Ascendis Pharma
BLA Submission Pediatric FDA 6.2020 / EMA geplant Q3
Novo
21 Sep ----------FDA APPROVAL Novo Somapacitan Pediatic Phase 3 https://clinicaltrials.gov/ct2/show/NCT02968004 Estimated Primary Completion Date : | June 5, 2021 | Estimated Study Completion Date : | December 1, 2024 |
March 2015 registered direct offering - Series A 28,144 1.07$ March 10, 2020
November 2016 registered direct offering 945,000 4.70$ May 1, 2020 December 2015 registered direct offering 2,331,000 7.10$ December 13, 2020 September 2019 registered direct offering 3,325,000 1.65$ September 24, 2024 Februar 2020 Investor Warrant 2,608,696 1.20$ Juli 21, 25 Februar 2020 Wainwright Warrants 243,478 1.61719$ February 19, 2025 Juli 2020 Common Warrants 17,544,516 0,45$ Juli 7, 2025
Juli 2020 Pre-funded Warrants 9,122,150 0,0001$
Termine 2020: Q1 ---- Ende PIP 01 (Kindrstudie) 10. März --- Ende der Serie A Warrants 24. März ----- Die 1,65$ September 2019 Warrants dürfen ausgeübt werden 1 April -------Beneficial Ownership Determination Date/ Record Date for Voting 6.April ------- Finale Ergebnisse PIP 01 (positive Results In Dose-finding) 1. Mai ------- Ende der 945T 4,7$ Warrants 15. Mai ------- Annual Meeting
8 Juni -------- Registrierung der 2019 und 2020 Warrants (Verkauf über den Markt zulässig)
25 Juni -------- Megapharm Distribution Agreement
7 Juli ----------- CLOSING OF $12 MILLION PUBLIC OFFERING
21 Sep ----------FDA APPROVAL Novo Somapacitan
5 Okt -------------- Nasdaq Listing (Rule 5550(b)(3))
13. Dez ---------- Ende der 2,33 Mio 7,1$ Warrants
Q1. 2021 -------- Anfang PIP 02
2022------- Ende PIP 02
? ------ EMA/FDA Zulassung pediatric
Table 1 Summary of long-acting recombinant human growth hormone preparations Class | Company | Product | Design | Status |
---|
Depot Formulations |
| BioPartners (Los Angeles, USA) LG Life Sciences (Seoul, South Korea) | Declage LB03002 | Growth hormone incorporated into sodum hyaluronate and suspended in MCT for injection | Approved for pediatric growth hormone deficiency in South Korea | PEGylated Formulations |
| GeneScience Pharmaceuticals (Changchun, China) | Jintrolong | 40-kDa PEG linked to growth hormone | Approved for pediatric growth hormone deficiency in China | Pro-drug Formulations
|
| Ascendis Pharma (Hellerup, Denmark)
| TransCon Growth Hormone
| Recombinant human growth hormone transiently bound to mPEG | BLA Submission pediatric
FDA 6.2020
EMA geplant Q3
| Non-Covalent Albumin Binding Growth Hormone |
| Novo Nordisk (Bagsvaerd, Denmark) | Somapacitan | Recombinant human growth hormone with a single point mutation attached to a terminal fatty acid that reversibly binds albumin | Ongoing pediatric phase 3 testing
adult PDUFA 9.2020
| Growth Hormone Fusion Proteins
|
| Genexine (Seongnam, South Korea) Handok (Seoul, South Korea) | HyTropin GX-H9 | Recombinant human growth hormone fused to hybrid Fc | Pending phase 3 trial
|
| OPKO Health (Miami, USA) Pfizer (New York City, USA) | Somatrogon Lagova MOD-4023
| Recombinant human growth hormone fused to 3 copies of carboxy-terminal of hCG’s beta subunit | Phase 3 testing in children underway.
|
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