Clinical Research Newsletter

08-06-2024

Alligator reveals positive data for pancreatic cancer drug

Alligator Bioscience shared positive results from its Phase Ib/II OPTIMIZE-1 trial (NCT04888312) for mitazalimab, a monoclonal antibody therapy targeting pancreatic can

08-06-2024

4DMT declares positive interim Phase I/II data for cystic fibrosis gene therapy

4DMT is advancing to Phase II of its AEROW trial following encouraging interim results for gene therapy 4D710 in cystic fibrosis (CF). Combining an AAV vector with a CF

07-06-2024

AbbVie declares positive Phase II ovarian cancer trial data

AbbVie announced positive results from the Phase II PICCOLO trial of mirvetuximab soravtansine (ELAHERE) monotherapy in heavily pre-treated high folate receptor-alpha (

03-06-2024

J&J’s seltorexant declares positive results from Phase III MDD trial

Johnson & Johnson (J&J) has reported positive results from its Phase III trial of seltorexant in major depressive disorder (MDD), meeting all primary and second

01-06-2024

Gilead’s phase 3 TROPiCS-04 study of Trodelvy for treating locally advanced or metastatic urothelial cancer fails to meet primary endpoint

Gilead Sciences, Inc. released findings from the phase 3 TROPiCS-04 study in metastatic urothelial cancer (mUC), comparing Trodelvy (SG) to chemotherapy in patients who

01-06-2024

Innovent’s phase 3 study of picankibart for treating moderate to severe plaque psoriasis meets all primary and key secondary endpoints

Innovent Biologics, Inc., a renowned biopharmaceutical firm focusing on cancer, metabolic, autoimmune, and other diseases, has revealed the success of its phase 3 study

01-06-2024

Xeris Biopharma declares positive results from phase 2 study of investigational XeriSol-formulated once-weekly SC levothyroxine to treat hypothyroidism

Xeris Biopharma Holdings, Inc., a biopharmaceutical company dedicated to advancing patient care, has unveiled promising results from its phase 2 trial of XP-8121 for tr

01-06-2024

Ultragenyx reports topline results from phase 3 study of DTX401 gene therapy for glycogen storage disease type Ia

Ultragenyx Pharmaceutical Inc., dedicated to addressing rare genetic diseases, reported positive findings from its phase 3 GlucoGene study (NCT05139316) evaluating DTX4

29-05-2024

Amgen, AstraZeneca report positive results from phase 2a COURSE trial of Tezspire in patients with moderate to very severe COPD

Amgen and AstraZeneca released results from the phase 2a COURSE trial assessing Tezspire (tezepelumab-ekko) in individuals with moderate to very severe chronic obstruct

29-05-2024

Merus declares positive Phase II data for head and neck cancer antibody

Merus's bispecific antibody petosemtamab targets both epidermal growth factor receptor (EGFR) and leucine-rich repeat-containing G-protein coupled receptor 5 (LGR5). Am

28-05-2024

Vicore Pharma declares positive results from phase 2a AIR trial of buloxibutid in idiopathic pulmonary fibrosis (IPF)

Vicore Pharma Holding AB unveiled positive final results from its phase 2a AIR trial evaluating buloxibutid (C21) in idiopathic pulmonary fibrosis (IPF) at the American

28-05-2024

Medtronic reports positive results from Affera Mapping and Ablation System with Sphere-9 Catheter to treat persistent AFib

Medtronic plc, a global healthcare technology leader, announced promising results from the SPHERE Per-AF study, evaluating the Affera Mapping and Ablation System with S

27-05-2024

GSK declares SWIFT-1 & SWIFT-2 phase III trials of depemokimab in patients with severe asthma meets primary endpoints

GSK plc reported positive outcomes from phase III trials SWIFT-1 and SWIFT-2, evaluating depemokimab's efficacy and safety in severe asthma with type 2 inflammation. Bo

27-05-2024

Nimbus declares positive data from Phase I/II solid tumour therapy trial

Nimbus Therapeutics has released encouraging results from its Phase I/II clinical trial of NDI-101150, an oral small-molecule inhibitor targeting hematopoietic progenit

21-05-2024

SPR Therapeutics announces positive data for PNS pain relief device

SPR Therapeutics announced positive results from a study evaluating its peripheral nerve stimulation (PNS) device for alleviating chronic knee pain post knee replacemen

20-05-2024

Vanda Pharmaceuticals declares positive data from motion sickness trial

Vanda Pharmaceuticals announced positive results from its Phase III trial of tradipitant for motion sickness, named Motion Serifos. The trial involved 316 participants

20-05-2024

Novo Nordisk reports positive results from Phase IIIa trial of haemophilia A drug

 Novo Nordisk has shared headline results from FRONTIER II, a Phase IIIa trial assessing subcutaneous Mim8 for haemophilia A treatment.

18-05-2024

AstraZeneca’s Phase III Covid-19 antibody trial meets primary endpoints

AstraZeneca reported successful results from its Phase III SUPERNOVA trial, evaluating sipavibart's efficacy in preventing Covid-19 among immunocompromised individuals.

18-05-2024

Roche targets obesity market with early positive trial data

Roche anticipates benefiting from the obesity therapy market following positive Phase Ib trial results for its investigational obesity and type 2 diabetes treatment, CT

13-05-2024

Boehringer declares positive findings from diabetic macular ischemia trial

Boehringer Ingelheim released positive findings from the HORNBILL Phase I/IIa trial assessing BI 764524, a humanized monoclonal anti-Sema3A antibody, for diabetic macul

12-05-2024

Teva and Medincell declared positive data for TEV-‘749 in schizophrenia trial

Teva and Medincell have disclosed positive outcomes from the Phase III Subcutaneous OLAnzapine Extended-Release Injection Study (SOLARIS), assessing TEV-‘749 (ola

11-05-2024

AngioDynamics touts positive data from AlphaVac trial

AngioDynamics has unveiled data showing the safety and efficacy of its AlphaVac F1885 System in patients with acute intermediate-risk pulmonary embolism (PE), demonstra

10-05-2024

Merck’s trial of Keytruda regimen fails to meet primary endpoint

Merck & Co (MSD) announced that its Phase III KEYNOTE-B21 trial, studying Keytruda with chemotherapy in newly diagnosed high-risk endometrial cancer post-surgery, d

09-05-2024

AstraZeneca declares positive interim data from mantle cell lymphoma trial

AstraZeneca's Phase III ECHO trial showed promising results for Calquence (acalabrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor, combined with standard chem

08-05-2024

LEO Pharma declares positive data from Phase III plaque psoriasis trial

Leo Pharma has released promising findings from a Phase III clinical trial of Enstilar (LEO 90100) for Chinese adult patients with stable plaque psoriasis. Enstilar, an

07-05-2024

Micron reveals positive data from needle-free measles and rubella vaccine study

Micron Medical's Phase I/II trial, detailed in The Lancet, underscores the safety and efficacy of its measles and rubella microneedle patch (MNP), offering a needle-fre

07-05-2024

Micron Medical's Phase I/II trial, detailed in The Lancet, underscores the safety and efficacy of its measles and rubella microneedle patch (MNP), offering a needle-free vaccination option. Results sh

Micron Medical's Phase I/II trial, detailed in The Lancet, underscores the safety and efficacy of its measles and rubella microneedle patch (MNP), offering a needle-free vaccination option. Results

07-05-2024

Newron’s add-on schizophrenia therapy mets endpoints in Phase II/III trial

Newron Pharmaceuticals' evenamide study has achieved its primary endpoint, demonstrating improvement in positive and negative symptoms, and severity in patients with tr

06-05-2024

Biological E declares positive results from phase-III trials of Pneubevax 14 in 6-8-week old infants

Biological E. Limited (BE), based in Hyderabad, disclosed phase-III trial results for its 14-Valent Pneumococcal Conjugate Vaccine (PCV), Pneubevax 14 (BE-PCV-14), in V

05-05-2024

Merck’s phase 3 KEYNOTE-811 trial of Keytruda in combo with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy meets dual primary endpoint of OS in patients with HER2-positive ad

Merck, known as MSD outside the US and Canada, announced that its phase 3 trial KEYNOTE-811 evaluating Keytruda (pembrolizumab) with trastuzumab and chemotherapy met it

30-04-2024

Neurocrine declares positive Phase II trial results for NBI-1065845

Neurocrine Biosciences reports positive findings from the Phase II SAVITRI trial of NBI-1065845 for major depressive disorder (MDD) in adults.

30-04-2024

Kintor Pharma’s GT20029 Phase II trial meets primary endpoint

Kintor Pharma has announced positive results from its GT20029 Phase II trial in China for treating male androgenetic alopecia (AGA), meeting the primary endpoint.

30-04-2024

Addex Therapeutics: Phase 2 epilepsy study of ADX71149 fails to meet primary endpoint

Addex Therapeutics, a clinical-stage biopharmaceutical company, disclosed phase 2 epilepsy study results for adjunctive ADX71149 (JNJ-40411813) in patients with inadequ

30-04-2024

AstraZeneca, Daiichi Sankyo report positive results from DESTINY-Breast06 phase III trial of Enhertu

The DESTINY-Breast06 phase III trial unveiled positive outcomes, showing Enhertu's (trastuzumab deruxtecan) significant progression-free survival (PFS) improvement

30-04-2024

Merck declares positive results from trial of pneumonia vaccine

German pharmaceutical company Merck KGaA (Merck) has reported positive results from its Phase III STRIDE-10 trial of V116, a pneumococcal conjugate vaccine aimed at pre

28-04-2024

Alto Neuroscience declares positive ALTO-101 Phase I trial results

Alto Neuroscience has reported positive results from its Phase I trial of ALTO-101, a PDE4 inhibitor for treating cognitive impairment in schizophrenia (CIAS). The stud

27-04-2024

Gain declares positive Phase I results for Parkinson’s therapy

In February, Gain Therapeutics revealed preclinical data indicating that GT-02287 restored motor function and significantly reduced plasma neurofilament light chain (Nf

20-04-2024

Joincare Pharmaceutical meets primary endpoint in Phase III flu trial

Joincare Pharmaceutical, based in China, has achieved the primary endpoint in a Phase III trial for its flu candidate TG-1000, in collaboration with Taiwan's TaiGen Bio

20-04-2024

GSK declares positive data from Phase III gonorrhoea antibiotic trial

GSK has reported favorable outcomes from the Phase III EAGLE-1 clinical trial of gepotidacin, an oral bactericidal triazaacenaphthylene antibiotic, in treating uncompli

20-04-2024

Marinus did not meet early stopping criteria for status epilepticus trial

Marinus Pharmaceuticals announced that its Phase III RAISE study (NCT04391569) of IV ganaxolone for status epilepticus (SE) didn't meet early stopping criteria. They pl

19-04-2024

Barinthus meets primary endpoint in Phase I/II trial of HPV therapy

Barinthus Biotherapeutics (formerly Vaccitech) released topline data from its Phase Ib/II APOLLO trial for HPV treatment, VTP-200. The randomized APOLLO trial (NCT04607

19-04-2024

Cerevel declares positive data from Phase III Parkinson’s treatment trial

Cerevel Therapeutics released positive Phase III TEMPO-3 trial results for tavapadon in Parkinson's disease. Tavapadon, a D1/D5 receptor partial agonist, showed efficac

14-04-2024

Acadia’s schizophrenia drug trial did not meet primary endpoint

US-based biopharmaceutical company Acadia Pharmaceuticals has announced that its Phase III ADVANCE-2 clinical trial evaluating pimavanserin for the treatment of negativ

14-04-2024

Enlivex declares positive data from Phase II sepsis treatment trial

Enlivex Therapeutics has disclosed promising top-line results regarding safety and efficacy from its Phase II clinical trial evaluating Allocetra, an off-the-shelf cell

14-04-2024

Teva’s Ajovy hits endpoint in Chinese Phase III Trial for Migraine Prevention

Teva Pharmaceuticals has released encouraging results from a Phase III trial assessing Ajovy (fremanezumab) for migraine prevention in Chinese adult patients.

14-04-2024

Amylyx reports positive results for failed ALS drug in Wolfram trial

Amyyx Pharmaceuticals has released promising interim results from its Phase II trial of Relyvrio (AMX0035) for Wolfram syndrome, a rare disease.

13-04-2024

NeuroGenesis declares positive data from multiple sclerosis trial

NeuroGenesis Bio's interim analysis of a Phase II clinical trial extension for NG-01 in progressive MS yielded promising results. NG-01, the company's lead candidate, i

10-04-2024

AstraZeneca reports positive results from the ADRIATIC phase III trial of Imfinzi in patients with limited-stage small-cell lung cancer

The ADRIATIC phase III trial unveiled promising results indicating AstraZeneca’s Imfinzi (durvalumab) significantly enhanced overall survival (OS) and progression

10-04-2024

Viking declares positive data from Phase I oral obesity treatment trial

Viking Therapeutics has reported positive data from its Phase I multiple ascending dose (MAD) clinical trial of VK2735, an oral tablet under investigation for treating

10-04-2024

Phase III trial of KRAZATI meets endpoints : Bristol Myers Squibb

Bristol Myers Squibb (BMS) disclosed positive results from its Phase III KRYSTAL-12 trial of KRAZATI (adagrasib) for treating non-small cell lung cancer (NSCLC) with KR

10-04-2024

Moderna: Phase III Covid-19 vaccine trial meets primary endpoints

Moderna has disclosed promising interim findings from the Phase III NextCOVE clinical trial, demonstrating the efficacy of its next-generation COVID-19 vaccine candidat

10-04-2024

LENZ declares positive results from presbyopia treatment trial

LENZ Therapeutics disclosed positive results from the Phase III CLARITY study assessing aceclidine formulations, LNZ100 and LNZ101, for presbyopia treatment.

09-04-2024

HealthNet Global presents a ground-breaking Tele-ICU Programme at Apollo Spectra Hospitals, Delhi

HealthNet Global (HNG) introduces its Tele-ICU program at the inauguration of Apollo Spectra Hospital in Pusa Road, Delhi, marking a significant advancement in critical

31-03-2024

Pfizer declares positive results from phase 3 trial of Adcetris regimen in relapsed/refractory DLBCL patients

Pfizer Inc. has announced positive results from a phase 3 trial of Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for relapsed/refractory

31-03-2024

Aurobindo Pharma arm CuraTeQ reports omalizumab biosimilar candidate BP11 meets phase 1 trial endpoints

CuraTeQ Biologics Private Limited, a subsidiary of Aurobindo Pharma Ltd, announced that their omalizumab biosimilar candidate BP11 met phase 1 trial endpoints compared

31-03-2024

OcuTerra’s Phase II diabetic retinopathy trial misses endpoints

OcuTerra Therapeutics reported that its Phase II DREAM trial of nesvategrast (OTT166) eye drops for diabetic retinopathy (DR) didn't meet endpoints. The study aimed to

30-03-2024

Bristol Myers Squibb reports CheckMate -9DW trial of Opdivo plus Yervoy meets primary endpoint of OS to treat advanced HCC

Bristol Myers Squibb has announced positive findings from the phase 3 CheckMate -9DW trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as first-line therapy

30-03-2024

Nuvectis Pharma reports positive preliminary data from NXP800 phase 1b trial in ovarian cancer (platinum-resistant ARID1a-mutated)

Nuvectis Pharma, Inc., a biopharmaceutical company, shared positive preliminary findings from a phase 1b trial of NXP800 for platinum-resistant ARID1a-mutated ovarian c

22-03-2024

Ionis Pharma reports positive results from the phase 2 study of ION224, demonstrating clinical efficacy in treating NASH/MASH

Ionis Pharmaceuticals, Inc. has released positive outcomes from a phase 2 trial of ION224, an investigational DGAT2 antisense inhibitor targeting metabolic dysfunction-

21-03-2024

GSK reports positive results from DREAMM-8 phase III trial for Blenrep vs standard of care combination in relapsed/refractory MM

GSK plc announced positive interim results from the DREAMM-8 phase III trial, comparing Blenrep (belantamab mafodotin) plus pomalidomide and dexamethasone (PomDex) agai

21-03-2024

Phase II KARDIA-2 study of zilebesiran in people with hypertension meets primary endpoint: Roche & Alnylam

Roche and Alnylam reported positive results from the phase II KARDIA-2 trial [NCT05103332] of zilebesiran, an investigational RNAi therapy for hypertension, a primary c

21-03-2024

BlueRock Therapeutics reports positive 18-month data from phase I trial for bemdaneprocel in Parkinson’s disease

Bayer AG and BlueRock Therapeutics LP, an independently operated subsidiary of Bayer AG, have disclosed 18-month data from a phase I clinical trial on bemdaneprocel, an

21-03-2024

MAIA Biotechnology declares positive data from NSCLC therapy trial

MAIA Biotechnology has released positive efficacy results from its Phase II THIO-101 trial, examining THIO combined with cemiplimab (Libtayo) for advanced non-small cel

16-03-2024

Viking Therapeutics, Inc. reported positive outcomes from its phase 2 trial of VK2735, a dual GLP-1 and GIP receptor agonist for metabolic disorders

Viking Therapeutics, Inc. (Viking), a clinical-stage biopharmaceutical company specializing in metabolic and endocrine disorder treatments, reported positive outcomes f

16-03-2024

GSK reports positive results for gepotidacin in uncomplicated urogenital gonorrhoea from EAGLE-1 phase III trial

GSK plc announced positive outcomes from the pivotal EAGLE-1 phase III trial of gepotidacin, an oral antibiotic targeting urogenital gonorrhea in adults and adolescents

16-03-2024

Biodexa reports an R&D update including positive results from the phase I trial of MTX110 in patients with diffuse midline glioma

Biodexa Pharmaceuticals PLC, a clinical-stage biopharmaceutical company, shares an R&D update. Positive top-line results from a recent phase 1 trial of MTX110 in di

15-03-2024

Bristol Myers Squibb declares positive results of Zeposia from phase 3 DAYBREAK open-label extension trial in patients with MS (relapsing forms)

Bristol Myers Squibb revealed findings from the phase 3 DAYBREAK trial, demonstrating Zeposia's (ozanimod) enduring efficacy and safety in relapsing forms of multiple s

15-03-2024

Cynata Therapeutics declares inspiring initial data from the phase 1 trial of CYP-006TK to treat a diabetic foot ulcer

Cynata Therapeutics Limited, a biotech firm specializing in cell therapeutics, completed the initial analysis of wound surface area in the first 16 patients of its phas

07-03-2024

Novartis proposes positive data from the SMART study of Zolgensma in older and heavier children with SMA at the 2024 MDA conference

Novartis revealed new data affirming the clinical advantages of Zolgensma (onasemnogene abeparvovec), the sole one-time gene therapy for spinal muscular atrophy (SMA).<

07-03-2024

Ultimovacs declares trial results of UV1 cancer vaccine.

Ultimovacs, a biotechnology company in its clinical stages, has unveiled data from the Phase II NIPU trial on the UV1 cancer vaccine, focusing on mesothelioma. This tri

07-03-2024

Pfizer notifies top-line results from Phase III RSV vaccine trial

Pfizer's Phase III RENOIR trial reveals top-line data on its respiratory syncytial virus (RSV) vaccine, ABRYSVO, targeting RSV-related lower respiratory tract disease (

06-03-2024

ViiV Healthcare demonstrates positive findings from the phase I study of cabotegravir long-acting injectable investigational formulation

GSK plc and ViiV Healthcare, a specialized HIV company majority-owned by GSK with Pfizer and Shionogi as shareholders, announced positive phase I study results for cabo

06-03-2024

CASI and BioInvent declare positive data from lymphoma treatment trial

CASI Pharmaceuticals and BioInvent International unveiled positive initial efficacy findings from their Phase I trial of BI-1206 in relapsed/refractory indolent non-Hod

26-02-2024

Sanofi communicates positive results from trial of frexalimab for multiple sclerosis (MS)

Sanofi, a French pharmaceutical company, is developing frexalimab under an exclusive license from ImmuNext. Positive Phase II trial results were recently announced for

26-02-2024

Hemab notifies positive Phase I Glanzmann thrombasthenia therapy data

HMB-001 is assessed as a prophylactic treatment for a bleeding disorder, Glanzmann thrombasthenia. Hemab Therapeutics has unveiled encouraging preliminary data from the

25-02-2024

Phase III thyroid eye disease trial of Innovent fulfils primary endpoint

The antibody IBI311 showed favorable safety in Thyroid Eye Disease (TED) patients. Innovent Biologics disclosed positive results from the Phase III RESTORE-1 trial in C

25-02-2024

UroMems declares positive results for stress urinary incontinence implant

Stress urinary incontinence, marked by urine leakage during activities like exercise or sneezing, is the focus of UroMems' latest trial evaluating its UroActive device.

24-02-2024

NeuroSense expands data in Phase IIb ALS study with positive update

Symptoms of amyotrophic lateral sclerosis (ALS) include hand and arm motor control loss and limb usage impairment. NeuroSense released additional top-line data from its

20-02-2024

AstraZeneca’s Tagrisso exhibited overwhelming efficacy benefit for patients with unresectable, stage III EGFR-mutated lung cancer in LAURA phase III trial

The LAURA phase III trial highlights AstraZeneca's Tagrisso (osimertinib) as a promising intervention, demonstrating a statistically significant improvement in progress

20-02-2024

Tharimmune’s buccal film liver drug exhibits efficacy in Phase I trial

Tharimmune, a US biotech firm, has unveiled promising data on TH104, a transmucosal buccal film designed for liver-related and inflammatory conditions. TH104 targets ai

20-02-2024

Sanofi and Denali’s ALS therapy misses preliminary endpoint in Phase II trials

Sanofi and Denali Therapeutics' ALS therapy, SAR443820/DNL788, didn't meet its primary endpoint in the Phase II HIMALAYA trial. The trial aimed to gauge its effect on t

15-02-2024

Grifols registers positive topline outcomes from phase 3 fibrinogen clinical tr

Grifols, a leading producer of plasma-derived medicines, announced positive results from Biotest's phase 3 trial of fibrinogen concentrate (FC), BT524, for acquired fib

15-02-2024

Grifols documents positive topline outcomes from the phase 3 fibrinogen clinical trial

Grifols, a global leader in plasma-derived medicines, celebrates Biotest's phase 3 trial success with BT524, a fibrinogen concentrate (FC) for acquired fibrinogen defic

10-02-2024

Beacon registers positive 12-month data from phase 2 SKYLINE trial of AGTC-501 in patients with X-linked retinitis pigmentosa

Beacon Therapeutics Holdings Limited, a leading ophthalmic gene therapy company, presented interim results from the phase 2 SKYLINE trial for X-linked retinitis pigment

10-02-2024

Chugai Pharma’s mosunetuzumab accomplishes the primary endpoint in expansion cohort of the Japanese phase I trial for r/r follicular lymphoma

Chugai Pharmaceutical Co., Ltd. announced that the anti-CD20/CD3 bispecific antibody mosunetuzumab met the primary endpoint of complete response rate (CRR) in a Japanes