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Latest Phase 2/3 Clinical Trials Stock News

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AN2 Therapeutics to Voluntarily Pause Enrollment in Phase 3 Part of Phase 2/3 Pivotal Clinical Trial Evaluating Epetraborole for Treatment-Refractory Mycobacterium Avium Complex (MAC) Lung Disease

February 12
Last Trade: 3.09 -0.22 -6.65

Enrolled patients allowed to continue on study MENLO PARK, Calif. / Feb 12, 2024 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced the company’s decision to voluntarily pause Phase 3 enrollment in the seamless Phase 2/3 clinical trial (EBO-301) evaluating...Read more

ImmunityBio Quality-of-Life Study in BCG-Unresponsive Bladder Cancer Trial Indicates Improved Physical Function in the 71% Complete Responders Suggesting a Favorable Risk-Benefit Ratio for N-803 Plus BCG

February 5
Last Trade: 3.50 -1.74 -33.21

Patient Reported Outcomes (PROs) based on a May 16, 2022 data cutoff in the QUILT 3.032 trial indicate stability of physical function and global health in patients who completed PRO questionnaires and reached month 24 on-study Overall, participants with complete responses (CRs) to combination therapy with the novel interleukin-15 (IL-15) superagonist N-803 and bacillus Calmette-Guerin (BCG) reported better physical function than those...Read more

FibroGen Announces Completion of the Pamrevlumab Arm in Precision Promise, Pancreatic Cancer Action Network’s Phase 2/3 Adaptive Platform Trial for Metastatic Pancreatic Cancer

January 25
Last Trade: 1.82 -0.07 -3.70

Pamrevlumab has now completed Stage 2 of the trial and topline data from this registration study in ~175 pamrevlumab treated patients is anticipated in 2Q 2024 Pamrevlumab is the first experimental arm to meet its required threshold for graduation in the seamless Phase 2/3 adaptive platform trial SAN FRANCISCO, Jan. 25, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced graduation and completion of the pamrevlumab...Read more

NRx Pharmaceuticals Announces Completion of Enrollment of its Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression

January 22
Last Trade: 0.44 0.00 0.00

Exceeded originally target enrollment (70) with n=74                        Last patient, last visit expected in approximately six weeks; data to follow shortly thereafter Positive data triggers milestone payment from Alvogen, as previously announced. RADNOR, Pa., Jan. 22, 2024 /PRNewswire/ -- NRx Pharmaceuticals,...Read more

Incannex Healthcare Receives IRB Approval for the RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea

January 17
Last Trade: 4.77 -1.62 -25.35

MELBOURNE, Australia and NEW YORK, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies is pleased to announce that an independent Institutional Review Board (IRB) has approved the protocol for the Company’s Phase 2/3 clinical trial to be conducted in the...Read more

Fusion Pharmaceuticals Announces Clinical Program and Manufacturing Updates

January 4
Last Trade: 12.14 -0.91 -6.97

Aligned with the FDA on submitted protocol for 225Ac-PSMA (FPI-2265) Phase 2/3 registrational program for patients with metastatic castration-resistant prostate cancer (mCRPC) Achieved target enrollment in ongoing TATCIST trial evaluating FPI-2265; Interim Phase 2 data expected to be presented in April 2024 FPI-1434 shows promising safety profile and early evidence of antitumor activity at 25 kBq/kg dose level Fusion's...Read more

Athira Pharma Completes Enrollment of Phase 2/3 LIFT-AD Clinical Trial of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease

January 3
Last Trade: 3.93 0.00 0.00

Topline data from LIFT-AD on track for second half of 2024 Previously reported independent, unblinded interim analysis supports trial continuation and potential clinically meaningful activity of fosgonimeton Potential first-in-class approach focused on HGF modulation for treatment of neurodegenerative diseases BOTHELL, Wash., Jan. 03, 2024 (GLOBE NEWSWIRE) --  Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage...Read more

Anavex Life Sciences Provides an Update on Rett Syndrome Program

January 2
Last Trade: 4.92 -0.09 -1.80

Anavex Announces Topline Results from Phase 2/3 EXCELLENCE Clinical Study in Pediatric Rett Syndrome Validation from Real World Evidence (RWE) of Rett Syndrome Patients under Compassionate Use Authorization NEW YORK, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of...Read more

HUTCHMED Announces that it has Completed Enrollment of a Phase II/III Trial of Fruquintinib in Combination with Sintilimab for Advanced Renal Cell Carcinoma in China

December 12
Last Trade: 15.72 0.06 0.38

HONG KONG, Shanghai and FLORHAM Park, N.J., Dec. 12, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“HUTCHMED”) today announces that it has completed enrollment of its Phase II/III trial of fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China. The study is a randomized, open-label, active-controlled study to evaluate...Read more

Incannex Healthcare Update on IHL-42X Drug Candidate in Phase 2/3 Clinical Trial in Obstructive Sleep Apnea

December 6
Last Trade: 4.77 -1.62 -25.35

MELBOURNE, Australia and NEW YORK, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies for unmet medical needs, is pleased to provide the following update on its proprietary IHL-42X drug candidate. Obstructive sleep apnea (OSA) is characterised by a narrowing or...Read more

Exelixis Announces Initiation of the STELLAR-305 Phase 2/3 Pivotal Trial Evaluating Zanzalintinib in Combination with Pembrolizumab in Patients with Previously Untreated Recurrent or Metastatic Head and Neck Cancer

December 4
Last Trade: 21.53 0.82 3.96

STELLAR-305 is Exelixis’ first pivotal study in squamous cell carcinoma of the head and neck  Trial will evaluate the potential of inhibition of VEGF, MET and AXL, which are elevated in these tumors  ALAMEDA, Calif. / Dec 04, 2023 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-305, a phase 2/3 pivotal trial evaluating zanzalintinib in combination with pembrolizumab versus...Read more

Acelyrin Provides Update on Izokibep Clinical Development Program

November 27
Last Trade: 7.41 -0.11 -1.46

LOS ANGELES, Nov. 27, 2023 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today provided an update on its izokibep clinical development program, including its ongoing global Phase 2b/3 trial for izokibep in psoriatic arthritis (“PsA trial”). Background In September 2023, ACELYRIN disclosed top-line...Read more

Immutep Announces Completion of the Safety Lead-In and Opening of the Randomized Phase II of the AIPAC-003 Phase II/III Trial in Metastatic Breast Cancer

November 6
Last Trade: 2.24 -0.04 -1.75

No safety or tolerability issues in open-label, safety lead-in phase evaluating the higher 90mg dose of efti in combination with weekly paclitaxel in the first 6 patients Good safety profile allows for lead-in phase to be closed early and the randomized Phase II portion of study will now proceed SYDNEY, AUSTRALIA, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a...Read more

Annovis Bio Receives Positive Recommendation to Continue Phase 2/3 Trial of Buntanetap for Alzheimer’s Disease Patients From the Independent Data and Safety Monitoring Board (DSMB)

October 30
Last Trade: 9.94 -0.42 -4.05

BERWYN, Pa. / Oct 30, 2023 / Business Wire / Annovis Bio, Inc. (NYSE: ANVS), announces the positive safety review by the Data and Safety Monitoring Board (DSMB) for its phase 2/3 trial of buntanetap, a drug candidate for moderate to mild Alzheimer’s Disease (AD) patients. The DSMB recommended that Annovis Bio continue the trial as originally designed. The feedback from the DSMB was: no drug-related SAEs (Serious Adverse Events) each AE...Read more

Ultragenyx Pharmaceutical and Mereo BioPharma Announce Interim Phase 2 Data from Phase 2/3 Orbit Study Demonstrating Setrusumab (UX143) Significantly Reduced Fracture Rates in Patients with Osteogenesis Imperfecta (OI)

October 14
Last Trade: 49.48 0.60 1.23

Phase 2 data presented at ASBMR 2023 show treatment with setrusumab resulted in 67% reduction in annualized fracture rate associated with continuous and meaningful improvements in bone mineral density (BMD) Ultragenyx hosting Analyst Day on Monday, October 16 at 8:30 a.m. ET NOVATO, Calif., VANCOUVER, British Columbia and LONDON, Oct. 14, 2023 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and Mereo BioPharma...Read more

Galectin Therapeutics Reports the Positive Outcome of the Fourth Data and Safety Monitoring Board Meeting for NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Portal Hypertension Caused by Non-Alcoholic SteatoHepatitis...

October 3
Last Trade: 1.88 0.10 5.62

NORCROSS, Ga., Oct. 03, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, today reported the positive outcome of its fourth data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, Phase 2b/3 study of belapectin in patients with portal hypertension caused by non-alcoholic steatohepatitis (NASH) liver cirrhosis. NAVIGATE is...Read more

Anavex’s Phase 2b/3 Trial of Blarcamesine (ANAVEX®2-73) in Patients with Alzheimer’s Disease Shows Robust Clinical Efficacy and Slows Neurodegeneration

September 14
Last Trade: 4.92 -0.09 -1.80

NEW YORK, Sept. 14, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders announced today that a follow-on analysis of the landmark Phase 2b/3 study to treat early Alzheimer’s disease with the investigational drug blarcamesine (ANAVEX®2-73) did...Read more

AN2 Therapeutics commences Phase 3 Part of Phase 2/3 Clinical Trial Evaluating Epetraborole for Treatment-Refractory Mycobacterium avium complex (MAC) Lung Disease

September 13
Last Trade: 3.09 -0.22 -6.65

Company announces Phase 2 part of the EBO-301 trial is now fully enrolled with 80 patients; Topline Phase 2 trial results expected in summer 2024 Over 100 sites across four countries (U.S., Japan, S. Korea & Australia) as epetraborole enters Phase 3 portion of EBO-301; expected to enroll ~230 patients MENLO PARK, Calif. / Sep 13, 2023 / Business Wire / AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical...Read more

Humacyte Announces Positive Top Line Results from Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) in Treatment of Patients with Vascular Trauma

September 12
Last Trade: 4.33 0.03 0.58

Single-arm clinical trial was a success and showed the HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks  BLA planned to be filed with FDA in 4th Quarter 2023 Conference call and live webcast with Key Opinion Leaders at 8:00 a.m. ET today  DURHAM, N.C., Sept. 12, 2023 (GLOBE NEWSWIRE) --  Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage...Read more

Acelyrin Announces Top-Line Results from Placebo-Controlled Clinical Trial of Izokibep for Moderate-to-Severe Hidradenitis Suppurativa

September 11
Last Trade: 7.41 -0.11 -1.46

The primary endpoint of HiSCR75 at week 16 did not meet statistical significance in the Non-Responder Imputation (NRI) primary analysis. HiSCR75 did meet statistical significance at week 16 in a Last Observation Carried Forward sensitivity analysis. HiSCR response rates of izokibep 160mg weekly (QW) were consistent with Part A open label results, demonstrating early onset of HiSCR100 at week 4, increasing through week 12 to 38%...Read more

Oncotelic Therapeutics: Sapu BioScience and Cromos Pharma initiating P201 – A Registrational trial for OT-101 in Pancreatic Cancer

August 23
Last Trade: 0.04 0.0001 0.25

AGOURA HILLS, Calif., Aug. 23, 2023 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We" or “Our”), announced today its joint venture partner, GMP Biotechnology Limited’s wholly owned subsidiary – Sapu Bioscience, LLC (“Sapu”), together with with Cromos Pharma, LLC (“Cromos”), a US-based international contract research organization (“CRO”), to conduct Sapu’s registrational trial for OT-101 in...Read more

Humanigen Announces First Participant Dosed in RATinG Trial of Lenzilumab for Early Treatment of Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation

August 7
Last Trade: 0.0002 0.00 0.00

The RATinG (Risk Adapted Therapy in Acute GvHD) is the first trial to explore granulocyte-macrophage colony-stimulating factor (GM-CSF) neutralization for the early treatment of participants with high-risk acute Graft versus Host Disease Planned interim assessment expected in 2024 following treatment of first 20 participants Short Hills, New Jersey--(Newsfile Corp. - August 7, 2023) - Humanigen, Inc. (OTC Pink: HGEN), a...Read more

Humacyte Completes Enrollment in Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) for Vascular Trauma Repair

July 26
Last Trade: 4.33 0.03 0.58

Top-line results planned to be released in third quarter 2023 Trial results are intended to support Biologics License Application (BLA) planned for fourth quarter 2023 DURHAM, N.C., July 26, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced completion of enrollment of its Phase...Read more

Gilead Sciences: Twice-Yearly Lenacapavir Demonstrates Sustained Impact on Health-Related Quality of Life in People With HIV

July 24
Last Trade: 73.55 0.77 1.06

Patient-Reported Outcomes From the CAPELLA Trial Align With the Demonstrated Safety and Tolerability Profile of Lenacapavir Analyses Show Oral Bridging Maintains Virologic Suppression When Subcutaneous Lenacapavir Doses are Missed FOSTER CITY, Calif. / Jul 24, 2023 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including...Read more

Incannex Healthcare engages Fortrea to Manage its FDA IND Opening Phase 2/3 Clinical Trial Investigating IHL-42X for Treatment of Obstructive Sleep Apnoea

July 18
Last Trade: 4.77 -1.62 -25.35

Highlights: Incannex has engaged Fortrea as the contract research organisation (‘CRO’) to manage the IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of OSA. The Phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X in people with OSA who are intolerant, non-compliant, or naïve to continuous positive airway pressure (‘CPAP’). The extensive trial will be conducted across 45 sites, including...Read more

Roche: Four-Year Follow-Up Data for Genentech’s Evrysdi Show Continued Increase in Number of Children With a Severe Form of Spinal ​Muscular ​Atrophy (SMA)​ Able to Sit, Stand and Walk

June 30
Last Trade: 32.96 0.47 1.45

Data from ongoing FIREFISH study confirm long-term efficacy and safety profile of Evrysdi in children with Type 1 SMA  Ninety-one percent of children were alive at month 48  More than 95% maintained the ability to swallow - without treatment they would have required feeding support and majority would have died within 2 years  Evrysdi is now approved in 99 countries with more than 8,500 patients treated...Read more

DiaMedica Therapeutics Announces that the FDA Has Removed Clinical Hold On DM199 Phase 2/3 Trial For Ischemic Stroke

June 21
Last Trade: 2.83 -0.04 -1.39

MINNEAPOLIS / Jun 21, 2023 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold placed on the investigational new drug application for its ReMEDy2 phase 2/3 clinical trial studying DM199 in the treatment of...Read more

Incannex Healthcare Appoints Principal Investigators for IHL-42X Phase 2/3 Clinical Trial

June 16
Last Trade: 4.77 -1.62 -25.35

MELBOURNE, Australia, June 16, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has recruited two highly experienced lead principal investigators (PIs) for the IND opening Phase 2/3...Read more

Humanigen Presents Promising New Hematologic Data from PREACH-M Trial for Chronic Myelomonocytic Leukemia Treatment at the 2023 European Hematology Association Congress

June 9
Last Trade: 0.0002 0.00 0.00

Of the 14 participants enrolled and treated with lenzilumab plus azacitidine, ten are evaluable with three to eighteen months of follow-up and all ten have had a rapid clinical response Building upon previously reported positive clinical responses, these additional data demonstrate statistically significant and clinically relevant improvements in hematologic outcomes, along with improvements in inflammatory markers, that occur...Read more

Anavex Life Sciences Announces Completion of ANAVEX(®)2-73 (blarcamesine) EXCELLENCE Phase 2/3 Rett Syndrome Clinical Trial

June 6
Last Trade: 4.92 -0.09 -1.80

NEW YORK, June 06, 2023 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, today announced the completion of dosing of all...Read more

Ultragenyx Pharmaceutical and Mereo BioPharma Announce Positive Data from the Ongoing Phase 2/3 Orbit Study of Setrusumab (UX143) in Osteogenesis Imperfecta (OI)

June 5
Last Trade: 49.48 0.60 1.23

Pediatric data show substantial induction of bone production in 1 week and a large increase in bone formation within 3 months of initiating monthly setrusumab treatment Phase 3 sites beginning to screen patients Conference call to discuss data planned for 5 p.m. Eastern Time NOVATO, Calif. and LONDON, June 05, 2023 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and Mereo BioPharma Group plc (NASDAQ: MREO) today...Read more

Immutep Doses First Patient in AIPAC-003 Phase II/III Trial for Metastatic Breast Cancer

May 25
Last Trade: 2.24 -0.04 -1.75

SYDNEY, AUSTRALIA, May 25, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces the first patient has been enrolled and safely dosed at a European clinical site for its integrated Phase II/III AIPAC-003 trial in metastatic breast cancer. AIPAC-003 is evaluating...Read more

Cantex Pharmaceuticals and Michigan Medicine Announce Initiation of a Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Clinical Study to Determine the Safety and Efficacy of Azeliragon in the Treatment of Patients Hospitalized for COVID-19

April 20
Last Trade: 8.36 -0.35 -4.02

WESTON, Fla. and ANN ARBOR, Mich., April 20, 2023 /PRNewswire/ -- Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions, and Michigan Medicine, a part of the University of Michigan and one of the nation's leading academic medical centers, announced today the initiation of a randomized double-blind,...Read more

Annovis Bio Announces Update On Recruitment Into Its Phase 2/3 Alzheimer's Study And Upcoming R&D Webcast

April 19
Last Trade: 9.94 -0.42 -4.05

Phase 2/3 AD Study continues to make steady progress in patient recruitment Company to hold R&D webcast on Thursday, April 20th to review ongoing clinical programs in Alzheimer's disease and Parkinson's disease BERWYN, Pa., April 19, 2023 /PRNewswire/ -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company addressing neurodegenerative diseases, today announced that...Read more

Seelos Therapeutics Doses the First Amyotrophic Lateral Sclerosis (ALS) Patient with SLS-005 in an Expanded Access Program

April 4
Last Trade: 1.00 0.17 20.17

The Expanded Access Program is funded by a grant from the National Institute of Neurological Disorders and Stroke (NINDS) under the Accelerating Access to Critical Therapies for ALS (ACT for ALS) for ALS patients who do not qualify for existing clinical trials NEW YORK, April 4, 2023 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies...Read more

Monopar Therapeutics Announces Result of Interim Analysis of Phase 2b/3 VOICE Trial Evaluating Validive for Severe Oral Mucositis

March 27
Last Trade: 1.30 0.18 16.07

WILMETTE, Ill., March 27, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, today announced completion of a pre-specified interim analysis for its Validive Phase 2b/3 VOICE trial for the prevention of severe oral mucositis (SOM) in patients...Read more

NRx Pharmaceuticals Announces Positive Recommendation to Continue Enrollment in the Ongoing Trial of NRX-101 in Patients with Suicidal Treatment-Resistant Bipolar Depression

March 27
Last Trade: 0.44 0.00 0.00

The independent Data Safety Monitoring Board recommended continuation of patient enrollment as planned No safety or futility signals were reported in the first 50 patients This patient population could represent up to 1 million bipolar depression patients in the US and represents a portion of the indication expansion recommended in recent correspondence with the FDA Trial has been upgraded to a Phase 2b/3 study that may be used for a...Read more

Galectin Therapeutics Reports the Positive Outcome of the Third Data and Safety Monitoring Board Meeting for NAVIGATE, its Seamless, Adaptive Phase 2b/3 Study of Belapectin in Patients with Liver Cirrhosis Caused by Non-Alcoholic Steatohepatitis

March 16
Last Trade: 1.88 0.10 5.62

NORCROSS, Ga., March 16, 2023 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin-3, today reported the positive outcome of its third data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, phase 2b/3 study of belapectin in patients with liver cirrhosis caused by non-alcoholic steatohepatitis (NASH). NAVIGATE is the first study of its...Read more

Immutep Announces Initiation of Phase II/III Trial for Eftilagimod Alpha plus Paclitaxel in Metastatic Breast Cancer

March 14
Last Trade: 2.24 -0.04 -1.75

Media Release Integrated Phase II/III trial design incorporates feedback from the FDA and EMA and will help inform a BLA and MAA HR+/HER2-neg/low metastatic breast cancer (MBC) patient population has been expanded to include triple-negative breast cancer, which together account for ~78% of breast cancer cases Approval for study start received in US and IRB approval in Spain, with more countries to follow shortly First patient...Read more

Merck: KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy Alone as First-Line Treatment for Advanced Malignant Pleural Mesothelioma

March 10
Last Trade: 129.45 0.19 0.15

RAHWAY, N.J. & KINGSTON, Ontario / Mar 10, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and the Canadian Cancer Trials Group (CCTG) today announced that the Phase 2/3 CCTG IND.227/KEYNOTE-483 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met its primary endpoint of overall survival (OS) for the first-line treatment of patients with unresectable...Read more

Ayala Pharmaceuticals Announces Continuation of RINGSIDE Phase 2/3 Study in Desmoid Tumors Following Recommendation of Independent Data Monitoring Committee

March 3
Last Trade: 0.89 0.04 4.48

Registration-enabling Phase 3 segment of RINGSIDE is enrolling patients globally Updated data on AL102 Phase 2 segment of RINGSIDE are planned for presentation at a medical meeting in 2023 REHOVOT, Israel and MONMOUTH JUNCTION, N.J., March 03, 2023 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that the Independent Data Monitoring Committee (IDMC) for its Phase 2/3...Read more

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