Latest Phase 3 Clinical Trials Stock News

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Immunocore announces clinical trial collaboration and supply agreement with Bristol Myers Squibb to evaluate IMC-F106C (PRAME HLA-A02) in combination with nivolumab in its registrational Phase 3 first-line advanced cutaneous melanoma trial

February 22
Last Trade: 69.86 0.43 0.62

IMC-F106C is Immunocore’s first-in-class bispecific TCR ImmTAC candidate targeting PRAME HLA-A02; nivolumab is manufactured by Bristol Myers Squibb The clinical trial collaboration relates to Immunocore’s PRISM-MEL-301 registrational Phase 3 clinical trial in first-line advanced cutaneous melanoma, evaluating IMC-F106C in combination with nivolumab versus a control arm of either nivolumab or the fixed-dose combination of nivolumab and...Read more

Ayala Pharmaceuticals Announces Completion of Enrollment in Phase 3 RINGSIDE Study Evaluating AL102 in Desmoid Tumors

February 20
Last Trade: 0.89 0.04 4.48

REHOVOT, Israel and MONMOUTH JUNCTION, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that patient enrollment has been completed in the Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors. A total of 156 patients were enrolled. ”Completion of enrollment in RINGSIDE represents a significant milestone in the development of AL102,” said Kenneth...Read more

Matinas BioPharma Successfully Reaches Agreement with FDA for a Single Phase 3 Registration Trial to Support an NDA for MAT2203 for the Treatment of Invasive Aspergillosis

February 20
Last Trade: 0.24 0.02 7.35

ORALTO Phase 3 trial focused on desired initial target indication of early oral step-down treatment of invasive aspergillosis infections in adults who have limited or no treatment options Non-inferiority trial will enroll approximately 216 patients with primary endpoint of all-cause mortality at day 42 Key secondary endpoint includes superiority of oral step-down treatment with MAT2203 vs. AmBisome® (liposomal amphotericin B) for...Read more

AstraZeneca: TAGRISSO® (osimertinib) demonstrated overwhelming efficacy benefit for patients with unresectable, Stage III EGFR-mutated lung cancer in LAURA Phase III trial

February 19
Last Trade: 65.83 1.70 2.65

First EGFR inhibitor and targeted treatment to demonstrate progression-free survival benefit in Stage III setting WILMINGTON, Del. / Feb 19, 2024 / Business Wire / Positive high-level results from the LAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage III...Read more

BioLineRx Announces Acceptance of Two Poster Presentations on APHEXDA® (motixafortide) for CD34+ Hematopoietic Stem Cell (HSC) Mobilization in Patients with Multiple Myeloma at the 2024 Tandem Meetings of ASTCT® and CIBMTR®

February 16
Last Trade: 1.18 -0.06 -4.84

 Results include pharmacokinetic and pharmacodynamic data, and post-hoc subgroup analyses of the Phase 3 GENESIS trial   Presentations on Thursday, February 22, 2024 in San Antonio, Texas TEL AVIV, Israel, Feb. 16, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that new post-hoc...Read more

KalVista Pharmaceuticals to Present Phase 3 Sebetralstat Data at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting

February 16
Last Trade: 12.58 0.00 0.00

Late-breaking phase 3 data for KONFIDENT trial on Sunday, February 25, 2024  CAMBRIDGE, Mass. & SALISBURY, England / Feb 16, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the acceptance of multiple abstracts at the 2024 American Academy of...Read more

Pacira BioSciences Announces Publication of Pivotal Study of EXPAREL as a Sciatic Nerve Block in the Popliteal Fossa for Patients After Bunionectomy

February 15
Last Trade: 30.04 0.07 0.23

Findings demonstrate significant reduction in pain and opioid consumption through 96 hours versus active comparator  Significantly greater proportion of opioid-free patients receiving EXPAREL  TAMPA, Fla., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the publication of its...Read more

Applied Therapeutics Announces Positive Results from 12-month Interim Analysis of Govorestat (AT-007) in the Ongoing INSPIRE Phase 3 Trial in Sorbitol Dehydrogenase (SORD) Deficiency

February 15
Last Trade: 5.74 0.14 2.50

Interim primary endpoint met; Statistically significant correlation of sorbitol with the CMT-FOM clinical outcome composite (p=0.05) Sustained, statistically significant reduction in sorbitol in govorestat-treated patients vs. placebo (p<0.001) Highly statistically significant effects on the CMT Health Index (CMT-HI) patient reported outcome measure (p=0.01), with benefit of govorestat on categories of lower limb function,...Read more

Tonix Pharmaceuticals Hosted KOL Webinar on Positive Phase 3 Fibromyalgia Trial for Tonmya™, Plans to File NDA for FDA Approval in Second Half of 2024

February 14
Last Trade: 0.32 0.0056 1.77

Clinical results show that Tonyma™ has broad-spectrum activity, addressing the three core fibromyalgia symptoms: pain, fatigue, and sleep disturbance Tonmya™ has a favorable tolerability profile well-suited for chronic treatment CHATHAM, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development...Read more

Opthea Completes Enrollment in First Pivotal Trial with Sozinibercept

February 14
Last Trade: 3.43 0.20 6.19

COAST trial is evaluating the superiority of sozinibercept combined with EYLEA® (aflibercept) over EYLEA alone in wet AMD Enrollment of second pivotal trial (ShORe) to complete in calendar Q2 2024 COAST and ShORe top-line results expected by mid-2025 MELBOURNE, Australia, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; NASDAQ:OPT), a clinical-stage biopharmaceutical company developing novel therapies to treat highly...Read more

Greenwich LifeSciences Provides Update on Phase III Clinical Trial, Flamingo-01

February 14
Last Trade: 12.93 -0.47 -3.51

STAFFORD, Texas, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today provided the following update on the Phase III clinical trial, Flamingo-01. Data Safety Monitoring Board (DSMB) The Flamingo-01 DSMB...Read more

Grifols announces positive topline phase 3 fibrinogen clinical trial results

February 14
Last Trade: 9.13 0.43 4.94

In the AdFIrst study, Biotest's fibrinogen concentrate (FC), BT524, met the primary endpoint, demonstrating its effectiveness in treating acquired fibrinogen deficiency (AFD) as equivalent to standard of care, while maintaining an excellent safety profile Regulatory approval process in Europe and United States set to begin in Q4 2024. It would be the first FC approved for an AFD indication in the U.S. in a global market for AFD with an...Read more

Ocular Therapeutics Announces First Subjects Screened in Phase 3 Pivotal Clinical Trial of AXPAXLI™ in Wet AMD

February 13
Last Trade: 9.86 0.16 1.65

BEDFORD, Mass., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the first three subjects have been screened and received their first aflibercept injection in the Phase 3 SOL-1 clinical trial of AXPAXLI™ (axitinib intravitreal implant,...Read more

KalVista Pharmaceuticals Reports Phase 3 KONFIDENT Trial Meets All Endpoints for Sebetralstat as First Oral On-demand Therapy for Hereditary Angioedema

February 13
Last Trade: 12.58 0.00 0.00

Sebetralstat 300 mg achieved beginning of symptom relief in 1.6 hours  Safety profile comparable to placebo  On track for submission of new drug application to U.S. FDA in the first half of 2024  Conference call to discuss trial results today at 8:30 a.m. ET  CAMBRIDGE, Mass. & SALISBURY, England / Feb 13, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical...Read more

G1 Therapeutics to Continue Pivotal Phase 3 Trial of Trilaciclib in Metastatic Triple Negative Breast Cancer Following Interim Analysis by Independent Data Monitoring Committee

February 12
Last Trade: 2.22 0.07 3.26

RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the independent Data Monitoring Committee (DMC) recommended continuation of the pivotal Phase 3 trial (PRESERVE 2), evaluating trilaciclib in combination with gemcitabine and carboplatin for the first line treatment of metastatic triple negative breast cancer (mTNBC), to the final...Read more

PolyPid Announces Enrollment of the 100th Patient in the Ongoing SHIELD II Phase 3 Trial

February 12
Last Trade: 5.67 0.20 3.66

Approximately 40 Centers Currently Open 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 Recent Successful $16 Million Financing Extends Company’s Cash Runway Through Late Q3 2024 and Beyond Expected Timing of Unblinded Interim Analysis; Potential Additional $19 Million if Warrants are Exercised to Fund PolyPid to the Start of a...Read more

Madrigal Pharmaceuticals Announces Publication of the Phase 3 MAESTRO-NASH Trial of Resmetirom in the New England Journal of Medicine

February 8
Last Trade: 236.54 -11.99 -4.82

Resmetirom is the first investigational medicine for NASH to achieve fibrosis improvement and NASH resolution primary endpoints in a Phase 3 trial Detailed analyses reinforce the safety profile of resmetirom Resmetirom has the potential to become the first and only medicine approved for NASH; PDUFA date is March 14, 2024 CONSHOHOCKEN, Pa., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a...Read more

BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA

February 8
Last Trade: 0.45 0.03 6.63

SUNNYVALE, Calif., Feb. 08, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (“BioCardia” or the “Company”) (Nasdaq: BCDA), a biotechnology company focused on advancing late-stage cell therapy interventions for cardiovascular disorders, is targeting heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates: autologous CardiAMP® cell therapy and allogeneic CardiALLO™ cell therapy. The Company...Read more

Tenax Therapeutics Enrolls First Patient in Phase 3 LEVEL Study Evaluating TNX-103 (Oral Levosimendan) for the Treatment of Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

February 7
Last Trade: 3.98 -0.10 -2.45

Over 40 sites (U.S. and Canada) have agreed to participate in the LEVEL study LEVEL is a randomized, controlled Phase 3 trial of 152 patients, and will recruit patients primarily from leading research centers with large PH-HFpEF populations Tenax forecasts topline LEVEL data will be available second half of 2025 CHAPEL HILL, N.C., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical...Read more

Reviva Pharmaceuticals to Host KOL Event to Discuss Topline Data from Phase 3 RECOVER Trial of Brilaroxazine in Schizophrenia

February 6
Last Trade: 4.37 0.04 0.92

CUPERTINO, Calif., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ:RVPH) (“Reviva” or the “Company”), a late-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), inflammatory and cardiometabolic diseases, today announced that it will host a key opinion leader (KOL) event on Thursday, February 15, 2024 at 12:00 PM ET,...Read more

Vertex Pharmaceuticals Announces Positive Results From Pivotal Trials of Vanzacaftor/Tezacaftor/Deutivacaftor, Next-In-Class Triple Combination Treatment for Cystic Fibrosis

February 5
Last Trade: 430.11 3.33 0.78

Treatment with the once-daily vanza triple CFTR modulator regimen met all primary and key secondary endpoints in two randomized controlled trials in people with CF ages 12 years and older  Results were more pronounced in the single-arm study in children ages 6 to 11 years, demonstrating the potential that treating early in life may prevent disease development  Vanza triple was generally well tolerated across all three...Read more

ARS Pharmaceuticals to Present Positive Clinical Efficacy Data for neffy® (epinephrine nasal spray) at 2024 AAAAI Annual Meeting

February 5
Last Trade: 8.35 0.75 9.87

Six posters and oral presentations to be presented, including efficacy data for neffy from two distinct clinical studies in oral food challenge induced anaphylaxis and chronic urticaria patients 100% response rate with a single dose of neffy observed in pediatric subjects experiencing anaphylaxis symptoms following oral food challenge; efficacy data intended to support post-marketing promotion of neffy, if approved On track to report...Read more

New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster

February 5
Last Trade: 37.42 -0.02 -0.05

Study conducted by Meiji Seika Pharma in Japan Short communication follows previously published data in The Lancet Infectious Diseases demonstrating Immunological Non-Inferiority to Wuhan Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster  New data demonstrates continuous advantage of sa-mRNA over conventional mRNA vaccine in terms of duration of immune...Read more

Palatin Technologies Announces Database Lock for PL9643 MELODY-1 Pivotal Phase 3 Clinical Trial in Patients with Dry Eye Disease (DED)

February 5
Last Trade: 3.13 -0.06 -1.88

Top-Line Results Expected in February CRANBURY, N.J., Feb. 5, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced database lock for its PL9643 MELODY-1 pivotal Phase 3 clinical trial evaluating the safety and efficacy of PL9643...Read more

Spectral Medical Provides Early February Tigris Trial Update

February 5
Last Trade: 0.51 -0.03 -5.56

88 patients enrolled January being the highest enrollment month since the launch of Tigris TORONTO, Feb. 05, 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

Orchard Therapeutics Announces First Patient Randomized in Registrational Trial of OTL-203 for MPS-I Hurler Syndrome

February 5
Last Trade: 16.70 0.00 0.00

Gene therapy being developed as a one-time treatment to address the underlying cause of the disease by inserting a functional copy of the human IDUA gene into a patient’s own hematopoietic stem cells HURCULES study to enroll 40 patients at clinical sites across the U.S. and Europe TOKYO, LONDON and BOSTON, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating...Read more

New Hope For Fibromyalgia Patients: Tonix Pharmaceuticals Details Results Of Second Successful Phase 3 Trial And Plans To File For FDA Approval

February 1
Last Trade: 0.32 0.0056 1.77

Fibromyalgia candidate TNX-102 SL hits primary endpoint of daily pain reduction (p=0.00005) Combination of broad-spectrum relief and favorable tolerability seen as distinguishing, competitive features Company plans to file an NDA for FDA approval in 2H 2024 CHATHAM, NJ / ACCESSWIRE / February 1, 2024 / Tonix Pharmaceuticals (NASDAQ:TNXP) appears to have a potential new weapon against fibromyalgia for the 6-12 million adults in...Read more

EDAP TMS Announces Completion of Enrollment in Phase 3 Study Evaluating Focal One HIFU Therapy for the Treatment of Deep Infiltrating Rectal Endometriosis

February 1
Last Trade: 6.01 -0.03 -0.50

60 Patients Completed Enrollment in Under 9 Months Study Results Expected in the Second Half of 2024 LYON, France, February 1, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced today that it has completed enrollment in its Phase 3 study (Endo-HIFU-R2) evaluating Focal One High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating rectal endometriosis. The...Read more

Acasti Pharma Announces Poster Detailing its GTX-104 STRIVE-ON Trial

February 1
Last Trade: 3.35 -0.02 -0.45

PRINCETON, N.J., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that a poster outlining its pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405) has been accepted for...Read more

Eupraxia Pharmaceuticals Initiates Phase 3 Development Program for EP-104IAR

February 1
Last Trade: 6.97 -0.17 -2.38

Decision to proceed with Phase 3 follows completion of End-of-Phase 2 meeting with the U.S. FDA VICTORIA, BC, Feb. 1, 2024 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology to optimize drug delivery for applications with significant unmet need, today announced the Company has initiated its Phase 3 development...Read more

Outlook Therapeutics® Doses First Subject in NORSE EIGHT

January 31
Last Trade: 0.44 0.0095 2.21

NORSE EIGHT clinical trial is being conducted under Special Protocol Assessment (SPA) from FDA to support expected resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024, if successful ISELIN, N.J., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment...Read more

Spectral Medical Provides January Tigris Trial Update

January 30
Last Trade: 0.51 -0.03 -5.56

TORONTO, Jan. 30, 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 randomized controlled trial of adults treated for endotoxemia and septic...Read more

Iterum Therapeutics Announces Positive Topline Results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections

January 30
Last Trade: 1.27 -0.08 -5.93

Phase 3 REASSURE Trial Met Primary Endpoint of Non-Inferiority to Augmentin®; Demonstrated Statistical Superiority Re-submission of NDA to FDA Expected in Q2 2024 Potential to be First Oral Penem Approved in the U.S. Management to host a conference call at 8:30 a.m. ET today DUBLIN and CHICAGO, Jan. 30, 2024 /PRNewswire/ -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on...Read more

Vertex Pharmaceuticals Announces Positive Results From the VX-548 Phase 3 Program for the Treatment of Moderate-to-Severe Acute Pain

January 30
Last Trade: 430.11 3.33 0.78

Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from baseline in both the abdominoplasty and bunionectomy randomized controlled trials  Treatment with VX-548 was also shown to be effective in the single arm study in a broad range of surgical and non-surgical pain conditions for up to 14 days  VX-548 was safe and well tolerated...Read more

Bristol-Myers Squibb: Subcutaneous Nivolumab (nivolumab and hyaluronidase) Shows Noninferiority Compared to Intravenous Opdivo (nivolumab) in Advanced or Metastatic Clear Cell Renal Cell Carcinoma in CheckMate -67T Trial

January 27
Last Trade: 51.66 0.33 0.64

CheckMate -67T is the first Phase 3 trial of the subcutaneous formulation of Opdivo to evaluate and demonstrate noninferior pharmacokinetics, efficacy and safety vs. its intravenous formulation Subcutaneous nivolumab demonstrated noninferior pharmacokinetics (co-primary endpoints) and objective response rate (key powered secondary endpoint) compared to intravenous Opdivo Results from the Phase 3 CheckMate -67T trial will be presented in...Read more

Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Disease-Free Survival (DFS) as Adjuvant Therapy Versus Observation in High-Risk Patients With Localized Muscle-Invasive and Locally Advanced Urothelial Carcinoma After Surgery

January 26
Last Trade: 129.45 0.19 0.15

KEYTRUDA doubled median DFS as adjuvant therapy versus observation – 29 months versus 14 months – in these patients AMBASSADOR (A031501)/KEYNOTE-123 is the first positive trial for KEYTRUDA as adjuvant therapy in urothelial carcinoma RAHWAY, N.J. / Jan 26, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 AMBASSADOR (A031501)/KEYNOTE-123 trial...Read more

New Long-Term Data for Genentech’s Vabysmo Show Sustained Retinal Drying and Vision Improvements in Retinal Vein Occlusion (RVO)

January 26
Last Trade: 32.96 0.47 1.45

Vabysmo sustained robust drying of retinal fluid, often associated with distorted or blurry vision Up to 60% of people receiving Vabysmo were able to extend treatment intervals to three or four months apart Detailed results from two global Phase III RVO studies will be presented at Angiogenesis, Exudation, and Degeneration 2024 Vabysmo is approved in the U.S. for RVO, and in more than 90 countries around the world for people living...Read more

Exelixis Announces Detailed Results of Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib in Combination with Atezolizumab in Metastatic Castration-Resistant Prostate Cancer Presented at ASCO GU 2024

January 25
Last Trade: 21.53 0.82 3.96

Cabozantinib in combination with atezolizumab reduced the risk of disease progression or death by 35% in patients with metastatic castration-resistant prostate cancer  Findings to be presented during an oral presentation at ASCO GU 2024  ALAMEDA, Calif. / Jan 25, 2024 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced detailed results from CONTACT-02, a phase 3 pivotal study evaluating cabozantinib (CABOMETYX®)...Read more

Ocular Therapeutix™ Announces FDA Agreement to Amend Special Protocol Assessment (SPA) for Pivotal Clinical Trial of AXPAXLI™ in Wet AMD

January 25
Last Trade: 9.86 0.16 1.65

SPA amendment expands eligibility criteria for SOL clinical trial Broadening of eligibility criteria anticipated to accelerate overall trial enrollment BEDFORD, Mass., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the U.S. Food...Read more

Cytokinetics Presents New Data at CMR 2024 From FOREST-HCM, the Open Label Extension Clinical Trial of Aficamten

January 25
Last Trade: 78.02 2.43 3.21

SOUTH SAN FRANCISCO, Calif., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data at CMR 2024 demonstrating favorable effects on cardiac structure, function and fibrosis related to treatment with aficamten in FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM), the open label extension clinical trial of aficamten in patients with hypertrophic...Read more

Panbela Therapeutics Exceeds 50% Enrollment for Aspire Trial in Pancreatic Cancer, Exceeding Anticipated Timelines with Accelerated Momentum

January 25
Last Trade: 1.12 0.01 0.90

Interim Data Analysis Anticipated in Mid-2024 Expects Full Enrollment by Q1 2025 MINNEAPOLIS, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced it has reached 50% enrollment for its ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic...Read more

Bristol Myers Squibb: Eight-Year Data for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Continue to Demonstrate Longest Survival Benefit vs. Sunitinib Reported in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

January 22
Last Trade: 51.66 0.33 0.64

Patients with previously untreated advanced or metastatic renal cell carcinoma treated with Opdivo plus Yervoy experienced a 28% reduction in the risk of death vs. sunitinib at eight years from the start of treatment, regardless of risk group The dual immunotherapy combination showed improved survival and durable responses compared to sunitinib among intermediate- and poor-risk patients, as well as all randomized patients Updated...Read more

Bristol Myers Squibb: Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) Demonstrates Long-Term Survival Benefits After Four Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma

January 22
Last Trade: 51.66 0.33 0.64

Opdivo in combination with CABOMETYX reduced the risk of death by 23% in the first-line treatment of advanced renal cell carcinoma vs. sunitinib Four-year results demonstrating continued benefits with immunotherapy-tyrosine kinase inhibitor combination to be shared in an oral presentation at ASCO GU 2024 PRINCETON, N.J. & ALAMEDA, Calif. / Jan 22, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ:...Read more

Gilead Sciences Provides Update on Phase 3 EVOKE-01 Study

January 22
Last Trade: 73.55 0.77 1.06

FOSTER CITY, Calif. / Jan 22, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival (OS) in previously treated metastatic non-small cell lung cancer (NSCLC). EVOKE-01 is evaluating Trodelvy® (sacituzumab govitecan-hziy; SG) vs. docetaxel in patients with metastatic or advanced NSCLC that had progressed on or after platinum-based...Read more

Ionis Pharmaceuticals announces positive topline results from Phase 3 OASIS-HAE study of investigational donidalorsen in patients with hereditary angioedema

January 22
Last Trade: 45.36 1.38 3.14

Donidalorsen met the primary endpoint with a statistically significant reduction in the rate of HAE attacks in patients treated every 4 weeks or patients treated every 8 weeks  Donidalorsen demonstrated a favorable safety and tolerability profile Ionis is preparing to submit a New Drug Application with U.S. FDA Data to be presented at an upcoming medical congress CARLSBAD, Calif., Jan. 22, 2024 /PRNewswire/ -- Ionis...Read more

BioNTech and DualityBio Initiate Pivotal Phase 3 Trial Of Antibody-Drug Conjugate Candidate BNT323/DB-1303 in Metastatic Breast Cancer

January 22
Last Trade: 93.97 0.40 0.43

The pivotal Phase 3 trial with BNT323/DB-1303 follows positive Phase 1/2 safety and efficacy data in patients with Human Epidermal Growth Factor Receptor 2 (“HER2”)-expressing advanced solid tumors with early signs of anti-tumor activity in heavily pretreated patients with HER2-low and HER2-positive breast cancer The trial is expected to enroll 532 patients with Hormone Receptor-positive (“HR+”) and HER2-low metastatic breast cancer...Read more

Bristol-Myers Squibb: Opdivo (nivolumab) Plus Yervoy (ipilimumab) Reduced the Risk of Disease Progression or Death by 79% Versus Chemotherapy in Patients with Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer...

January 20
Last Trade: 51.66 0.33 0.64

First presentation of data from the Phase 3 randomized trial shows statistically significant and clinically meaningful improvement in progression-free survival with Opdivo plus Yervoy compared to chemotherapy as first-line treatment in this patient population Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy as first-line treatment in MSI-H/dMMR...Read more

AstraZeneca: IMFINZI® (durvalumab) plus transarterial chemoembolization (TACE) and bevacizumab reduced the risk of disease progression or death by 23% vs. TACE in liver cancer eligible for embolization

January 19
Last Trade: 65.83 1.70 2.65

EMERALD-1 is first global Phase III trial to show improved clinical outcome for systemic therapy in combination with TACE in this setting WILMINGTON, Del. / Jan 19, 2024 / Business Wire / Positive results from the EMERALD-1 Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) in combination with TACE and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of...Read more

Sarepta Therapeutics Initiates Screening in EMERGENE, a Phase 3 Clinical Study of SRP-9003 for the Treatment of Limb-Girdle Muscular Dystrophy Type 2E/R4

January 16
Last Trade: 136.53 1.75 1.30

CAMBRIDGE, Mass. / Jan 16, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that screening is underway in Study SRP-9003-301. Also known as EMERGENE, Study 9003-301 is a Phase 3, multi-national, open-label study of SRP-9003 (bidridistrogene xeboparvovec) for the treatment of limb-girdle muscular dystrophy Type 2E (LGMD2E/R4), or beta...Read more

Regeneron Pharmaceuticals: Dupixent® (dupilumab) U.S. Label Updated with Data Further Supporting Use in Atopic Dermatitis with Moderate-to-Severe Hand and Foot Involvement

January 16
Last Trade: 981.20 16.31 1.69

Data included from first and only Phase 3 trial specifically evaluating a biologic in this difficult-to-treat population Phase 3 trial showed more than twice as many patients treated with Dupixent achieved clear or almost clear skin and nearly four times as many had improvement in itch, compared with placebo TARRYTOWN, N.Y. and PARIS, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today...Read more

Arcutis Biotherapeutics: Majority of Individuals with Atopic Dermatitis Improved with Arcutis’ Roflumilast Cream 0.15% According to New Data from Phase 3 Program

January 14
Last Trade: 9.68 0.06 0.62

Individual patient response data highlight 91.5% of individuals treated with roflumilast cream had a measurable improvement in Eczema Area and Severity Index (EASI) in just 4 weeks 85% achieved measurable improvement by Week 1 (the earliest timepoint measured) Data presented at the 2024 Winter Clinical Dermatology Conference - Hawaii WESTLAKE VILLAGE, Calif., Jan. 14, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics,...Read more

Spectral Medical Enrolls Patient 82 in Its Phase 3 FDA Tigris Septic Shock Trial

January 10
Last Trade: 0.51 -0.03 -5.56

New patient enrollment sites accelerating screening activity Screening activity exceeding 100 patients per week Approaching interim enrollment target of 90 patients TORONTO, Jan. 10, 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...Read more

Alcon Announces Positive Topline Results From Phase 3 COMET Trials of AR-15512, a Novel Topical Drug Candidate for Dry Eye

January 9
Last Trade: 80.06 -0.34 -0.42

AR-15512, a topical transient receptor potential melastatin 8 (TRPM8) agonist, is a first-in-class product candidate for the treatment of the signs and symptoms of dry eye disease In both pivotal efficacy and safety studies (COMET-2 and COMET-3), the primary endpoint was achieved (p <0.0001) Dry eye affects an estimated 38 million people in the U.S. and less than 10% of diagnosed patients are treated with a prescription...Read more

Novocure Announces Last Patient Enrolled in Phase 3 TRIDENT Trial in Newly Diagnosed Glioblastoma

January 9
Last Trade: 15.22 -0.02 -0.13

Final data from the TRIDENT trial anticipated in 2026 ROOT, Switzerland / Jan 09, 2024 / Business Wire / Novocure (NASDAQ: NVCR) today announced that the final patient has been enrolled in the global phase 3 TRIDENT clinical trial evaluating the safety and efficacy of initiating Optune Gio® (formerly known as Optune®) concurrent with radiation therapy and temozolomide (TMZ) for the treatment of adult patients with newly diagnosed...Read more

Tonix Pharmaceuticals Presents Additional Data Highlighting the Favorable Tolerability and Differentiated Side Effect Profile of TNX-102 SL in Second Positive Phase 3 Clinical Trial for the Management of Fibromyalgia

January 9
Last Trade: 0.32 0.0056 1.77

As previously announced, Phase 3 RESILIENT study of TNX-102 SL met its primary endpoint (p=0.00005) with statistically significant and clinically meaningful daily pain reduction over placebo Results demonstrated a favorable tolerability and side effect profile, including improvement in female sexual function and no increases in weight or blood pressure – three treatment-limiting side effects often observed with currently approved...Read more

Bayer’s elinzanetant meets all primary and key secondary endpoints in pivotal OASIS 1 and 2 Phase III studies

January 8
Last Trade: 7.76 -0.04 -0.51

OASIS 1 and 2 pivotal studies evaluating investigational compound elinzanetant met all primary endpoints demonstrating a statistically significant reduction in frequency and severity of moderate to severe vasomotor symptoms (VMS) compared to placebo in postmenopausal women Both studies also showed superiority over placebo for all key secondary endpoints with a statistically significant reduction in frequency of VMS at week 1, as well as...Read more

Novo Nordisk: COMBINE 3 phase 3a trial successfully completed with once-weekly IcoSema demonstrating non-inferior reduction in HbA1c versus daily basal-bolus treatment (insulin glargine U100 and insulin aspart) in people with type 2 diabetes

January 8
Last Trade: 123.45 -1.07 -0.86

COMBINE 3 phase 3a trial successfully completed with once-weekly IcoSema demonstrating non-inferior reduction in HbA1c versus daily basal-bolus treatment (insulin glargine U100 and insulin aspart) in people with type 2 diabetes Bagsværd, Denmark, 8 January 2024 – Novo Nordisk today announced topline results from the COMBINE 3 phase 3a trial of once-weekly IcoSema, a fixed-ratio combination of basal insulin icodec and...Read more

Mural Oncology Announces Enhancements to Late-Stage Clinical Trials

January 8
Last Trade: 4.73 0.08 1.72

Strategic changes to ARTISTRY-6 and ARTISTRY-7, both potentially registrational trials of nemvaleukin, are intended to result in more clinically meaningful data Mural intends to nominate development candidates for its engineered therapies targeting interleukin-18 and interleukin-12 programs in 2024 The Company reiterates current cash runway projection into 4Q 2025 DUBLIN, Ireland, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Mural Oncology...Read more

Merck Announces Phase 3 Trial Initiations for Four Investigational Candidates From its Promising Hematology and Oncology Pipeline

January 5
Last Trade: 129.45 0.19 0.15

Global Phase 3 studies started for bomedemstat (LSD1 inhibitor), nemtabrutinib (BTK inhibitor), MK-2870 (anti-TROP2 ADC) and MK-5684 (CYP11A1 inhibitor) Comprehensive clinical development programs being initiated for each investigational candidate Demonstrates company's commitment to research across novel mechanisms of action in hematologic neoplasms/malignancies, as well as lung, endometrial and prostate cancers RAHWAY, N.J. / Jan...Read more

Applied Therapeutics Announces Topline Results from the ARISE-HF Phase 3 Study of AT-001 in Diabetic Cardiomyopathy

January 4
Last Trade: 5.74 0.14 2.50

AT-001 (caficrestat) demonstrated a strong trend in stabilizing cardiac functional capacity, while the placebo group declined over 15 months AT-001 treatment resulted in a statistically significant difference in cardiac functional capacity in a prespecified subgroup of patients not receiving concomitant treatment with an SGLT2 or GLP-1 (p=0.040) and prevented clinically significant worsening (odds ratio 0.56; p=0.035) AT-001...Read more

Ocuphire Pharma Receives FDA Agreement Under Special Protocol Assessment for LYNX-2 Phase 3 Trial of Phentolamine Ophthalmic Solution for the Treatment of Decreased Visual Acuity under Dim (mesopic) Light Conditions

January 4
Last Trade: 2.50 0.00 0.00

FARMINGTON HILLS, Mich., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced it has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the clinical trial protocol...Read more

Verrica Pharmaceuticals Announces Receipt of Minutes from Type C Meeting with FDA Regarding Clinical Development of YCANTH™ for the Treatment of Common Warts

January 4
Last Trade: 5.18 0.07 1.37

WEST CHESTER, Pa., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that it received the minutes from the Company’s recent Type C meeting with the U.S. Food and Drug Administration (FDA), which was held on November 6, 2023, to discuss the Phase 3 clinical...Read more

Rhythm Pharmaceuticals Announces Completion of Screening for Enrollment in Setmelanotide Phase 3 Hypothalamic Obesity Trial and Additional Updates

January 4
Last Trade: 45.16 1.10 2.50

Phase 3 hypothalamic obesity top-line data expected in 1H2025  Positive reimbursement decision achieved for IMCIVREE® (setmelanotide) to treat patients with Bardet-Biedl syndrome and POMC/LEPR deficiencies in Spain  IND application for RM-718 accepted by the FDA  BOSTON, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on...Read more

Intensity Therapeutics Provides Business Update Reflecting Progress in Phase 3 Sarcoma Program

January 3
Last Trade: 3.17 0.17 5.67

FDA provides "Study May Proceed" letter for open-label, randomized phase 3 protocol in soft tissue sarcoma, and plans to initiate phase 3 study in first half of 2024 SHELTON, Conn., Jan. 3, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or the "Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies...Read more

New Published Data Demonstrates Correlation Between Itch Cytokine Interleukin-31 Reduction and Pruritis Improvement in Primary Biliary Cholangitis in Phase 3 Post-Hoc Analysis of CymaBay's Seladelpar

January 3
Last Trade: 32.23 0.06 0.19

First clinical trial in PBC to show coordinate reductions of IL-31, bile acids and pruritus  NEWARK, Calif., Jan. 3, 2024 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced the first published findings demonstrating the impact of seladelpar on serum interleukin-31 (IL-31) levels and its...Read more

Apollomics Completes Enrollment in Phase 3 Bridging Study of Uproleselan in Chinese Patients with Relapsed/Refractory Acute Myeloid Leukemia

January 3
Last Trade: 0.70 0.04 6.07

FOSTER CITY, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a clinical-stage biopharmaceutical company developing medicines to address difficult-to-treat cancers, today announced the completion of enrollment in its Phase 3 bridging study evaluating uproleselan (APL-106), an investigational, first-in-class E-selectin antagonist, added to a standard chemotherapy regimen for the...Read more

Alkermes Announces Topline Results From Long-Term, Open-Label Safety and Durability of Treatment Effect Study of LYBALVI® (olanzapine and samidorphan)

January 3
Last Trade: 29.57 0.66 2.28

Results Demonstrated that LYBALVI was Generally Well Tolerated With Stability of Body Weight and Metabolic Profile, and Durable Symptom Control, for Up to Four Years of Treatment  DUBLIN, Jan. 3, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced topline results from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI®...Read more

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

January 3
Last Trade: 32.99 3.21 10.78

Mitapivat Demonstrated a Statistically Significant Increase in Hemoglobin Response Rate Compared to Placebo  Statistical Significance Also Achieved for Key Secondary Endpoints of Change From Baseline in Both FACIT-Fatigue Score and Hemoglobin Concentration  ENERGIZE is the First Phase 3 Study to Demonstrate Efficacy of an Oral Treatment for Non-Transfusion-Dependent Alpha- and Beta-Thalassemia  Agios to Host...Read more

Citius Pharmaceuticals Completes Enrollment in Pivotal Phase 3 Trial of its Mino-Lok® Therapeutic to Salvage Catheters

January 2
Last Trade: 0.76 -0.03 -3.80

Topline results expected 2Q 2024 Study enrolled a total of 241 patients; 109 catheter failures observed First-and-only antibiotic lock solution in development to salvage catheters in patients with CRBSI CRANFORD, N.J., Jan. 2, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class...Read more

Spero Therapeutics Announces First Patient, First Visit for Phase 3 PIVOT-PO Trial Evaluating Tebipenem HBr in Complicated Urinary Tract Infections

January 2
Last Trade: 1.51 0.04 2.72

CAMBRIDGE, Mass., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and commercializing treatments in high unmet need areas involving rare diseases and multi-drug resistant (MDR) bacterial infections, announced today the first patient, first visit for PIVOT-PO, a global pivotal Phase 3 clinical trial of tebipenem HBr in...Read more

Cytokinetics Announces Positive Results From SEQUOIA-HCM, the Pivotal Phase 3 Clinical Trial of Aficamten in Patients With Obstructive Hypertrophic Cardiomyopathy

December 27
Last Trade: 78.02 2.43 3.21

Statistically Significant and Clinically Meaningful Increase in Primary Efficacy Endpoint at 24 Weeks of Treatment; Improvement Consistent Across All Prespecified Subgroups Statistically Significant and Clinically Meaningful Improvements in All Secondary Endpoints No Instances of Treatment Interruptions Due to Low LVEF Company to Host Conference Call and Webcast Today at 8:30 a.m. Eastern Time SOUTH SAN FRANCISCO, Calif., Dec. 27,...Read more

Amylyx Pharmaceuticals Announces First Participant Dosed in the Global Phase 3 ORION Study of AMX0035 in Progressive Supranuclear Palsy (PSP)

December 22
Last Trade: 17.65 -0.89 -4.80

Largest ever PSP clinical trial will evaluate the efficacy and safety of AMX0035 in adults with PSP compared to placebo Trial to enroll approximately 600 participants across the U.S., Canada, Europe, and Japan CAMBRIDGE, Mass. / Dec 22, 2023 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced that the first participant has been dosed in ORION, a randomized, double-blind,...Read more

AlloVir Provides Updates on Phase 3 Clinical Development Program for Posoleucel, an Allogeneic Virus-Specific T Cell Therapy

December 22
Last Trade: 0.70 -0.0033 -0.47

Company to discontinue its three Phase 3 posoleucel studies following separate, pre-planned DSMB futility analyses concluding the studies were unlikely to meet their primary endpoints; no safety concerns identified Company to prioritize capital preservation and review strategic options AlloVir reported $213.3 million in cash, cash equivalents, and short-term investments as of September 30, 2023 WALTHAM, Mass., Dec. 22,...Read more

Mineralys Therapeutics Announces First Subject Dosed in Launch-HTN, the Second Pivotal Trial of Lorundrostat for the Treatment of Hypertension

December 21
Last Trade: 15.88 0.22 1.40

Topline data from confirmatory Launch-HTN trial expected in 2H 2025  Topline data from ongoing Advance-HTN pivotal trial expected in 2H 2024 RADNOR, Pa., Dec. 21, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today...Read more

RenovoRx Engages Oklahoma University (OU) Health as First Clinical Site in Preparation for the Pivotal Phase III CouGar Clinical Trial in Bile Duct Cancer

December 21
Last Trade: 1.41 0.05 3.68

This study will be the Second Clinical Trial Evaluating RenovoGem™, a Combination Drug-Device Product, in a Difficult-to-Access Solid Tumor Cancer LOS ALTOS, Calif. / Dec 21, 2023 / Business Wire / RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, today announced the expansion of their clinical...Read more

Ocugen Gains FDA Alignment on Key Aspects of OCU400—Modifier Gene Therapy—Pivotal Phase 3 Study Design

December 21
Last Trade: 0.79 -0.20 -20.28

MALVERN, Pa., Dec. 21, 2023 (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 Company received alignment from FDA on key aspects of the Phase 3 clinical trial design to assess the safety and efficacy of OCU400 in patients with RHO and other gene mutations associated...Read more

Annexon Outlines Global Registrational Program for ANX007 in Geographic Atrophy with FDA Alignment on Vision Preservation as Primary Endpoint

December 20
Last Trade: 5.25 0.25 5.00

Alignment with FDA on Best Corrected Visual Acuity ≥ 15-Letter Loss as Primary Outcome Measure - Representing the Highest Value Outcome to Patients and Physicians ARCHER II, a Global Sham-Controlled Trial Supporting a Potentially Faster Path to Registration, Expected to Initiate in Mid-2024 ARROW, a Head-to-Head Trial using SYFOVRE® as an Injection Comparator to Differentiate Vision Protection from Slowing of Lesion Growth, Expected...Read more

Dermata Therapeutics Enrolls First Patient in Pivotal DMT310 Phase 3 STAR-1 Clinical Trial for Acne

December 20
Last Trade: 0.47 0.04 10.10

About 550 patients will be treated once weekly for 12 weeks  STAR-1 topline results expected in first quarter of 2025  Acne affects about 50 million patients in the U.S.  SAN DIEGO, CA / ACCESSWIRE / December 20, 2023 / Dermata Therapeutics, Inc. (Nasdaq:DRMA, DRMAW) ("Dermata" or the "Company"), a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions, today announced...Read more

Tonix Pharmaceuticals Announces Highly Statistically Significant and Clinically Meaningful Topline Results in Second Positive Phase 3 Clinical Trial of TNX-102 SL for the Management of Fibromyalgia

December 20
Last Trade: 0.32 0.0056 1.77

Phase 3 RESILIENT study of TNX-102 SL successfully demonstrated daily pain reduction over placebo (primary endpoint, p = 0.00005) All six key secondary endpoints, including patient global impression, fibromyalgia-specific symptoms and dysfunction, fatigue and sleep measures were significantly improved (all p ≤ 0.001) Positive results support planned New Drug Application (NDA) submission to the FDA in the second half of 2024An...Read more

Oculis Announces First Patient First Visit in Phase 3 OPTIMIZE-2 Trial of OCS-01 for the Treatment of Inflammation and Pain Following Cataract Surgery

December 20
Last Trade: 12.40 -0.10 -0.80

Initiation of the second Phase 3 OPTIMIZE-2 trial with OCS-01 once daily eye drop, follows the recently reported positive OPTIMIZE-1 trial results OPTIMIZE-2 topline readout expected before end of 2024 to support NDA submission OCS-01 is also being evaluated as potentially the first topical eye drop treatment for Diabetic Macular Edema (DME) in the DIAMOND program and for the treatment of Cystoid Macular Edema (CME) in the LEOPARD...Read more

argenx Reports Topline Results from ADDRESS Study of Efgartigimod SC in Pemphigus

December 20
Last Trade: 409.52 3.51 0.86

ADDRESS study did not meet primary or secondary endpoints Pemphigus deprioritized as efgartigimod indication Update on BALLAD study GO/NO GO decision Conference call scheduled for today, December 20, 2023, at 8:30am ET (2:30pm CET) Regulated Information – Inside Information December 20, 2023, 7:00am CET - AMSTERDAM, THE NETHERLANDS — argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving...Read more

Ascendis Pharma: TransCon™ hGH (lonapegsomatropin) Achieved Statistically Superior Outcomes Compared to Placebo in Phase 3 foresiGHt Trial of Adults with Growth Hormone Deficiency

December 19
Last Trade: 159.40 1.20 0.76

On primary efficacy and key secondary endpoints, TransCon hGH demonstrated statistically significant reduction from baseline in trunk fat and increase in total body lean mass at Week 38 compared to placebo TransCon hGH was generally safe and well tolerated, similar to daily hGH, with no discontinuations related to study drug Exploratory post-hoc analysis suggests the same treatment effects on target tissues as daily hGH COPENHAGEN,...Read more

Compugen will be Eligible to Receive $10 Million Milestone Payment upon Dosing of First Patient in AstraZeneca Phase 3 Rilvegostomig Trial in Biliary Tract Cancer

December 19
Last Trade: 2.34 0.02 0.86

Dosing of first patient in Phase 3 trial of rilvegostomig, a PD-1/TIGIT bispecific antibody, will trigger $10 million milestone payment from AstraZeneca HOLON, Israel, Dec. 19, 2023 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced it will be eligible to receive a milestone payment of $10 million from...Read more

Invivyd Announces Positive Initial Results from Ongoing CANOPY Phase 3 Pivotal Clinical Trial Investigating VYD222 for the Prevention of COVID-19

December 18
Last Trade: 4.32 0.28 6.93

VYD222 produced high serum virus neutralizing antibody titer levels in immunocompromised participants Data supportive of an immunobridging approach to the EVADE study of adintrevimab Overall favorable safety and tolerability profile of VYD222 including no study drug-related serious adverse events (SAEs) to date VYD222 demonstrates continued in-vitro neutralization activity against major SARS-CoV-2 variants, including against HV.1,...Read more

Cara Therapeutics Announces Outcome from Dose-Finding Part A of KIND 1 Study Evaluating Oral Difelikefalin for Moderate-to-Severe Pruritus in Patients with Atopic Dermatitis

December 18
Last Trade: 0.91 0.11 13.56

Oral difelikefalin as adjunct to topical corticosteroids (TCS) did not demonstrate meaningful clinical benefit compared to TCS alone; As a result, Cara will discontinue its clinical program in pruritus associated with atopic dermatitis  Late-stage oral difelikefalin clinical programs for pruritus associated with notalgia paresthetica and advanced chronic kidney disease continue to enroll on track with key data readouts expected in...Read more

Akero Therapeutics Announces First Patients Dosed in Efruxifermin Phase 3 SYNCHRONY Program

December 18
Last Trade: 25.34 1.13 4.67

Week 96 Phase 2b HARMONY Results for Treatment of Patients with Pre-Cirrhotic NASH/MASH (F2-F3) to be Reported in March 2024 End-of-Phase 2 FDA Meeting Scheduled for the first quarter of 2024 to Review Phase 3 Study and Regulatory Path for Treatment of NASH/MASH Patients with Compensated Cirrhosis (F4) SOUTH SAN FRANCISCO, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a...Read more

Oculis Announces First Patient First Visit in Phase 3 DIAMOND-1 Trial of OCS-01 Eye Drop in Diabetic Macular Edema

December 18
Last Trade: 12.40 -0.10 -0.80

DIAMOND-1 Phase 3 trial, assessing the efficacy and safety of OCS-01 eye drops following 52 weeks of treatment in Diabetic Macular Edema (DME) patients, was initiated as planned Stage 1 results showed superiority of OCS-01 eye drops vs. vehicle with robust statistical significance with no unexpected adverse events observed Second 52 weeks Phase 3 trial of OCS-01 in DME, DIAMOND-2, is anticipated to start in Q1 2024 If approved,...Read more

Bristol Myers Squibb Provides Update on RELATIVITY-123 Trial Evaluating the Fixed-Dose Combination of Nivolumab and Relatlimab in Patients with Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer

December 15
Last Trade: 51.66 0.33 0.64

PRINCETON, N.J. / Dec 15, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the Phase 3 RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab for the treatment of microsatellite stable (MSS) metastatic colorectal cancer (mCRC) patients whose disease has progressed following at least one, but no more than four, prior lines of therapy for metastatic disease will be discontinued due...Read more

Spectral Medical Provides Tigris Trial Update

December 14
Last Trade: 0.51 -0.03 -5.56

81 patients enrolled TORONTO, Dec. 14, 2023 (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 randomized controlled trial of adults treated for endotoxemia and septic...Read more

Rezolute Initiates Phase 3 Clinical Study for RZ358 in Congenital Hyperinsulinism

December 14
Last Trade: 1.72 0.12 7.50

REDWOOD CITY, Calif., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced the initiation of sunRIZE, a pivotal Phase 3 clinical study of RZ358 in patients with congenital hyperinsulinism (cHI). Following country-level regulatory and ethics committee approvals,...Read more

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