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Latest Phase 2 Clinical Trials Stock News

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UNITY Biotechnology Announces Extension of Phase 2b ASPIRE Clinical Study Evaluating UBX1325 in DME

April 23
Last Trade: 1.49 0.01 0.68

SOUTH SAN FRANCISCO, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (“UNITY”) [NASDAQ: UBX], a biotechnology company developing therapeutics to slow, halt or reverse diseases of aging, today announced that the ongoing Phase 2b ASPIRE study of UBX1325 has been extended from 24 to 36 weeks to assess potentially greater durability compared to aflibercept. In addition, the study is being upsized from 40 to 50 patients to...Read more

Lisata Therapeutics and Qilu Pharmaceutical Announce First Patient Treated in Qilu’s Phase 2 Trial in China of LSTA1 in Patients with Metastatic Pancreatic Ductal Adenocarcinoma

April 23
Last Trade: 2.65 -0.02 -0.75

BASKING RIDGE, N.J. and JINAN, China, April 23, 2024 (GLOBE NEWSWIRE) --  Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, and Qilu Pharmaceutical Co., Ltd. (“Qilu”), one of the leading vertically integrated pharmaceutical companies in China that develops, manufactures,...Read more

Neurocrine Biosciences Reports Positive Phase 2 Data for NBI-1065845 in Adults with Major Depressive Disorder

April 23
Last Trade: 140.09 6.43 4.81

SAVITRI™ Study Met Primary Endpoint with Statistically Significant Reduction in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score at Day 28 Met Key Secondary Endpoints, Including Statistically Significant Reduction in MADRS Score at Day 56 NBI-1065845 Was Generally Well-Tolerated SAN DIEGO, April 23, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced positive topline data for its Phase 2...Read more

Tiziana Life Sciences Announces FDA Allowance for Additional Twenty Patients to be Enrolled in the Intranasal Foralumab Multiple Sclerosis Expanded Access Program

April 23
Last Trade: 0.78 0.02 2.84

NEW YORK, April 23, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed its intranasal foralumab non-active Secondary Progressive Multiple Sclerosis (na-SPMS) Expanded Access (EA) Program to expand from 10...Read more

ASLAN Pharmaceuticals Announces Positive Interim Results From Phase 2 Study of Eblasakimab in Dupilumab-Experienced Atopic Dermatitis Patients

April 22
Last Trade: 0.47 0.01 3.08

Interim readout of 22 patients shows unprecedented efficacy data compared to prior atopic dermatitis (AD) studies with biologics: 60.0% of dupilumab-experienced AD patients treated with 400mg eblasakimab weekly achieved EASI-90 (at least a 90% reduction in their Eczema Area Severity Index (EASI) score) and 66.7% achieved a vIGA score of 0 or 1 (clear or almost clear skin) after 16 weeks, versus 14.3% of patients on placebo. 20% of...Read more

Lantern Pharma Receives Regulatory Approval to Expand Harmonic™ Clinical Trial for Non-Small Cell Lung Cancer in Never-Smokers into Japan and Taiwan

April 22
Last Trade: 5.77 0.05 0.87

Approximately 33% of all non-small cell lung cancer patients in East Asia are never smokers – a growing and unaddressed patient population. Dr. Yashushi Goto a leading lung cancer clinician-scientist at the renowned National Cancer Center of Japan will be a lead investigator. DALLAS / Apr 22, 2024 / Business Wire / Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (“AI”) company developing targeted and transformative...Read more

IDEAYA Biosciences Announces Selection of Move-Forward Phase 2 Expansion Dose for IDE397 Monotherapy in MTAP-Deletion Squamous Non-Small Cell Lung Cancer

April 22
Last Trade: 39.02 1.43 3.80

Selected a move-forward Phase 2 expansion dose for IDE397 monotherapy in MTAP-deletion squamous NSCLC, based on AE profile and preliminary clinical efficacy observed, including multiple partial responses by RECIST 1.1 Evaluating over 40 MTAP PDX preclinical models, squamous NSCLC was identified as the most sensitive tumor type to IDE397 monotherapy where ~50% of the models observed tumor regressions at 30mg/kg QD Over 100,000...Read more

Hepion Pharmaceuticals Initiates Wind-Down Activities in Phase 2b ‘ASCEND-NASH’ Trial

April 19
Last Trade: 1.49 0.08 5.67

EDISON, N.J., April 19, 2024 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company that has been developing a treatment for non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today announced that it has begun wind-down activities in its ASCEND-NASH Trial, while continuing to explore strategic alternatives, as previously announced...Read more

Celldex Therapeutics Announces Completion of Enrollment in Phase 2 Study of Barzolvolimab in Patients with Chronic Inducible Urticaria

April 17
Last Trade: 37.77 -1.08 -2.78

HAMPTON, N.J., April 17, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that patient enrollment has been completed in the Company’s Phase 2 clinical study of barzolvolimab for the treatment of the two most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). CIndU is characterized by the occurrence of hives or wheals that have an attributable...Read more

Evaxion Biotech Announces Phase 2 Clinical Trial Update: First Patient Completed Dosing with Personalized Cancer Vaccine EVX-01

April 17
Last Trade: 4.14 -0.05 -1.19

Significant Phase 2 clinical trial progress obtained with first patient finalizing EVX-01 vaccine dosing Favorable safety profile confirmed Trial on track for one-year clinical efficacy readout in Q3 2024 COPENHAGEN, Denmark, April 17, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces that...Read more

Arch Biopartners: St. Michael’s Hospital Joins the Phase II Trial of LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

April 16
Last Trade: 2.22 -0.09 -3.90

TORONTO, April 16, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that a research team from St. Michael’s Hospital, a site of Unity Health Toronto, has joined the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing...Read more

PureTech Health Announces Completion of Enrollment in Phase 2b ELEVATE IPF Trial of LYT-100 (Deupirfenidone) in Idiopathic Pulmonary Fibrosis

April 16
Last Trade: 26.15 0.00 0.00

Topline results are expected in Q4 2024 BOSTON / Apr 16, 2024 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that enrollment has been completed in the ELEVATE IPF Phase 2b clinical trial evaluating LYT-100 (deupirfenidone) in patients with idiopathic pulmonary...Read more

Atossa Therapeutics and Quantum Leap Healthcare Announce I-SPY 2 Clinical Trial to Evaluate (Z)-Endoxifen in Combination with Abemaciclib (VERZENIO®) in Women with ER+/HER2- Breast Cancer

April 15
Last Trade: 1.49 0.07 4.93

SEATTLE, April 15, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) and Quantum Leap Healthcare Collaborative™ today announced the initiation of a new study to evaluate Atossa’s proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, in women with ER+/HER2- breast cancer. Atossa is a clinical stage...Read more

Organovo Announces Positive Phase 2 Results for FXR314 in Metabolic Dysfunction-Associated Steatohepatitis (MASH) Showing Both Reduction in Liver Fat Content and Strong Safety and Tolerability Compared to Placebo

April 15
Last Trade: 1.00 -0.03 -2.91

SAN DIEGO, April 15, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches based on demonstration of clinical promise in three-dimensional (3D) human tissues, today released the complete details of its 16-week, randomized, placebo-controlled, multi-center Phase 2 study of the non-steroidal, non-bile acid FXR agonist FXR314 for the treatment...Read more

Corcept Therapeutics Completes Enrollment in Phase 2 DAZALS Trial in Patients With Amyotrophic Lateral Sclerosis (ALS)

April 15
Last Trade: 22.98 0.68 3.05

MENLO PARK, Calif., April 15, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in DAZALS, a randomized, double-blind, placebo-controlled Phase 2 trial of its...Read more

TFF Pharmaceuticals Announces Additional Positive Data from the Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial Following Oral Presentation at the ISHLT 44th Annual Late Breaking Clinical Science Abstract Sessions

April 15
Last Trade: 2.97 0.39 15.12

New Gene Expression Analysis from Ongoing Phase 2 Study Provides Strong Biomarker Evidence that Treatment with TFF TAC Results in Normalization of Rejection-Related Genes TFF TAC Prevented Rejection at 1/6 of Oral Tacrolimus Dose and with 2/3 of Oral Tacrolimus Systemic Trough Exposures 4 out of 4 Patients Who Completed the 12-Week Treatment Have Chosen to Remain on TFF TAC by Proceeding to the Safety Extension Phase FORT WORTH,...Read more

Innate Pharma Announces Advancement of Sanofi-developed NK Cell Engager SAR443579 / IPH6101 Progressing to Phase 2 for Blood Cancer Patients

April 15
Last Trade: 2.37 -0.06 -2.27

Partner Sanofi advances SAR443579 / IPH6101, ANKET® platform lead asset, a trifunctional anti-CD123 NKp46xCD16 NK cell engager, to Phase 2 dose expansion in blood cancers Dosing of the first patient in the dose expansion part of the trial triggers a €4m milestone payment to Innate MARSEILLE, France / Apr 15, 2024 / Business Wire / Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today...Read more

Enlivex Therapeutics Announces Topline Results of Its Phase II Trial Evaluating Allocetra™ In Patients With Sepsis

April 11
Last Trade: 1.33 0.06 4.72

Analysis of eligible1 patients from the sepsis Phase II study (NCT# NCT04612413) In accordance with the study protocol, the safety and efficacy topline analysis includes sequential organ failure assessment (SOFA) scores and mortality for the 28-day period post treatment. Efficacy: Stand-alone analysis of the Allocetra™-treated patients, of which 78% had septic shock and 65% had invasive ventilation at screening,...Read more

Lipocine Announces Positive LPCN 2401 Clinical Results Showing Improved Body Composition in Participants with Obesity

April 11
Last Trade: 4.80 -0.27 -5.33

LPCN 2401 treatment resulted in statistically significant body composition improvement in men Increased lean mass (LM) by 4.4% and decreased fat mass (FM) by 6.7% Reduced android fat (AF) by 4.1% and increased bone mineral content (BMC) by 2.8% Well-tolerated, adverse events (AEs) similar to placebo Potential for use in combination with incretin mimetics (GLP-1/GIP agonists and/or post GLP-1/GIP agonist) or as a...Read more

Amylyx Pharmaceuticals Announces Interim Data From Ongoing Phase 2 HELIOS Clinical Trial Demonstrating Improvements in Pancreatic Function and Glycemic Control with AMX0035 in People with Wolfram Syndrome

April 10
Last Trade: 1.95 -0.03 -1.52

Interim analysis, including eight participants assessed at Week 24, demonstrated improvements in pancreatic function and glycemic control, as measured by C-peptide and other markers of glucose metabolism, rather than worsening typically expected with disease progression All eight participants met prespecified responder criteria demonstrating either improvement or stabilization of disease according to both the Patient Reported Global...Read more

AIM ImmunoTech Announces Positive Top-Line, Protocol-Planned Interim Report Data from the Study of Ampligen Combined with Pembrolizumab for the Treatment of Recurrent Ovarian Cancer

April 10
Last Trade: 0.43 0.0055 1.31

OCALA, Fla., April 10, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced top-line interim data indicating that combining Ampligen (rintatolimod) with Keytruda (pembrolizumab) in the treatment of recurrent ovarian cancer may have a powerful synergistic effect, leading the investigator to conclude that the combination therapy could be far more effective than pembrolizumab alone as a therapy for...Read more

Fusion Pharmaceuticals Announces Presentation of Interim Data from the Phase 2 TATCIST Clinical Trial Evaluating FPI-2265 at the AACR Annual Meeting 2024

April 9
Last Trade: 21.42 0.10 0.47

Preliminary data demonstrate FPI-2265 is active in heavily pretreated patients with progressive metastatic castration-resistant prostate cancer (mCRPC), including those who received prior lutetium-based radioconjugates HAMILTON, ON and BOSTON, April 9, 2024 /CNW/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines,...Read more

RAPT Therapeutics Announces Promising Results from Phase 2 Trial of Tivumecirnon in Combination with Anti-PD-1 Immunotherapy in CPI-Experienced Head and Neck Cancer Patients

April 9
Last Trade: 8.00 0.14 1.78

Confirmed objective response rate (ORR) of 15.6% in all patients regardless of PD-L1 or HPV status Confirmed ORR of 17.4% in subset of patients with PD-L1+ disease Confirmed ORR of 22.2% in subset of patients with HPV+ disease Median duration of treatment in responders was 19.6 months at the time of data cutoff SOUTH SAN FRANCISCO, Calif., April 09, 2024 (GLOBE NEWSWIRE) --  RAPT Therapeutics, Inc. (Nasdaq: RAPT), a...Read more

Atossa Therapeutics Presents Data from 40mg Cohort of Phase 2 EVANGELINE Clinical Trial Showing 100% Disease Control Rate After 24-Weeks of Treatment with (Z)-Endoxifen

April 9
Last Trade: 1.49 0.07 4.93

SEATTLE, April 09, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced promising safety and efficacy data from the Company’s Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) clinical trial. The EVANGELINE study is evaluating (Z)-endoxifen as a neoadjuvant treatment for pre-menopausal women with Grade 1 or 2 Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor...Read more

Biophytis launches OBA phase 2 clinical study in obesity with BIO101 (20-hydroxyecdysone)

April 8
Last Trade: 10.19 9.94 4,050.71

Promising preclinical results obtained in obesity support the OBA Phase 2 clinical study expected to start mid-2024 PARIS, FRANCE AND CAMBRIDGE, MA / ACCESSWIRE / April 8, 2024 / Biophytis SA (Nasdaq:BPTS)(Euronext Growth Paris: ALBPS), ("Biophytis" or the "Company"), a clinical-stage biotechnology company specialized in the development of therapeutics for age-related diseases, today announces that it is launching a new clinical...Read more

BioRestorative Therapies Partners with Galen Patient Recruitment to Accelerate Completion of Enrollment in Phase 2 Trial of BRTX-100 in Chronic Lumbar Disc Disease

April 8
Last Trade: 1.34 -0.04 -2.90

Collaboration follows recent manufacturing/clinical process enhancements that have tripled monthly trial capacity  Patient enrollment expected to be completed in 2024  MELVILLE, N.Y., April 08, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced a collaboration with Galen Patient...Read more

IntelGenx Announces First Parkinson’s Disease Patients Dosed with Montelukast VersaFilm® in Phase 2 ‘MONTPARK’ Clinical Trial

April 8
Last Trade: 0.20 -0.05 -20.00

SAINT LAURENT, Quebec, April 08, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that Montelukast VersaFilm® has been administered to the first Parkinson’s Disease (“PD”) patients in the Phase 2 (‘MONTPARK’) clinical trial. MONTPARK (EudraCT number 2023-504278-39-00) is a Phase 2, randomized, double-blind, placebo-controlled, parallel arm, multicentre trial that will...Read more

Arrowhead Pharmaceuticals Announces New Phase 2 Data of Plozasiran Published in JAMA Cardiology and Presented at American College of Cardiology 73rd Annual Scientific Session & Expo

April 7
Last Trade: 23.78 -0.14 -0.59

Plozasiran reduced triglycerides and APOC3 up to a mean maximum of 86% and 90% respectively in patients with severe hypertriglyceridemia SHASTA-3 and SHASTA-4 Phase 3 studies to be initiated PASADENA, Calif. / Apr 07, 2024 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today presented final data from the double-blind treatment period of its Phase 2 SHASTA-2 study of investigational plozasiran (formerly ARO-APOC3) in...Read more

Alnylam Pharmaceuticals Presents Positive Results from the KARDIA-2 Phase 2 Study of Zilebesiran Added to Standard of Care Antihypertensives in Patients with Inadequately Controlled Hypertension

April 7
Last Trade: 146.07 0.28 0.19

Study Met Primary Endpoint Demonstrating Clinically Significant Additive Reductions in Ambulatory Systolic Blood Pressure of Up to 12.1 mmHg Across Three Independent Study Cohorts at Month 3 A Single Dose of Zilebesiran Resulted in Clinically Significant Additive Reductions in Office Systolic Blood Pressure at Month 3 and in Time-Adjusted Office Systolic Blood Pressure at Month 6 Across Three Independent Study Cohorts Zilebesiran...Read more

Ocular Therapeutix™ Announces Positive Phase 2 PAXTRAVA™ Glaucoma Data at the American Society of Cataract and Refractive Surgery 2024 Annual Meeting

April 6
Last Trade: 5.00 -0.08 -1.57

Phase 2 data highlight consistent and sustained reductions in Intraocular Pressure (IOP), statistically significant (p<0.0001) through six months, with clinically meaningful reductions of 24-30% achieved with a single PAXTRAVA implant Generally well tolerated with no impact on corneal health observed Consistent durability of IOP reduction and implant bioresorption shows potential for repeat dosing without stacking of...Read more

Protara Therapeutics Announces Positive Three-Month Data from TARA-002 Clinical Program in NMIBC

April 5
Last Trade: 3.00 -0.05 -1.64

TARA-002 demonstrated a complete response rate of 43% at three months in BCG-Unresponsive/Experienced patients in ongoing NMIBC program TARA-002 demonstrated a complete response rate of 63% at three months in CIS-only patients in ongoing NMIBC program TARA-002 demonstrated a favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse events Preliminary data from six-month evaluable patients in...Read more

eFFECTOR Therapeutics Announces Topline Results of Phase 2 KICKSTART Trial of Tomivosertib Combined with Pembrolizumab in Non-Small Cell Lung Cancer

April 4
Last Trade: 1.94 0.16 8.99

SOLANA BEACH, Calif. and REDWOOD CITY, Calif., April 04, 2024 (GLOBE NEWSWIRE) -- eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a leader in the development of selective translation regulator inhibitors (STRIs) for the treatment of cancer, today announced topline results from the primary analysis of the randomized Phase 2 KICKSTART trial which tested tomivosertib or placebo, each combined with pembrolizumab, as frontline treatment for...Read more

Candel Therapeutics Announces Positive Interim Data from Randomized Phase 2 Clinical Trial of CAN-2409 in Non-Metastatic Pancreatic Cancer

April 4
Last Trade: 5.91 0.37 6.68

Updated positive interim data showed notable improvements in estimated median overall survival of 28.8 months after experimental treatment with CAN-2409 versus only 12.5 months in control group in borderline resectable pancreatic ductal adenorcarcinoma (PDAC) At 24 months, survival rate was 71.4% in CAN-2409 treated patients versus only 16.7% in the control group after chemoradiation. At 36 months, estimated survival was 47.6% in the...Read more

CureVac Announces Promising Phase 2 Interim Data from Seasonal Influenza Vaccine Development Program in Collaboration with GSK

April 4
Last Trade: 2.60 0.07 2.77

Seasonal flu vaccine candidate boosted antibody titers at all dose levels and for all encoded seasonal influenza strains across younger and older adults Potentially differentiated, multivalent candidate encodes antigens matched to all four WHO-recommended flu strains For influenza A strains, geometric mean titers numerically exceeded those elicited by the licensed comparator vaccines consistently across all tested dose levels and age...Read more

MacroGenics Provides Phase 2 TAMARACK Study Early Interim Safety Data and Plans for Future Disclosures

April 3
Last Trade: 16.23 0.82 5.32

Early interim safety data from Phase 2 TAMARACK study, including comparison to retrospective analysis from Phase 1 study, as submitted in ASCO abstract Company plans to provide updated interim data, including safety and preliminary efficacy, by May 31 Company plans to provide additional clinical data – including rPFS – in the Fall of 2024 ROCKVILLE, MD, April 03, 2024 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ: MGNX),...Read more

Neurocrine Biosciences Announces First-Patient Dosed in Phase 2 Clinical Study Evaluating NBI-1070770 in Adults with Major Depressive Disorder

April 3
Last Trade: 140.09 6.43 4.81

SAN DIEGO, April 3, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the first patient has been randomized for its Phase 2 clinical study to evaluate the efficacy, safety, and tolerability of investigational compound NBI-1070770 in adults with major depressive disorder. NBI-1070770 is a novel, selective, and orally active, negative allosteric modulator (NAM) of the NR2B subunit-containing...Read more

VBI Vaccines Presents Encouraging Early Tumor Response Data From Randomized Controlled Phase 2b Study of VBI-1901 in Recurrent Glioblastoma

April 3
Last Trade: 0.61 0.0055 0.91

Data highlighted in oral presentation at World Vaccine Congress 2024 on April 3, 2024 Early data from patients eligible for evaluation at week 12 show two observations of stable disease, indicating no tumor progression, in VBI-1901 treatment arm (n=2/5; 40% disease control rate [DCR]) By comparison, no tumor responses have been observed in the control arm to-date (n=0/6; 0% DCR), with all patients seeing a 2-8x increase in tumor size by...Read more

Alto Neuroscience Announces Initiation of Phase 2 Study of ALTO-203 in Patients with Major Depressive Disorder

April 3
Last Trade: 13.88 0.00 0.00

Phase 2 study designed to evaluate the pharmacodynamic effects, pharmacokinetics, and tolerability of ALTO-203 in patients with major depressive disorder (MDD) and higher levels of anhedonia ALTO-203 demonstrated a favorable tolerability profile across three Phase 1 clinical trials and produced a variety of emotional and brain effects that support its unique antidepressant potential LOS ALTOS, Calif. / Apr 03, 2024 / Business Wire /...Read more

Aligos Therapeutics Announces First Subjects Dosed in the Phase 2a HERALD Study of ALG-055009 in MASH Subjects

April 3
Last Trade: 0.82 0.02 2.82

SOUTH SAN FRANCISCO, Calif., April 03, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that dosing in the Phase 2a HERALD study of ALG-055009 has been initiated in subjects with metabolic dysfunction-associated steatohepatitis (MASH). “Dosing the first...Read more

TRACON Pharmaceuticals Provides Update on Ongoing ENVASARC Phase 2 Pivotal Trial Following Independent Data Monitoring Committee Recommendation to Continue the Trial as Planned

April 3
Last Trade: 1.85 0.03 1.65

ENVASARC Trial is Fully Enrolled and Final Data are Expected in Third Quarter 2024 SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent Product Development Platform (PDP) to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced the independent...Read more

Can-Fite BioPharma: Submits FDA with an IND Application to Conduct Phase IIb Clinical Trial of Namodenoson in MASH Patients

April 3
Last Trade: 1.97 -0.01 -0.51

Namodenoson demonstrated anti-fibrosis, anti-steatosis and anti-inflammatory effects in former Phase IIa study Patient enrolment for Phase IIb study is ongoing in Europe and Israel RAMAT GAN, Israel / Apr 03, 2024 / Business Wire / Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today...Read more

Arch Biopartners: UHN Joins the Phase II Trial of LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

April 3
Last Trade: 2.22 -0.09 -3.90

TORONTO, April 03, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that Anesthesia Clinical Trials Unit (ACTU), an academic research organization in the Department of Anesthesia and Pain Management at the University Health Network (UHN), has joined the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute...Read more

Petros Pharmaceuticals Reports Positive Results in an Initial Cohort Two-Arm Self-Selection (Phase 2-Equivalent) Study for STENDRA(R) (avanafil) as it Pursues OTC Status

April 2
Last Trade: 0.68 0.03 4.60

Nitrate patients subgroup demonstrated 100% correct self-selection when utilizing the web app technology with the drug facts label compared to 40% when using drug facts label alone (among 86% vs. 56% of all users) underscoring the significant potential benefits of technology assistance in an OTC setting (Please see important safety information below) NEW YORK, NY / ACCESSWIRE / April 2, 2024 / Petros Pharmaceuticals, Inc....Read more

Arch Biopartners Adds Three New Clinical Sites into the Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

April 2
Last Trade: 2.22 -0.09 -3.90

TORONTO, April 02, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that three additional clinical sites in Turkey have joined the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury...Read more

Disc Reports Topline Results from Phase 2 AURORA Study of Bitopertin in Patients with Erythropoietic Protoporphyria (EPP)

April 1
Last Trade: 27.00 0.02 0.07

Met primary endpoint, demonstrating dose-dependent, statistically significant reductions in protoporphyrin IX (PPIX) compared to placebo in both 20 mg and 60 mg dose groups Improved measures of light tolerance, including the key secondary endpoint, in both 20 mg and 60 mg dose groups, but did not meet statistical significance compared to placebo Dose-dependent reductions in the rate of phototoxic reactions with pain, with statistical...Read more

NeuroBo Pharmaceuticals Completes Enrollment of Part 1 of Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of MASH

April 1
Last Trade: 3.02 -0.10 -3.21

Full Data Readout Expected in the Second Half of 2024 CAMBRIDGE, Mass., April 1, 2024  /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced the completion of enrollment of Part 1 of its two-part, Phase 2a clinical trial evaluating the efficacy and safety, of DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119)...Read more

Lipocine Announces Positive Week 52 Results from LPCN 1148 Phase 2 Study in Patients with Cirrhosis

March 28
Last Trade: 4.80 -0.27 -5.33

Met primary and Hepatic Encephalopathy (HE) endpoints in Phase 2 study Increase in Skeletal Muscle Index (SMI) observed at Week 24 was maintained through 52 weeks Participants on placebo increased SMI when switched to LPCN 1148 Fewer Overt Hepatic Encephalopathy (OHE) events and time to first recurrent OHE event was longer while on LPCN 1148 therapy LPCN 1148 was well-tolerated, with AE rates and severities...Read more

Ironwood Pharmaceuticals Announces Positive Results from its Phase II Exploratory STARGAZE Trial of Apraglutide in Patients with Steroid-Refractory Gastrointestinal Acute Graft-versus-Host Disease (SR GI aGVHD)

March 28
Last Trade: 8.31 0.25 3.10

First prospective trial of a glucagon-like peptide (GLP-2) analog in SR GI aGVHD  Results up to Day 91 show that apraglutide in SR GI aGVHD was well-tolerated with an acceptable safety profile, the study’s primary objective  Exploratory secondary efficacy data showed lower GI tract responses maintained through Day 91 in SR GI aGVHD patients treated with apraglutide and standard of care  BOSTON / Mar 28, 2024 / Business...Read more

Syndax Pharmaceuticals Announces Completion of Enrollment in AUGMENT-101 Pivotal Trial Cohort of Patients with Relapsed/Refractory mNPM1 Acute Myeloid Leukemia

March 28
Last Trade: 20.97 0.01 0.05

Topline data expected in 4Q24 could support sNDA filing in 1H25  Revumenib has the potential to address $2 billion mNPM1 and KMT2Ar R/R acute leukemia U.S. market opportunity  WALTHAM, Mass., March 28, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced completion of enrollment in the AUGMENT-101...Read more

TFF Pharmaceuticals Announces Updated Data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) Clinical Programs

March 27
Last Trade: 2.97 0.39 15.12

Eight of Eight Patients Successfully Transitioned from Oral Tacrolimus to TFF TAC with No Sign of Acute Rejection at Reduced Systemic Exposures Data from TFF VORI Phase 2 and EAP Program Continue to Demonstrate Antifungal Activity and a Favorable Safety and Tolerability Profile TFF TAC Program Prioritized Based on Positive Phase 2 Data, the Potential to Address a Significant Unmet Need in Lung Transplant Medicine and Substantial...Read more

Kintara Therapeutics Announces Expansion of REM-001 Clinical Study to Include Patients on Pembrolizumab

March 27
Last Trade: 0.13 0.02 16.10

SAN DIEGO, March 27, 2024 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced the expansion of the inclusion criteria in the open label 15- patient REM-001 study in cutaneous metastatic breast cancer (CMBC) to include patients receiving pembrolizumab (KEYTRUDA®) for at least three months at...Read more

PMV Pharmaceuticals Announces First Patient Dosed in Global Tumor-Agnostic Phase 2 PYNNACLE Trial for Rezatapopt in TP53 Y220C-Positive Solid Tumors

March 27
Last Trade: 1.81 0.08 4.34

Rezatapopt is a first-in-class precision oncology investigational therapy for patients with advanced solid tumors with a TP53 Y220C mutation and KRAS wild-type (WT) First patient dosed in Phase 2 portion of the PYNNACLE trial which will assess rezatapopt as monotherapy in patients with TP53 Y220C and KRAS WT advanced solid tumors PRINCETON, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a...Read more

atai Life Sciences Announces Positive Initial Results from Beckley Psytech’s Phase 2a Open Label Study of BPL-003 (Intranasal 5-MeO-DMT) in Treatment Resistant Depression

March 27
Last Trade: 1.97 0.10 5.35

A single dose of BPL-003 demonstrated a rapid and durable antidepressant effect in TRD patients, with 45% of patients in clinical remission at week 12 55% of patients achieved a clinical response on the day after dosing and this rate of response was maintained at week 4 and week 12 BPL-003 showed a good safety profile and was well-tolerated with no serious adverse events reported Acute effects resolved on average in less than...Read more

Zevra Therapeutics Announces Top-Line Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia

March 26
Last Trade: 4.58 0.01 0.22

KP1077 demonstrates clinically meaningful benefits for key IH symptoms Top-line data provide key information for the design of a Phase 3 study CELEBRATION, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial (NCT05668754) evaluating the safety...Read more

SELLAS Life Sciences Announces Positive Topline Data from the Phase 2a Study of SLS009 in r/r AML and Provides Steering Committee Update on Phase 3 REGAL Study

March 26
Last Trade: 1.63 0.09 5.84

Phase 3 REGAL Study of GPS in AML: Enrollment Completed; Steering Committee Guided Interim Analysis Imminent; IDMC Now Scheduled in Late April  Phase 2a study of SLS009 in r/r AML: 50% Response Rate in the Selected Optimal Dose of 30 mg BIW Exceeding the Targeted 20%; 100% Response Rate in Patients with Identified Biomarkers to Date  Median OS Has Not Been Reached in the Phase 2a Study of SLS009; First CR Patient Continues...Read more

Eledon Pharmaceuticals Announces 12th Participant Enrolled in Phase 2 BESTOW Trial Evaluating Tegoprubart for the Prevention of Organ Rejection

March 25
Last Trade: 2.16 0.14 6.93

IRVINE, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced the enrollment of the 12th participant on March 23, 2024, in the Company’s ongoing Phase 2 BESTOW trial assessing tegoprubart head-to-head with tacrolimus for the prevention of rejection in kidney transplantation. “We are pleased with the strong pace of enrollment in our Phase 2 BESTOW trial and believe it speaks...Read more

Thiogenesis Therapeutics Announces Acceptance of Clinical Trial Application - Part I in the EU for MELAS

March 25
Last Trade: 0.77 0.02 2.67

San Diego, California--(Newsfile Corp. - March 25, 2024) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) ("Thiogenesis" or the "Company") a clinical-stage biotechnology company developing disulfides that are precursors to thiol-active compounds and that have the potential to treat unmet pediatric diseases, today announced that the European Medicines Agency ("EMA") has accepted its Clinical Trial Application ("CTA") Part I - Scientific and...Read more

Lipocine Announces First Cohort Dosed in Pivotal Study of LPCN 1154

March 25
Last Trade: 4.80 -0.27 -5.33

Company anticipates topline results from this crossover pivotal study late in the second quarter of 2024 SALT LAKE CITY, March 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that study enrollment is complete and the first cohort of subjects has been dosed in pivotal pharmacokinetic...Read more

BeyondSpring Announces First Patient Dosed with Pembrolizumab, Plinabulin Plus Etoposide/Platinum in a Phase 2 Investigator-initiated Study of First-Line Extensive-Stage Small-Cell Lung Cancer

March 25
Last Trade: 2.29 0.18 8.53

FLORHAM PARK, N.J., March 25, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that the first patient has been dosed in a Phase 2 investigator-initiated trial (IIT) with Pembrolizumab, Plinabulin, BeyondSpring’s lead asset, plus Etoposide/Platinum (EP) for first-line (1L)...Read more

OKYO Pharma Announces OK-101 Successfully Achieved Statistical Significance for Multiple Signs and Symptoms of Dry Eye Disease including Ocular Pain Relief in its First-in-Human Phase 2 Trial of OK-101

March 22
Last Trade: 1.40 0.04 2.94

Ocular Pain Relief showed statistically significant improvement as early as day 15 and the benefit was durable throughout the trial. Conjunctival Staining improved as early as day 29 with a durable benefit throughout the trial. Tear Film Break-up Time showed statistically significant improvement as early as day 15 with the benefit durable for the remainder of the trial. Burning/Stinging, and Blurred Vision improved as early as day 15...Read more

Bionomics Reports Results of the Full Dataset Analysis from ATTUNE Phase 2b Trial of BNC210 in Patients with Post-Traumatic Stress Disorder

March 21
Last Trade: 0.92 -0.04 -3.82

BNC210 demonstrated a statistically significant improvement in post-traumatic stress disorder (PTSD) symptom severity with a clinically meaningful effect size suggesting a potential advantage over approved medications. BNC210’s emerging safety and tolerability profile continues to support its differentiation over approved, available, and experimental psychoactive treatments. Bionomics will meet with the U.S. Food & Drug...Read more

TFF Pharmaceuticals Announces Update on Clinical Programs

March 20
Last Trade: 2.97 0.39 15.12

Company to Prioritize Clinical Development of Tacrolimus Inhalation Powder (TFF TAC) based on Positive Phase 2 Data, the Potential to Address a Significant Unmet Need in Lung Transplant Medicine and Substantial Market Opportunity Company to Evaluate Strategic Options for TFF VORI, including Partnerships, Collaborations, and Grants following Positive Data from Phase 2 Study and the Expanded Access Program (EAP) Company to Discuss...Read more

Puma Biotechnology Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

March 20
Last Trade: 5.13 -0.04 -0.77

LOS ANGELES / Mar 20, 2024 / Business Wire / Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), has been notified by the U.S. Food and Drug Administration (FDA) that its Investigational New Drug Application (IND) submission has been reviewed, and Puma can proceed with the clinical development of alisertib for the treatment of patients with human epidermal growth factor receptor 2-negative (HER2-negative),...Read more

MindBio Therapeutics Begins Landmark Phase 2B Take-Home Microdosing (MB22001) Clinical Trial in Patients with Major Depressive Disorder

March 20
Last Trade: 0.06 0.005 9.09

First doses of MB22001 administered in Phase 2B take-home trial in patients with Major Depressive Disorder. Follows successful Phase 2A trial where 53% of depressed patients were in complete remission from their depression at week 8 marked by a mean 14.1 point drop in MADRS score (Montgomery-Asberg Depression Rating Scale), a 60% mean drop in depressive symptoms. VANCOUVER, BC / ACCESSWIRE / March 20, 2024 / MindBio Therapeutics...Read more

Aligos Therapeutics Announces the Initiation of the Phase 2a HERALD Study of ALG-055009 in MASH Subjects

March 18
Last Trade: 0.82 0.02 2.82

Screening of subjects has begun at clinical study sites The Phase 2a study is being led by Principal Investigator, Dr. Stephen Harrison Aligos anticipates dosing the first subject in Q2 2024 with topline safety and efficacy data expected in Q4 2024 SOUTH SAN FRANCISCO, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel...Read more

ZyVersa Therapeutics Announces IRB Approval of Phase 2a Clinical Trial Protocol to Evaluate Cholesterol Efflux Mediator™ VAR 200 in Patients with Diabetic Kidney Disease

March 18
Last Trade: 0.56 -0.01 -2.11

Phase 2a trial is on track to begin in the first half of 2024. Cholesterol Efflux MediatorTM VAR 200 is in development to ameliorate renal lipid accumulation that damages the kidneys’ filtration system, leading to chronic kidney disease and its progression. WESTON, Fla., March 18, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing...Read more

Anavex Life Sciences Initiates Placebo-Controlled U.S. Phase 2 Clinical Trial of ANAVEX®3-71 in Schizophrenia

March 18
Last Trade: 3.68 0.00 0.00

First patient screened ahead of schedule Trial to investigate positive, negative, and cognitive domains of schizophrenia ANAVEX®3-71’s differentiated dual novel mechanism of action offers the potential to synergistically activate both SIGMAR1 and M1 muscarinic receptors and treat all symptom domains of schizophrenia without the side effects of standard of care antipsychotics NEW YORK, March 18, 2024 (GLOBE NEWSWIRE) -- Anavex Life...Read more

Cybin Initiates Phase 2 Proof-of-Concept Study of CYB004 in Generalized Anxiety Disorder

March 15
Last Trade: 0.36 -0.0054 -1.50

Anxiety disorders are the most prevalent mental health disorders globally1, contributing to over 28 million disability-adjusted life years (“DALYs”)2 Highly scalable intermittent treatment for Generalized Anxiety Disorder (“GAD”) with an expected treatment time of approximately 90-minutes from a single administration Proprietary deuterated dimethyltryptamine (“DMT”) molecule with U.S. composition of matter patent granted with protection...Read more

Spruce Biosciences Announces Topline Results from CAHmelia-203 in Adult Classic CAH and CAHptain-205 in Pediatric Classic CAH

March 13
Last Trade: 0.70 0.0092 1.33

CAHmelia-203 Study of Tildacerfont in Adult Classic Congenital Adrenal Hyperplasia (CAH) with Severe Hyperandrogenemia Did Not Meet Primary Efficacy Endpoint Positive Data from CAHptain-205 Study of Tildacerfont in Pediatric Classic CAH Supports Further Dose-Ranging Across Additional Dosing Cohorts Topline Results from CAHmelia-204 Study of Tildacerfont in Adult Classic CAH Evaluating Glucocorticoid (GC) Reduction Anticipated in Third...Read more

Takeda Announces Positive Topline Results from Phase 2 Study Evaluating Mezagitamab (TAK-079), a Potential Best-in-Class Anti-CD38 Monoclonal Antibody, for Primary Immune Thrombocytopenia

March 13
Last Trade: 13.38 0.02 0.15

Pre-Specified Interim Analysis Shows Positive Safety and Efficacy Results; Mezagitamab Safe and Well Tolerated Takeda Intends to Initiate a Global Phase 3 Trial of Mezagitamab in Patients with Primary Immune Thrombocytopenia in Fiscal Year 2024 Late-Stage Pipeline Continues to Gain Momentum With Five New Molecular Entities in Phase 3 Development in Fiscal Year 2024 OSAKA, Japan & CAMBRIDGE, Mass. / Mar 13, 2024 / Business Wire /...Read more

NeuroBo Pharmaceuticals Receives Safety Review Committee Approval to Continue With Its Phase 2a Clinical Trial Evaluating DA-1241 for the Treatment of MASH

March 13
Last Trade: 3.02 -0.10 -3.21

Blinded Safety Review Completed for the First 6 Months of the Phase 2a Clinical Trial Conduct; Recommending Trial Continue Without Modification Full Data Readout Expected in the Second Half of 2024 CAMBRIDGE, Mass., March 13, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced receipt of Safety Review...Read more

Ionis Pharmaceuticals announces positive results from Phase 2 study of ION224, an investigational medicine demonstrating clinical efficacy in the treatment of NASH/MASH

March 13
Last Trade: 41.84 0.77 1.87

Significant improvement in steatohepatitis with >2 point improvement in NAS score without worsening fibrosis, the primary endpoint of the study Achieved key secondary endpoint of MASH resolution without worsening of fibrosis More ION224 treated patients had an improvement of >1 stage fibrosis compared to placebo ION224 was safe and well-tolerated in this study with once-monthly subcutaneous dosing CARLSBAD, Calif., March 13,...Read more

Crinetics Pharmaceuticals Announces Positive Topline Results from Phase 2 Trial of Paltusotine for the Treatment of Carcinoid Syndrome

March 12
Last Trade: 44.22 0.78 1.80

Paltusotine Treatment Demonstrated Rapid and Sustained Reductions in Frequency and Severity of Flushing Episodes and Bowel Movements Paltusotine was Generally Well-Tolerated and Showed an Overall PK Profile Consistent with Prior Studies Results Confirm Initial Positive Data Previously Reported Management to Host a Conference Call Today at 4:30 p.m. Eastern Time SAN DIEGO, March 12, 2024 (GLOBE NEWSWIRE) -- Crinetics...Read more

Larimar Therapeutics Announces the Dosing of the First Patient in Long-term Open Label Extension Study for Nomlabofusp in Patients with Friedreich’s Ataxia

March 11
Last Trade: 6.46 0.06 0.94

Study will inform on long-term safety profile and tissue frataxin levels OLE initiated with 25 mg daily subcutaneous injections of nomlabofusp Frataxin data and safety data from the OLE study are intended to help support a potential Biologics License Application (“BLA”) submission for accelerated approval targeted for H2 2025 Initial data expected in Q4 2024 BALA CYNWYD, Pa., March 11, 2024 (GLOBE NEWSWIRE) -- Larimar...Read more

Acelyrin Announces Long-term 32-Week Data from the Phase 2b Trial of Izokibep in Hidradenitis Suppurativa Demonstrating Sustained Responses and Deepening Clinical Benefit - Improving Quality of Life for Patients

March 11
Last Trade: 4.60 -0.22 -4.56

Dose ordered and robust HiSCRs were rapidly demonstrated with about a third of patients achieving HiSCR100, or resolution of abscesses and nodules, by week 16 and through week 32 Deep and consistent HiSCR responses were observed for placebo patients switching to active treatment Marked reductions in draining tunnels and skin pain also contributed to clinically meaningful improvements in quality of life Potential for differentiation...Read more

Immuneering Doses First Patient in Phase 2a Clinical Trial of IMM-1-104 in RAS-mutant Solid Tumors

March 11
Last Trade: 1.63 -0.09 -5.23

First patient dosed with IMM-1-104 in combination with modified gemcitabine plus nab-paclitaxel for first-line treatment of pancreatic ductal adenocarcinoma (PDAC)  Phase 2a portion of Phase 1/2a clinical trial will evaluate IMM-1-104 as monotherapy in PDAC, non-small cell lung cancer (NSCLC) and melanoma, and as combination therapy in PDAC  Topline data from the Phase 1 portion of Phase 1/2a trial of IMM-1-104 expected in...Read more

Incyte Announces New Data from Phase 2 Study Evaluating Ruxolitinib Cream (Opzelura®) in Patients with Mild-to-Moderate Hidradenitis Suppurativa

March 10
Last Trade: 51.65 -0.27 -0.52

Randomized Phase 2 study met the primary endpoint in patents with hidradenitis suppurativa (HS), reinforcing efficacy and safety profile of ruxolitinib cream Results presented as a late-breaking oral presentation at the American Academy of Dermatology (AAD) Annual Meeting WILMINGTON, Del. / Mar 10, 2024 / Business Wire / Incyte (Nasdaq:INCY) today announced new results from a Phase 2 study evaluating the efficacy and safety of...Read more

Incyte Presents New Late-Breaking Data from Phase 2 Study Evaluating Povorcitinib in Patients with Prurigo Nodularis

March 10
Last Trade: 51.65 -0.27 -0.52

Randomized Phase 2 study met its primary and secondary endpoints following 16 weeks of treatment across all dosing groups, reinforcing povorcitinib’s potential role in treating prurigo nodularis (PN) Results presented as a late-breaking oral presentation at the American Academy of Dermatology (AAD) Annual Meeting marks Incyte’s first presentation of data in PN WILMINGTON, Del. / Mar 10, 2024 / Business Wire / Incyte (Nasdaq:INCY)...Read more

Arch Biopartners Announces Dosing of First Patient in Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

March 7
Last Trade: 2.22 -0.09 -3.90

TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury...Read more

Immuron Announces Positive Results Support Travelan® progress to Phase 3 Clinical Trials in the US

March 7
Last Trade: 2.46 -0.14 -5.44

Highlights: Immuron proceeding to Phase 3 registration strategy with the FDA Travelan® topline clinical trial results demonstrate protective efficacy with single daily dose 36.4% protective efficacy against Enterotoxigenic Escherichia coli (ETEC) induced moderate to severe diarrhea was observed in the Travelan® group compared to the placebo group (primary endpoint) 66.7% protective efficacy against ETEC induced severe diarrhea was...Read more

Gilead Sciences and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24

March 6
Last Trade: 67.03 0.08 0.12

Week 24 Results Support Continued Development as a Potential Long-Acting Oral Combination Treatment Option in Virologically Suppressed People with HIV Novel Investigational Combination Regimen has the Potential to be the First Oral Weekly HIV Treatment, Helping to Address Unmet Needs FOSTER CITY, Calif., & RAHWAY, N.J. / Mar 06, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside...Read more

MAIA Biotechnology Announces Strong Efficacy of THIO as Third-Line Treatment for Non-Small Cell Lung Cancer Patients

March 6
Last Trade: 2.46 0.20 8.85

Combination THIO 180mg + cemiplimab achieved 38% overall response rate (ORR) in difficult-to-treat, third-line non-small cell lung cancer (NSCLC) ORR of 38% significantly exceeds standard of care ORR in NSCLC third-line in patients without a targetable mutation who progressed on checkpoint inhibitors and chemotherapy CHICAGO / Mar 06, 2024 / Business Wire / MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a...Read more

Bausch Health: Salix Pharmaceuticals Announces a Phase 2 Investigator-Initiated Study of RELISTOR(R) (methylnaltrexone bromide: MNTX) in Patients with Resectable Head and Neck Squamous Cell Carcinoma

March 6
Last Trade: 8.53 0.08 0.95

LAVAL, QC / ACCESSWIRE / March 6, 2024 / Bausch Health Companies Inc. (NYSE:BHC) (TSX:BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced that it is supporting a Phase 2 investigator-initiated study (IIS) of RELISTOR® (methylnaltrexone bromide: MNTX) in patients with resectable head and neck squamous cell carcinoma. An IIS is a study that is proposed, developed, and conducted by a qualified sponsor external to...Read more

Nektar Therapeutics Announces Initiation of Phase 2b Clinical Study Evaluating Rezpegaldesleukin in Patients with Severe to Very Severe Alopecia Areata

March 5
Last Trade: 1.42 0.06 4.41

SAN FRANCISCO, March 5, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a biotechnology company developing medicines for the treatment of auto-immune disorders, today announced the initiation of its Phase 2b clinical trial evaluating rezpegaldesleukin in patients with severe to very severe alopecia areata. Rezpegaldesleukin (REZPEG) is a novel agonistic T regulatory cell biologic that is designed to both dampen the inflammatory...Read more

Vir Biotechnology Completes Enrollment of Phase 2 Chronic Hepatitis Delta SOLSTICE Trial Ahead of Schedule

March 5
Last Trade: 8.12 0.02 0.25

Over 60 participants dosed in two additional cohorts; initial data expected in the second quarter  Approximately 50% of participants have compensated cirrhosis  SAN FRANCISCO / Mar 05, 2024 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that its Phase 2 SOLSTICE clinical trial evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic...Read more

INmune Bio Reports Significant EEG Improvement in Alzheimer’s Patients Treated with XPro™

March 5
Last Trade: 10.14 -0.48 -4.52

Patients with Alzheimer’s Disease show improvement in brainwaves following 4 weeks of XPro™ therapy. Boca Raton, Florida, March 05, 2024 (GLOBE NEWSWIRE) --  INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s disease (AD) reports significant improvements in electroencephalography (EEG), a biomarker of...Read more

Oragenics Prepares Drug for Phase II Clinical Trials to Treat Concussion

March 5
Last Trade: 1.09 0.03 2.83

SARASOTA, Fla. / Mar 05, 2024 / Business Wire / Oragenics, Inc. (NYSE American: OGEN), a company focused on developing unique, intranasal pharmaceuticals for the treatment of neurological disorders, today announced it is preparing to undertake the final steps of GMP manufacturing and formulation of its drug candidate for its expected Phase IIA clinical trial. The drug candidate is expected to be combined with its novel intranasal device,...Read more

Alnylam Pharmaceuticals Reports Positive KARDIA-2 Topline Study Results Demonstrating Clinically Significant Blood Pressure Reductions When Zilebesiran is Added to Standard of Care Antihypertensives

March 5
Last Trade: 146.07 0.28 0.19

Study Met the Primary Endpoint Demonstrating Clinically Significant Systolic Blood Pressure Reductions at Month 3 When Zilebesiran Was Added to a Diuretic, Calcium-Channel Blocker or Angiotensin Receptor Blocker  Zilebesiran Demonstrated an Encouraging Safety and Tolerability Profile When Added to Standard of Care Antihypertensives  Study Results Support Potential for Biannual Dosing of Zilebesiran  Full Study Results to...Read more

Vaxcyte Completes Enrollment of Phase 2 Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease (IPD) in Infants

March 4
Last Trade: 60.88 -0.72 -1.17

Company Expects to Announce Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series by the End of the First Quarter of 2025, Followed by Topline Data from Booster Dose by the End of 2025  VAX-24, a 24-Valent Pneumococcal Conjugate Vaccine (PCV), is Designed to Cover More Serotypes Than Any Infant Pneumococcal Vaccine On-Market or in U.S. Clinics Today  Company’s Potential Best-in-Class,...Read more

GRI Bio Receives MHRA Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in the United Kingdom

March 4
Last Trade: 0.45 -0.01 -2.17

MHRA authorization expands ongoing U.S. Phase 2a biomarker study evaluating lead program GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”) with interim data expected H1 2024 and topline data H2 2024 UK enrollment to be supported by collaboration with UK consortia, National Institute for Health and Care Research Respiratory Translational Research Collaboration (“NIHR Respiratory TRC”) LA JOLLA, CA, March 04, 2024...Read more

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Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....