Tuesday - July 8, 2025
Company | Regeneron Pharmaceuticals |
Stock Quote | NASDAQ: REGN |
Study Name | Linvoseltamab (BCMAxCD3) |
Treatment | Relapsed/Refractory (R/R) Multiple Myeloma (MM) |
Status | supplemental Biologics License Applications (sBLA) |
Catalyst Date | July 10, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Ascendis Pharma |
Stock Quote | NASDAQ: ASND |
Study Name | TransCon hGH (Lonapegsomatropin) |
Treatment | Pediatric Growth Hormone Deficiency (GHD) |
Status | supplemental Biologics License Applications (sBLA) |
Catalyst Date | July 27, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Apellis Pharmaceuticals |
Stock Quote | NASDAQ: APLS |
Study Name | pegcetacoplan |
Treatment | Paroxysmal nocturnal hemoglobinuria (PNH) |
Status | supplemental New Drug Application (sNDA) |
Catalyst Date | July 28, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Regeneron Pharmaceuticals |
Stock Quote | NASDAQ: REGN |
Study Name | Odronextamab |
Treatment | To treat adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) |
Status | Biologics License Applications (BLA) |
Catalyst Date | July 30, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Tonix Pharmaceuticals |
Stock Quote | NASDAQ: TNXP |
Study Name | TNX-102 SL |
Treatment | Fibromyalgia |
Status | New Drug Application (NDA) |
Catalyst Date | August 15, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Ultragenyx Pharmaceutical |
Stock Quote | NASDAQ: RARE |
Study Name | UX111 |
Treatment | For Sanfilippo syndrome type A (MPS IIIA) |
Status | Biologics License Applications (BLA) |
Catalyst Date | August 18, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | PTC Therapeutics |
Stock Quote | NASDAQ: PTCT |
Study Name | Vatiquinone (MOVE-FA) |
Treatment | Friedreich ataxia |
Status | New Drug Application (NDA) |
Catalyst Date | August 19, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Regeneron Pharmaceuticals |
Stock Quote | NASDAQ: REGN |
Study Name | Aflibercept |
Treatment | For the treatment of patients with wet age-related macular degeneration (wAMD) |
Status | supplemental Biologics License Applications (sBLA) Priority Review |
Catalyst Date | August 19, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Capricor Therapeutics |
Stock Quote | NASDAQ: CAPR |
Study Name | deramiocel |
Treatment | For the treatment of Duchenne muscular dystrophy (DMD) |
Status | Biologics License Applications (BLA) |
Catalyst Date | August 31, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Capricor Therapeutics |
Stock Quote | NASDAQ: CAPR |
Study Name | deramiocel |
Treatment | For the treatment of Duchenne muscular dystrophy (DMD) |
Status | Biologics License Applications (BLA) |
Catalyst Date | August 31, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | BioCryst Pharmaceuticals |
Stock Quote | NASDAQ: BCRX |
Study Name | ORLADEYO (berotralstat) |
Treatment | Hereditary angioedema (HAE) |
Status | New Drug Application (NDA) |
Catalyst Date | September 12, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Cytokinetics |
Stock Quote | NASDAQ: CYTK |
Study Name | Aficamten |
Treatment | Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) |
Status | Phase 3 |
Catalyst Date | September 26, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Unicycive Therapeutics |
Stock Quote | NASDAQ: UNCY |
Study Name | Oxylanthanum Carbonate (OLC) |
Treatment | Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) |
Status | Phase 1 |
Catalyst Date | June 28, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Jazz Pharmaceuticals |
Stock Quote | NASDAQ: JAZZ |
Study Name | Zepzelca (lurbinectedin) |
Treatment | Relapsed Small Cell Lung Cancer (SCLC) |
Status | Phase 3 |
Catalyst Date | October 7, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Arcutis Biotherapeutics |
Stock Quote | NASDAQ: ARQT |
Study Name | ZORYVE™ (roflumilast) |
Treatment | Inhibitor of phosphodiesterase-4 (PDE4) |
Status | supplemental New Drug Application (sNDA) |
Catalyst Date | October 13, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Syndax Pharmaceuticals |
Stock Quote | NASDAQ: SNDX |
Study Name | Revumenib |
Treatment | Relapsed/Refractory KMT2Ar Acute Leukemia |
Status | supplemental New Drug Application (sNDA) |
Catalyst Date | October 25, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Merck |
Stock Quote | NYSE: MRK |
Study Name | sotatercept-csrk |
Treatment | In adults with pulmonary arterial hypertension |
Status | Biologics License Applications (BLA) Priority Review |
Catalyst Date | October 25, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | REGENXBIO |
Stock Quote | NASDAQ: RGNX |
Study Name | RGX-121 |
Treatment | MPS II (Hunter Syndrome) |
Status | Biologics License Applications (BLA) |
Catalyst Date | November 9, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Ascendis Pharma |
Stock Quote | NASDAQ: ASND |
Study Name | TransCon CNP |
Treatment | In Children with Achondroplasia |
Status | New Drug Application (NDA) |
Catalyst Date | November 30, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Kura Oncology |
Stock Quote | NASDAQ: KURA |
Study Name | Ziftomenib |
Treatment | Treatment of genetically defined AML patients with high unmet need |
Status | New Drug Application (NDA) |
Catalyst Date | November 30, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Innoviva |
Stock Quote | NASDAQ: INVA |
Study Name | Zoliflodacin |
Treatment | For the Treatment of Uncomplicated Gonorrhea |
Status | Phase 3 |
Catalyst Date | December 15, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Cytokinetics |
Stock Quote | NASDAQ: CYTK |
Study Name | Aficamten |
Treatment | Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) |
Status | New Drug Application (NDA) |
Catalyst Date | December 26, 2025 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Aquestive Therapeutics |
Stock Quote | NASDAQ: AQST |
Study Name | Anaphylm |
Treatment | For epinephrine prodrug candidate product |
Status | New Drug Application (NDA) |
Catalyst Date | January 31, 2026 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Company | Vanda Pharmaceuticals |
Stock Quote | NASDAQ: VNDA |
Study Name | Bysanti |
Treatment | For the Treatments of Acute Bipolar I Disorder and Schizophrenia |
Status | New Drug Application (NDA) |
Catalyst Date | February 21, 2026 |
Catalyst | PDUFA Date |
Announcement | Read More |
Website | Click Here |
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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