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Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.

Speaking at a conference this morning, Pfizer CEO Albert Bourla suggested that Metsera’s therapies could begin hitting the market in 2028.

Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.

Korro Bio is moving back to square one as a preclinical biotech after the failure of KRRO-110 in alpha-1 antitrypsin deficiency. The company’s stock is down 80% on all the news.

Follow along as BioSpace tracks job cuts and restructuring initiatives.

The decision to pause dapiglutide will help Zealand focus investment into assets that have “the greatest potential for clinical differentiation” in obesity.

In January, AbbVie and Calico’s fosigotifator failed to show significant signs of efficacy in the HEALEY ALS platform trial for amyotrophic lateral sclerosis.

Alixorexton’s Phase II performance sets it up for late-stage success, according to analysts at Truist Securities. Alkermes expects to launch a global late-stage program early next year for narcolepsy type 2.

The plausible mechanism pathway “could accelerate gene therapy/editing development,” analysts at William Blair said Thursday, while adding that additional clarity is needed.

The back-heavy deal includes a $5 million upfront payment for two novel T cell engagers, though the companies have yet to disclose priority indications.

In this episode presented by Slone Partners, Leslie Loveless, Co-CEO and Managing Partner discusses how hiring and the building of executive teams has responded to the current biotech environment.

One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.

Strong VINIA Momentum and New CDMO Win Delivers 39% Year-Over-Year GrowthCompany Fortifies Balance Sheet with Recent $19.9 Million Instiutional Equity Raise Following $14.7 Million Strengthening of Balance Sheet via Accelerated Warrant Exercises and Debt-to-Equity Conversions in September

Clinical Trial has Advanced to Fifth and Final Cohort at Maximum Dose of INSTASYL PH-762 in Skin Cancer Trial Positive Pathology Results at Maximum Dose: 100% Tumor Clearance (Complete Response) in One Patient, Greater than 90% (Near Complete Response) in Second Patient, Greater than 50% (Partial Response) in Third Patient Safety Monitoring Committee Issues Favorable Review of Safety Data at Maximum Dose of INTASYL PH-762 Warrant Inducement Financing in November 2025 for Expected Net Proceeds Totaling Approximately $12.1 million, Extending Cash Runway into the First Half of 2027

Session led by neurosurgeon Dr. Fraser Henderson and Hemostemix CEO Thomas Smeenk for the University of Florida’s Department of Surgery, Division of Vascular Surgery & Endovascular Therapy (Gainesville)

Once issued, this new U.S. patent covers the use of CardiolRx™ and CRD-38 for a broad range of cardiac disorders, including atherosclerosis and heart failure, significantly expanding intellectual property protection in the world’s largest pharmaceutical market. This allowance fortifies Cardiol’s global intellectual property portfolio, adding to granted and pending patent applications in Europe, Japan, Canada, Australia, and China.

Management to host conference call at 8:00 AM Eastern time on Thursday, November 13, 2025

Near-term applications include combinations with kinase inhibitors (KIs) that achieve enhanced concentration at target sites and synergistic delivery of multiple KIs to the same location