Latest Phase 2 Clinical Trials Stock News

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Genentech’s Kadcyla Is First Targeted Therapy to Show Significant Overall Survival Benefit in People With HER2-Positive Early-Stage Breast Cancer With Residual Invasive Disease After Neoadjuvant Treatment

December 8
Last Trade: 36.00 0.42 1.18

Phase III KATHERINE results reinforce Kadcyla as the standard of care for this population, with more than 82,000 people treated to date Long-term data also showed continued benefit in invasive disease-free survival for adjuvant Kadcyla compared to Herceptin in this study These data will be presented as an oral presentation at the 2023 San Antonio Breast Cancer Symposium and included in the official press program SOUTH SAN FRANCISCO,...Read more

Jazz Pharmaceuticals Presents Updated Phase 2a Data at SABCS 2023 Showcasing Potential of Zanidatamab in HER2+/HR+ Metastatic Breast Cancer

December 8
Last Trade: 120.42 0.87 0.73

First presentation of progression-free survival (PFS) primary endpoint data show zanidatamab plus palbociclib and fulvestrant demonstrated a PFS of 67% at 6 months and a median PFS of 12 months in patients with heavily pre-treated HER2+/HR+ metastatic breast cancer (mBC) Efficacy and safety results support further investigation of this targeted combination therapy as a potential chemotherapy-free option for patients with HER2+/HR+ mBC...Read more

ABVC BioPharma Announces Completion of Subject Treatment for Interim Analysis on ADHD Phase IIb Clinical Study

December 7
Last Trade: 1.19 -0.06 -4.80

FREMONT, CA, Dec. 07, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced an update on the Company's eight-week long ADHD Phase II part II clinical study taking place at the University of California San Francisco (UCSF) Medical Center and five Taiwanese...Read more

Harmony Biosciences Announces Positive Topline Data From Phase 2 Signal Detection Study Evaluating Pitolisant In Adult Patients With Myotonic Dystrophy Type 1

December 7
Last Trade: 31.00 -0.05 -0.16

PLYMOUTH MEETING, Pa., Dec. 7, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY) today announced positive topline results from its Phase 2 signal detection study evaluating the safety and efficacy of pitolisant in adult patients with myotonic dystrophy type 1 (DM1). A clinically meaningful improvement was demonstrated on the primary efficacy endpoint, the change from baseline to the end...Read more

Kymera Therapeutics Announces First Patient Dosed in Phase 2 Atopic Dermatitis Clinical Trial of KT-474 (SAR444656), a First-in-Class, Investigational IRAK4 Degrader, Generating a $15 Million Payment from Sanofi

December 7
Last Trade: 23.00 -0.68 -2.87

Atopic Dermatitis (AD) trial is the second KT-474 Phase 2 clinical trial to begin enrolling patients this quarter following trial in Hidradenitis Suppurativa (HS) Topline Phase 2 data from both the AD and HS trials expected in the first half of 2025 WATERTOWN, Mass., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule...Read more

Oculis Announces First Patient First Visit in Phase 2b RELIEF Trial of Topical Anti-TNFα Licaminlimab (OCS-02) in Dry Eye Disease

December 7
Last Trade: 11.75 0.39 3.43

Licaminlimab is a novel anti-TNFα biologic eye drop with an established dual mechanism of action, anti-inflammatory and anti-apoptotic, and a potential transformative impact on the treatment of inflammatory eye diseases RELIEF Phase 2b trial will evaluate the efficacy and safety of licaminlimab in moderate-to-severe Dry Eye Disease, and further explore the potential of a genetic biomarker Trial was initiated as planned with topline...Read more

Merck Announces Findings from Phase 2 KeyVibe-002 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)

December 7
Last Trade: 103.75 -0.13 -0.13

First Presentation of KeyVibe-002 Results at ESMO I-O 2023 Annual Meeting RAHWAY, N.J. / Dec 07, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced full results from the non-registrational Phase 2 KeyVibe-002 trial evaluating vibostolimab/pembrolizumab, an investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1...Read more

Cocrystal Pharma Announces First-Patient-In for Phase 2a Human Challenge Study Evaluating Oral CC-42344 in Pandemic and Seasonal Influenza A

December 6
Last Trade: 1.72 -0.05 -3.04

BOTHELL, Wash., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces the achievement of first-patient-in for the Phase 2a human challenge clinical trial with CC-42344, an investigational new oral antiviral inhibitor for the treatment of pandemic and seasonal influenza A. This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, viral and...Read more

Syros Pharmaceuticals Announces Encouraging Initial Data from Randomized SELECT-AML-1 Phase 2 Clinical Trial Evaluating Tamibarotene in Combination with Venetoclax and Azacitidine

December 6
Last Trade: 4.14 -0.52 -11.16

100% CR/CRi Rate in Patients Treated with Tamibarotene, Venetoclax and Azacitidine Compared to 70% in Patients Randomized to Treatment with Venetoclax and Azacitidine Alone  Triplet Regimen Continues to Demonstrate Favorable Tolerability  Additional Data Expected in 2024  Management to Host Conference Call at 8:30 a.m. ET Today  CAMBRIDGE, Mass. / Dec 06, 2023 / Business Wire / Syros Pharmaceuticals (NASDAQ:...Read more

Pharvaris Announces Positive Top-line Phase 2 Data from the CHAPTER-1 Study of Deucrictibant for the Prophylactic Treatment of HAE Attacks

December 6
Last Trade: 25.42 0.00 0.00

Primary endpoint met; 40 mg/day orally administered deucrictibant significantly reduced mean monthly attack rate by 84.5% (p=0.0008) compared to placebo 92.3% reduction in occurrence of moderate and severe attacks 92.6% fewer attacks treated with on-demand medication by participants Deucrictibant well-tolerated Pharvaris to host a conference call today at 8:00 a.m. EST ZUG, Switzerland, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Pharvaris...Read more

NeuroSense Therapeutics' Phase 2b ALS Trial Achieves Primary Safety and Tolerability & Secondary Clinical Efficacy Endpoints

December 5
Last Trade: 0.74 -0.06 -7.66

Top-Line Results from 6-month double-blind Phase 2b PARADIGM trial with NeuroSense's lead drug candidate for ALS, PrimeC, include: PrimeC achieved primary safety and tolerability endpoints with a safety and tolerability profile comparable to placebo Meaningful slowing of disease progression: 29% difference (P=0.12) in favor of ALSFRS-R outcome for patients treated with PrimeC vs placebo Slow Vital Capacity: observed a positive...Read more

Trevi Therapeutics Announces the Initiation of its Phase 2b CORAL Clinical Trial of Haduvio™ for Chronic Cough in Idiopathic Pulmonary Fibrosis (IPF)

December 5
Last Trade: 1.15 0.06 5.50

Expect to enroll approximately 160 subjects and study 3 doses of Haduvio against placebo Primary efficacy endpoint is the relative change in 24-hour cough frequency of Haduvio versus placebo NEW HAVEN, Conn., Dec. 5, 2023 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for patients with chronic cough in...Read more

Allarity Therapeutic’ Early Phase 2 Stenoparib Data Indicates Clinical Benefit in Women with Advanced Ovarian Cancer Selected with DRP® Companion Diagnostic

December 5
Last Trade: 0.56 0.07 15.00

All evaluable participants, with prior PARP inhibitor therapy and chemotherapy, showed significant tumor shrinkage including one complete response Early data follows Phase 2 dose optimization change from once-daily to twice-daily Boston (December 5, 2023) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (Nasdaq: ALLR), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with...Read more

Bolt Biotherapeutics Enrolls First Patient in Phase 2 Clinical Study Evaluating BDC-1001 in Patients with HER2-Positive Breast Cancer Previously Treated with Enhertu®

December 5
Last Trade: 0.90 -0.25 -21.73

BDC-1001 is a Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) in Phase 2 development for HER2-positive breast, colorectal, endometrial, and gastroesophageal cancers Poster detailing trial design and rationale to be presented at the 2023 San Antonio Breast Cancer Symposium on Wednesday, December 6 REDWOOD CITY, Calif., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage...Read more

Can-Fite’s Namodenoson for the Treatment of Pancreatic Cancer Patients: Progress in Clinical Development

December 4
Last Trade: 2.14 -0.08 -3.61

Study will aim to enroll about 20 patients to establish safety and clinical activity PETACH TIKVA, Israel / Dec 04, 2023 / 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 announced that it completed the design of a Phase IIa study protocol for the treatment of patients...Read more

EyePoint Pharmaceuticals Announces Positive Topline Data from the Phase 2 DAVIO 2 Trial of EYP-1901 in Wet AMD Achieving All Primary and Secondary Endpoints

December 4
Last Trade: 19.15 -2.03 -9.58

Both EYP-1901 cohorts demonstrated a statistically non-inferior change in BCVA versus aflibercept control with a numerical difference of only -0.3 and -0.4 letters, respectively for the 2 mg and 3 mg dose at blended six-month endpoint   Positive safety profile continues with no EYP-1901-related ocular or systemic SAEs  Key secondary endpoints were achieved with both EYP-1901 doses. These include an over 80% reduction in...Read more

OKYO Pharma Announces Last Patient Enrolled in OK-101 Phase 2 Clinical Trial to Treat Dry Eye Disease Has Completed Final Protocol Visit

December 4
Last Trade: 1.67 -0.03 -1.76

LONDON and NEW YORK, Dec. 04, 2023 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and for neuropathic corneal pain, a severe ocular condition without an FDA approved therapy, is pleased to announce the last patient of a planned 240-patient double-blind...Read more

Immuron Announces First Patients Enrolled in Campylobacter Challenge Clinical Study

December 4
Last Trade: 2.06 -0.01 -0.48

Highlights: First participants enrolled in the US Naval Medical Research Command Clinical Trial Clinical Study initiated to evaluate the efficacy of a new Immuron clinical product to protecting volunteers against moderate to severe campylobacteriosis New CampETEC product is a prophylactic therapeutic designed to protect against Campylobacter and Enterotoxigenic Escherichia coli (ETEC) infections, two of the major causes of...Read more

Pfizer Announces Topline Phase 2b Results of Oral GLP-1R Agonist, Danuglipron, in Adults with Obesity

December 1
Last Trade: 28.78 0.15 0.52

Danuglipron demonstrated mean placebo-adjusted weight reductions ranging from -8% to -13% at 32 weeks and -5% to -9.5% at 26 weeks While most common adverse events were mild and gastrointestinal in nature consistent with the mechanism, high rates were observed; no new safety signals were observed High discontinuation rates, greater than 50%, were seen across all doses compared to approximately 40% with placebo Ongoing pharmacokinetic...Read more

Altimmune Announces Positive Topline Results from MOMENTUM 48-Week Phase 2 Obesity Trial of Pemvidutide

November 30
Last Trade: 6.48 -0.10 -1.52

Achieved mean weight loss of 15.6% on 2.4 mg dose of pemvidutide at Week 48, with weight loss continuing at the end of treatment Over 30% of subjects achieved 20% or more weight loss on 2.4 mg dose at 48 weeks Robust reductions in BMI and serum lipids and improvements in blood pressure without imbalances in cardiac events, arrhythmias or clinically meaningful increases in heart rate Altimmune to host conference call tomorrow at 8:30...Read more

Cybin Reports Positive Topline Data from Phase 2 Study of CYB003 in Major Depressive Disorder with 79% of Patients in Remission after Two 12mg Doses

November 30
Last Trade: 0.41 -0.001 -0.24

Rapid, robust, and clinically significant reduction of depression symptoms observed after a single dose of CYB003, with a clear incremental benefit of a second dose  Primary efficacy endpoint achieved with an impressive mean -14 point difference in Montgomery-Asberg Depression Rating Scale (“MADRS”) score reduction from baseline between CYB003 (12mg) vs. placebo (p=0.0005) at 3 weeks  At 6 weeks, incremental MADRS score...Read more

Lexicon Pharmaceuticals Enrolls First Patient in Phase 2b Progress Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP)

November 30
Last Trade: 1.25 0.00 0.00

The PROGRESS study marks initiation of the late-stage development program for AAK1 inhibitor LX9211, with potential to become the first new, non-opioid drug therapy in high-unmet need neuropathic pain in more than 20 years LX9211 has previously received Fast Track designation from the U.S. Food and Drug Administration (FDA) for DPNP THE WOODLANDS, Texas, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX)...Read more

Tiziana Life Sciences Announces Foralumab Dosing of Four New Patients in the Expanded Access Program for Multiple Sclerosis

November 30
Last Trade: 0.59 -0.01 -2.46

NEW YORK, Nov. 30, 2023 (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 company has successfully enrolled and dosed four new patients with non-active secondary progressive multiple sclerosis (na-SPMS) in the Brigham and Women’s Hospital, a founding member of...Read more

BriaCell Therapeutics Records New Responder with Remarkable Improvement of “Eye-Bulging” Metastatic Tumor

November 30
Last Trade: 4.72 -0.18 -3.67

After only 3 cycles, patient experienced a remarkable improvement of eye-bulging “proptosis” caused by orbital metastatic breast cancer tumor behind the eye. Significant ocular pain reduction recorded. Heavily treated patient had 7 prior failed regimens. The patient continues to receive treatment. PHILADELPHIA and VANCOUVER, British Columbia, Nov. 30, 2023 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW)...Read more

Calliditas Therapeutics initiates clinical study to evaluate setanaxib in Alport Syndrome

November 30
Last Trade: 18.19 0.13 0.72

STOCKHOLM, Nov. 30, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas') today announced the initiation of a Phase 2 clinical study to evaluate setanaxib in Alport syndrome. Calliditas is a company focused on developing and commercializing novel treatments in rare diseases with significant unmet medical needs. This randomized, double-blind, placebo-controlled study will evaluate...Read more

AbbVie Announces Positive Topline Results from Phase 2 LUMINOSITY Trial Evaluating Telisotuzumab-Vedotin (Teliso-V) for Patients with Previously Treated Non-Small Cell Lung Cancer (NSCLC)

November 29
Last Trade: 149.28 1.31 0.89

LUMINOSITY trial demonstrated compelling clinical benefits across key endpoints Teliso-V is an investigational first-in-class, c-Met protein directed antibody-drug conjugate (ADC) being studied in patients with previously treated non-small cell lung cancer (NSCLC) with c-Met overexpression Data from the study will be presented at a future medical meeting and we will discuss with global health authorities the potential to support an...Read more

Skye Bioscience Treats First Patient in Glaucoma Phase 2 Study of SBI-100 Ophthalmic Emulsion

November 28
Last Trade: 3.50 -0.72 -17.06

SBI-100 Ophthalmic Emulsion, a CB1 agonist/activator delivered as a topical eye drop, was developed to treat patients with elevated intraocular pressure Phase 2 study evaluating efficacy and safety using two concentrations of SBI-100 OE vs. placebo, dosing twice a day for 14 days Analysis of IOP data from 50% of patients enrolled in Phase 2 study to be performed in Q1 2024 SAN DIEGO, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Skye...Read more

Inari Medical Announces First Patient Enrollment in PEERLESS II Randomized Controlled Trial (RCT)

November 27
Last Trade: 63.05 -0.26 -0.41

IRVINE, Calif., Nov. 27, 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, today announced the first patient enrollment in the PEERLESS II study. This prospective, global, multi-center randomized controlled trial (“RCT”) compares the outcomes of intermediate-risk acute pulmonary embolism (“PE”)...Read more

Acadia Pharmaceuticals Initiates Phase 2 Clinical Trial of ACP-204 for the Treatment of Alzheimer’s Disease Psychosis

November 27
Last Trade: 20.98 -0.81 -3.72

SAN DIEGO / Nov 27, 2023 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the initiation of a Phase 2 study evaluating the efficacy and safety of ACP-204 for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis (ADP). Of the more than 6.5 million people in the United States living with Alzheimer’s disease (AD), approximately 30% will experience psychosis, commonly consisting...Read more

89bio Announces New Positive Long-Term Data from the ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Nonalcoholic Steatohepatitis (NASH)

November 27
Last Trade: 9.86 -0.09 -0.90

Data at week 48 demonstrated that treatment with pegozafermin led to sustained statistically significant improvements across liver fat and non-invasive tests (NITs) of liver injury/inflammation and fibrosis in NASH patients with fibrosis stage F2-F3 Subgroups of patients treated with pegozafermin on background GLP-1-based therapies and patients with compensated cirrhosis (F4) each showed robust benefits at week 48 Pegozafermin...Read more

Roivant and Priovant Announce Results from Phase 2 Study of Oral Brepocitinib in Systemic Lupus Erythematosus

November 27
Last Trade: 9.83 0.08 0.82

Oral brepocitinib failed to meet its primary endpoint of Systemic Lupus Erythematosus Responder Index (SRI-4) change of 4 at Week 52 Priovant plans to continue progressing the program in indications outside of Systemic Lupus Erythematosus (SLE) given the drug’s favorable safety and tolerability profile, six other positive phase 2 studies, and active arm performance in this study Priovant expects to announce topline results from the...Read more

Xenon Pharmaceuticals Announces Topline Results from Phase 2 Proof-of-Concept X-NOVA Clinical Trial of XEN1101 in Major Depressive Disorder (MDD)

November 27
Last Trade: 38.34 -0.70 -1.79

VANCOUVER, British Columbia, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today reported topline results from the randomized, double-blind, placebo-controlled, Phase 2 proof-of-concept X-NOVA clinical trial, which evaluated the clinical efficacy, safety, and tolerability of 10 mg and 20 mg of XEN1101 in 168 patients with moderate to severe major...Read more

AIM ImmunoTech Completes Treatment of Last Subject in Phase 2 Study Evaluating Ampligen® for the Treatment of Post-COVID Conditions

November 21
Last Trade: 0.56 -0.0022 -0.39

No severe adverse events reported to date Topline data expected as early as Q1 2024 OCALA, Fla., Nov. 21, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the last subject has completed treatment in the Company’s Phase 2 study evaluating Ampligen® as a potential therapeutic for people with the Post-COVID condition of fatigue (“AMP-518”). AIM Chief Executive Officer...Read more

Ainos Announces Positive Data Reported from its Clinical Studies for VELDONA as Potential Treatment of Oral Warts in HIV-Seropositive Patients, an Orphan Drug Designated by the FDA

November 21
Last Trade: 0.59 -0.001 -0.17

Data partially fulfills the safety and efficacy hypotheses of one pilot and two Phase II clinical studies Ainos aims to pursue a pre-IND meeting with the U.S. FDA ahead of a planned Phase III study SAN DIEGO, CA / ACCESSWIRE / November 21, 2023 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) ("Ainos", or the "Company"), a diversified healthcare company focused on the development of AI-powered point-of-care testing, low-dose interferon...Read more

Can-Fite BioPharma: Complete Response and 6.9 Years Overall Survival in a Patient with Advanced Liver Cancer Treated with Namodenoson

November 21
Last Trade: 2.14 -0.08 -3.61

PETACH TIKVA, Israel / Nov 21, 2023 / 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 announced that a patient who participated in the Phase II Liver Cancer Study and was treated with namodenoson has a complete response and overall survival of 6.9 years (82.8 months). Liver...Read more

Connect Biopharma Announces Positive Long-Term Data from the China Pivotal Trial of Rademikibart in Patients with Moderate-to-Severe Atopic Dermatitis

November 21
Last Trade: 0.92 -0.01 -1.08

Clinical response (IGA 0/1 and EASI-75) achieved at Week 16 with rademikibart treatment was maintained through Week 52 with both every two weeks (Q2W) and every four weeks (Q4W) dosing regimens Approximately 90% of patients on Q4W dose maintained both IGA 0/1 and EASI-75 through Week 52 Over 36 weeks of treatment in Stage 2 of the study, the percentage of patients achieving IGA 0/1 and EASI-75 continued to increase Rademikibart...Read more

Aerovate Therapeutics Announces Simultaneous Completion of Enrollment in Phase 2b Portion and Enrollment of First Patient into Phase 3 in the IMPAHCT Trial Evaluating AV-101 for the Treatment of Pulmonary Arterial Hypertension

November 20
Last Trade: 17.04 0.39 2.34

Topline Phase 2b data expected in June 2024 More than 120 sites around the world actively recruiting in the Phase 3 portion of the IMPAHCT trial WALTHAM, Mass., Nov. 20, 2023 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today announced the Phase 2b portion of...Read more

Edesa Biotech Reports Final Phase 2b Results for Dermatitis Study

November 20
Last Trade: 4.17 0.25 6.38

1.0% Formulation Reached Primary Endpoint with Statistical Significance Full Analysis Identified Additional Efficacy Signals TORONTO, ON / ACCESSWIRE / November 20, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced favorable final results from a Phase 2b dose-ranging clinical study of the company's drug candidate, EB01...Read more

Atossa Therapeutics Announces Full Enrollment of Phase 2 Karisma-Endoxifen Clinical Trial

November 20
Last Trade: 0.75 0.02 2.30

SEATTLE, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced that it has reached full enrollment in the Company’s Karisma-Endoxifen clinical trial, the 240-person Phase 2 study investigating (Z)-endoxifen in premenopausal women with...Read more

Alzamend Neuro Receives FDA “Study May Proceed” Notification for a Phase IIA Clinical Trial of AL001, a Next‑Generation Lithium Therapeutic Drug Candidate, in Major Depressive Disorder Patients

November 20
Last Trade: 1.07 -0.04 -3.60

Alzamend’s recently completed Phase IIA study of AL001 in Alzheimer’s patients and healthy subjects showed a benign safety profile and identified a candidate dose that is unlikely to require therapeutic drug monitoring Safety aspects of AL001 development may qualify for a 505(b)(2) NDA pathway for FDA approval ATLANTA / Nov 20, 2023 / Business Wire / Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical...Read more

Agios Pharmaceuticals Announces Clinical Proof-of-Concept in Phase 2a Trial of AG-946 for the Treatment of Anemia in Lower-Risk Myelodysplastic Syndromes

November 20
Last Trade: 22.05 -1.09 -4.71

40 Percent of Low Transfusion Burden Cohort Achieved Transfusion IndependenceOne Study Patient Achieved Hemoglobin Response Endpoint  Safety Profile Consistent with Data Reported in Healthy Volunteers Study  Company Expects to Initiate Phase 2b Study in Mid-2024  CAMBRIDGE, Mass., Nov. 20, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering...Read more

MediciNova Announces New Data and Results of a Phase 2 Clinical Trial of MN-166 (ibudilast) in Glioblastoma Presented at the 28th Annual Meeting of the Society for Neuro-Oncology

November 19
Last Trade: 1.70 -0.05 -2.86

LA JOLLA, Calif., Nov. 19, 2023 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that MediciNova’s collaborator, Justin Lathia PhD, Co-Director of the Brain Tumor Research and Therapeutic Development Center of Excellence at Cleveland Clinic Lerner Research Institute, and Professor,...Read more

Vigil Neuroscience Reports Positive Interim Data from Phase 2 IGNITE Proof-of-Concept Clinical Trial Evaluating Iluzanebart (VGL101) as a Treatment for ALSP and from Ongoing Natural History Study ILLUMINATE

November 16
Last Trade: 3.53 0.08 2.32

Iluzanebart demonstrated favorable safety and tolerability, including no hematologic adverse events  Clear CNS target engagement and downstream pharmacological activity at 20 mg/kg consistent with Phase 1 data; Directionally supportive changes in individual patients at 6 months on MRI and NfL biomarkers  Natural History Study continued to provide critical insights on MRI and NfL biomarkers; sCSF1R emerging as key biomarker...Read more

Ensysce Biosciences Announces Enrollment Completion for PF614-201 Clinical Study

November 16
Last Trade: 1.09 0.11 10.85

Enrollment Completion Signifies Critical Progress to Phase 3 of PF614  Trial Results Expected in December 2023  SAN DIEGO, CA / ACCESSWIRE / November 16, 2023 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced that the PF614-201 study, ‘A Randomized, Double-Blind, Placebo-Controlled Crossover...Read more

SpringWorks Therapeutics Announces Positive Topline Results from the Phase 2b ReNeu Trial of Mirdametinib in NF1-PN

November 16
Last Trade: 31.50 1.00 3.28

Confirmed objective response rate of 52% in pediatric patients and 41% in adult patients, as assessed by Blinded Independent Central Review  Mirdametinib treatment resulted in deep and durable responses and significant improvements in key secondary patient-reported outcome measures  Mirdametinib was generally well tolerated with low rates of Grade 3+ adverse events  Additional data expected to be presented at medical...Read more

INmune Bio Announces Expansion of Phase II Clinical Trial for Alzheimer’s Disease in Europe

November 15
Last Trade: 10.81 0.66 6.50

The Company received a cash refund of approximately $2.8M USD pursuant to an Australian Research and Development Tax Incentive. Boca Raton, Florida, Nov. 15, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company dedicated to  advancing treatments that leverage the patient’s innate immune system to combat disease, has received acceptance of a Clinical Trial Application...Read more

ChromaDex: Newly Published Phase II Clinical Study Demonstrates that Supplementation with Niagen®, Patented Nicotinamide Riboside (NR), Elevates NAD+ Up to Fourfold, Improving Motor Coordination and Eye Movement in Ataxia Telangiectasia (AT) Patients

November 15
Last Trade: 1.34 -0.05 -3.60

This is the longest Niagen NR clinical trial to date spanning two years and showcases that long-term Niagen NR is safe and well tolerated LOS ANGELES / Nov 15, 2023 / Business Wire / ChromaDex Corp. (NASDAQ:CDXC), one of the global authorities on Nicotinamide Adenine Dinucleotide (NAD+) and healthy aging research, shares results from a phase II clinical study published in the peer-reviewed journal, Movement Disorders, by a team of...Read more

SciSparc Celebrates Major Breakthrough: Positive Results Show its Treatment has a Remarkable Impact on Alzheimer's Agitation

November 15
Last Trade: 6.10 -0.34 -5.28

Phase IIa trial outcome indicates the potential for a new way to help Alzheimer’s patients’ agitation Tel-Aviv, Nov. 15, 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”), unveiled positive topline results from its investigator-initiated Phase IIa trial at the...Read more

IntelGenx Receives Approval to Conduct ’MONTPARK’ Montelukast VersaFilm® Phase 2 Clinical Trial in Patients with Parkinson's Disease

November 14
Last Trade: 0.19 0.00 0.00

SAINT LAURENT, Quebec, Nov. 14, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that the Swedish Medical Products Agency (“MPA”), the Swedish Ethical Review Authority, and the Regional Biobank Centre have approved the planned clinical study to investigate the use of IntelGenx’s Montelukast VersaFilm® for the treatment of Parkinson’s Disease (“PD”). PD is the second most...Read more

BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure

November 14
Last Trade: 0.63 -0.03 -4.55

SUNNYVALE, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the Food and Drug Administration (FDA) approval of its Phase III clinical trial of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure. BioCardia announces that the Food and Drug...Read more

PureTech's LYT-300 (Oral Allopregnanolone) Achieved Primary Endpoint in a Phase 2a Acute Anxiety Trial in Healthy Volunteers

November 14
Last Trade: 18.00 0.92 5.39

Orally administered LYT-300 achieved a statistically significant (p=0.0001) reduction in the stress hormone response, as measured by salivary cortisol, compared to placebo This proof-of-concept trial demonstrating a reduction in the physiological stress response supports the further development of LYT-300 as a potential treatment for a range of anxiety disorders Anxiety disorders affect nearly 30 percent of U.S. adults1, yet current...Read more

Viking Therapeutics Presents New Data from Phase 2b VOYAGE Study of VK2809 in Patients with Biopsy-Confirmed Non-Alcoholic Steatohepatitis (NASH) at The Liver Meeting® 2023

November 13
Last Trade: 18.48 0.44 2.44

Late Breaking Poster Presentation Reports New Results Demonstrating Robust Liver Fat Reductions Across Key Subgroups, Including Patients with Type 2 Diabetes and Among Those with F2 or F3 Fibrosis Presentation also Highlights Previously Reported Results Showing Successful Achievement of Study's Primary Endpoint, Statistically Significant Liver Fat Reductions from Baseline to Week 12 Among Patients Receiving VK2809 52-Week Biopsy...Read more

ProKidney Announces Positive Interim Data from RMCL-002 Phase 2 Clinical Trial of Renal Autologous Cell Therapy (REACT®) for Diabetic CKD and Provides Corporate Updates

November 13
Last Trade: 1.80 -0.01 -0.55

Updated positive interim Phase 2 data demonstrate potential efficacy of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients Focusing Phase 3 development program on patients with Stage 3b and 4 diabetic CKD at highest risk of advancing to kidney failure and need for renal replacement therapy Dr. Bruce Culleton appointed ProKidney CEO following Dr. Tim Bertram’s transition to advisory role Sufficient...Read more

Hepion Pharmaceuticals Announces Major Reductions in Liver Stiffness with Rencofilstat Treatment in 17-week Phase 2 Study of Advanced (F3) MASH Liver Disease

November 13
Last Trade: 3.31 0.25 8.17

Demonstrated improvements among best reported of fibrosis-reducing compounds Liver stiffness results complemented by positive changes in disease biomarkers and HepQuant Duo liver function test “These findings presented today at AASLD The Liver Meeting® confirm that rencofilstat’s novel mechanism of action represents a fresh approach to the treatment of severe liver disease.” (Patrick Mayo, PhD, Hepion’s Senior VP, Clinical...Read more

Lipocine Releases Late Breaking Presentation on LPCN 1148 Phase 2 Results at The Liver Meeting® 2023

November 13
Last Trade: 2.56 -0.04 -1.50

Results demonstrate improvements in sarcopenia and other clinically meaningful outcomes Patients converting from placebo to LPCN 1148 in the ongoing open label extension also showed improvement in sarcopenia SALT LAKE CITY, Nov. 13, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that results of its Phase 2 study evaluating...Read more

NGM Biopharmaceuticals Presents Positive Phase 2b Results from the ALPINE 4 Trial of Aldafermin in Patients with Compensated Cirrhosis (F4) Due to NASH at AASLD The Liver Meeting®

November 13
Last Trade: 0.86 0.07 9.56

As previously reported, the ALPINE 4 study met its primary endpoint, with aldafermin 3 mg demonstrating a statistically significant reduction in Enhanced Liver Fibrosis (ELF) score compared to placebo after 48 weeks of treatment ELF, an FDA-approved non-invasive blood test, can be used to predict liver-related events in patients with nonalcoholic steatohepatitis (NASH) and compensated cirrhosis Dose-dependent improvements reported...Read more

Arrowhead Pharmaceuticals Presents New Phase 2 Data on Plozasiran and Zodasiran at AHA 2023

November 13
Last Trade: 23.95 -0.58 -2.36

Plozasiran achieved mean max reductions of up to 90% in APOC3 and 87% in triglycerides in patients with severe hypertriglyceridemia In patients with mixed dyslipidemia, mean max reduction in APOC3 was up to 89% leading to robust and durable reductions in multiple atherogenic lipoproteins Company will host a virtual analyst and investor event today, November 13, 2023, at 4:30 pm ET PASADENA, Calif. / Nov 13, 2023 / Business Wire /...Read more

Intercept Pharmaceuticals Announces New Phase 2 Data Showing Significant Impact of OCA-Bezafibrate Combination on Normalization of Multiple Key Biomarkers of PBC-Induced Liver Damage at AASLD The Liver Meeting® 2023

November 13
Last Trade: 19.00 0.00 0.00

Data from two Phase 2 studies in PBC show combination of OCA + bezafibrate achieved biochemical remission (normalization of ALP, total bilirubin, GGT, ALT and AST) in 40-44% of patients in the first 12 weeks OCA 5 or 5-10 mg + bezafibrate 400 mg cohorts in both studies showed a >60% reduction from baseline in serum ALP (primary endpoint) Treatment-emergent adverse events were generally balanced across all cohorts in both...Read more

Aclaris Therapeutics Announces Top-line Results from 12-Week Phase 2b Trial of Oral Zunsemetinib (ATI-450) for Moderate to Severe Rheumatoid Arthritis and Provides Corporate Update

November 13
Last Trade: 1.01 0.01 1.00

Study Did Not Meet Primary or Secondary Efficacy Endpoints in Rheumatoid Arthritis Efficacy Results Do Not Support Further Development of Zunsemetinib Company to Host Conference Call and Webcast Today at 8:00 AM ET WAYNE, Pa., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drugs for immuno-inflammatory diseases, today announced...Read more

Tonix Pharmaceuticals Announces Enrollment Initiated in Mass General Brigham Phase 2 Investigator-Initiated Study of TNX-1900 (Intranasal Potentiated Oxytocin) for Bone Health in Children with Autism Spectrum Disorder

November 13
Last Trade: 0.40 0.02 4.74

Children with Autism Spectrum Disorder are at Risk for Low Bone Density Preliminary Data Suggest that the Administration of Oxytocin May Favorably Impact Bone Formation and Strength Recent Meta-Analysis Reported that Plasma Oxytocin Levels Tend to be Lower in Children with Autism Spectrum Disorder than Controls1 CHATHAM, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the...Read more

Ionis Pharmaceuticals presents positive two-year results from the Phase 2 open label extension study of donidalorsen in patients with hereditary angioedema

November 9
Last Trade: 48.69 -0.78 -1.58

Continued treatment over two years with donidalorsen demonstrated sustained reduction in hereditary angioedema attacks and improved quality of life Donidalorsen recently received orphan drug designation in the U.S. Topline Phase 3 results expected in H1 2024 CARLSBAD, Calif., Nov. 9, 2023 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive results from an ongoing Phase 2 open-label extension (OLE)...Read more

Immutep Completes Enrollment in TACTI-003 Phase IIb Trial of Efti and KEYTRUDA® in First Line Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma

November 9
Last Trade: 2.08 0.01 0.48

A total of 171 head and neck squamous cell carcinoma (HNSCC) patients enrolled in randomised, multicentre Phase IIb trial evaluating efti in combination with pembrolizumab Efti has FDA Fast Track designation for first-line treatment of HNSCC SYDNEY, AUSTRALIA, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3...Read more

PDS Biotechnology Announces Updated Survival Data from NCI-Led Phase 2 Clinical Trial of PDS0101-Based Triple Combination Therapy in Advanced HPV16-Positive Cancer Patients which Show 75% Survival of ICI Naïve Patients at 36 Months

November 9
Last Trade: 5.15 0.03 0.59

75% of immune checkpoint inhibitor (ICI) naïve patients remain alive at 36 months; published median overall survival (OS) in similar patients is 7-11 months 12-month survival rate in ICI resistant patients is 72% Median OS in ICI resistant patients is approximately 20 months; published median OS is 3.4 months PRINCETON, N.J., Nov. 09, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the...Read more

Atara Biotherapeutics Announces Primary Analysis Data from Phase 2 EMBOLD Clinical Trial of ATA188 in Non-Active Progressive Multiple Sclerosis

November 8
Last Trade: 0.67 -0.02 -3.51

Primary Endpoint of Confirmed Disability Improvement at 12 Months Not Achieved Company to Further Analyze Data and Evaluate Strategic Options for ATA188 Program with Focusing of Resources and Planned Expense Reductions Expected to Extend Cash Runway Beyond Q3 2025 Allogeneic CAR-T Portfolio Advancing with Several Catalysts Anticipated in the Next 18 Months THOUSAND OAKS, Calif. / Nov 08, 2023 / Business Wire / Atara Biotherapeutics,...Read more

AIM ImmunoTech Announces Encouraging Translational Data from Phase 2 Study Evaluating Ampligen® for the Treatment of Advanced Recurrent Ovarian Cancer

November 8
Last Trade: 0.56 -0.0022 -0.39

Data presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting Longitudinal comparison of biomarkers in tumor microenvironment showed a gradual, durable response over time in T lymphotactic CXCR3 ligands and cytolytic factors Phase 2 study ongoing; topline interim results expected before year end OCALA, Fla., Nov. 08, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”), an...Read more

BioXcel Therapeutics Reports Positive Overall Survival Results from Single-Arm, Open-Label Phase 2 Trial of BXCL701 in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) of Adenocarcinoma Phenotype

November 8
Last Trade: 3.17 -0.33 -9.43

Median overall survival of 15.5 months with BXCL701 + KEYTRUDA® (pembrolizumab), compared to 9.6 months with checkpoint inhibitor monotherapy in late-line refractory patients in separate Phase 2 trial1 59% of studied patients alive at one year following treatment with BXCL701 + KEYTRUDA Median progression-free survival of 4.2 months with BXCL701 + KEYTRUDA compared to 2.1 months with checkpoint inhibitor monotherapy in...Read more

Alterity Therapeutics Completes Enrolment in ATH434-201 Phase 2 Clinical Trial in Multiple System Atrophy

November 8
Last Trade: 2.63 -0.17 -6.07

ATH434-201 is a randomized, double-blind, placebo-controlled study in early-stage MSA  Lead clinical development program enrolled 77 participants globally  MELBOURNE, Australia and SAN FRANCISCO, Nov. 08, 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...Read more

Lumos Pharma Announces Topline Data from Phase 2 OraGrowtH210 and OraGrowtH212 Trials of LUM-201 in PGHD Met All Primary and Secondary Endpoints

November 7
Last Trade: 2.87 -0.04 -1.37

OraGrowtH210 Results Show LUM-201 Dose of 1.6 mg/kg Achieves Annualized Height Velocities (AHV) of 8.2 cm/yr at 6 Months and 8.0 cm/yr at 12 Months, Comparable to Growth Rates for Moderate PGHD Population Delta at 6 and 12-month AHV Between Optimal LUM-201 Dose of 1.6 mg/kg and rhGH Comparator Arm is Within the Non-inferiority Margin (< 2 cm/yr) Suggested by FDA for Recent Approvals Initial 24-month LUM-201 Data from Combined...Read more

Takeda Announces Late-Breaking Data from Phase 2b Study of TAK-279, an Investigational, Oral, Once-Daily TYK2 Inhibitor, in Patients with Active Psoriatic Arthritis at American College of Rheumatology Convergence Annual Meeting

November 7
Last Trade: 14.06 -0.02 -0.14

The Study Met Its Primary Endpoint with 53.3% and 54.2% of Patients Treated With TAK-279 (15 mg and 30 mg Respectively) Achieving At Least an ACR 20 Response Compared to 29.2% in the Placebo Group at Week 12 (p = 0.002)1 TAK-279 Demonstrated Improvements in Key Secondary Endpoints and a Safety Profile Consistent with the Phase 2b Psoriasis Study1 Takeda Will Initiate Phase 3 Studies in Plaque Psoriasis in FY23 and Psoriatic Arthritis in...Read more

Cognition Therapeutics Completes Enrollment in Phase 2 SHINE Study of CT1812 in Mild-to-Moderate Alzheimer’s Disease

November 7
Last Trade: 1.66 0.24 16.90

Top-line results expected mid 2024  Strong physician interest drove SHINE study completion  PURCHASE, N.Y., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), (the “Company” or “Cognition”), today announced that the last participant was randomized in the Phase 2 SHINE study (NCT03507790) of CT1812, the company’s lead candidate for the treatment of age-related neurodegenerative diseases of the...Read more

DURECT Announces Topline Results from Phase 2b AHFIRM Trial of Larsucosterol in Alcohol-Associated Hepatitis with Promising Effect on Mortality

November 7
Last Trade: 0.64 -0.007 -1.08

Compelling efficacy signal in favor of larsucosterol in the key secondary endpoint of mortality at 90 days.  Clinically relevant reduction in 90-day mortality of 41% for 30 mg dose and 35% for 90 mg dose compared with standard of care (SOC) Numerical improvement in primary endpoint of mortality or transplant at 90 days did not achieve statistical significance More pronounced effect in the U.S. trial population of 232 patients,...Read more

Gilead Sciences and Arcus Biosciences Announce New Data Showing Encouraging Clinical Activity of Anti-TIGIT Domvanalimab-Containing Regimen as First-line Treatment for Upper GI Cancers

November 6
Last Trade: 79.02 0.97 1.24

Preliminary data from Arm A1 of the Phase 2 EDGE-Gastric study showed promising ORR and six-month PFS results, irrespective of PD-L1 expression  Domvanalimab is the only Fc-silent anti-TIGIT antibody in Phase 3 for upper GI adenocarcinomas and has the potential to be first to market for these cancers  Detailed results will be presented on November 7 at 12pm PT / 3pm ET during the ASCO Monthly Plenary Series  FOSTER...Read more

Ventyx Biosciences Announces Results from the Phase 2 Trial of VTX958 in Patients with Moderate to Severe Plaque Psoriasis and Provides Corporate Update

November 6
Last Trade: 2.21 0.06 2.79

VTX958 225 mg BID and 300 mg BID doses achieved statistical significance on the primary endpoint (PASI 75) and all key secondary endpoints at Week 16 Efficacy results did not meet the internal target to support further development of VTX958 in psoriasis; Ventyx to terminate Phase 2 trials of VTX958 in plaque psoriasis and psoriatic arthritis The ongoing Phase 2 trial of VTX958 in Crohn’s disease will continue to enroll; Ventyx intends...Read more

“Extra-Strength” 40U Formulation of Jeuveau® Demonstrates Effects Lasting 26 Weeks in Phase II Data Presented at 2023 ASDS Annual Meeting

November 6
Last Trade: 9.78 0.19 1.98

“Extra-strength” 40U formulation demonstrated a duration of 26 weeks, or 6 months, when measuring the time for a patient to return back to their baseline Glabellar Line score after a single treatment 40U results indicate a similar safety profile to lower dose arms in the study NEWPORT BEACH, Calif. / Nov 06, 2023 / Business Wire / Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio...Read more

Celldex Therapeutics Announces Positive Topline Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria

November 6
Last Trade: 31.43 -0.40 -1.26

Barzolvolimab met primary endpoint with clinically meaningful and statistically significant decreases in urticaria disease activity across multiple dose groups Mean change from baseline to week 12 in UAS7 of -23.87 in 300 mg q8w dose group and -23.02 in 150 mg q4w dose group Barzolvolimab was generally well tolerated with a favorable safety profile Treatment will continue to 52 weeks; results support further development of...Read more

Verastem Oncology Announces Efficacy and Safety Data of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) in Heavily Pretreated Patient Population

November 6
Last Trade: 7.36 -0.23 -3.03

Planned Subgroup Analysis of RAMP 201 Data Showed Combination Demonstrated Robust Efficacy in Recurrent LGSOC Regardless of Number and Class of Prior Therapies Including After Poor Response to Prior Therapy Late-Breaking Abstract Featured as an Oral Presentation during a Plenary Session at the Annual Global Meeting of the International Gynecologic Cancer Society BOSTON / Nov 06, 2023 / Business Wire / Verastem Oncology (Nasdaq: VSTM)...Read more

NeuroSense Therapeutics Completes Dosing of Last Patient in the Double-Blind Segment of Phase 2b ALS Trial: Topline Clinical Efficacy Results Expected December 2023

November 6
Last Trade: 0.74 -0.06 -7.66

Clinical efficacy results (secondary endpoints) and safety results (primary endpoints) expected December 2023 Biogen collaboration biomarker results expected Q1 2024 Primary biomarker endpoints to be reported H1 2024  CAMBRIDGE, Mass., Nov. 6, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced it has completed...Read more

AstraZeneca: Zibotentan/dapagliflozin combination demonstrated significant albuminuria reduction in patients with chronic kidney disease and proteinuria in ZENITH-CKD Phase IIb trial

November 3
Last Trade: 63.25 -0.26 -0.41

52.5% reduction with high-dose and 47.7% reduction with low-dose combination compared to baseline, and an acceptable tolerability profile Novel investigational drug leverages SGLT2 inhibition and high selectivity ETA receptor antagonism with potential to deliver step-change efficacy and acceptable fluid retention Plans for Phase III start underway WILMINGTON, Del. / Nov 03, 2023 / Business Wire / Combination of zibotentan with...Read more

Immutep Announces New Biomarker Data from TACTI-002 Phase II in First Line Non-Small Cell Lung Cancer

November 3
Last Trade: 2.08 0.01 0.48

Media Release Statistically significant increases of Th1 biomarkers (IFN-gamma, CXCL-10), circulating immune cells (lymphocytes), and RNA levels of immune activating genes were observed and linked to improved clinical outcomes Early increase in absolute lymphocyte count is correlated with the positive Overall Survival results in non-small cell lung cancer patients recently reported at ESMO 2023, and is a potential on-treatment...Read more

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

November 3
Last Trade: 0.90 0.00 0.00

Initial positive interim data revealed notable improvements in patients with borderline resectable pancreatic ductal adenorcarcinoma (PDAC) after experimental treatment with CAN-2409 Estimated overall survival rate was 71.4% at 36 months in CAN-2409 treated patients versus 16.7% in the control arm after chemoradiation In patients with progressive disease, there was both a CA19-9 and a survival response to salvage chemotherapy in the...Read more

RegenXBio Presents Positive One Year Data from Phase II ALTITUDE® Trial of ABBV-RGX-314 for Treatment of Diabetic Retinopathy Using Suprachoroidal Delivery

November 3
Last Trade: 19.58 -1.02 -4.95

ABBV-RGX-314 continues to be well tolerated in 50 patients from dose levels 1 and 2 (Cohorts 1-3) with no drug-related serious adverse events Dose level 2 prevented disease progression and reduced vision-threatening events in non-proliferative diabetic retinopathy patients at 1 Year  70.8% of patients achieved Diabetic Retinopathy Severity Scale improvement vs. 25.0 % in control  0% of patients worsened ≥2 steps vs. 37.5...Read more

RAPT Therapeutics Announces Positive Data, Including Objective Response Rates and Progression-Free Survival, from its Phase 2 Trial of FLX475 in Combination with a Checkpoint Inhibitor in Patients with Advanced NSCLC

November 3
Last Trade: 17.48 -0.02 -0.11

Confirmed objective response rate (ORR) of 40% in PD-L1 positive (TPS ≥1%) patients with no prior checkpoint inhibitor therapy (CPI) Median progression-free survival (PFS) of 6.3 months in PD-L1 positive patients at time of data cut off Confirmed ORR of 50% in patients with PD-L1 high expression (TPS ≥50%) and 38% in patients with PD-L1 low expression (TPS 1-49%) RAPT to host webcast conference call today at 10:00 am PT SOUTH SAN...Read more

Acurx Pharmaceuticals Announces Positive Top-Line Ibezapolstat Phase 2 Efficacy Results with 96% Clinical Cure Rate in Patients with C. difficile Infection

November 2
Last Trade: 4.00 -0.34 -7.83

In a total of 26 ibezapolstat-treated patients in Phases 2a and 2b, the Clinical Cure rate is 96% Meets protocol primary objective of assessing the primary efficacy endpoint of the Clinical Cure rate after 10 days of oral treatment Ibezapolstat was well tolerated; no drug-related Serious Adverse Events Further analyses forthcoming regarding secondary and exploratory endpoints, including Sustained Clinical Cure data,...Read more

Trevi Therapeutics Announces the Initiation of its Phase 2a RIVER Clinical Trial of Haduvio™ for Refractory Chronic Cough

November 2
Last Trade: 1.15 0.06 5.50

Expect to enroll 60 subjects across a broad range of cough frequencies RIVER topline data expected in the second half of 2024 NEW HAVEN, Conn., Nov. 2, 2023 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for difficult to treat patients with chronic cough in idiopathic pulmonary fibrosis (IPF), refractory chronic...Read more

Breakthrough Results: Cybin's CYB003 Demonstrates Remarkable Interim Data in Treating Major Depressive Disorder, Achieving Primary Efficacy Milestone and Delivering Prompt Relief from Depression Symptoms with a Single Dose - Comprehensive Topline...

November 1
Last Trade: 0.41 -0.001 -0.24

Interim readout shows rapid, robust, and clinically significant reduction of depression symptoms three weeks after a single 12mg dose, with an unprecedented mean -14 point Montgomery-Asberg Depression Rating Scale ("MADRS") score reduction from baseline between CYB003 (12mg) vs. placebo (p= 0.0005)  For reference, pooled data from 232 industry studies of current standard of care antidepressants, selective serotonin reuptake...Read more

CureVac Announces Solid Progress in Phase 2 COVID-19 and Seasonal Flu Clinical Development Programs in Collaboration with GSK

November 1
Last Trade: 5.48 -0.06 -1.08

COVID-19 Phase 2 clinical trial fully enrolled Study compares mono- and bivalent vaccine candidates against licensed comparator COVID-19 vaccine First participant dosed in seasonal flu Phase 2 part of combined Phase 1/2 study Study compares a potentially differentiated, multivalent vaccine candidate with broad antigen coverage against licensed comparator vaccine TÜBINGEN, GERMAN and BOSTON, MA / ACCESSWIRE / November...Read more

Clearside Biomedical Completes Recruitment in ODYSSEY Phase 2b Clinical Trial of CLS-AX in Wet AMD

November 1
Last Trade: 1.09 -0.07 -6.03

Successful Completion of Recruitment Driven by Strong Clinical Site Participation and Investigator Support  Topline Data Expected in Q3 2024  ALPHARETTA, Ga., Nov. 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 the completion of recruitment in...Read more

Cardiol Therapeutics Announces It Has Exceeded 50% Enrollment in Its Phase II MAvERIC-Pilot Study in Recurrent Pericarditis

November 1
Last Trade: 0.97 0.04 4.59

Toronto, Ontario--(Newsfile Corp. - November 1, 2023) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, is pleased to announce that it has exceeded 50% of the patient enrollment target for its Phase II open-label pilot study...Read more

Kazia Therapeutics Provides Preliminary Update From Ongoing Phase 2 Study Of Paxalisib In Primary CNS Lymphoma

November 1
Last Trade: 0.40 -0.03 -6.96

SYDNEY, Nov. 1, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to provide a preliminary update from the ongoing investigator-initiated Phase 2 clinical trial (NCT04906096) evaluating paxalisib as monotherapy treatment in patients with relapsed/refractory primary central nervous system lymphoma (r/r PCNSL). This is an open-label, Phase 2 clinical trial,...Read more

Daré Bioscience Announces Additional Positive Data from Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women and Proposed Endpoints and Patient Population for Phase 3 Program

November 1
Last Trade: 0.29 -0.03 -9.35

Additional Analyses of Phase 2b Data Conducted in Population of Study Participants with Female Sexual Interest/Arousal Disorder (FSIAD), With Primary Complaint of Arousal Dysfunction Achieved Statistical Significance and Clinically Meaningful Improvement in Phase 2b Co-Primary Endpoint Assessing Arousal Sensation, and Statistical Significance in Items from Phase 2b Co-Primary Endpoint Scale Evaluating Concern Related to Difficulties...Read more

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C4 Therapeutics

C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...