Recombinant Human Granulocyte/Macrophage Colonystimulating Factor（rhGM-CSF）

Savara Inc. initiated a rolling BLA submission to the FDA for MOLBREEVI, a potential treatment for aPAP, with plans to complete the submission by end of 1Q 2025. MOLBREEVI has Fast Track, Breakthrough Therapy, and Orphan Drug designations.

Savara Inc. initiated a rolling BLA submission to the FDA for MOLBREEVI, targeting aPAP treatment, expecting completion by Q1 2025. MOLBREEVI has Fast Track, Breakthrough Therapy, and Orphan Drug designations, with positive Phase 3 IMPALA-2 trial results. If approved, it could be the first aPAP treatment in the U.S. and Europe.

Zachary Klaassen and Mark Tyson discuss the PIVOT-006 trial evaluating cretostimogene versus surveillance for intermediate-risk non-muscle invasive bladder cancer. The trial, designed for both low-grade and high-grade disease, includes an induction phase followed by maintenance therapy, with a surveillance arm allowing crossover upon recurrence. Dr. Tyson emphasizes the importance of exploring treatment options for this patient group, especially given recurring tumors and potential BCG shortages. The discussion highlights strong enrollment progress and the role of partnerships with SUO-CTC and BCAN in supporting patient-centered research.

Namilumab failed to show treatment benefit in pulmonary sarcoidosis patients; Kinevant Sciences to discontinue further development of namilumab for sarcoidosis treatment.

Greenwich LifeSciences partners with Italy's Gruppo Italiano Mammella (GIM) for Phase III FLAMINGO-01 trial evaluating GLSI-100 immunotherapy to prevent breast cancer recurrences. Nine top GIM institutions join the trial, with Italy being the first country to have all participating sites personally visited and trained by the company.

Replimune submitted a BLA to the FDA for RP1 in combination with nivolumab for advanced melanoma patients who have previously received an anti-PD1 regimen, under the Accelerated Approval pathway. The FDA also granted Breakthrough Therapy designation to RP1 in this setting, based on safety and clinical activity observed in the IGNYTE clinical trial.

Savara Inc. granted inducement awards to four new employees, including options for 80,000 shares and RSUs for 70,000 shares, under the 2021 Inducement Equity Incentive Plan.

Savara Inc. announces encore presentation of IMPALA-2 trial results at BTS Winter Meeting on Nov 29, 2024, focusing on inhaled molgramostim's impact on aPAP patients.