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News and Press Releases

Iksuda Therapeutics receives FDA IND clearance for IKS014

FDA decision will enable Iksuda to expand its ongoing clinical trial in the US, Australia and Singapore Preliminary data from an ongoing dose-escalation study of IKS014 has shown meaningful clinical activity across...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: July 1, 2025

Iksuda
The Biosphere, Draymans Way, Newcastle Helix Newcastle upon Tyne NE4 5BX

FDA Grants OKYO Pharma Fast Track Designation to Urcosimod for Neuropathic Corneal Pain

1 May 2025 -- London, UK and New York, US -- OKYO Pharma Limited, an ophthalmology-focused bio-pharmaceutical company which is developing urcosimod (formerly called OK-101) to treat NCP, an ocular...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 1, 2025

OKYO Pharma
info@okyopharma.com
OKYO Pharma Floor 4, 14/15 Conduit St London W1S 2XJ

PLL Therapeutics enrolls first patient in phase I/II trial of drug candidate PLL001 for Amyotrophic Lateral Sclerosis (ALS)

Multi-stage Australian study will evaluate safety of PLL001 in 12 ALS patients, testing three different doses along with placebo 140 ALS patients will participate in second stage of study to...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 15, 2025

PLL Therapeutics
contact@pll-therapeutics.com
10 Avenue Roger Lapébie 33140 Villenave d’Ornon France

Lundbeck to present positive pipeline data at American Academy of Neurology (AAN) Annual Meeting

4 April 2025 -- Valby, Denmark -- H. Lundbeck A/S (Lundbeck) to present positive interim results from the PACIFIC trial open-label extension investigating bexicaserin, in addition to new analyses from...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 4, 2025

Lundbeck
Iveco House Station Road Watford Hertfordshire WD17 1ET

OKYO Pharma Announces Positive Data in Long-Term Stability of Urcosimod

Urcosimod in Phase 2 clinical trial for Neuropathic Corneal Pain shown to have Long-Term Stability Urcosimod stable in single-use ampoules for more than 2½ years FDA requires drug to show...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 31, 2025

OKYO Pharma
info@okyopharma.com
OKYO Pharma Floor 4, 14/15 Conduit St London W1S 2XJ

Sanofi to acquire Dren Bio’s bispecific myeloid cell engager for deep B-cell depletion, broadening immunology pipeline

Dren Bio deep B-cell depleter program has the potential to reset the immune system Acquisition underpins path for Sanofi becoming leading immunology company Sanofi to pay $600 million up front....

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 20, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Lundbeck announces positive results from 12-month Open-Label Extension (OLE) of the PACIFIC trial evaluating bexicaserin in participants with Developmental and Epileptic Encephalopathies

Bexicaserin achieved an overall median seizure reduction of 59.3 percent in countable motor seizures over a 12-month open-label extension (OLE) treatment period. The treatment with bexicaserin demonstrated favorable safety and...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 30, 2025

Lundbeck
Iveco House Station Road Watford Hertfordshire WD17 1ET

Rentschler Biopharma announces strategic realignment of its global business operations

30 January 2025 – Laupheim, Germany – Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, announced today a realignment of its global business operations...

Category: BioManufacturing
Posted: January 30, 2025

Rentschler Biopharma
info@rentschler-biopharma.com
Erwin-Rentschler-Str. 21 88471 Laupheim Germany

Neumora Therapeutics Reports Data from KOASTAL-1 Study of Navacaprant in Major Depressive Disorder

Study did not demonstrate statistically significant improvement on primary endpoint of reduction in depressive symptoms as measured by MADRS total score compared to placebo Navacaprant showed an efficacy signal in...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: January 2, 2025

Neumora
investors@neumoratx.com
490 Arsenal Way, Suite 200 Watertown, MA 02472

Medidata and Cogstate Strike Strategic Partnership Transforming Clinical Trials in Neurology with Clinical Outcome Assessment (eCOA) and Clinician Solutions Powered by AI and Advanced Analytics

Science-driven collaboration ameliorates neurological assessments and endpoint data quality, enhances the rater and patient experience, and integrates Medidata App innovations with Cogstate capabilities 29 October 2024 -- New York, US...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other
Posted: October 29, 2024

Medidata
helpdesk@mdsol.com
350 Hudson Street New York, NY 10014 USA

Recursion Announces FDA Clearance of Investigational New Drug Application for REC-1245, a Potential First-In-Class RBM39 Degrader for Biomarker-Enriched Solid Tumors and Lymphoma

First program to combine Recursion’s end-to-end suite of AI-enabled active learning modules, resulting in target identification to IND enabling studies in under 18 months Plan to initiate dosing of Phase...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 2, 2024

Recursion
info@recursion.com
41 S Rio Grande Street Salt Lake City, UT 84101

AzurBio Pharma Launches to Fast-Track European Market Entry for Biopharma Companies with Breakthrough Treatments

1 October 2024 -- Paris, France -- AzurBio Pharma, specializing in bringing innovative pharmaceutical products to European markets and focusing on rare and serious diseases with unmet medical needs, is...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 1, 2024

AzurBio Pharma
32 Av. Kléber, 75116 Paris, France

RHYTHM AI announces FDA clearance of the commercial release version of STAR Apollo Mapping System

First-in-human cases successfully completed using this new system at Baptist Health, Jacksonville, Florida 23 September 2024, – London, UK – RHYTHM AI Ltd (“RHYTHM AI” or “the Company”), a UK...

Category: Biotechnology, Clinical Trials
Posted: September 23, 2024

Rhythm AI
info@rhythm-ai.com

One2Treat launches ground-breaking treatment-decision approach to clinical research and market access analysis

One2Treat reflects patient priorities in a single comprehensive treatment evaluation, reducing trial sample size and accelerating patient access to new treatments 26 March 2024 -- Brussels, Belgium -- One2Treat, a...

Category: Clinical Trials, Pharmaceutical
Posted: March 26, 2024

One2Treat
info@one2treat.com
Rue Emile Francqui, 1-1435 Mont-Saint-Guibert, Belgium

Abzena launches AbZelect platforms for improving cell line development efficiency on the pathway to IND

16 January 2023 -- California, US -- Abzena, the leading end-to-end CDMO for biologics and bioconjugates, has launched AbZelect and AbZelectPRO cell line development (CLD) platforms for accelerating the generation...

Category: Biotechnology
Posted: January 16, 2024

Abzena
Babraham Research Campus, Cambridge, CB22 3AT United Kingdom