Phosphate ion

China Approves First-in-Class Tenapanor for Hyperphosphatemia in Dialysis Patients

3 months ago

• Fosun Pharma's Wan Ti Le (tenapanor hydrochloride tablets) has received NMPA approval for controlling serum phosphorus in dialysis patients with chronic kidney disease who have inadequate response to phosphate binders. • As the world's first and only approved phosphate absorption inhibitor, tenapanor works through a novel mechanism by inhibiting NHE3, reducing intestinal phosphate absorption through the paracellular pathway. • Clinical studies show tenapanor can decrease serum phosphate levels by an additional 0.57 mmol/L when combined with phosphate binders, potentially addressing the low phosphate control rates (39%) among China's one million hemodialysis patients.

Daré Bioscience and Theramex Partner to Develop Novel Biodegradable Contraceptive Implant

3 months ago

• Daré Bioscience and Theramex have entered into a co-development agreement for Casea S, a first-in-category biodegradable contraceptive implant designed to last 18-24 months. • The innovative implant eliminates the need for surgical removal, addressing a key barrier in current contraceptive implants while offering women a convenient, long-acting contraceptive option. • A foundation-funded Phase 1 trial is currently underway to evaluate the pharmacokinetics, removability, safety, and tolerability of Casea S.

Unicycive and ORIC Pharmaceuticals Receive Buy Ratings Based on Promising Clinical Data

4 months ago

• Unicycive Therapeutics' OLC shows promise in treating hyperphosphatemia by reducing pill burden and adverse events, potentially gaining FDA approval by June 2025. • ORIC Pharmaceuticals' ORIC-944, combined with apalutamide, demonstrates significant PSA level decreases in metastatic castration-resistant prostate cancer patients. • Durability of ORIC-944 responses, with some patients maintaining PSA90 responses for 38 weeks, supports confidence in Oric Pharmaceuticals' strategic advancements. • H.C. Wainwright analyst Ed Arce maintains a Buy rating on Unicycive with a $4.00 price target, while Robert Burns reiterates a Buy rating on Oric with a $21.00 target.

Lisocabtagene Maraleucel Shows Promise in Relapsed/Refractory Lymphomas

5 months ago

• Lisocabtagene maraleucel (liso-cel) demonstrates efficacy and safety in second-line treatment of relapsed/refractory large B-cell lymphoma (LBCL), aligning with pivotal trial outcomes. • The TRANSCEND FL trial indicates liso-cel achieved a significant overall response rate in relapsed/refractory marginal zone lymphoma (MZL), meeting the primary endpoint. • Five-year data from TRANSCEND-NHL-001 underscore the curative potential of liso-cel in third-line LBCL, showing a 38% overall survival rate. • Real-world data supports liso-cel's effectiveness across diverse LBCL patient subgroups, reinforcing its role as a standard-of-care treatment option.

Unicycive's OLC Receives FDA Acceptance for Hyperphosphatemia NDA

6 months ago

• The FDA has accepted Unicycive Therapeutics' New Drug Application for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis. • The FDA has set a PDUFA target action date of June 28, 2025, for OLC, a next-generation lanthanum-based phosphate binding agent. • OLC aims to reduce pill burden and improve patient compliance, potentially offering a more convenient treatment option compared to existing therapies. • Clinical data supports OLC's safety and bioequivalence, with Unicycive preparing for a commercial launch in the second half of 2025, pending approval.

FDA Approves Bizengri for NRG1 Fusion-Positive Lung and Pancreatic Cancers

7 months ago

• The FDA has granted accelerated approval to Bizengri (zenocutuzumab-zbco) for advanced pancreatic adenocarcinoma and non-small cell lung cancer with NRG1 gene fusions. • Bizengri is the first systemic therapy approved by the FDA specifically targeting NRG1 gene fusions in these cancers after prior systemic therapy. • Clinical trial data showed overall response rates of 40% in pancreatic cancer and 33% in NSCLC, with manageable side effects, supporting the approval. • This approval highlights the importance of biomarker testing to identify NRG1 fusions, enabling personalized treatment for these difficult-to-treat cancers.

RYBREVANT® Plus Lazertinib Shows Significant PFS Improvement in EGFR-Mutated NSCLC

2 years ago

• The Phase 3 MARIPOSA study demonstrated that RYBREVANT® (amivantamab-vmjw) plus lazertinib significantly improved progression-free survival (PFS) compared to osimertinib in first-line EGFR-mutated NSCLC. • The combination therapy reduced the risk of disease progression or death by 30% compared to osimertinib, establishing a potential new standard of care. • An interim overall survival (OS) analysis showed a favorable trend for the RYBREVANT® and lazertinib combination, with ongoing monitoring to determine statistical significance. • The safety profile of the combination was consistent with individual treatments, with manageable adverse events and infrequent discontinuations, supporting its clinical utility.