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C4 Therapeutics

Latest Phase 3 Clinical Trials Stock News

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Gilead Sciences’ Twice-Yearly Lenacapavir Demonstrated 100% Efficacy and Superiority to Daily Truvada® for HIV Prevention

June 20
Last Trade: 70.02 1.53 2.23

First Phase 3 HIV Prevention Trial Ever to Show Zero Infections  Independent Data Monitoring Committee Recommended That Gilead Stop the Blinded Phase of the PURPOSE 1 Trial at Interim Analysis and Offer Open-Label Lenacapavir to All Participants  FOSTER CITY, Calif. / Jun 20, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1...Read more


Ocugen Announces First Patient Dosed in Phase 3 liMeliGhT Clinical Trial for OCU400—First Gene Therapy in Phase 3 with a Broad Retinitis Pigmentosa Indication

June 20
Last Trade: 1.34 0.05 3.95

MALVERN, Pa., June 20, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the first patient has been dosed in its Phase 3 liMeliGhT clinical trial for OCU400—a modifier gene therapy product candidate being developed for retinitis pigmentosa (RP). “Each clinical...Read more


Johnson & Johnson: TREMFYA® (guselkumab) studies underscore its potential to be the only IL-23 inhibitor to offer both subcutaneous and intravenous induction

June 20
Last Trade: 148.59 0.81 0.55

TREMFYA® Phase 3 Crohn's disease study achieves all primary and secondary endpoints SPRING HOUSE, Pa., June 20, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced positive topline results from the pivotal Phase 3 GRAVITI investigational study of TREMFYA® (guselkumab) subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn's disease.1 The study met both co-primary endpoints,...Read more


Takeda Presents Long-Term Data from Phase 3 ADVANCE-CIDP 3 Clinical Trial of HYQVIA® in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) at PNS Annual Meeting

June 18
Last Trade: 12.65 0.04 0.32

Favorable Findings from the Longest Public Clinical Study in CIDP Support HYQVIA as an Effective Long-Term Treatment Option for Maintaining Stable Disease Course in CIDP ADVANCE Clinical Program Reflects Takeda’s Commitment to Continued Research on the Role of Immunoglobulin (IG) Therapy for Patients with Rare Neuroimmunological Disorders OSAKA, Japan & CAMBRIDGE, Mass. / Jun 18, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK)...Read more


Erasca Initiates SEACRAFT-2 Pivotal Phase 3 Trial Evaluating Naporafenib Plus Trametinib in Patients with NRAS-Mutant Melanoma

June 18
Last Trade: 2.05 0.02 0.74

Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor for multiple RAS/MAPK pathway-driven tumors and has been dosed in over 500 patients to date Favorable mOS and mPFS demonstrated in pooled analysis of Phase 1b and Phase 2 trials in NRASm melanoma Randomized Stage 1 readout for naporafenib plus trametinib vs. trametinib monotherapy expected in 2025 SAN DIEGO, June 18, 2024 (GLOBE NEWSWIRE) -- Erasca, Inc....Read more


Intra-Cellular Therapies Announces Positive Topline Results in Second Phase 3 Trial Evaluating Lumateperone as Adjunctive Therapy in Patients with Major Depressive Disorder

June 18
Last Trade: 76.51 0.95 1.26

In Study 502, lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints Lumateperone 42 mg met the primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (4.5 point reduction v. placebo; p<0.0001; Cohen’s d effect size (ES)=0.56) Lumateperone 42 mg also met the key...Read more


BridgeBio Pharma Surpasses Interim Analysis Enrollment Target and Receives U.S. FDA Rare Pediatric Disease Designation for BBP-418, a Potential Treatment for Limb-girdle Muscular Dystrophy Type 2I/R9 (LGMD2I/R9)

June 18
Last Trade: 26.67 -0.38 -1.40

BridgeBio has surpassed its interim analysis enrollment target for its Phase 3 FORTIFY study of BBP-418 in individuals living with LGMD2I/R9, with top-line results from the interim analysis expected in 2025 Recent Type C interactions with U.S. Food and Drug Administration (FDA) focused on the validated glycosylated alpha-dystroglycan (αDG) bioassay and our interim analysis plans reinforce BridgeBio's belief that there is potential to...Read more


Immunocore announces randomization of first patient in the global, registrational Phase 3 clinical trial testing brenetafusp for the treatment of first-line advanced or metastatic cutaneous melanoma

June 18
Last Trade: 35.40 0.28 0.80

The Phase 3 PRISM-MEL-301 trial will study the efficacy and safety of brenetafusp (IMC-F106C; PRAME-A02) in combination with nivolumab versus nivolumab or nivolumab + relatlimab in first-line advanced or metastatic cutaneous melanoma First registrational Phase 3 trial investigating PRAME-targeted therapy (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 18 June 2024) Immunocore Holdings plc (Nasdaq: IMCR)...Read more


Takeda Announces Phase 3 Topline Results for Soticlestat (TAK-935) in Patients with Dravet Syndrome and Lennox-Gastaut Syndrome

June 17
Last Trade: 12.65 0.04 0.32

SKYLINE Study in Dravet Syndrome Narrowly Missed its Primary Endpoint of Reduction in Convulsive Seizure Frequency and Showed Clinically Meaningful and Nominally Significant Effects in Multiple Key Secondary Efficacy Endpoints SKYWAY Study in Lennox-Gastaut Syndrome Missed its Primary Endpoint of Reduction in Major Motor Drop Seizures Soticlestat Showed a Consistent and Favorable Safety and Tolerability Profile in Both Studies Takeda...Read more


SELLAS Life Sciences Announces Positive Recommendation from the Independent Data Monitoring Committee of the Phase 3 REGAL Trial in Acute Myeloid Leukemia

June 17
Last Trade: 1.20 0.04 3.46

The Independent Data Monitoring Committee (IDMC) Recommends Continuation of Phase 3 REGAL Trial Without Any Modifications  No Safety or Futility Concerns Were Raised Based on the Efficacy and Safety Assessment of All REGAL Patients   Interim Analysis Anticipated by Q4 2024   NEW YORK, June 17, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage...Read more


iTeos Therapeutics and GSK Initiate GALAXIES Lung-301 Phase 3 Study, Assessing Belrestotug and Dostarlimab in Previously Untreated, Unresectable Locally Advanced / Metastatic PD-L1 Selected Non-Small Cell Lung Cancer

June 17
Last Trade: 14.80 0.06 0.41

WATERTOWN, Mass. and GOSSELIES, Belgium, June 17, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS) (“iTeos”), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, and its development partner GSK, have initiated the first, global Phase 3 registration study of belrestotug + dostarlimab doublet versus placebo + pembrolizumab in...Read more


Marinus Pharmaceuticals Announces Topline Results from Phase 3 RAISE Trial of IV Ganaxolone in Refractory Status Epilepticus

June 17
Last Trade: 1.32 -0.03 -2.22

RAISE trial met its first co-primary endpoint demonstrating rapid cessation of status epilepticus in a highly refractory patient population The trial failed to achieve statistical significance on the second co-primary endpoint of the proportion of patients not progressing to IV anesthesia Marinus will continue to prioritize the ZTALMY® franchise and expansion opportunities in highly refractory, chronic epilepsies with Phase 3 TrustTSC...Read more


AstraZeneca: CALQUENCE® (acalabrutinib) plus chemoimmunotherapy reduced the risk of disease progression or death by 27% vs. standard of care in patients with untreated mantle cell lymphoma in ECHO Phase III trial

June 16
Last Trade: 78.95 0.39 0.50

First and only BTK inhibitor to demonstrate favorable overall survival trend vs. standard-of-care chemoimmunotherapy in this setting WILMINGTON, Del. / Jun 16, 2024 / Business Wire / Positive results from the ECHO Phase III trial showed AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS)...Read more


Genentech’s Phase III STARGLO Study Demonstrates Columvi Significantly Extends Survival in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

June 15
Last Trade: 35.50 0.27 0.77

The study met its primary endpoint of overall survival with a 41% reduction in the risk of death in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated with Columvi plus chemotherapy This Columvi combination could provide a much-needed off-the-shelf treatment option for people with transplant-ineligible R/R DLBCL Data were featured in the congress Press Briefing and presented today in the Plenary...Read more


Agios Pharmaceuticals Presents Positive Results from Phase 3 ENERGIZE Study of Mitapivat in Non-Transfusion-Dependent Thalassemia in Plenary Session at the European Hematology Association 2024 Hybrid Congress

June 15
Last Trade: 44.56 2.11 4.97

ENERGIZE is the First Study to Demonstrate Efficacy of an Oral Treatment for Non-Transfusion-Dependent Alpha- and Beta-Thalassemia Additional ENERGIZE Poster Presentation Highlights Improvements in Fatigue and Exercise Capacity in Patients Treated with Mitapivat Compared to Placebo Agios to Webcast Virtual Investor Event on June 16, 2024 at 10 a.m. Eastern Time or 4 p.m. Central European Summer Time CAMBRIDGE, Mass., June 15,...Read more


UroGen Pharma Announces Unprecedented 82.3% Duration of Response at 12 Months in the ENVISION Trial Investigating UGN-102 as Potentially the First FDA-Approved Non-Surgical Treatment for LG-IR-NMIBC

June 13
Last Trade: 16.67 1.20 7.76

Kaplan-Meier Estimate of Duration of Response at 12 Months in Patients Who Achieved a Complete Response at Three Months was 82.3% (95% CI, 75.9%, 87.1%) Side Effect Profile Consistent with Previous Clinical Trials of UGN-102 UroGen will Host a Virtual Event Today at 11:00 AM Eastern Time PRINCETON, N.J. / Jun 13, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing...Read more


Moderna Announces Positive Phase 3 Efficacy Data for mRNA-1283, the Company’s Next Generation COVID-19 Vaccine

June 13
Last Trade: 134.35 -0.05 -0.04

mRNA-1283 met its primary vaccine efficacy endpoint in a Phase 3 trial, demonstrating non-inferior vaccine efficacy against COVID-19 compared to Spikevax® in participants 12 years of age and older Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older CAMBRIDGE, MA / ACCESSWIRE / June 13, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1283, an...Read more


Aldeyra Therapeutics Completes Enrollment in Phase 3 Clinical Trial of Reproxalap in Dry Eye Disease

June 13
Last Trade: 3.50 0.11 3.09

Clinical Trial Results and Potential New Drug Application Resubmission Expected in the Second Half of 2024 LEXINGTON, Mass. / Jun 13, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced the completion of enrollment in a Phase 3 dry eye chamber clinical trial...Read more


Pfizer Provides Update on Phase 3 Study of Investigational Gene Therapy for Ambulatory Boys with Duchenne Muscular Dystrophy

June 12
Last Trade: 27.67 -0.07 -0.25

NEW YORK / Jun 12, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that CIFFREO, a Phase 3 global, multicenter, randomized, double-blind, placebo-controlled study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD) did not meet its primary endpoint of improvement in motor function among boys 4 to 7 years of age treated with...Read more


Akero Therapeutics Announces Initiation of Phase 3 SYNCHRONY Outcomes Trial of Efruxifermin in Patients with Compensated Cirrhosis (F4) Due to MASH

June 11
Last Trade: 23.05 1.27 5.83

SOUTH SAN FRANCISCO, Calif., June 11, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced initiation of the SYNCHRONY Outcomes study, a Phase 3 trial evaluating the efficacy and safety of efruxifermin (EFX) in patients with compensated cirrhosis,...Read more


Arcus Biosciences Completes Patient Enrollment in Phase 3 Trial Evaluating a Domvanalimab-Containing Regimen in First-Line Metastatic Upper GI Cancers

June 10
Last Trade: 16.58 0.39 2.41

Domvanalimab is the only anti-TIGIT antibody in Phase 3 for upper gastrointestinal (GI) adenocarcinomas with the potential to be first-to-market for this patient population HAYWARD, Calif. / Jun 10, 2024 / Business Wire / Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced the completion...Read more


Moderna Announces Positive Phase 3 Data for Combination Vaccine Against Influenza and COVID-19

June 10
Last Trade: 134.35 -0.05 -0.04

mRNA-1083 met its primary endpoints, eliciting higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older, including an enhanced influenza vaccine in adults 65 years and older CAMBRIDGE, MA / ACCESSWIRE / June 10, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1083, an investigational combination vaccine against influenza and...Read more


BioMarin Pharmaceutical Presents New Phase 3, Four-Year Data Underscoring Long-Term Safety and Efficacy of ROCTAVIAN® (valoctocogene roxaparvovec-rvox) at International Society on Thrombosis and Haemostasis 2024 Congress

June 7
Last Trade: 82.68 -2.03 -2.40

Data from Longest and Largest Hemophilia Gene Therapy Study Show Durable and Sustained Bleed Control and Factor VIII Expression Maintained Four Years Post-ROCTAVIAN Infusion Additional Data Show Meaningful Impact of ROCTAVIAN on Health-Related Quality of Life (HRQoL)  SAN RAFAEL, Calif., June 7, 2024 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that new data supporting the long-term safety and...Read more


Melt Pharmaceuticals Announces First Patient Dosed in Pivotal Phase 3 Program of Its Lead Product Candidate, MELT-300, for Needle- and Opioid-Free Sedation in Patients Undergoing Cataract Surgery

June 6
Last Trade: 20.94 1.01 5.07

Topline Readout Expected in Q4 2024 NASHVILLE, Tenn. / Jun 06, 2024 / Business Wire / Melt Pharmaceuticals, Inc. (“Melt”), a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced that the first patient has been dosed in its Phase 3 program evaluating the safety and efficacy of its lead product candidate, MELT-300, a non‑IV, non-opioid tablet that combines fixed doses of midazolam...Read more


AbbVie Advances Oncology Pipeline With Start of Multiple Myeloma Phase 3 Clinical Trial for Investigational Asset ABBV-383

June 5
Last Trade: 170.38 -1.75 -1.02

ABBV-383 is a B-cell maturation antigen (BCMA) bispecific antibody T-cell engager being evaluated in relapsed/refractory multiple myeloma (r/r MM) The CERVINO Phase 3 trial will evaluate the efficacy, safety, and tolerability of ABBV-383 monotherapy compared with standard available therapies (SATs) in patients with r/r MM who have received at least two lines of prior therapy NORTH CHICAGO, Ill., June 5, 2024 /PRNewswire/ --...Read more


Amgen Announces Positive Results For Phase 3 Registrational Trial Evaluating Uplizna® (inebilizumab-cdon) For Treatment Of Immunoglobulin G4-related Disease (IgG4-RD)

June 5
Last Trade: 309.24 -0.65 -0.21

Data Show a Statistically Significant 87% Reduction in IgG4-RD Flares, With Primary and All Key Secondary Endpoints Met First Randomized, Placebo-Controlled Trial to Demonstrate Benefit in IgG4-RD THOUSAND OAKS, Calif., June 5, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced positive topline results from its randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical trial (NCT04540497) evaluating the...Read more


Can-Fite BioPharma Updates on its Advanced Liver Cancer Pivotal Phase 3 Study

June 5
Last Trade: 2.77 0.06 2.30

Namodenoson granted Orphan Drug and Fast track status from the FDA RAMAT GAN, Israel / Jun 05, 2024 / Business Wire / Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced an update on the status of its oncological lead drug candidate, Namodenoson in the treatment of advanced liver...Read more


Harrow Announces 52-Week Data from VEVYE® ESSENCE-2 Open-Label Extension Study

June 5
Last Trade: 20.94 1.01 5.07

Data Demonstrates Sustained Safety and Efficacy in Treating Signs and Symptoms of Dry Eye Disease NASHVILLE, Tenn. / Jun 05, 2024 / Business Wire / Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, is pleased to announce results from its ESSENCE‑2 open-label extension (OLE) clinical study for VEVYE® (cyclosporine ophthalmic solution) 0.1%, the first and only cyclosporine to treat the signs and symptoms of...Read more


Gilead Sciences’ Seladelpar Demonstrated a Sustained and Consistent Long-Term Efficacy and Safety Profile in Primary Biliary Cholangitis

June 5
Last Trade: 70.02 1.53 2.23

Positive Results from Two-year Interim Analysis Includes Participants from Phase 3 RESPONSE Study and are Highly Consistent with One-year Interim Analysis  Reduction in Patient-Reported Pruritus (Itching) was Rapid and Durable in Participants with Moderate to Severe Symptoms  Subset Analysis of Participants with Compensated Cirrhosis Demonstrated Clinically Meaningful Improvements in Markers of Cholestasis and Liver...Read more


Bristol Myers Squibb Announces Opdivo (nivolumab) Plus Yervoy (ipilimumab) Significantly Improved Overall Survival Compared to Lenvatinib or Sorafenib as First-Line Treatment for Patients with Advanced Hepatocellular Carcinoma in CheckMate -9DW Trial

June 4
Last Trade: 41.18 0.14 0.34

Late-breaking data to be presented at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting Dual immunotherapy combination of Opdivo plus Yervoy demonstrated improved survival benefit compared to lenvatinib or sorafenib in this patient population Objective response rate (ORR) for Opdivo plus Yervoy was more than double that for lenvatinib or sorafenib, with median duration of response of 30 months PRINCETON, N.J. /...Read more


GlycoMimetics Announces Comprehensive Results from Pivotal Phase 3 Study of Uproleselan in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

June 4
Last Trade: 0.27 0.02 6.60

Company exploring path forward for uproleselan in multiple AML settings based on observed efficacy results, including clinically meaningful results in primary refractory AML, and significant unmet patient need Uproleselan demonstrated a clinically meaningful improvement in median overall survival (mOS) for patients with primary refractory AML; mOS was 31.2 months for the uproleselan arm compared to 10.1 months for the placebo arm in this...Read more


Annexon Announces Positive Topline Results from Pivotal Phase 3 Trial for First-in-Class C1q Blocking Antibody ANX005 in Guillain-Barré Syndrome

June 4
Last Trade: 5.04 -0.16 -3.08

Single Infusion of ANX005 30 mg/kg Met Primary Endpoint, Delivering a Highly Statistically Significant and Clinically Meaningful 2.4-fold Improvement in GBS-DS vs. Placebo at Week 8, p=0.0058 ANX005 Demonstrated Early and Sustained Improvements in Key Secondary Endpoints Including Muscle Strength, Nerve Damage and Ventilation ANX005 Displayed Rapid Target Engagement and was Generally Well-Tolerated Across Doses Real-World Evidence...Read more


Crinetics Pharmaceuticals Presents New Data at ENDO 2024 that Increases Body of Evidence Positioning Once-Daily, Oral Paltusotine as Potential First-Choice Treatment Option for Acromegaly

June 3
Last Trade: 45.45 1.24 2.80

First Scientific Presentation of PATHFNDR-2 Acromegaly Safety and Efficacy Data Following Positive Topline Announcement, Showing Rapid and Sustained IGF-1 Responses in People Treated with Paltusotine New PATHFNDR-1 Patient-Reported Outcomes Analysis Showed Paltusotine Lessened Day-to-Day Breakthrough Symptom Exacerbations versus Prior Treatment with Standard of Care Injections, as Assessed by Acromegaly Symptom Diary Long-Term Data...Read more


Bristol Myers Squibb’s Breyanzi Demonstrates Clinically Meaningful Outcomes Across Broad Range of B-Cell Malignancies in New Data Presented at 2024 ASCO® Annual Meeting

June 3
Last Trade: 41.18 0.14 0.34

Three-year follow-up results from TRANSFORM show ongoing event-free survival and durable responses with Breyanzi compared to standard of care Results from a subgroup analysis from mantle cell lymphoma cohort of TRANSCEND NHL 001 show Breyanzi demonstrated consistent clinical benefit regardless of number of prior lines of therapy, supporting use of Breyanzi in earlier lines of treatment Data from bridging therapy subgroup analysis of...Read more


Arrowhead Pharmaceuticals Reports Successful Topline Results for Plozasiran from the Pivotal Phase 3 PALISADE Study in Patients with Familial Chylomicronemia Syndrome

June 3
Last Trade: 25.10 1.31 5.51

Plozasiran achieved statistically significant median reductions in triglycerides up to 80% and mean reductions in APOC3 up to 94% at month 10 Plozasiran achieved a statistically significant reduction in incidence of acute pancreatitis versus placebo Plozasiran is the company’s first investigational RNAi-based therapy to show clinical efficacy in a Phase 3 study Arrowhead plans to highlight recent data for its cardiometabolic pipeline...Read more


Agios Pharmaceuticals Announces Phase 3 ENERGIZE-T Study of Mitapivat Met Primary Endpoint and All Key Secondary Endpoints in Adults with Transfusion-Dependent Alpha- or Beta-Thalassemia

June 3
Last Trade: 44.56 2.11 4.97

Study Achieved the Primary Endpoint; Mitapivat Demonstrated a Statistically Significant Transfusion Reduction Response Compared to Placebo  Statistical Significance Achieved for All Key Secondary Endpoints Evaluating Additional Measures of Reduction of Transfusion Burden Compared to Placebo  ENERGIZE-T is the First Phase 3 Study to Demonstrate Efficacy of an Oral, Disease-Modifying Treatment for Transfusion-Dependent Alpha-...Read more


AstraZeneca: IMFINZI® (durvalumab) is the first and only immunotherapy to show survival benefit in limited-stage small cell lung cancer in global Phase III trial, reducing the risk of death by 27% vs. placebo

June 2
Last Trade: 78.95 0.39 0.50

57% of patients treated with IMFINZI were alive at three years in ADRIATIC Phase III trial WILMINGTON, Del. / Jun 02, 2024 / Business Wire / Positive results from the ADRIATIC Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) ​demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to placebo for patients...Read more


Takeda and Pfizer Announce Four-Year Results from Positive Phase 3 HD21 Trial of Additional ADCETRIS® (brentuximab vedotin) Combination in Frontline Hodgkin Lymphoma

June 1
Last Trade: 12.65 0.04 0.32

Four-year Analysis Conducted by GHSG Reported ADCETRIS + ECADD Combination Improved Progression-Free Survival, Showing Superior Efficacy and Tolerable Safety Profile in Patients with Newly Diagnosed Stage IIb/III/IV Classical Hodgkin Lymphoma vs eBEACOPP, a Current Standard of Care in This Setting in Europe The HD21 Study Adds to the Body of Evidence Supporting ADCETRIS as a Backbone Agent in the Treatment of Specific Lymphomas Results...Read more


Pfizer’s ADCETRIS® Regimen Produces Clinically Meaningful Improvement in Overall Survival in Patients with Relapsed/​Refractory Diffuse Large B-cell Lymphoma (DLBCL)

June 1
Last Trade: 27.67 -0.07 -0.25

Detailed data from Phase 3 ECHELON-3 study demonstrate investigational ADCETRIS regimen reduced risk of death by 37 percent compared to chemotherapy alone, resulting in median overall survival of 13.8 months versus 8.5 months Third Phase 3 trial in third type of lymphoma to show improvement in overall survival with an ADCETRIS-containing regimen NEW YORK / Jun 01, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced detailed...Read more


Bristol-Myers Squibb: KRAZATI (adagrasib) Demonstrated Statistically Significant Improvement in Progression-Free Survival in Patients with Pretreated Locally Advanced or Metastatic KRASG12C-Mutated Non-Small Cell Lung Cancer

June 1
Last Trade: 41.18 0.14 0.34

First presentation of data from Phase 3 KRYSTAL-12 study showed statistically significant and clinically meaningful improvement in progression-free survival with KRAZATI compared to standard of care chemotherapy Late-breaking data featured in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting PRINCETON, N.J. / Jun 01, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced...Read more


Pfizer’s LORBRENA® CROWN Study Shows Majority of Patients with ALK-Positive Advanced Lung Cancer Living Beyond Five Years Without Disease Progression

May 31
Last Trade: 27.67 -0.07 -0.25

An unprecedented 60% of patients remain alive without disease progression after five years Updated results show continued 81% reduction in risk of progression or death and 94% reduction in progression of brain metastases compared to XALKORI® NEW YORK / May 31, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up results from the Phase 3 CROWN trial evaluating LORBRENA® (lorlatinib, a third-generation...Read more


Ionis Pharmaceuticals presents positive results from OASIS-HAE and OASISplus studies of investigational medicine donidalorsen in patients with hereditary angioedema

May 31
Last Trade: 41.56 0.75 1.84

Donidalorsen delivered significant and sustained reductions in HAE attacks, with high levels of disease control and improvement in quality of life measures with monthly or every two-month dosing; continued attack rate reduction over time In first-of-its-kind prospective analysis, patients switching from prior prophylactic treatment to donidalorsen experienced further reductions in mean monthly HAE attack rates from...Read more


Ultragenyx Pharmaceutical Announces Positive Top-Line Results from Phase 3 Study of DTX401 Gene Therapy for Glycogen Storage Disease Type Ia (GSDIa)

May 30
Last Trade: 39.14 1.12 2.95

Treatment with DTX401 resulted in a statistically significant reduction in daily cornstarch intake at Week 48 (p<0.0001) with maintenance of glucose control Company will host investor call today at 5:00 p.m. ET NOVATO, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced positive topline results from the Phase 3 GlucoGene study (NCT05139316) evaluating DTX401, an investigational...Read more


Summit Therapeutics: Ivonescimab Monotherapy Decisively Beats Pembrolizumab Monotherapy Head-to-Head, Achieves Statistically Significant Superiority in PFS in First-Line Treatment of Patients with PD-L1 Positive NSCLC in China

May 30
Last Trade: 7.99 0.19 2.44

Unprecedented: Ivonescimab Is the First Drug to Achieve Clinically Meaningful Benefit over Pembrolizumab in Randomized Phase III Clinical Trial in NSCLC Monotherapy Ivonescimab Achieved Clinically Meaningful PFS Benefit in HARMONi-2 Trial Conducted by Akeso PFS Improvement Was Observed Broadly in Patients Across Subgroups, including PD-L1 Low and PD-L1 High Expressing Tumors, Squamous and Non-Squamous Histologies Full Data Set to be...Read more


Cyclo Therapeutics Achieves Landmark Milestone with Completion of Enrollment of Last Patient in Phase 3 Pivotal TransportNPC™ Trial of Niemann-Pick Type C1

May 30
Last Trade: 1.22 0.02 1.67

TransportNPC™ is the most comprehensive ongoing controlled pivotal study regarding patient size, global footprint, duration and clinical outcomes for the treatment of Niemann-Pick Disease Type C1 (NPC1) Topline data from the 48-week interim analysis of 104 enrolled patients is anticipated for H1 2025 If 48-week data demonstrate significance, submission of New Drug Application (NDA) to the Food and Drug Administration (FDA) and Marketing...Read more


BriaCell Therapeutics Initiates Patient Enrollment in First-in-Human Study of Bria-OTS™ in Advanced Metastatic Breast Cancer

May 30
Last Trade: 1.24 -0.04 -3.12

PHILADELPHIA and VANCOUVER, British Columbia, May 30, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces initiation of a first-in-human, Phase 1/2 study evaluating safety and efficacy of Bria-OTS™, BriaCell’s personalized off-the-shelf next generation...Read more


Immunocore converts Phase 2/3 TEBE-AM clinical trial into registrational Phase 3 trial evaluating KIMMTRAK for previously treated advanced cutaneous melanoma

May 29
Last Trade: 35.40 0.28 0.80

Following recent consultation with FDA, all patients randomized from start of TEBE-AM Phase 2/3 trial will be included in the Phase 3 intent-to-treat population Phase 3 will continue three arms: KIMMTRAK monotherapy, KIMMTRAK in combination with pembrolizumab, and control Expected to accelerate time to final Phase 3 overall survival analysis (OXFORDSHIRE, England & CONSHOHOCKEN, PA & ROCKVILLE, MD, US, 29 May 2024)...Read more


Corcept Therapeutics Announces Primary Endpoint Met in Pivotal Phase 3 GRACE Trial of Relacorilant in Patients With Hypercortisolism (Cushing’s Syndrome)

May 28
Last Trade: 30.20 0.80 2.72

MENLO PARK, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating the effects of the hormone cortisol, today announced that GRACE, the Phase 3 trial of its proprietary selective cortisol modulator relacorilant in patients with...Read more


Opthea Completes Enrollment in Pivotal Phase 3 Clinical Program with Sozinibercept in Wet AMD

May 28
Last Trade: 2.01 -0.03 -1.47

Phase 3 program enrolled 1,984 patients across COAST and ShORe trials Trials designed to replicate superiority in visual outcomes demonstrated in Phase 2b Topline data from both pivotal trials expected in mid-CY2025 MELBOURNE, Australia and PRINCETON, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX/NASDAQ: OPT “Opthea”, the “Company”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly...Read more


Merck Announces Phase 3 KEYNOTE-522 Trial Met its Overall Survival (OS) Endpoint in Patients With High-Risk Early-Stage Triple Negative Breast Cancer (TNBC)

May 28
Last Trade: 129.65 -0.02 -0.02

KEYTRUDA® (pembrolizumab) is the first and only immunotherapy-based regimen to show a statistically significant improvement in OS as pre-operative (neoadjuvant) treatment with chemotherapy and then as a single agent after surgery (adjuvant) compared to pre-operative chemotherapy in patients with high-risk early-stage TNBC New OS results build on the pathological complete response and event-free survival data previously reported from the...Read more


Insmed Announces Positive Topline Results from Landmark ASPEN Study of Brensocatib in Patients with Bronchiectasis

May 28
Last Trade: 67.18 2.47 3.82

Phase 3 Study Achieves Primary Endpoint for Both Dosage Strengths of Brensocatib with Statistically Significant and Clinically Meaningful Reduction in Frequency of Pulmonary Exacerbations Versus Placebo Treatment with Brensocatib Also Achieves Statistical Significance on Multiple Secondary Endpoints for Both Dosage Strengths Versus Placebo Brensocatib Well-Tolerated at Both Dosage Strengths Results from ASPEN Validate DPP1 Inhibition...Read more


AstraZeneca: Datopotamab deruxtecan showed clinically meaningful overall survival improvement vs. chemotherapy in patients with advanced nonsquamous non-small cell lung cancer in TROPION-Lung01 Phase III trial

May 27
Last Trade: 78.95 0.39 0.50

In the overall trial population, survival results numerically favoured AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan but did not reach statistical significance TROPION-Lung01 previously met the dual primary endpoint of progression-free survival in the overall trial population Results support applications currently under review by regulatory authorities globally including in the US and EU This announcement contains inside...Read more


Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction further advancing company's IgA nephropathy (IgAN) portfolio

May 25
Last Trade: 105.20 -0.55 -0.52

In the ALIGN study, atrasentan, in addition to supportive care with a renin-angiotensin system (RAS) inhibitor, demonstrated a statistically significant 36.1% proteinuria (protein in urine) reduction vs. placebo + supportive care at 36 weeks1 Endothelin A (ETA) receptor activation contributes to elevated proteinuria in IgAN2-5; atrasentan is a potent, selective ETA receptor antagonist with potential to reduce persistent proteinuria and...Read more


Novartis presents latest Phase III Fabhalta® (iptacopan) data in C3 glomerulopathy (C3G) showing clinically meaningful and statistically significant 35.1% proteinuria reduction vs. placebo

May 25
Last Trade: 105.20 -0.55 -0.52

Secondary endpoint data for estimated glomerular filtration rate (eGFR) showed numerical improvement over 6 months vs. placebo1; additional 6-month open-label data to be presented at a future medical meeting2,3 Fabhalta showed a favorable safety profile with no new safety signals1 C3G, an ultra-rare kidney disease caused by alternative complement pathway overactivation, progresses to kidney failure in ∼50% of patients within 10...Read more


More than one-half of patients with Crohn's disease treated with Eli Lilly's mirikizumab achieved clinical remission at one year, including patients with previous biologic failure

May 21
Last Trade: 888.33 2.34 0.26

Nearly one-half of patients on mirikizumab achieved endoscopic response at 52 weeks; most of these patients were also in clinical remission INDIANAPOLIS, May 21, 2024 /PRNewswire/ -- In Eli Lilly and Company's (NYSE: LLY) pivotal Phase 3 VIVID-1 study, patients with moderately to severely active Crohn's disease, with or without previous biologic failure, achieved statistically significant and clinically meaningful...Read more


PureTech Health Founded Entity Vedanta Biosciences Enrolls First Patient in Pivotal Phase 3 RESTORATiVE303 Study of VE303 for the Prevention of Recurrent C. difficile Infection

May 21
Last Trade: 26.56 -0.75 -2.75

VE303 is an orally administered, potential first-in-class live biotherapeutic product candidate being developed to prevent recurrence of Clostridioides difficile infection (CDI) BOSTON / May 21, 2024 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted today that its Founded Entity, Vedanta Biosciences, a clinical-stage company that is developing...Read more


Citius Pharmaceuticals Achieves Primary and Secondary Endpoints in Phase 3 Trial of Mino-Lok Antibiotic Lock Solution

May 21
Last Trade: 0.63 -0.008 -1.25

Trial achieves statistically significant primary endpoint (p=0.0006) Secondary endpoint demonstrates statistically significant overall success of Mino-Lok therapy with a greater percentage of patients retaining their catheters (p=0.0025) CRANFORD, N.J., May 21, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and...Read more


Esperion: Bempedoic Acid Met Primary Endpoint of Phase 3 Trial in Japan for the Treatment for Hypercholesterolemia

May 20
Last Trade: 2.25 -0.04 -1.75

ANN ARBOR, Mich., May 20, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) and Otsuka Pharmaceutical Co., Ltd (Otsuka) announced today that the primary endpoint was achieved in the Phase 3 trial in Japan for bempedoic acid as a potential treatment for patients with hypercholesterolemia. The trial demonstrated statistically significant outcomes on the primary endpoint for bempedoic acid and highlighted its potential future value to...Read more


Marinus Pharmaceuticals Announces Key Business Updates for Tuberous Sclerosis Complex Program

May 17
Last Trade: 1.32 -0.03 -2.22

Enrollment complete in Phase 3 TrustTSC trial with topline data anticipated in the first half of Q4 2024 USPTO grants additional method of use patent for ganaxolone in TSC RADNOR, Pa. / May 17, 2024 / Business Wire / Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced completion of enrollment in the global Phase 3...Read more


MoonLake Immunotherapeutics starts Phase 3 VELA program of the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa

May 16
Last Trade: 39.45 -0.04 -0.10

VELA is the first Phase 3 program in hidradenitis suppurativa to use the higher clinical response level of HiSCR75 as the primary endpoint The topline primary endpoint readout at week 16, together with data on other endpoints, is expected as of mid-2025 Program will evaluate sonelokimab for a total of 52 weeks, across VELA-1 and VELA-2, at sites in the United States and Europe, using a design informed by the landmark Phase 2 MIRA...Read more


Eli Lilly: With Once-a-Week Dosing, Insulin Efsitora Alfa Delivers A1C Reduction and Safety Profile Consistent with Daily Insulin

May 16
Last Trade: 888.33 2.34 0.26

Efsitora met the primary endpoint in both QWINT-2 and QWINT-4 with once-a-week dosing regimen for people living with type 2 diabetes Efsitora was equally safe and effective among adults naïve to insulin therapy currently using and not using GLP-1 receptor agonists INDIANAPOLIS, May 16, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the QWINT-2 and QWINT-4 phase 3 clinical trials...Read more


Equillium Announces Interim Enrollment Achieved in Phase 3 EQUATOR Study of Itolizumab in Acute Graft-Versus-Host Disease

May 14
Last Trade: 0.67 0.0082 1.23

More than 100 patients enrolled from over 100 clinical trial sites active in 12 countries Delivery of the interim data review to Ono Pharmaceutical Co. Ltd. (Ono) expected during Q3 will trigger Ono’s option exercise period LA JOLLA, Calif. / May 14, 2024 / Business Wire / Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders,...Read more


89bio Initiates Phase 3 ENLIGHTEN-Cirrhosis Trial of Pegozafermin in Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients with Compensated Cirrhosis

May 14
Last Trade: 8.46 0.53 6.68

With the initiation of ENLIGHTEN-Cirrhosis, pegozafermin is the first FGF21 analog to enter a Phase 3 trial in MASH patients with compensated cirrhosis (F4) Regression of fibrosis by histology at month 24 will serve as the basis for potential accelerated approval with clinical outcomes to support the potential for confirmatory or full approval SAN FRANCISCO, May 14, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a...Read more


aTyr Pharma Announces Second Positive DSMB Review for Efzofitimod in Phase 3 EFZO-FIT™ Study in Pulmonary Sarcoidosis

May 14
Last Trade: 1.45 0.00 0.00

Independent data and safety monitoring board (DSMB) recommends continuation of study without any modifications. Findings further support favorable safety profile of efzofitimod. SAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (aTyr or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform,...Read more


HUTCHMED Initiates the RAPHAEL Registrational Phase III Trial of HMPL-306 for Patients with IDH1- and/or IDH2-Mutated Relapsed/Refractory Acute Myeloid Leukemia in China

May 13
Last Trade: 17.86 0.60 3.48

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 14, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a registrational Phase III clinical trial of HMPL-306 in patients with mutated isocitrate dehydrogenase (“IDH”) 1 or 2 relapsed / refractory acute myeloid leukemia (“AML”) in China. The first patient received their first dose on May 11,...Read more


Kodiak Sciences Announces Treatment of First Patients in Phase 3 GLOW2 Study of Tarcocimab Tedromer in Diabetic Retinopathy

May 13
Last Trade: 2.64 0.12 4.76

PALO ALTO, Calif., May 13, 2024 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases, announced today that the first patients with diabetic retinopathy (DR) have been treated in the randomized double masked Phase 3 GLOW2 study of tarcocimab tedromer. GLOW2 is the second Phase 3...Read more


Novo Nordisk: Once-weekly and once-monthly Mim8 demonstrate superior reduction of treated bleeding episodes compared to on-demand and prior prophylaxis treatment in people with haemophilia A in the Frontier 2 trial

May 13
Last Trade: 142.10 1.11 0.79

Bagsværd, Denmark, 13 May 2024 – Novo Nordisk (NYSE: NVO) today announced the headline results from the FRONTIER 2 trial, a pivotal phase 3a, 26-week open-label, randomised, controlled, multi-arm trial in 254 people. The trial investigated the efficacy and safety of once-weekly and once-monthly subcutaneous Mim8 versus no prophylaxis and versus prior coagulation factor prophylaxis treatment in people aged 12 years or older with...Read more


Ascendis Pharma: Significant and Sustained Improvements in Renal Function Reported for Adults with Chronic Hypoparathyroidism Treated with TransCon™ PTH (Palopegteriparatide): 2-year Results from Phase 3 PaTHway Trial

May 13
Last Trade: 124.12 2.50 2.06

COPENHAGEN, Denmark, May 13, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced 2-year results from a post-hoc analysis of the Company’s Phase 3 PaTHway Trial demonstrating significant and sustained improvements in renal function in adults with chronic hypoparathyroidism treated with TransCon PTH (palopegteriparatide). The data were shared in an oral presentation on May 12 by Peter Schwarz, M.D., Professor of...Read more


Merck Provides Update on Phase 3 KeyVibe-010 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab as Adjuvant Treatment for Patients With Resected High-Risk Melanoma

May 13
Last Trade: 129.65 -0.02 -0.02

RAHWAY, N.J. / May 13, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial. The trial is evaluating the investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, compared to KEYTRUDA alone, as adjuvant...Read more


Bristol Myers Squibb Provides Update on Phase 3 CheckMate -73L Trial

May 10
Last Trade: 41.18 0.14 0.34

PRINCETON, N.J. / May 10, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC). CheckMate -73L evaluated Opdivo® (nivolumab) with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy® (ipilimumab) versus CCRT followed by...Read more


Actym Therapeutics Announces Positive Top-Line GEMINI-2 Phase 3 Clinical Trial Results of Imsidolimab (IL-36R) in Generalized Pustular Psoriasis (GPP)

May 9
Last Trade: 24.28 1.39 6.07

All eight patients from GEMINI-1 who responded to a single intravenous (IV) imsidolimab dose and were subsequently re-randomized to monthly subcutaneous (SC) maintenance dosing of imsidolimab in GEMINI-2 through at least 24 weeks maintained clear to almost clear skin and none experienced a flare Of the remaining eight responding patients from GEMINI-1 re-randomized to placebo in GEMINI-2, 25% maintained clear to almost clear skin and...Read more


Merck Provides Update on Phase 3 KEYNOTE-B21 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Radiotherapy, for Patients With Newly Diagnosed, High-Risk Endometrial Cancer After Surgery With Curative Intent

May 9
Last Trade: 129.65 -0.02 -0.02

RAHWAY, N.J. / May 09, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-B21 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as adjuvant treatment, with or without radiotherapy, did not meet its primary endpoint of disease-free survival (DFS) for the treatment of patients with newly diagnosed, high-risk endometrial...Read more


Aldeyra Therapeutics Enrolls First Patient in Phase 3 Clinical Trial Designed to Enable Potential Resubmission of New Drug Application of Reproxalap in Dry Eye Disease

May 8
Last Trade: 3.50 0.11 3.09

Clinical Results and Potential New Drug Application Submission Expected in the Second Half of 2024 LEXINGTON, Mass. / May 08, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced enrollment of the first patient in a Phase 3 dry eye chamber clinical trial...Read more


Teva Pharmaceutical and Medincell Announce Positive Phase 3 Efficacy Results from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable in Adults with Schizophrenia

May 8
Last Trade: 16.99 -0.07 -0.41

The study met its primary endpoint achieving clinically meaningful and statistically significant reductions across all TEV-‘749 dose groups versus placebo in the Positive and Negative Syndrome Scale (PANSS) total score, a widely used assessment tool for schizophrenia symptom severity TEV-‘749 was well tolerated, with no incidence of post-injection delirium/sedation syndrome (PDSS) observed to date: additional safety data is being...Read more


Lyra Therapeutics Reports Topline Results from Phase 3 ENLIGHTEN 1 Trial for LYR-210 in Chronic Rhinosinusitis

May 6
Last Trade: 0.27 0.0088 3.36

ENLIGHTEN 1 trial did not meet its primary endpoint Company plans to evaluate full dataset and path forward WATERTOWN, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), today announced topline results from the Company’s Phase 3 ENLIGHTEN 1 trial evaluating LYR-210 for the treatment of chronic rhinosinusitis (CRS). ENLIGHTEN 1 did not meet its primary endpoint of demonstrating...Read more


Spectral Medical Provides April Tigris Trial Update

May 6
Last Trade: 0.49 -0.01 -2.00

105 patients enrolled April represents a record breaking month for patient enrollment  TORONTO, May 06, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a...Read more


GlycoMimetics Announces Results of Pivotal Phase 3 Study of Uproleselan in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)

May 6
Last Trade: 0.27 0.02 6.60

Study of uproleselan combined with chemotherapy did not meet its primary endpoint of overall survival in the intent to treat population Adverse events were consistent with known side effect profiles of chemotherapy used in the study Comprehensive data analysis with medical, statistical, and regulatory experts underway and will be shared as appropriate; company will submit results for presentation at an upcoming medical meeting National...Read more


CG Oncology: Cretostimogene Monotherapy Demonstrated 75.2% Complete Response Rate in High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

May 3
Last Trade: 31.90 0.00 0.00

Phase 3 BOND-003 study results showed sustained, durable complete responses over 12 months with novel investigational oncolytic immunotherapy Company will hold an investor conference call today at 4:30pm EDT IRVINE, Calif., May 03, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. today announced that data from the Phase 3 BOND-003 study evaluating the efficacy and safety of cretostimogene monotherapy in patients with high-risk Non-Muscle...Read more


Science 37 Delivers 22x Faster Enrollment than Traditional Methods in Phase 3 Asthma Clinical Trial

May 2
Last Trade: 5.75 0.00 0.00

RESEARCH TRIANGLE PARK, N.C., May 02, 2024 (GLOBE NEWSWIRE) -- Science 37 Holdings, Inc. today disclosed the latest enrollment figures resulting from its Metasite™ and Patient Recruitment partnership with a leading biotech company whose asthma drug is currently undergoing a Phase 3 clinical trial. Leveraging its proprietary Metasite™ and Patient Recruitment solutions, Science 37 contributed 28% of all randomized study participants over a...Read more


AstraZeneca: CALQUENCE combination regimen demonstrated statistically significant and clinically meaningful improvement in progression-free survival in 1st-line mantle cell lymphoma in ECHO Phase III trial

May 2
Last Trade: 78.95 0.39 0.50

First BTK inhibitor to show favorable trend in overall survival vs. standard-of-care chemoimmunotherapy in this setting WILMINGTON, Del. / May 02, 2024 / Business Wire / Positive high-level results from an interim analysis of the ECHO Phase III trial showed AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with standard-of-care chemoimmunotherapy, bendamustine and rituximab, demonstrated a statistically significant and clinically...Read more


Organogenesis Achieves Primary Endpoint in Phase 3 Clinical Trial of ReNu® for Knee Osteoarthritis

May 2
Last Trade: 2.51 0.05 2.02

Statistically significant (p=0.0177) reduction in knee pain at six months Statistically significant (p<0.0001) maintenance of function at six months Transformational opportunity for Organogenesis to enter large and growing pain management market with innovative therapy Will address critical unmet medical need for all knee OA patients, including the most severe, if approved CANTON, Mass., May 02, 2024 (GLOBE NEWSWIRE) --...Read more


Merck Announces Phase 3 KEYNOTE-811 Trial Met Dual Primary Endpoint of Overall Survival (OS) as First-Line Treatment in Patients With HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

May 1
Last Trade: 129.65 -0.02 -0.02

These OS results build on positive data previously reported from KEYNOTE-811 that supported its FDA-approved indication RAHWAY, N.J. / May 01, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab and fluoropyrimidine- and platinum-containing...Read more


Ultragenyx Pharmaceutical Announces Completion of Enrollment in Phase 3 Orbit and Cosmic Studies Evaluating Setrusumab (UX143) for the Treatment of Osteogenesis Imperfecta (OI)

April 30
Last Trade: 39.14 1.12 2.95

NOVATO, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that all patients have been enrolled across the Phase 3 Orbit and Cosmic studies evaluating setrusumab (UX143) in pediatric and young adult patients with osteogenesis imperfecta (OI). The pivotal Phase 3 portion of the Orbit study has randomized 158 patients ages 5 to 25 years, and the Cosmic study has completed enrollment of...Read more


PolyPid Announces Enrollment of 200th Patient in Ongoing SHIELD II Phase 3 Trial Evaluating D-PLEX₁₀₀ for the Prevention of Abdominal Colorectal Surgical Site Infections

April 30
Last Trade: 4.00 0.00 0.00

Study Approximately Half Enrolled to the Planned Unblinded Interim Analysis Unblinded Interim Analysis to be Conducted Once Approximately 400 Patients Complete Their 30-Day Follow-up Top-line Results Expected in Second Half of 2024 PETACH TIKVA, Israel, April 30, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced...Read more


Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults

April 29
Last Trade: 129.65 -0.02 -0.02

Late-breaker Phase 3 STRIDE-10 trial presented as an oral presentation at European Society of Clinical Microbiology and Infectious Diseases Results build on the data supporting the clinical profile of V116 for adults RAHWAY, N.J. / Apr 29, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from STRIDE-10, a Phase 3 trial evaluating V116, the company’s...Read more


SELLAS Life Sciences Announces Positive Recommendation of Independent Data Monitoring Committee Following Completion of Enrollment in REGAL Phase 3 Study

April 29
Last Trade: 1.20 0.04 3.46

Based on the Efficacy and Safety Data Assessed, the Independent Data Monitoring Committee (IDMC) Recommends Continuation of Phase 3 REGAL Trial Patients Treatment and Follow-Up Without Any Modifications – IDMC Will Convene Again Ahead of Scheduled IDMC Charter Meeting – Next Efficacy and Safety Assessment of All REGAL Patients (n=127) in June 2024 – NEW YORK, April 29, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group,...Read more


AstraZeneca: ENHERTU® (fam-trastuzumab deruxtecan-nxki) improved PFS in HER2-low and ultralow

April 29
Last Trade: 78.95 0.39 0.50

ENHERTU demonstrated statistically significant and clinically meaningful improvement in progression-free survival in HR-positive, HER2-low metastatic breast cancer following one or more lines of endocrine therapy in DESTINY-Breast06 Phase III trial AstraZeneca and Daiichi Sankyo’s ENHERTU also demonstrated a clinically meaningful progression-free survival improvement in patients with HER2-ultralow expression WILMINGTON, Del. / Apr 29,...Read more


Calliditas Therapeutics Announces Positive NefIgArd Open Label Extension Results

April 24
Last Trade: 38.78 0.09 0.23

STOCKHOLM, April 24, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT), (NASDAQ STOCKHOLM: CALTX) ("Calliditas") today announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study across endpoints of urine protein to creatinine ration (UPCR) and estimated glomerular filtration rate (eGFR) at 9 months across all IgAN patients, including...Read more


Corcept Therapeutics Announces Positive Results From Open-Label Portion of Pivotal Phase 3 GRACE Trial in Patients With Cushing’s Syndrome

April 22
Last Trade: 30.20 0.80 2.72

MENLO PARK, Calif., April 22, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating the effects of the hormone cortisol, today announced positive results from the open-label portion of the pivotal Phase 3 GRACE trial of its proprietary selective...Read more


AbbVie: Phase 3 SELECT-GCA Study of Upadacitinib (RINVOQ®) Showed Positive Results in Patients With Giant Cell Arteritis

April 18
Last Trade: 170.38 -1.75 -1.02

Results from the Phase 3 SELECT-GCA study showed 46 percent of patients with giant cell arteritis (GCA) who were treated with upadacitinib (RINVOQ®; 15 mg) with a 26-week steroid taper regimen achieved sustained remission from week 12 through week 52 compared to 29 percent of patients receiving placebo with a 52-week steroid taper regimen1 The safety profile in GCA was generally consistent with that in approved indications, and no new...Read more


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