Akebia Therapeutics

PeptiSystems and Asahi Kasei Bioprocess America Form Strategic Partnership to Revolutionize Peptide Manufacturing

7 days ago

• PeptiSystems and Asahi Kasei Bioprocess America have established an exclusive global partnership combining PeptiSystems' flow-through platform with AKBA's THESYS® ACS Ergo synthesis column technology. • The collaboration aims to streamline peptide manufacturing processes by reducing changeover times between batches while maintaining high standards of user safety, product quality, and synthesis efficiency. • This strategic alliance will serve pharmaceutical companies and CDMOs globally, enabling more efficient production of complex peptide and oligonucleotide therapeutics with reduced material waste and enhanced reproducibility.

EMA Recommends Approval of Averoa's XOANACYL for Chronic Kidney Disease Treatment

2 months ago

• The European Medicines Agency's CHMP has issued a positive opinion for XOANACYL, an oral therapy for chronic kidney disease, with final European Commission approval expected by June 2025. • XOANACYL offers a dual mechanism of action, providing ferric iron for addressing iron deficiency while controlling phosphorus absorption in CKD patients, addressing two common complications of the disease. • Averoa, which licensed XOANACYL from Akebia Therapeutics in 2022, is actively seeking strategic commercial partnerships to bring the treatment to market across Europe following anticipated regulatory approval.

Akebia Therapeutics Secures $50 Million Through Public Offering to Advance Kidney Disease Treatments

2 months ago

• Akebia Therapeutics has priced its public offering of 25 million shares at $2.00 per share, expecting to raise $50 million in gross proceeds to support its kidney disease-focused pipeline. • The Cambridge-based biopharmaceutical company has granted underwriters a 30-day option to purchase up to an additional 3.75 million shares, potentially increasing the capital raised. • Leerink Partners and Piper Sandler are serving as joint bookrunning managers for the offering, which is expected to close on March 21, 2025, subject to customary closing conditions.

Akebia Therapeutics Expands Vafseo Access and Plans Phase 3 Trial for Non-Dialysis CKD Patients

4 months ago

• Akebia Therapeutics has secured commercial supply contracts for Vafseo, covering nearly 100% of U.S. dialysis patients, with shipments commencing in January 2025. • A Phase 3 trial is planned to begin in mid-2025 to evaluate Vafseo for treating anemia in late-stage chronic kidney disease (CKD) patients not on dialysis. • Market research indicates strong nephrologist interest in prescribing Vafseo, with 99% considering it for eligible patients and 75% planning to prescribe within six months. • Akebia believes Vafseo has the potential to become a new standard of care for CKD patients, with label expansion representing a multi-billion dollar market opportunity.

GLP-1 Receptor Agonists and SGLT2 Inhibitors Show Promise in Cardio-Renal Protection

5 months ago

• Vadadustat (Vafseo) was approved by the FDA for treating anemia caused by chronic kidney disease (CKD) in adults on dialysis for at least 3 months. • Combination therapy with GLP-1 receptor agonists (GLP-1RAs) and SGLT2 inhibitors reduces CKD by 33% and slows kidney function loss by nearly 60%. • Semaglutide shows benefits in treating CKD and cardiovascular events in patients with type 2 diabetes, according to the FLOW randomized trial. • GLP-1s may improve cardiovascular outcomes and promote weight loss in breast cancer patients, according to research presented at ASCO.

Volixibat Receives FDA Breakthrough Therapy Designation for Cholestatic Pruritus in Primary Biliary Cholangitis

7 months ago

• The FDA granted Breakthrough Therapy Designation to Mirum Pharmaceuticals' volixibat for treating cholestatic pruritus in patients with primary biliary cholangitis (PBC). • Phase 2b VANTAGE study results showed statistically significant improvements in pruritus levels and serum bile acid reduction with volixibat. • Volixibat targets pruritus reduction, a debilitating symptom of PBC, unlike other treatments that focus on decreasing alkaline phosphatase (ALP) levels. • Analyst Ed Arce maintains a Buy rating for Mirum, citing volixibat's potential to improve patients' quality of life and its competitive advantages.

Akebia Prepares Vafseo Launch for Dialysis Patients, Seeks Expansion to Pre-Dialysis Market

8 months ago

• Akebia Therapeutics is set to launch Vafseo (vadadustat) in January 2025 for anemia treatment in dialysis patients, following its FDA approval in March. • The company plans to re-engage with the FDA to explore Vafseo's potential use in pre-dialysis chronic kidney disease (CKD) patients. • Akebia aims to present data from the Phase 3 PRO2TECT trial to support the drug's efficacy and safety in the pre-dialysis population, addressing an unmet medical need. • Company anticipates feedback from the FDA by the end of the year regarding further testing and approval pathways for the pre-dialysis market.

Akebia Resubmits FDA Application for Vadadustat in Dialysis-Dependent CKD Anemia

2 years ago

• Akebia Therapeutics has resubmitted its New Drug Application (NDA) to the FDA for vadadustat for anemia due to chronic kidney disease in adults on dialysis. • The resubmission includes post-marketing safety data from tens of thousands of patients in Japan, where vadadustat is already approved. • The FDA is expected to acknowledge the resubmission within 30 days and set a PDUFA date approximately six months from the submission date. • Vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is designed to mimic the physiological effect of altitude on oxygen availability.