| Company | Heron Therapeutics |
| Stock Quote | NASDAQ: HRTX |
| Study Name | ZYNRELEF (bupivacaine and meloxicam HTX-011) |
| Treatment | Postoperative pain |
| Status | Phase 3 |
| Catalyst Date | September 23, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Merck |
| Stock Quote | NYSE: MRK |
| Study Name | KEYNOTE-483 |
| Treatment | for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. |
| Status | supplemental Biologics License Applications (sBLA) Priority Review |
| Catalyst Date | September 25, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Karuna Therapeutics |
| Stock Quote | NASDAQ: KRTX |
| Study Name | KarXT (xanomeline-trospium) |
| Treatment | Healthy Elderly Volunteers |
| Status | New Drug Application (NDA) |
| Catalyst Date | September 26, 2024 |
| 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 | New Drug Application (NDA) |
| Catalyst Date | September 26, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Sanofi |
| Stock Quote | NASDAQ: SNY |
| Study Name | Dupixent (dupilumab) |
| Treatment | moderate-to-severe asthma |
| Status | supplemental Biologics License Applications (sBLA) |
| Catalyst Date | September 27, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Sanofi |
| Stock Quote | NASDAQ: SNY |
| Study Name | isatuximab |
| Treatment | Transplant-ineligible newly diagnosed multiple myeloma (NDMM). |
| Status | supplemental Biologics License Applications (sBLA) Priority Review |
| Catalyst Date | September 27, 2024 |
| Catalyst | PDUFA Date |
| Announcement | N/A |
| Website | Click Here |
| Company | NeuroOne Medical Technologies |
| Stock Quote | NASDAQ: NMTC |
| Study Name | ICD-10 |
| Treatment | sEEG RF Ablation |
| Status | N/A |
| Catalyst Date | October 1, 2024 |
| Catalyst | Data Presentation |
| Announcement | Read More |
| Website | Click Here |
| Company | Iterum Therapeutics |
| Stock Quote | NASDAQ: ITRM |
| Study Name | sulopenem etzadroxil/probenecid |
| Treatment | Uncomplicated urinary tract infections (uUTIs) |
| Status | Phase 3 |
| Catalyst Date | October 25, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | PTC Therapeutics |
| Stock Quote | NASDAQ: PTCT |
| Study Name | Upstaza |
| Treatment | Aromatic L-amino acid decarboxylase (AADC) deficiency |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | November 13, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Autolus Therapeutics |
| Stock Quote | NASDAQ: AUTL |
| Study Name | Obe-cel (AUTO1 - ALLCAR19) ALL |
| Treatment | Adult Acute lymphoblastic leukemia (ALL) |
| Status | N/A |
| Catalyst Date | November 16, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Applied Therapeutics |
| Stock Quote | NASDAQ: APLT |
| Study Name | AT-007 |
| Treatment | Galactosemia |
| Status | New Drug Application (NDA) |
| Catalyst Date | November 28, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | BridgeBio Pharma |
| Stock Quote | NASDAQ: BBIO |
| Study Name | Acoramidis (ATTRibute-CM) |
| Treatment | Symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM) |
| Status | New Drug Application (NDA) |
| Catalyst Date | November 29, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Jazz Pharmaceuticals |
| Stock Quote | NASDAQ: JAZZ |
| Study Name | Zanidatamab |
| Treatment | In HER2+/HR+ Metastatic Breast Cancer |
| Status | Biologics License Applications (BLA) Priority Review |
| Catalyst Date | November 29, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | AstraZeneca |
| Stock Quote | NASDAQ: AZN |
| Study Name | Datopotamab deruxtecan (Dato-DXd) |
| Treatment | Hormone Receptor Positive |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | December 20, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Lexicon Pharmaceuticals |
| Stock Quote | NASDAQ: LXRX |
| Study Name | sotagliflozin |
| Treatment | INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). |
| Status | New Drug Application (NDA) |
| Catalyst Date | December 20, 2024 |
| 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 | New Drug Application (NDA) |
| Catalyst Date | December 26, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Rhythm Pharmaceuticals |
| Stock Quote | NASDAQ: RYTM |
| Study Name | IMCIVREE (setmelanotide) |
| Treatment | Obesity and Control of Hunger Associated with POMC |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | December 26, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Soleno Therapeutics |
| Stock Quote | NASDAQ: SLNO |
| Study Name | Diazoxide Choline Controlled-Release (DCCR- DESTINY PWS) |
| Treatment | Prader-Willi syndrome (PWS) |
| Status | New Drug Application (NDA) |
| Catalyst Date | December 27, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Checkpoint Therapeutics |
| Stock Quote | NASDAQ: CKPT |
| Study Name | Cosibelimab (cSCC) |
| Treatment | Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC) |
| Status | Biologics License Applications (BLA) |
| Catalyst Date | December 28, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Neurocrine Biosciences |
| Stock Quote | NASDAQ: NBIX |
| Study Name | crinecerfont |
| Treatment | For the Treatment of Congenital Adrenal Hyperplasia (CAH) |
| Status | New Drug Application (NDA) |
| Catalyst Date | December 30, 2024 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Axsome Therapeutics |
| Stock Quote | NASDAQ: AXSM |
| Study Name | AXS-07 |
| Treatment | Acute Treatment of Migraine |
| Status | New Drug Application (NDA) |
| Catalyst Date | January 31, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Vertex Pharmaceuticals |
| Stock Quote | NASDAQ: VRTX |
| Study Name | suzetrigine |
| Treatment | Moderate-to-Severe Acute Pain |
| Status | New Drug Application (NDA) |
| Catalyst Date | January 30, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Supernus Pharmaceuticals |
| Stock Quote | NASDAQ: SUPN |
| Study Name | SPN-830 (apomorphine infusion pump) |
| Treatment | Continuous treatment of motor fluctuations in Parkinson's disease (PD) |
| Status | New Drug Application (NDA) |
| Catalyst Date | February 1, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Bristol-Myers Squibb |
| Stock Quote | NYSE: BMY |
| Study Name | Opdivo (nivolumab) |
| Treatment | resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting |
| Status | Phase 3 |
| Catalyst Date | February 28, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Eton Pharmaceuticals |
| Stock Quote | NASDAQ: ETON |
| Study Name | ET-400 |
| Treatment | Hydrocortisone Oral Solution |
| Status | New Drug Application (NDA) |
| Catalyst Date | February 28, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | SpringWorks Therapeutics |
| Stock Quote | NASDAQ: SWTX |
| Study Name | Mirdametinib |
| Treatment | Adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN) |
| Status | New Drug Application (NDA) |
| Catalyst Date | February 28, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | scPharmaceuticals |
| Stock Quote | NASDAQ: SCPH |
| Study Name | FUROSCIX |
| Treatment | Decompensated heart failure |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | March 6, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Exelixis |
| Stock Quote | NASDAQ: EXEL |
| Study Name | Cabozantinib |
| Treatment | Neuroendocrine Tumors |
| Status | supplemental New Drug Application (sNDA) |
| Catalyst Date | April 3, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | Bristol-Myers Squibb |
| Stock Quote | NYSE: BMY |
| Study Name | Opdivo (nivolumab) |
| Treatment | Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting |
| Status | supplemental Biologics License Applications (sBLA) |
| Catalyst Date | April 21, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
| Company | KalVista Pharmaceuticals |
| Stock Quote | NASDAQ: KALV |
| Study Name | sebetralstat |
| Treatment | Therapy for hereditary angioedema (HAE). |
| Status | New Drug Application (NDA) |
| Catalyst Date | June 17, 2025 |
| Catalyst | PDUFA Date |
| Announcement | Read More |
| Website | Click Here |
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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