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Although it was a short week due to the Labor Day holiday, the FDA maintained a steady pace of business.

There are several approaches on the horizon in ALS, a space that is gaining momentum. BioSpace spoke with GeNeuro, NeuroSense and the Tisch MS Research Center about their progress.

Dermatology drugmaker Arcutis is acquiring Ducentis Biotherapeutics for $14 million in cash, $16 million in stock and milestones.

Homology Medicines and MiMedx both posted new CEOs. Other C-suite positions, including CFOs and CMOs were also filled this week.

A collaborative team of scientists formed The Long COVID Research Initiative to study and treat those battling the long-term effects of the virus, which include serious mental and physical symptoms.

A new report has shed light on some pharmaceutical companies’ attempts to circumvent federal anti-kickback statutes by profiting from large donations to patient assistance organizations.

Human lungs are delicate organs and are the main portal for entry and exit of aerosolized materials and gases.

SpringWorks, Eli Lilly, EMD Serono and Mirati released data ahead of the European Society of Medical Oncology (ESMO) 2022 Meeting in Paris.

Alnylam announced results Thursday from the APOLLO-B study of patisiran that showed improved functional capacity in (ATTR) amyloidosis patients with cardiomyopathy.

Photys Therapeutics launched Thursday with $75 million in financing and a focus on developing phosphorylation-inducing chimeric small molecule medicines to target underserved diseases.

SpringWorks announced the expansion of its partnership with GlaxoSmithKline to develop nirogacestat in combination with GSK’s Blenrep for relapsed or refractory multiple myeloma.

BioVie announced topline results from a Phase II biomarker study in Alzheimer’s disease showing patient improvements in cognition and reductions in neural inflammation.

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