Latest News
& Press Releases

Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.

TOP STORIES
Clene, Inc. released data that shows its add-on treatment, CNM-Au8, significantly improved survival in patients with amyotrophic lateral sclerosis (ALS) by 70%.
Founded by George Church, known by many as the Father of Genomics, Manifold Bio launched with a $40 million Series A financing round to advance its “protein barcoding” platform.
CytoDyn Inc. has tapped Cyrus Arman as its new president and he is expected to take over the reins of the company as chief executive officer and be added to the board of directors within six months.
Key findings identify the mechanism behind how senescent cells become zombified, migraine drugs could combat obesity and new AI may identify vaccine hesitancy.
Beigene and Novartis announced the FDA has deferred action on the BLA for tislelizumab until inspections of facilities in China can be completed.
Regeneron Pharmaceuticals and Sanofi announced positive results from a Phase III trial of Dupixent (dupilumab) in kids ages one to 11 years with eosinophilic esophagitis (EoE).
Under the terms of the deal, Theravance and Innoviva are surrendering 85% and 15% of their stakes in Trelegy in exchange for $1.1 billion and $282 million from Royalty, respectively.
FDA
The FDA granted Novavax’s COVID-19 vaccine Emergency Use Authorization after a lengthy and obstacle-riddled journey. It is authorized as a two-dose primary series for adults 18 years and older.
At the end of June, Novartis announced the latest data readouts in a long string of successes for tislelizumab. BioSpace spoke with Ken Kato, an investigator on the most recent RATIONALE 306 trial.
Kyowa Kirin announced it is dropping its Parkinson’s disease candidate, KW-6356, a follow-up to Nourianz, despite promising Phase II data that showed the drug is “potentially effective.”
The agreement with Merck brings $290 million upfront to Orion to access the latter’s investigational candidate, ODM-208, for mCPRC and other related drugs.
Aviv Clinics reported data from a study that suggests hyperbaric oxygen therapy may alleviate long COVID symptoms, particularly those associated with cognition.
UPCOMING EVENTS
PRESS RELEASES
Expanded sweetener molecule development program aims to broaden access to plant-based sweetening solutions tailored to diverse customer food and beverage categories.
• $5.5 million financing that closed on April 2, 2026 together with $5.7 million in capital raised in Q1-2026, expected to provide Company with cash runway into 2027 • $4.5 million of accrued VAT refunds and R&D refundable tax credits from UK subsidiary begin maturing, including $1.9 million VAT cash refund expected in June 2026 • Successful EMA and Australia TGA (ATGA) meetings aligned around use of existing biomarker and pending release of 3-year overall survival data to support Conditional Marketing Authorisations (CMAs) for OST-HER2 in prevention or delay of recurrence in fully-resected, pulmonary metastatic osteosarcoma (“Metastatic Osteosarcoma”) • 2.5-year overall survival data expected to be released during ASCO 2026 • EMA and ATGA have aligned on key design aspects of confirmatory Phase 3 Metastatic Osteosarcoma protocol required to have commenced prior to grant of CMAs or FDA BLA, including alignment on 3-year overall survival as a primary clinical efficacy endpoint • Upcoming U.S. FDA Type C meeting and U.K. MHRA SAM meeting to align with EMA & ATGA prior to Australia Clinical Trial Notification submission for Phase 3, including alignment on 3-year overall survival as a primary clinical efficacy endpoint. U.S. FDA (“FDA”) Pre-BLA meeting to confirm alignment on surrogate and primary clinical efficacy endpoints with EMA/ATGA, including alignment on 3-year overall survival as a primary clinical efficacy endpoint, and seek decisions on rolling review acceptance and RMAT designation following the EMA and U.K. MHRA granting ATMP designation (EMA/MHRA RMAT equivalent) for OST-HER2 in Metastatic Osteosarcoma • OS Animal Health S-1 filing for proposed ‘Go-Public’ transaction and receipt of SEC comments
MARKET RESEARCH REPORTS