positive Top-Line Final Results From Phase 2 Randomized Clinical Trial of BX1000

April 25
Last Trade: 0.55 0.03 5.77

All Patients in Three BX1000 Treatment Cohorts Met Criteria for Good or Excellent Intubation Conditions at 60 Seconds Results to be Discussed in Key Opinion Leader Webinar Today at 10:00am Eastern Time MALVERN, Pa., April 25, 2023 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (Nasdaq:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for hospital and related settings, today announced positive top-line results...Read more

HilleVax Announces Completion of Enrollment of NEST-IN1 Phase 2b Clinical Study of HIL-214 Norovirus Vaccine Candidate

April 25
Last Trade: 18.76 0.62 3.42

Topline safety and clinical efficacy data from NEST-IN1 expected in the first quarter of 2024 HIL-214 is the most advanced vaccine candidate for norovirus infection There are currently no approved vaccines for norovirus BOSTON, April 25, 2023 (GLOBE NEWSWIRE) -- HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today announced completion of enrollment...Read more

Artelo Biosciences Initiates the Phase 2a Portion of its CAReS Trial EvaluatingART27.13 for the Treatment of Cancer-Related Anorexia and Weight Loss

April 25
Last Trade: 1.91 0.06 3.24

SOLANA BEACH, Calif., April 25, 2023 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, and neurological conditions, today announced it has initiated the Phase 2a portion of its Cancer Appetite Recovery Study (CAReS), evaluating ART27.13 for the treatment of...Read more

First Wave Biopharma Exceeds 50% Enrollment Target for Phase 2 Span Adrulipase Clinical Trial in Cystic Fibrosis

April 25
Last Trade: 1.95 0.01 0.52

Three U.S. clinical trial sites actively screening and enrolling patients Top line data of adrulipase in Cystic Fibrosis patients expected in July 2023 BOCA RATON, Fla., April 25, 2023 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc. ("First Wave BioPharma" or the “Company”) (NASDAQ: FWBI), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI)...Read more

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