Press Releases

Company press releases and official corporate announcements.

A centralized feed of corporate press releases, earnings announcements, mergers, and official statements. Content is presented for informational purposes and may require additional analysis for market relevance.

Articles

23,630 total articles

Filana Therapeutics Announces FDA Lift of Clinical Hold on Simufilam, Enabling Phase 2a Study in TSC-Related Epilepsy

Filana Therapeutics Announces FDA Lift of Clinical Hold on Simufilam, Enabling Phase 2a Study in TSC-Related Epilepsy

Filana Therapeutics announced the FDA has lifted the clinical hold on simufilam, allowing the company to proceed with a Phase 2a study targeting Tuberous Sclerosis Complex-related epilepsy. Patient screening is expected to begin in early 2027. The 16-week trial will assess safety, tolerability, and efficacy in seizure reduction in 40 patients, supp…

Host Digital Debuts on NYSE American as HOST and Exercises its Right to Acquire a Second Site from its Sponsor for its AI Data Center Platform

Host Digital Debuts on NYSE American as HOST and Exercises its Right to Acquire a Second Site from its Sponsor for its AI Data Center Platform

Host Digital Inc., a U.S.-based digital infrastructure company specializing in AI and high-performance computing data centers, has begun trading on the NYSE American under ticker HOST. The company completed a merger to acquire its initial Site I data center and signed an agreement granting preferential rights to acquire additional sites from its Sp…

Lantheus Receives Final FDA Approval for BRAVNETSA™ (Lutetium Lu 177 Dotatate), the Only Radiopharmaceutical FDA has Determined to be Bioequivalent and Therapeutically Equivalent to LUTATHERA® for the Treatment of GEP-NETs

Lantheus Receives Final FDA Approval for BRAVNETSA™ (Lutetium Lu 177 Dotatate), the Only Radiopharmaceutical FDA has Determined to be Bioequivalent and Therapeutically Equivalent to LUTATHERA® for the Treatment of GEP-NETs

Lantheus Holdings, Inc. announced that the FDA has granted final approval for BRAVNETSA™ (lutetium Lu 177 dotatate), establishing it as the only radiopharmaceutical deemed bioequivalent and therapeutically equivalent to LUTATHERA® for treating somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Approval via the A…

Lianhe Sowell International Group Ltd. Signs Strategic Cooperation Agreement with Subsidiary of Chery Group Holding Company to Advance Intelligent Equipment in China’s Automotive Aftermarket

Lianhe Sowell International Group Ltd. Signs Strategic Cooperation Agreement with Subsidiary of Chery Group Holding Company to Advance Intelligent Equipment in China’s Automotive Aftermarket

Lianhe Sowell International Group Ltd., a Nasdaq-listed provider of industrial machine vision and automation solutions, has signed a strategic cooperation agreement with Kumquat Technology Co., a Chery Group subsidiary operating 1,000 4S stores across China. This partnership aims to promote intelligent equipment solutions for 24 automotive aftermar…

Genius Group to host Genius Future Summit on November 5-6, 2026.

Genius Group to host Genius Future Summit on November 5-6, 2026.

Genius Group Limited (NYSE American: GNS) is hosting its second annual Genius Future Summit on November 5-6, 2026, at Genius City in Bali. The event will showcase leading futurists like Dr. Michio Kaku and Peter Diamandis, discuss key future trends in AI, blockchain, and community, and launch new projects including the Genius Awards and Genius City…

EagleNXT Provides Update on American-Made Drone and Sensor Shipments from U.S. Headquarters in Allen, Texas

EagleNXT Provides Update on American-Made Drone and Sensor Shipments from U.S. Headquarters in Allen, Texas

AgEagle Aerial Systems Inc., trading as EagleNXT (NYSE: UAVS), announced that its Allen, Texas headquarters is now shipping domestically-produced eBee VISION ISR drones and the newly released MicaSense RedEdge-MX multispectral sensors. The company recently fulfilled a key order delivering nine eBee VISION kits to the U.S. Army's National Training C…

Rhythm Pharmaceuticals Announces Health Canada Approval of IMCIVREE® (setmelanotide) for Weight Management in Adult and Pediatric Patients 4 years of Age and Older with Acquired Hypothalamic Obesity

Rhythm Pharmaceuticals Announces Health Canada Approval of IMCIVREE® (setmelanotide) for Weight Management in Adult and Pediatric Patients 4 years of Age and Older with Acquired Hypothalamic Obesity

Rhythm Pharmaceuticals announced Health Canada’s approval of IMCIVREE® (setmelanotide) for managing weight in adult and pediatric patients aged 4 and older with acquired hypothalamic obesity (HO). This indication expansion follows successful Phase 3 trial results showing significant BMI reduction. IMCIVREE is a first-in-class MC4R agonist targeting…

Clene to Present at Upcoming Investor Conferences

Clene to Present at Upcoming Investor Conferences

Clene Inc., a late-stage biopharmaceutical company focused on mitochondrial health therapies for neurodegenerative diseases, announced its participation in the 5th Annual ROTH Healthcare Opportunities Conference and the Lytham Partners Investor Conference Fall Event on September 29-30, 2026. Management will conduct one-on-one investor meetings and …

Adagene Announces NMPA Clearance of Investigational New Drug Application for ADG138, a Novel HER2xCD3 Double-Masked Bispecific T-Cell Engager

Adagene Announces NMPA Clearance of Investigational New Drug Application for ADG138, a Novel HER2xCD3 Double-Masked Bispecific T-Cell Engager

Adagene announced that China's National Medical Products Administration (NMPA) has approved its IND application for ADG138, a novel double-masked HER2xCD3 bispecific T-cell engager designed with proprietary SAFEbody technology to selectively target HER2-expressing tumors with reduced systemic toxicity. The company plans to initiate a Phase 1 study …

Swvl Establishes Presence in Madinah, Launching 24/7 Shuttle Service Across Seven Hotels in the Pilgrimage Transport Segment

Swvl Establishes Presence in Madinah, Launching 24/7 Shuttle Service Across Seven Hotels in the Pilgrimage Transport Segment

Swvl Holdings Corp announces the launch of a 24/7 shuttle service in Madinah, Saudi Arabia, connecting seven hotels to Al-Masjid an-Nabawi and key city landmarks. This initiative deepens Swvl's presence in the Kingdom of Saudi Arabia, targeting the high-demand pilgrimage transport segment with technology-enabled mass mobility solutions. The move al…

Natural design. Amplified: Smith+Nephew announces FDA 510(k) clearance and first surgical cases of LANDMARK™ Total Knee System

Natural design. Amplified: Smith+Nephew announces FDA 510(k) clearance and first surgical cases of LANDMARK™ Total Knee System

Smith+Nephew announced FDA 510(k) clearance for its LANDMARK Total Knee System, a next-generation knee replacement designed to replicate healthy knee anatomy and support personalized knee arthroplasty. The company has completed first surgical cases and plans a phased commercial launch starting with early adopters and broader availability in 2027.

Marker Therapeutics Highlights Expanded Manufacturing Support of CDMO Partner Following Formation of Kincellis Advanced Therapies

Marker Therapeutics Highlights Expanded Manufacturing Support of CDMO Partner Following Formation of Kincellis Advanced Therapies

Marker Therapeutics highlights enhanced manufacturing support for its lead immuno-oncology program MT-601 following the combination of its CDMO partner Cellipont Bioservices with Kincell Bio to form Kincellis Advanced Therapies. This expanded U.S.-based organization offers broader infrastructure and expertise to support late-stage clinical developm…

FTI Consulting Appoints Eileen Fargis as Senior Managing Director to Enhance Power, Renewables and Energy Transition Advisory Capabilities

FTI Consulting Appoints Eileen Fargis as Senior Managing Director to Enhance Power, Renewables and Energy Transition Advisory Capabilities

FTI Consulting has appointed Eileen Fargis as Senior Managing Director in its global Power, Renewables & Energy Transition practice. With extensive experience in the energy sector, Ms. Fargis will advise clients on strategic, financial, and operational challenges amid growing electricity demand, regulatory changes, and capital constraints. Her appo…

Beta Bionics Announces Agreement Integrate the iLet® Bionic Pancreas and mint™ with Senseonics’ Eversense® 365

Beta Bionics Announces Agreement Integrate the iLet® Bionic Pancreas and mint™ with Senseonics’ Eversense® 365

Beta Bionics announced a partnership with Senseonics to integrate its iLet Bionic Pancreas and mint automated insulin delivery systems with the Eversense 365 continuous glucose monitoring system. The combined system is expected to launch commercially in Q4 2026, offering users broader device choice and improved diabetes management through advanced …

Cerenome Secures In-Network Agreement with Blue Cross Blue Shield of Michigan, Expanding CNSide® Contracted Coverage to Approximately 158 Million Covered Lives

Cerenome Secures In-Network Agreement with Blue Cross Blue Shield of Michigan, Expanding CNSide® Contracted Coverage to Approximately 158 Million Covered Lives

Cerenome, Inc. announced that its subsidiary CNSide Diagnostics has signed an in-network agreement with Blue Cross Blue Shield of Michigan, expanding CNSide® CSF Tumor Cell Enumeration assay coverage to approximately 158 million commercial and Medicare Advantage covered lives. This agreement significantly enhances patient access and supports the co…