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Latest Phase 2 Clinical Trial News

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

March 18
Last Trade: 0.94 0.05 5.04

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


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

March 17
Last Trade: 0.33 0.006 1.88

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


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

March 17
Last Trade: 0.02 0.00 0.00

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


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

March 15
Last Trade: 1.77 -0.12 -6.35

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


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

March 13
Last Trade: 3.33 0.15 4.72

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


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

March 12
Last Trade: 4.69 -0.03 -0.64

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


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

March 11
Last Trade: 1.35 -0.11 -7.53

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


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

March 10
Last Trade: 9.34 0.29 3.20

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


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

March 10
Last Trade: 54.52 1.51 2.85

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


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

March 10
Last Trade: 146.28 -2.97 -1.99

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


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

March 10
Last Trade: 164.79 1.95 1.20

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


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

March 10
Last Trade: 15.43 1.21 8.51

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


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

March 10
Last Trade: 6.56 0.02 0.31

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


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

March 8
Last Trade: 32.95 0.00 0.00

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


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

March 8
Last Trade: 4.48 0.15 3.46

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


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

March 6
Last Trade: 5.69 0.00 0.00

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


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

March 6
Last Trade: 14.95 -0.19 -1.25

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


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

March 5
Last Trade: 1.35 -0.11 -7.53

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


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

March 4
Last Trade: 2.18 -0.17 -7.23

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


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

March 4
Last Trade: 0.94 0.05 5.04

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


MBX Biosciences Completes Enrollment in Phase 2 Avail™ Trial of MBX 2109 (Canvuparatide) for Hypoparathyroidism

March 3
Last Trade: 8.42 -0.43 -4.86

CARMEL, Ind., March 03, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced the completion of enrollment in its Phase 2 Avail™ trial of MBX 2109 (canvuparatide), the Company’s parathyroid hormone (PTH) peptide prodrug. Canvuparatide is...Read more


Lexicon Pharmaceuticals Announces Topline Results from Phase 2b PROGRESS Study Evaluating Pilavapadin (LX9211) in Adults with Diabetic Peripheral Neuropathic Pain

March 3
Last Trade: 0.36 -0.02 -6.32

Pilavapadin achieved meaningful pain reduction versus placebo and was well-tolerated in the 10 mg dose, meeting the Company’s objectives for the study Advancement of 10 mg dose into Phase 3 development in DPNP supported by both PROGRESS and RELIEF DPN-1 studies, which collectively enrolled approximately 600 pilavapadin-treated patients Conference call and webcast at 8:00 a.m. ET THE WOODLANDS, Texas, March 03, 2025 (GLOBE NEWSWIRE)...Read more


Celldex Therapeutics Presents Positive Results from Barzolvolimab Phase 2 Studies in Patients with Chronic Urticaria Demonstrating Improved Disease Control and Quality of Life at AAAAI 2025

March 1
Last Trade: 19.89 -0.46 -2.26

Greatly improved patient quality of life and reduced disease impact in patients with CSU and CIndU 82% of CSU patients reported that symptoms no longer had an impact on their quality of life at Week 52 60% of CIndU patients reported that symptoms no longer had an impact on their quality of life at Week 12 HAMPTON, N.J., March 01, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive data on...Read more


Adagene Announces Investigator Initiated Phase 2 Trial for Neoadjuvant Muzastotug (ADG126) in Colorectal Cancer

February 27
Last Trade: 1.81 -0.16 -8.12

Trial to begin enrolling in April; expected primary completion in mid-2027  Primary study endpoint of rate of major pathological response  SAN DIEGO and SUZHOU, China, Feb. 27, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced an investigator initiated (IIT) Phase 2 neoadjuvant trial of ADG126 for...Read more


Cognition Therapeutics Successfully Passes Pre-defined Futility Analysis of Phase 2 Study of Oral Zervimesine (CT1812) in Geographic Atrophy

February 26
Last Trade: 0.44 -0.0069 -1.54

Masked Analysis Shows Participants Receiving Oral Zervimesine for at Least 6 Months Experienced Slower Lesion Growth than Participants Receiving Placebo Following the Futility Analysis, Management Concluded the Phase 2 Study, Preserving Capital Full Analysis will be Provided in the Second Quarter of 2025 PURCHASE, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company...Read more


Nektar Therapeutics Announces Completion of Target Enrollment in REZOLVE-AA Phase 2b Clinical Trial of Rezpegaldesleukin in Patients with Severe-to-Very Severe Alopecia Areata

February 26
Last Trade: 0.88 -0.03 -3.22

SAN FRANCISCO, Feb. 26, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced the company has completed target enrollment in its REZOLVE-AA Phase 2b study of rezpegaldesleukin in patients with severe-to-very-severe alopecia areata. Rezpegaldesleukin is an investigational biologic therapy that targets the interleukin-2 receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as...Read more


TNF Pharmaceuticals Initiates Phase 2b Clinical Trial of First Oral TNF-Alpha Inhibitor

February 25
Last Trade: 1.20 0.00 0.00

Fully funded multi-center study initiated at University of Florida to further explore efficacy of isomyosamine for preventing progressive muscle loss and frailty Study builds on positive results achieved in earlier Phase 2a trial TNF-alpha inhibitor market estimated at $40+ billion with no FDA-approved oral treatments BALTIMORE / Feb 25, 2025 / Business Wire / TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a...Read more


AIM ImmunoTech Doses First New Subject in Phase 2 Study of Ampligen and Imfinzi as a Potential Combination Therapy for Late-Stage Pancreatic Cancer

February 25
Last Trade: 0.12 -0.002 -1.67

OCALA, Fla., Feb. 25, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the first new subject has been dosed in Phase 2 of the Phase 1b/2 clinical trial involving AIM’s Ampligen (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer (“DURIPANC”). Several subjects from Phase 1 who...Read more


Alzamend Neuro Announces Initiation Date of First Phase II Clinical Trial of AL001 to take Place at Massachusetts General Hospital

February 25
Last Trade: 0.94 0.05 5.04

ATLANTA, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced its plans to initiate the first of five highly anticipated phase II clinical studies of...Read more


Actuate Therapeutics Announces Completion of Enrollment in a Phase 2 Trial of Elraglusib in Combination with FOLFIRINOX and Losartan in Patients with Previously Untreated Metastatic Pancreatic Cancer

February 25
Last Trade: 7.46 -0.05 -0.67

Initial Data from this Phase 2 Trial Demonstrates Early Evidence of Clinical Activity of Elraglusib (9-ING-41) in Combination with FOLFIRINOX and Losartan in Untreated Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) The Final Results from the Trial are Anticipated in 2026 CHICAGO and FORT WORTH, Texas, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage...Read more


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

February 25
Last Trade: 8.82 -0.01 -0.11

Positive final survival data after additional follow-up showed notable improvement in estimated median overall survival of 31.4 months after experimental treatment with CAN-2409 versus only 12.5 months in the control group in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC). Three of seven patients treated with CAN-2409 were still alive with survival of 66.0, 63.6 and 35.8 months after enrollment,...Read more


Evaxion Biotech extends phase 2 trial with personalized cancer vaccine EVX-01 to further enhance clinical data package

February 25
Last Trade: 1.85 -0.02 -1.07

Originally planned as a two-year study, the trial has been extended by an additional year to collect three-year clinical outcome data  The additional third year of EVX-01 dosing may provide further insights into potential enhanced treatment effects and durability of induced immune response The trial already yielded convincing one-year data and remains on track for two-year data readout in the second half of 2025 COPENHAGEN,...Read more


Trevi Therapeutics Completes Enrollment for Phase 2b CORAL Trial of Haduvio in Idiopathic Pulmonary Fibrosis Patients with Chronic Cough

February 25
Last Trade: 6.56 0.02 0.31

Topline results continue to be expected in the first half of 2025 NEW HAVEN, Conn., Feb. 25, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that it has completed...Read more


Allarity Therapeutics to Begin Enrollment for New Phase 2 Protocol to Advance Stenoparib Toward FDA Approval in Advanced Ovarian Cancer Patients

February 24
Last Trade: 0.85 -0.08 -8.41

Patient enrollment set to begin at leading U.S. clinical trial sites, new drug product already delivered Trial will advance stenoparib and the stenoparib-DRP Companion Diagnostic toward FDA approval Two patients in the ongoing phase 2 trial have now exceeded 17 months on stenoparib treatment Boston (February 24, 2025)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical...Read more


Teva Pharmaceutical and Sanofi Present New Positive Phase 2b Study Results at ECCO 2025 Reinforcing Best-in-Class Potential of Duvakitug (Anti-TL1A) in Ulcerative Colitis and Crohn’s Disease

February 22
Last Trade: 16.48 -0.23 -1.38

New detailed data from the RELIEVE UCCD study support overall efficacy and safety of duvakitug in all pre-specified subgroups across the different doses New endpoints presented include findings on clinical and endoscopic outcomes and histological- endoscopic mucosal improvement Findings to form the basis for a Phase 3 program, anticipated to start in H2 2025 PARSIPPANY, N.J. and PARIS, Feb. 22, 2025 (GLOBE NEWSWIRE) -- Teva...Read more


SELLAS Life Sciences Announces Positive Data from Phase 2a Trial of SLS009 in Combination with Zanubrutinib in DLBCL

February 20
Last Trade: 1.08 -0.05 -4.42

Combination Achieved a 67% of Overall Response Rate, More than Double that of Zanubrutinib Alone; 83% Disease Control Rate in Difficult-to-Treat Non-GCB DLBCL (ABC DLBCL) Patients  Median Overall Survival Not Reached Yet – 67% of Patients Still Alive  NEW YORK, Feb. 20, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company...Read more


NKGen Biotech Appoints Dr. Anita Fletcher as National Principal Investigator for Phase 2a Troculeucel Trial Evaluating Moderate Alzheimer’s Disease with AdventHealth Orlando as First East Coast Site

February 19
Last Trade: 0.18 0.04 28.57

SANTA ANA, Calif., Feb. 19, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (Nasdaq: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced that Anita Fletcher, M.D. has been appointed as the National Principal Investigator (“PI”) for its Phase 2a clinical trial of troculeucel,...Read more


Supernus Pharmaceuticals Announces Topline Results from Phase 2b Study in Adults with Treatment Resistant Depression

February 18
Last Trade: 32.28 0.12 0.37

Study did not demonstrate statistically significant improvement on primary endpoint of reduction in depressive symptoms as measured by MADRS total score compared to placebo SPN-820 was well-tolerated with few adverse events, consistent with previously reported studies ROCKVILLE, Md., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing...Read more


Tiziana Life Sciences Announces Dosing of Additional Patients in Multiple Sclerosis Expanded Access Program

February 18
Last Trade: 1.52 -0.03 -1.94

NEW YORK, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the dosing of an additional four patients in its Intermediate Size Patient Population Expanded Access (ISPPEA) for patients with...Read more


Purple Biotech Advances NT219 into Phase 2 Head and Neck Cancer Trial

February 18
Last Trade: 2.70 -0.10 -3.57

NT219, a novel agent designed to overcome tumor resistance to drug therapy, will be evaluated in combination with the standard-of-care head and neck cancer drugs pembrolizumab (Keytruda) or cetuximab (Erbitux) The study is conducted in collaboration with the University of Colorado Anschutz Medical Campus and is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program REHOVOT, Israel, Feb. 18, 2025...Read more


Medicus Pharma Provides Update on SKNJCT-003 Phase 2 Clinical Study for the Treatment of Nodular Basal Cell Carcinoma (BCC)

February 14
Last Trade: 5.69 0.00 0.00

The Company Is on Track to Complete the Interim Data Analysis Before the End of Q1 2025 and to Submit the Findings to the U.S. Food and Drug Administration (FDA) Philadelphia, Pennsylvania--(Newsfile Corp. - February 14, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is also pleased to announce that its phase 2 clinical study (SKNJCT-003), which is currently underway in nine (9) clinical sites in United...Read more


TC Biopharm Announces Successful Completion of Cohort A in the ACHIEVE Clinical Trial

February 13
Last Trade: 1.63 -0.12 -6.86

No adverse events related to TCB008 have occurred Evidence of stable disease following TCB008 infusion EDINBURGH, Scotland, Feb. 13, 2025 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced that it has concluded dosing of Cohort A patients in...Read more


Pliant Therapeutics Announces Next Steps Following DSMB Recommendation on BEACON-IPF, a Phase 2b/3 Trial in Patients with Idiopathic Pulmonary Fibrosis

February 13
Last Trade: 1.69 -0.01 -0.59

SOUTH SAN FRANCISCO, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced that, per the charter of the trial’s independent Data Safety Monitoring Board (DSMB), the Company has initiated the assembly of an outside expert panel to review unblinded data from the ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). The panel, consisting of...Read more


Alto Neuroscience Announces Favorable Outcome from Interim Analysis of ALTO-300 Phase 2b Major Depressive Disorder Trial

February 12
Last Trade: 2.88 -0.21 -6.80

Interim analysis resulted in a recommendation to continue the study with a total targeted biomarker population of ~200 patients in the final analysis sample  Topline results are expected in mid-2026  The company recently reported an estimated preliminary 2024 year-end cash balance of approximately $168 million, which is expected to support planned operations into 2028  MOUNTAIN VIEW, Calif. / Feb 12, 2025 / Business...Read more


Ocugen Announces Dosing Completion in the Phase 2 ArMaDa Clinical Trial for OCU410—a Multifunctional Modifier Gene Therapy for the Treatment of Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

February 12
Last Trade: 0.52 -0.06 -9.88

Completed Phase 2 enrollment with randomization of 51 subjects into treatment and control arms Phase 1/2 study (N=60) demonstrated favorable safety and tolerability profile with no serious adverse events related to OCU410, including no cases of ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization Subjects showed considerably slower lesion growth (44%) from baseline in treated...Read more


AnaptysBio Announces Rosnilimab Achieved Positive Results in RA Phase 2b Trial and Highest Ever Reported CDAI LDA Response Over 6 Months

February 12
Last Trade: 16.14 -0.37 -2.24

Achieved statistical significance on primary endpoint at Week 12 on mean change from baseline DAS-28 CRP across all rosnilimab doses vs. placebo Achieved statistical significance on key secondary endpoints at Week 12 on ACR20, ACR50 and CDAI LDA Demonstrated highest ever reported responses on key secondary endpoints at Week 14 on ACR20, ACR50, ACR70 and CDAI LDA 69% of rosnilimab-treated patients achieved CDAI LDA at Week 14 and...Read more


Kairos Pharma Adds Huntsman Cancer Institute for Phase 2 ENV105 Clinical Trial

February 11
Last Trade: 0.91 -0.05 -4.74

ENV105 can potentially address resistance in a wide range of cancers as they become resistant to standard treatments. LOS ANGELES / Feb 11, 2025 / Business Wire / Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company developing therapies to surmount current cancer drug resistance and immune suppression, today announces the addition of Huntsman Cancer Institute in Salt Lake City, Utah for the Phase 2...Read more


Rallybio Announces Initiation of Dosing in RLYB212 Phase 2 Clinical Trial

February 11
Last Trade: 0.73 0.09 14.29

Key Data Readouts from Sentinel Participant Expected in 2Q 2025 and 3Q 2025  NEW HAVEN, Conn. / Feb 11, 2025 / Business Wire / Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company translating scientific advances into transformative therapies for patients with devastating rare diseases, today announced that the first participant has been dosed in the Phase 2 trial investigating RLYB212 in pregnant women at...Read more


Lipella Pharmaceuticals Reports Positive Topline Phase 2a Results for LP-310 in the Treatment of Oral Lichen Planus

February 11
Last Trade: 2.25 0.04 1.81

LP-310 Treatment Demonstrates Clinically Meaningful Reductions in Pain, Ulceration, and Inflammation Across All Key Metrics Findings Highlight Favorable Safety Profile and Tolerability of Twice-Daily Oral Rinse Multicenter Phase 2a Trial Advancing to Higher Treatment Dose with Recruitment Expected to Conclude the First Half of 2025 Lipella Leadership to Present Findings at BIO CEO & Investor Conference on Tuesday, February 11,...Read more


Bristol Myers Squibb Announces Positive Topline Results for Breyanzi® (lisocabtagene maraleucel) in Adult Patients with Relapsed or Refractory Marginal Zone Lymphoma

February 10
Last Trade: 59.90 -0.09 -0.15

Trial met primary endpoint of overall response rate and key secondary endpoint of complete response rate With these data, Breyanzi demonstrates efficacy and manageable safety in a fifth cancer type, the most of any CD19-directed CAR T cell therapy PRINCETON, N.J. / Feb 10, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the Phase 2 TRANSCEND FL trial evaluating Breyanzi® (lisocabtagene maraleucel) in adult...Read more


TC Biopharm Announces Successful Completion of Initial Cohort B Patient Dosing in the ACHIEVE Clinical Trial

February 10
Last Trade: 1.63 -0.12 -6.86

First Cohort B patient received 4 doses (approx. 819 million Gamma Delta T-cells) Cohort B recruitment continues at multiple clinical sites across the United Kingdom EDINBURGH, Scotland, Feb. 10, 2025 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications,...Read more


4D Molecular Therapeutics Presents Positive 52-Week Results from Phase 2b Cohort of PRISM Wet AMD Study and Long-term Durability Data Supporting 4D-150 4FRONT Global Registration Program

February 8
Last Trade: 3.82 -0.36 -8.61

3E10 vg/eye achieved an 83% reduction in injection burden vs. projected on-label aflibercept 2 mg Q8W, 70% required 0-1 supplemental injection, and 57% were injection-free through 52 weeks In the recently diagnosed subgroup, which most resembles the Phase 3 4FRONT-1 and 4FRONT-2 patient populations, 87% required 0-1 supplemental injection and 80% were injection-free through 52 weeks Durable and stable aflibercept expression...Read more


Maze Therapeutics Doses First Patient in Phase 2 HORIZON Clinical Trial Evaluating MZE829 as a Potential Treatment for APOL1 Kidney Disease

February 7
Last Trade: 0 0.00 0.00

SOUTH SAN FRANCISCO, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular, and metabolic diseases, today announced the first patient has been dosed in the company’s Phase 2 clinical trial, the HORIZON Study, of MZE829 in patients...Read more


Coya Therapeutics Reports Statistically Significant Improvement of Inflammatory Blood Markers in Patients with Alzheimer’s Disease Following Monthly Dosing with Low-Dose IL-2, Further Supporting Clinical Development

February 6
Last Trade: 6.45 -0.40 -5.84

Investigator-initiated data from Houston Methodist Hospital showed LD IL-2 reduced proinflammatory factors, both systemically and within the central nervous system, while demonstrating statistically significant improvement in beta amyloid 42 clearance with stabilization of cognitive decline over a five-month treatment period Comprehensive data set will be presented and released throughout 2025 and in a peer reviewed...Read more


Equillium Announces Positive Data from Phase 2 Study Evaluating Itolizumab in Patients with Moderate to Severe Ulcerative Colitis

February 6
Last Trade: 0.79 0.02 2.60

Itolizumab demonstrated clinical efficacy after 12 weeks of treatment, achieving a clinical remission rate of 23.3% compared to 20.0% for adalimumab and 10.0% for placebo Itolizumab achieved key secondary endpoint of endoscopic remission of 16.7% compared to 16.7% for adalimumab and 6.7% for placebo Itolizumab was generally well tolerated consistent with prior clinical experience LA JOLLA, Calif. / Feb 06, 2025 / Business Wire /...Read more


Allarity Therapeutics Announces Expansion of Phase 2 Clinical Trial to Accelerate Development of Stenoparib in Advanced Ovarian Cancer

February 6
Last Trade: 0.85 -0.08 -8.41

Boston (February 6, 2025)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated dual PARP/Wnt pathway inhibitor—as a personalized cancer treatment using its proprietary, drug-specific patient selection technology—the Drug Response Predictor (DRP®)—today announced plans for the next step in advancing the clinical...Read more


Palatin Technologies Completes Phase 2 Obesity Study With MC4R Bremelanotide Plus GLP-1/GIP Tirzepatide

February 6
Last Trade: 0.80 -0.02 -1.86

Last Patient / Last Visit Completed Topline Data Readout Expected Later This Quarter CRANBURY, N.J., Feb. 6, 2025 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced the completion of its Phase 2 BMT-801 clinical study of the co-administration of MC4R...Read more


Recursion Presents Phase 2 Data for REC-994 in CCM in Late-Breaking Oral Presentation at the International Stroke Conference

February 5
Last Trade: 6.39 -0.45 -6.58

Met primary endpoint of safety and tolerability in CCM patients with no treatment-related discontinuations or Grade 3 adverse events In comparison to placebo, treatment with REC-994 400 mg showed promising signals in both MRI-based lesion volume reduction and functional outcome as measured by changes in the modified Rankin scale (mRS) score In patients with cavernomas located in the brainstem, a subset of patients with...Read more


Kura Oncology and Kyowa Kirin Announce Positive Ziftomenib Monotherapy Registrational Trial and Positive FDA Feedback for Upcoming Frontline Combination Trial Designs

February 5
Last Trade: 7.34 0.05 0.69

KOMET-001 registrational trial in R/R NPM1-m AML achieved primary CR/CRh endpoint; topline data submitted for presentation at an upcoming medical meeting  NDA submission for ziftomenib on track for 2Q 2025  Registrational KOMET-017-IC trial of intensive chemotherapy combination will assess MRD negative CR and EFS as dual-primary endpoints to support potential U.S. accelerated approval and full approval  Registrational...Read more


Vaxcyte Advances to Second Stage of Ongoing Phase 2 Study Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease in Infants

February 5
Last Trade: 74.72 -0.51 -0.68

Advancement to Stage 2 of Infant Study Supported by Review of Stage 1 Safety and Tolerability Data  Company Expects to Announce VAX-31 Infant Study Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series in Mid-2026, Followed by Topline Data from the Booster Dose Approximately Nine Months Later  VAX-31 is Designed to Cover Approximately 94% of Invasive Pneumococcal Disease and Approximately 93%...Read more


EyePoint Pharmaceuticals Announces Positive Six-Month Results for the Phase 2 VERONA Clinical Trial of DURAVYU™ for Diabetic Macular Edema Meeting Primary and Secondary Endpoints

February 5
Last Trade: 6.21 -0.42 -6.33

Primary endpoint achieved by both DURAVYU doses (1.34mg and 2.7mg) with extended time to first supplemental injection versus aflibercept control  DURAVYU 2.7mg demonstrated an early and sustained improvement in BCVA with a 24-week gain of +7.1 letters and anatomical improvement of 76 microns reduction in CST paired with reduction in treatment burden of two-thirds Favorable safety profile continues with no DURAVYU-related ocular...Read more


MAIA Biotechnology Announces Positive Efficacy Updates for Phase 2 THIO-101 Trial in Advanced Non-Small Cell Lung Cancer

February 4
Last Trade: 1.67 0.00 0.00

Median overall survival (OS) from THIO treatment extends to 16.9 months Newest data strengthens regulatory strategy CHICAGO / Feb 04, 2025 / Business Wire / MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical...Read more


Mineralys Therapeutics Completes Enrollment in Explore-CKD Phase 2 Trial of Lorundrostat for the Treatment of Hypertension in Subjects with Stage 2 to 3b CKD and Albuminuria

February 4
Last Trade: 15.43 1.21 8.51

RADNOR, Pa., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that it has completed enrollment in the Explore-CKD Phase 2 trial evaluating the efficacy and safety of lorundrostat for...Read more


Cumberland Pharmaceuticals Announces Breakthrough Results from the Phase 2 FIGHT DMD Trial in Duchenne Muscular Dystrophy Heart Disease

February 4
Last Trade: 5.14 -0.03 -0.58

NASHVILLE, Tenn., Feb. 4, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company with development efforts focused on new products for rare diseases, today announced positive top-line results from its Phase 2 FIGHT DMD trial. The study evaluated ifetroban, a novel oral therapy for Duchenne muscular dystrophy (DMD) heart disease – the leading cause of death in DMD patients. It marks...Read more


RedHill Biopharma Announces Initiation of Phase 2 Study of Opaganib and Darolutamide in Advanced Prostate Cancer

February 4
Last Trade: 2.90 -0.11 -3.65

The 80-patient placebo-controlled randomized Phase 2 study will evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC), testing the potentially enhancing effect of opaganib in patients with a poor prognosis The study is being financially supported by Bayer (ETR: BAYN) and the Ramsay Hospital Research Foundation, and will be led by Professor Lisa...Read more


Apogee Therapeutics Announces First Patient Dosed in Part B of Phase 2 APEX Trial of APG777 in Patients with Moderate-to-Severe Atopic Dermatitis

February 3
Last Trade: 38.83 -1.52 -3.77

Enrollment of Part A completed ahead of schedule and exceeded enrollment target with 123 patients enrolled Part A 16-week proof-of-concept data anticipated in mid-2025 SAN FRANCISCO and BOSTON, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology...Read more


GH Research Announces Primary Endpoint Met in Phase 2b Trial with GH001 in TRD Demonstrating -15.5 Point Placebo-adjusted MADRS Reduction

February 3
Last Trade: 10.60 -0.05 -0.47

Primary endpoint met, GH001 led to an ultra-rapid anti-depressant effect with a significant placebo-adjusted MADRS reduction from baseline of -15.5 on Day 8 (p<0.0001) The majority of the patients treated with GH001 achieved remission with a 57.5% remission rate on Day 8 compared with 0% in the placebo group (p<0.0001) All other secondary endpoints were met with clinically and statistically significant improvements on Day 8,...Read more


Jaguar Health Announces First Patient Dosed in Short Bowel Syndrome with Intestinal Failure in Investigator-Initiated Trial of Crofelemer; Proof-of-Concept Data Potentially Available H1 2025

February 3
Last Trade: 0.25 -0.22 -46.91

Trial taking place at Sheikh Khalifa Medical City, a flagship United Arab Emirates hospital and largest teaching medical center in Abu Dhabi Crofelemer, Jaguar's novel plant-based prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both SBS-IF and MVID Proof-of-concept (POC) data generated from this study could potentially lead to reimbursed early patient access in certain...Read more


Alterity Therapeutics Announces Positive ATH434 Phase 2 Trial Results in Multiple System Atrophy Led By Robust Clinical Efficacy

January 30
Last Trade: 3.83 -0.20 -4.96

Clinically Meaningful Benefit Observed at Both ATH434 Doses Studied  Achieved Statistical Significance with Up to 48% Slowing of Clinical Progression on UMSARS Rating Scale  Key MRI Biomarker Shows Iron Stabilization in MSA Affected Brain Regions  ATH434 Demonstrated a Favorable Safety Profile  Webcast Held Yesterday with Access to the Recording Below  MELBOURNE, Australia and SAN FRANCISCO, Jan. 30, 2025...Read more


PepGen Announces CONNECT Program Updates

January 29
Last Trade: 2.18 -0.17 -7.23

BOSTON / Jan 29, 2025 / Business Wire / PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today provided recent updates on its CONNECT clinical program investigating PGN-EDO51 in Duchenne muscular dystrophy (DMD) for patients amenable to an exon-51 skipping...Read more


OKYO Pharma to Complete Enrollment of Neuropathic Corneal Pain Trial by End of Second Quarter

January 29
Last Trade: 1.37 -0.12 -8.05

LONDON and NEW YORK, Jan. 29, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP), a severe ocular condition without an FDA approved therapy, and for inflammatory dry eye disease (DED), a multi-billion-dollar market, today announces a clinical update and its interim results for the six months ended 30...Read more


Leap Therapeutics Reports Initial Clinical Data from Part B of the DeFianCe Study and Part C of the DisTinGuish Study

January 28
Last Trade: 0.41 -0.02 -4.66

35% objective response rate (ORR) in second-line colorectal cancer (CRC) patients treated with sirexatamab (DKN-01) plus bevacizumab and chemotherapy, compared to 23% ORR in the control arm DKK1 levels highly correlated with clinical activity in CRC population ORR benefit with sirexatamab observed across multiple potential Phase 3 CRC populations Preparations will begin for a registrational Phase 3 study in second-line CRC patients...Read more


atai Life Sciences Announces Positive Topline Results from Beckley Psytech’s BPL-003 (intranasal 5-MeO-DMT benzoate) Phase 2a Open-Label Study for Alcohol Use Disorder

January 28
Last Trade: 1.35 -0.11 -7.53

A single dose of BPL-003, combined with relapse prevention therapy, produced meaningful and sustained reductions in alcohol use, with 50% of patients maintaining complete abstinence out to three months BPL-003 was well-tolerated with no serious or severe adverse events reported NEW YORK and BERLIN, Jan. 28, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical...Read more


MindBio Therapeutics Announces Successful Outcome of Mandatory Independent Safety Audit in Phase 2b Clinical Trials

January 28
Last Trade: 0.02 0.00 0.00

Vancouver, British Columbia – TheNewswire - 28 January, 2025 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), is a clinical stage biopharmaceutical company in psychiatric medicine development using microdoses of psychedelic medicines to treat depressive disorders.  The Company is delighted to report the outcome of a mandatory independent safety audit of its two currently dosing Phase 2B clinical...Read more


Fortress Biotech Announces First Patient Dosed in Phase 2 Clinical Trial of Triplex Vaccination in Stem Cell Donors to Reduce CMV Events in Recipients of HSCT

January 27
Last Trade: 1.72 -0.03 -1.71

Study is the first randomized, controlled trial examining a vaccine’s effectiveness in controlling CMV in recipients of HSCT from vaccinated donors Encouraging pilot study results demonstrated the benefit of vaccinating donors with Triplex to convey protective CMV-specific T cell immunity to allogeneic HSCT recipients at risk for CMV reactivation MIAMI, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO)...Read more


Akero Therapeutics Reports Preliminary Topline Results Showing Statistically Significant Reversal of Compensated Cirrhosis (F4) Due to MASH—by Both Completer and ITT Analyses—at Week 96 in Phase 2b SYMMETRY Study

January 27
Last Trade: 43.53 -1.29 -2.88

Among patients with baseline and week 96 biopsies, 39% of the 50mg EFX group (p=0.009) demonstrated ≥1 stage improvement in fibrosis with no worsening of MASH, representing a 24% effect size over placebo at 15% By ITT analysis, with all missing week 96 biopsies treated as failures, 29% of the 50mg EFX group (p=0.031) demonstrated ≥1 stage improvement in fibrosis with no worsening of MASH, representing a 17% effect size over placebo at...Read more


Veru Announces Positive Topline Data from Phase 2b QUALITY Clinical Study: Enobosarm Preserved Lean Mass in Patients Receiving WEGOVY® (Semaglutide) for Weight Reduction

January 27
Last Trade: 0.48 -0.01 -2.82

Study met primary endpoint: Enobosarm treatment resulted in statistically significant reduction in the loss of lean mass in subjects receiving WEGOVY (p=0.002)  Patients on Enobosarm on average lost 71% less lean mass than patients receiving WEGOVY alone  Patients on Enobosarm on average lost 27% more fat mass than patients receiving WEGOVY alone  Enobosarm improved body composition as mean total body weight loss was...Read more


Sarepta Therapeutics Announces Results from Part 2 of the EMBARK Study Demonstrating Sustained Benefits and Disease Stabilization in Ambulatory Individuals with Duchenne Muscular Dystrophy Following Treatment with ELEVIDYS

January 27
Last Trade: 73.18 -28.17 -27.79

Treatment with ELEVIDYS corresponded with increases on the North Star Ambulatory Assessment (NSAA) at one year in crossover patients, while the study remained blinded MRI results at two years in patients treated in Part 1 show minimal muscle pathology progression, aligning closely with observed functional benefits Crossover-treated patients show statistically significant benefits of ELEVIDYS treatment on NSAA, Time to Rise (TTR), and...Read more


Genprex Announces First Patient Dosed in Phase 2 Expansion Portion of Acclaim-3 Clinical Study of Reqorsa® Gene Therapy in Combination with Tecentriq® to Treat Small Cell Lung Cancer

January 23
Last Trade: 0.34 -0.06 -16.00

Expects to Complete Enrollment of First 25 Patients in Phase 2 Expansion Study During Second Half of 2025 for Interim Analysis Acclaim-3 Study Has FDA Orphan Drug and Fast Track Designations AUSTIN, Texas, Jan. 23, 2025 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced...Read more


ALX Oncology Presents Positive Updated Data from ASPEN-06 Phase 2 Trial Demonstrating Evorpacept Generates Strong Response and Durable Clinical Benefit in Patients with HER2-Positive Gastric Cancer

January 23
Last Trade: 0.74 -0.04 -5.31

Oral presentation at 2025 ASCO Gastrointestinal Cancers Symposium today highlights evorpacept as the first CD47 blocker to show substantial tumor response and a well-tolerated safety profile in a prospective randomized trial Greatest benefit observed among patients with confirmed HER2-positive cancer, as demonstrated by either fresh biopsy or ctDNA HER2-expression, with confirmed ORR of 48.9% and mDOR of 15.7 months vs. 24.5% ORR and...Read more


Jaguar Health Announces First Patient Dosed in Investigator-Initiated Trial (IIT) Evaluating Crofelemer for the Rare Disease Indication of Microvillus Inclusion Disease (MVID), with Proof-of-Concept (POC) Data Potentially Available H1 2025

January 22
Last Trade: 0.25 -0.22 -46.91

Trial taking place at Sheikh Khalifa Medical City, a flagship tertiary hospital in the United Arab Emirates POC data generated from this study could potentially lead to reimbursed early patient access in certain European countries for crofelemer for MVID Crofelemer, Jaguar's novel plant-based prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both MVID and short bowel syndrome...Read more


Lisata Therapeutics Reports Encouraging Preliminary Cohort A Data from the AGITG-led Phase 2 ASCEND Trial Evaluating Certepetide with Standard-of-Care Chemotherapy in Metastatic Pancreatic Ductal Adenocarcinoma

January 22
Last Trade: 2.21 -0.17 -7.14

Cohort A data to be presented in a poster session at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium Data reported positive trend in overall survival, including 4 complete responses observed in the certepetide treatment group compared to none in placebo group Data from Cohort B expected in the coming months, with full data from both cohorts to be reported thereafter BASKING RIDGE, N.J., Jan. 22,...Read more


Immutep Patient Enrolment Completed for EFTISARC-NEO Phase II Trial

January 22
Last Trade: 1.85 0.03 1.37

Phase II trial evaluating efti in combination with radiotherapy plus KEYTRUDA® (pembrolizumab) in patients with soft tissue sarcoma reaches enrolment target of 40 patients Data updates from EFTISARC-NEO expected in 2025 SYDNEY, AUSTRALIA, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and...Read more


Coherus BioSciences Presents Final Phase 2 Clinical Casdozokitug Combination Data in Patients with Metastatic Hepatocellular Carcinoma at ASCO-GI 2025

January 22
Last Trade: 0.89 -0.03 -3.03

Casdozokitug, in combination with atezolizumab/bevacizumab, final data demonstrate durability of response and improvement in depth of response including a 17.2% complete response rate  Antitumor activity was observed across both viral and non-viral etiologies  Data support continued evaluation of casdozokitug with VEGF and PD-(L)1 blockade in HCC  Randomized Phase 2 trial evaluating casdozokitug/bevacizumab/toripalimab...Read more


Xilio Therapeutics Announces Initial Phase 2 Data for Vilastobart (XTX101), a Tumor-Activated Anti-CTLA-4, in Combination with Atezolizumab in Patients with Metastatic Microsatellite Stable Colorectal Cancer

January 21
Last Trade: 0.78 -0.03 -3.99

27% preliminary response rate observed in heavily pre-treated microsatellite stable colorectal cancer (MSS CRC) patients without liver metastases Responses were accompanied by decreases in levels of carcinoembryonic antigen (CEA) and circulating tumor DNA (ctDNA) and improvement in clinical symptoms Data continue to demonstrate differentiated safety and tolerability profile for the combination with low incidence of immune-related...Read more


Shuttle Pharmaceuticals Reaches Milestone in Patient Enrollment for Phase 2 Clinical Trial of Ropidoxuridine for Treatment of Patients with Glioblastoma

January 21
Last Trade: 0.42 -0.03 -6.67

GAITHERSBURG, Md., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today that it has achieved 25% enrollment in the initial randomized portion of its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of...Read more


Cytokinetics Announces Start of AMBER-HFpEF, a Phase 2 Clinical Trial of CK-586 in Patients With Symptomatic Heart Failure With Preserved Ejection Fraction

January 21
Last Trade: 43.28 -1.63 -3.63

SOUTH SAN FRANCISCO, Calif., Jan. 21, 2025 (GLOBE NEWSWIRE) --  Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that AMBER-HFpEF (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF) is open to enrollment. AMBER-HFpEF is a Phase 2 randomized, placebo-controlled, double-blind, multi-center, dose-finding clinical trial of CK-4021586 (CK-586) in patients with symptomatic heart...Read more


Evaxion Biotech completes dosing in phase 2 trial with personalized cancer vaccine EVX-01

January 15
Last Trade: 1.85 -0.02 -1.07

Trial remains on track for completion and data readout in the second half of 2025 COPENHAGEN, Denmark, January 15, 2025 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, has now completed the dosing of all 16 patients in its phase 2 trial with the company’s lead asset EVX-01. Designed with Evaxion’s AI-Immunology™ platform, EVX-01 is a...Read more


OS Therapies Announces Phase 2b Clinical Trial of OST-HER2 Achieves Primary Endpoint with Statistical Significance in the Prevention of Recurrent, Fully Resected, Lung Metastatic Osteosarcoma

January 15
Last Trade: 1.60 -0.03 -1.84

The primary endpoint of 12-month Event Free Survival (EFS) for OST-HER2- treated patients (33.3%) was statistically significant (p= 0.0158) when compared with peer-reviewed comparable historical control (20%) Ongoing follow up demonstrates strong trend in favor of OST-HER2 in 1-year and 2-year interim analyses of the secondary endpoint, 3-year overall survival (OS) when compared with comparable peer-reviewed historical control 100% of...Read more


Keros Therapeutics Announces Additional Update on the Phase 2 TROPOS Trial

January 15
Last Trade: 11.40 -0.22 -1.89

LEXINGTON, Mass., Jan. 15, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros” or the “Company”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (“TGF-ß”) family of proteins, today announced that it has voluntarily halted all dosing...Read more


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