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Cara Therapeutics Announces Outcome of Part A of KOURAGE-1 Study Evaluating Oral Difelikefalin in Notalgia Paresthetica

June 12
Last Trade: 0.35 -0.09 -21.10

Oral difelikefalin did not demonstrate meaningful clinical benefit compared to placebo  Company will discontinue clinical program in NP and explore strategic alternatives  STAMFORD, Conn., June 12, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the...Read more


Ultragenyx Pharmaceutical and Mereo BioPharma Announce New Phase 2 Data from Phase 2/3 Orbit Study Demonstrating Sustained Reductions in Fracture Rates Following Treatment with Setrusumab (UX143) in Patients with Osteogenesis Imperfecta (OI)

June 11
Last Trade: 39.05 -4.07 -9.44

14-month data show treatment with setrusumab resulted in a large, sustained 67% reduction in annualized fracture rate and persistent median annualized fracture rate of 0.00 (p=0.0014) Treatment resulted in continued, substantial improvements in bone mineral density (BMD) with a mean increase from baseline of 22% (p<0.0001) and a mean improvement in Z-score of +1.25 (p<0.0001) NOVATO, Calif. and LONDON, June 11, 2024...Read more


Incannex Healthcare: Patient dosing commenced in RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea

May 30
Last Trade: 3.32 0.17 5.40

NEW YORK and MELBOURNE, Australia, May 30, 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 patient dosing has commenced in the Company’s Phase 2/3 clinical trial to assess safety and efficacy of IHL-42X in patients with obstructive sleep...Read more


HUTCHMED Initiates Phase II/III Trial of the Combination of Surufatinib and Camrelizumab for Treatment-Naïve Pancreatic Ductal Adenocarcinoma in Collaboration with Hengrui

May 13
Last Trade: 18.12 -0.52 -2.79

Almost half a million people diagnosed each year across the globe Collaboration based on synergistic potential of inhibiting angiogenesis and tumor-associated macrophages with HUTCHMED’s surufatinib and anti-PD-1 activity with Hengrui’s camrelizumab, promoting the immune response against tumor cells HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 14, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”)...Read more


Denali Therapeutics Announces Completion of Enrollment for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial

May 1
Last Trade: 20.73 -1.39 -6.28

SOUTH SAN FRANCISCO, Calif., May 01, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative and lysosomal storage diseases, today announced that the Sean M. Healey & AMG Center in collaboration with the Northeast ALS Consortium (NEALS) completed enrollment...Read more


NRx Pharmaceuticals Announces Promising Findings in Phase 2b/3 Clinical Trial of NRX-101 vs. Lurasidone for Treatment of Suicidal Bipolar Depression

April 30
Last Trade: 3.03 -0.41 -11.92

NRX-101 is first oral antidepressant to show 33% advantage in sustained remission in suicidality (not statistically significant at this sample size) and 75% advantage in relief from Akathisia relative to lurasidone - never previously shown with an oral antidepressant. Suicidality signal met the study's promising zone criteria and the akathisia signal approached statistical significance (P=0.076)  Both NRX-101...Read more


Annovis Bio Announces Statistically Significant Phase II/III Data in Patients With Early Alzheimer’s Disease

April 29
Last Trade: 5.85 -0.16 -2.66

Significantly higher rate of improvement in ADAS-Cog 11 scores in each treatment dose relative to placebo for patients with mild AD Improvement in cognition measured by ADAS-Cog 11 at three months is 3.3 points as compared to 0.3 for placebo, consistent with our previous Phase II AD/PD and Discover studies Plasma Tau protein levels are reduced, consistent with our previous Phase II biomarker data Based on the findings of this...Read more


HOOKIPA Pharma Announces Pivotal Phase 2/3 Trial Design for HB-200 in Combination with Pembrolizumab

April 25
Last Trade: 0.74 -0.04 -4.92

Phase 2/3 pivotal trial design and protocol for HB-200 in combination with pembrolizumab for the first-line treatment of patients with HPV16+ recurrent or metastatic OPSCC aligned with FDA feedback HB-200 accepted for oral abstract presentation at ASCO 2024 Annual Meeting with data from approximately 40 patients treated with HB-200 in combination with pembrolizumab Two additional abstracts for HB-200 and HB-700 accepted for the ASCO...Read more


DiaMedica Therapeutics Announces First Patient Dosed in Relaunch of its Pivotal Phase 2/3 ReMEDy2 Trial of DM199 for the Treatment of Acute Ischemic Stroke

April 17
Last Trade: 2.40 0.05 2.13

MINNEAPOLIS / Apr 17, 2024 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today announced the first patient being dosed in DiaMedica’s relaunch of its pivotal Phase 2/3 ReMEDy2 Trial of DM199 for the treatment of acute ischemic stroke. The company continues to work closely with its contract...Read more


Galectin Therapeutics Reports the Positive Outcome of the Fifth Data and Safety Monitoring Board Meeting for NAVIGATE Phase 2b/3 Study of Belapectin in Patients with Cirrhotic Portal Hypertension Caused by Metabolic Dysfunction-Associated SteatoHepatitis...

April 9
Last Trade: 2.62 -0.04 -1.50

Data and Safety Monitoring Board (DSMB) recommends the continuation, without modifications, of the adaptive Phase 2b/3 NAVIGATE study of belapectin in metabolic dysfunction-associated steatohepatitis (MASH) liver cirrhosis Fifth positive recommendation further supports favorable tolerability and safety profile of belapectin Interim Phase 2b efficacy readout anticipated in Q4 2024 NORCROSS, Ga., April 09, 2024 (GLOBE NEWSWIRE) --...Read more


NRx Pharmaceuticals Announces Data-Lock of Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression

April 8
Last Trade: 3.03 -0.41 -11.92

Data transferred for independent statistical analysis Top-line data expected in April 2024 RADNOR, Pa., April 8, 2024 /PRNewswire/ -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the "Company"), a clinical-stage biopharmaceutical company, today announced that the Company has achieved data-lock in its Phase 2b/3 Suicidal Treatment Resistant Bipolar Depression Study with NRX-101.  With data-lock, as forecast...Read more


Merck: REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug Deruxtecan Initiated in Patients with Platinum-Resistant Ovarian Cancer

April 3
Last Trade: 129.48 0.11 0.09

BASKING RIDGE, N.J. & RAHWAY, N.J. / Apr 03, 2024 / Business Wire / Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the first patient has been dosed in the REJOICE-Ovarian01 phase 2/3 trial evaluating the efficacy and safety of investigational raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer. The phase 2 portion of the trial...Read more


Gritstone bio Announces Positive Preliminary Progression-free Survival and Long-term Circulating Tumor DNA (ctDNA) Data from Phase 2 Portion of Ongoing Phase 2/3 Study of its Personalized Cancer Vaccine, GRANITE, in Front-line Metastatic Microsatellite...

April 1
Last Trade: 0.78 -0.01 -1.76

Early progression-free survival (PFS) trends favor GRANITE recipients with hazard ratios of 0.82 in the overall population ([95% CI, 0.34-1.67]; 62% censored) and 0.52 (48% relative risk reduction of progression or death with GRANITE vs. control) in a high-risk group, where clinical data are more mature ([95% CI, 0.15-1.38]; 44% censored); >90% of high-risk patients have liver metastases  Short-term molecular response (as...Read more


Vertex Pharmaceuticals Advances Inaxaplin (VX-147) into Phase 3 Portion of Adaptive Phase 2/3 Clinical Trial for the Treatment of APOL1-Mediated Kidney Disease

April 1
Last Trade: 480.73 1.70 0.35

45 mg once daily oral dose selected for Phase 3  Results support trial expansion to lower age group and study will now include adolescents ages 10-17 years  If positive, pre-planned interim analysis at Week 48 may serve as the basis for accelerated approval in the U.S.  BOSTON / Apr 01, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that inaxaplin (VX-147) has advanced into...Read more


Natera and Alliance for Clinical Trials in Oncology Announce Activation of Alliance A032103 (MODERN): A Randomized, Phase II/III Adjuvant Trial in Urothelial Cancer

April 1
Last Trade: 110.20 -0.59 -0.53

First of its kind study in muscle-invasive urothelial cancer, with both escalation and de-escalation arms Approximately 1,000 patients will be enrolled at more than 300 sites AUSTIN, Texas / Apr 01, 2024 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, and the Alliance for Clinical Trials in Oncology, which is part of the National Clinical Trials Network (NCTN) funded by the National Cancer...Read more


HUTCHMED Initiates Registration Stage of the ESLIM-02 Phase II/III Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China

March 21
Last Trade: 18.12 -0.52 -2.79

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 22, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated the registration stage of the Phase II/III clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (“wAIHA”) in China. This follows positive data from the proof-of-concept Phase II stage of the trial and...Read more


Seelos Therapeutics Provides Update on Top-Line Results from its Amyotrophic Lateral Sclerosis (ALS) Study with SLS-005 (IV Trehalose)

March 19
Last Trade: 0.91 -0.05 -5.53

NEW YORK, March 19, 2024 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today provided an update on top-line data of the Phase 2/3 HEALEY ALS Platform trial. This study was performed in collaboration with The Sean M. Healey and AMG Center, which is viewed as an influential force...Read more


Acelyrin Announces Positive Top-line Results from Its Global Phase 2b/3 Clinical Trial of Izokibep in Psoriatic Arthritis

March 11
Last Trade: 4.18 -0.18 -4.13

Study met primary endpoint of ACR50 at 16 weeks versus placebo with high statistical significance and is expected to be the first of two registrational trials in psoriatic arthritis Robust clinical responses achieved for the high hurdles of ACR70, PASI100, as well as composite endpoints ACR50/PASI100 and Minimal Disease Activity Favorable safety profile consistent with the IL-17A class and previous izokibep experience LOS ANGELES,...Read more


Immutep Announces First Clinical Data from 90mg Dosing of Efti

March 5
Last Trade: 2.71 -0.02 -0.73

Data from the safety lead-in of the AIPAC-003 trial shows 90mg efti in combination with paclitaxel is safe and well tolerated Encouraging initial efficacy in six metastatic breast cancer patients, who exhausted all endocrine therapy including CDK4/6 inhibitors, demonstrated by a 50% overall response rate, including one complete response, and a 100% disease control rate SYDNEY, AUSTRALIA, March 05, 2024 (GLOBE NEWSWIRE) -- Immutep...Read more


NRx Pharmaceuticals Announces Last Patient, Last Visit in its Phase 2b/3 Trial of NRX-101 in Suicidal Treatment Resistant Bipolar Depression

March 4
Last Trade: 3.03 -0.41 -11.92

Marks a major step in the development of what could be the first drug approved for Suicidal Bipolar Depression The study database is being cleaned and locked; statistical analysis and top-line data to follow shortly thereafter Study maintained 95% concordance rate between study sites and central raters on primary endpoint. No unexpected Serious Adverse Events were reported. Positive data and FDA comment would trigger the next $4...Read more


Oncotelic Therapeutics: Invitation to Participate in STOP-PC Clinical Trial

March 4
Last Trade: 0.04 0.00 0.00

AGOURA HILLS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc (OTCQB:OTLC) invites participation in our STOP-PC clinical trial which is now open for recruitment. Additional information can be obtained at www.stop-pc.com. An explainer video is available at https://www.youtube.com/watch?v=C4ZsE3fulIU. STOP-PC is a Randomized Phase 2b/Phase 3 Study of the TGF-β2 Targeting Antisense Oligonucleotide OT-101 in...Read more


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: 2.17 0.18 9.05

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: 5.96 0.09 1.53

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: 1.12 -0.04 -3.45

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: 3.03 -0.41 -11.92

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: 3.32 0.17 5.40

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: 21.55 0.00 0.00

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: 2.54 -0.01 -0.39

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: 3.77 0.04 1.07

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: 18.12 -0.52 -2.79

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: 3.32 0.17 5.40

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: 21.74 -0.22 -1.00

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: 4.18 -0.18 -4.13

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: 2.71 -0.02 -0.73

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: 5.85 -0.16 -2.66

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: 39.05 -4.07 -9.44

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: 2.62 -0.04 -1.50

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: 3.77 0.04 1.07

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: 2.17 0.18 9.05

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: 7.05 -0.15 -2.08

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: 4.18 -0.18 -4.13

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 0.00 0.00

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


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

July 26
Last Trade: 7.05 -0.15 -2.08

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: 65.06 1.50 2.36

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: 3.32 0.17 5.40

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: 34.67 0.14 0.41

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


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Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...

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