CLSD (Mkap $39 M) (Cash $65 M) NDA bei der FDA eingereicht =200%+ Chance (Seite 5)
eröffnet am 05.02.19 16:28:54 von
neuester Beitrag 13.03.24 14:14:12 von
neuester Beitrag 13.03.24 14:14:12 von
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ISIN: US1850631045 · WKN: A2ALP6 · Symbol: CLM
1,2000
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-0,0500 EUR
Letzter Kurs 25.04.24 Tradegate
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16.04.24 · globenewswire  |
02.04.24 · globenewswire |
18.03.24 · globenewswire |
12.03.24 · globenewswire |
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| 1,9000 | +59,66 | |
| 4,7450 | +35,57 | |
| 0,5250 | +19,08 | |
| 5,8900 | +17,80 | |
| 12,800 | +17,43 |
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|---|---|---|
| 1,6900 | -14,50 | |
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Gibt es nen Grund, warum wir hier so stark konsolidieren?
https://www.globenewswire.com/en/news-release/2021/11/10/233…
clinical product, XIPERE, to final FDA approval, validating our ability to successfully develop ophthalmic therapies for suprachoroidal administration.
closely and cooperatively with Bausch + Lomb as they prepare to launch XIPERE in the U.S. in the first quarter of 2022.”
we expect to receive a total of $19 million in non-dilutive funding for approval and pre-launch milestones from our commercialization partners. This additional capital will be utilized to advance our clinical development pipeline led by CLS-AX (axitinib injectable suspension) for suprachoroidal administration.
results from Cohort 2 by the end of this year
Key Highlights
XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis was approved by the U.S. Food and Drug Administration in October 2021.
Enrollment and dosing were completed in Cohort 2 of OASIS, Clearside’s U.S. based, open-label, dose-escalation Phase 1/2a trial in patients with wet AMD, to assess the safety and tolerability of a 0.1 mg dose of CLS-AX (axitinib injectable suspension) administered by suprachoroidal injection via Clearside’s SCS Microinjector.
Exclusive XIPERE license agreement with Arctic Vision, a China-based biotechnology company focused on innovative ophthalmic therapies, was expanded from Greater China and South Korea to also include Australia, New Zealand, India and the ASEAN Countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam).
REGENXBIO presented positive initial data from two Phase 2 clinical trials testing RGX-314 using suprachoroidal delivery. In the AAVIATE® trial for the treatment of wet AMD, RGX-314 was well tolerated in 50 patients in Cohorts 1-3, with no drug-related serious adverse events, and a treatment effect observed in Cohort 1 patients at six months after one-time treatment. In the ALTITUDE™ trial for the treatment of diabetic retinopathy, RGX-314 was well tolerated in 15 patients in Cohort 1, with no drug-related serious adverse events, no intraocular inflammation observed, and positive interim data from Cohort 1 at three months after one-time treatment.
Aura Biosciences presented interim Phase 2 safety data evaluating suprachoroidal administration of AU-011 in patients with choroidal melanoma, reporting that there have been no related serious adverse events, dose limiting toxicities, or grade 3 adverse events observed during the trial and that suprachoroidal administration may improve the therapeutic index and optimize treatment parameters.
Multiple presentations featuring the use of Clearside’s proprietary suprachoroidal space injection platform were highlighted at global conferences, including the American Society of Retina Specialists Annual Meeting, the Retina Society 54th Annual Scientific Meeting, the OIS Retina Summit and the Ophthalmology Futures European 2021 Virtual Retina Forum.
A data manuscript entitled, “Suprachoroidal CLS-TA with and without Systemic Corticosteroid and/or Steroid-Sparing Therapy: A Post-Hoc Analysis of the Phase 3 PEACHTREE Clinical Trial”, was published in Ocular Immunology & Inflammation in August 2021.
the Company believes it will have sufficient resources to fund its planned operations into 2023
Nice!
https://www.globenewswire.com/news-release/2021/11/11/233250…
clinical product, XIPERE, to final FDA approval, validating our ability to successfully develop ophthalmic therapies for suprachoroidal administration.
closely and cooperatively with Bausch + Lomb as they prepare to launch XIPERE in the U.S. in the first quarter of 2022.”
we expect to receive a total of $19 million in non-dilutive funding for approval and pre-launch milestones from our commercialization partners. This additional capital will be utilized to advance our clinical development pipeline led by CLS-AX (axitinib injectable suspension) for suprachoroidal administration.
results from Cohort 2 by the end of this year
Key Highlights
XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis was approved by the U.S. Food and Drug Administration in October 2021.
Enrollment and dosing were completed in Cohort 2 of OASIS, Clearside’s U.S. based, open-label, dose-escalation Phase 1/2a trial in patients with wet AMD, to assess the safety and tolerability of a 0.1 mg dose of CLS-AX (axitinib injectable suspension) administered by suprachoroidal injection via Clearside’s SCS Microinjector.
Exclusive XIPERE license agreement with Arctic Vision, a China-based biotechnology company focused on innovative ophthalmic therapies, was expanded from Greater China and South Korea to also include Australia, New Zealand, India and the ASEAN Countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam).
REGENXBIO presented positive initial data from two Phase 2 clinical trials testing RGX-314 using suprachoroidal delivery. In the AAVIATE® trial for the treatment of wet AMD, RGX-314 was well tolerated in 50 patients in Cohorts 1-3, with no drug-related serious adverse events, and a treatment effect observed in Cohort 1 patients at six months after one-time treatment. In the ALTITUDE™ trial for the treatment of diabetic retinopathy, RGX-314 was well tolerated in 15 patients in Cohort 1, with no drug-related serious adverse events, no intraocular inflammation observed, and positive interim data from Cohort 1 at three months after one-time treatment.
Aura Biosciences presented interim Phase 2 safety data evaluating suprachoroidal administration of AU-011 in patients with choroidal melanoma, reporting that there have been no related serious adverse events, dose limiting toxicities, or grade 3 adverse events observed during the trial and that suprachoroidal administration may improve the therapeutic index and optimize treatment parameters.
Multiple presentations featuring the use of Clearside’s proprietary suprachoroidal space injection platform were highlighted at global conferences, including the American Society of Retina Specialists Annual Meeting, the Retina Society 54th Annual Scientific Meeting, the OIS Retina Summit and the Ophthalmology Futures European 2021 Virtual Retina Forum.
A data manuscript entitled, “Suprachoroidal CLS-TA with and without Systemic Corticosteroid and/or Steroid-Sparing Therapy: A Post-Hoc Analysis of the Phase 3 PEACHTREE Clinical Trial”, was published in Ocular Immunology & Inflammation in August 2021.
the Company believes it will have sufficient resources to fund its planned operations into 2023
Nice!
https://www.globenewswire.com/news-release/2021/11/11/233250…
Antwort auf Beitrag Nr.: 69.694.975 von liquidx am 25.10.21 16:25:32leider das übliche spiel, sell on news. hätte mir eigentlich die woche für den run-up gewünscht
Der Kurs taucht aber ab, trotz der Meldung 
https://ir.clearsidebio.com/news-releases/news-release-detai…
https://ir.clearsidebio.com/news-releases/news-release-detai…
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Antwort auf Beitrag Nr.: 69.688.117 von yelw0rc am 24.10.21 21:14:35nun, wirds noch spannender! 
https://www.reuters.com/article/bausch-lomb-fda/bausch-clear…
https://www.reuters.com/article/bausch-lomb-fda/bausch-clear…
Diese Woche wird spannend
https://www.globenewswire.com/news-release/2021/10/13/231332…
wenn man die statements liest, kann es nur noch 📈 gehen
wenn man die statements liest, kann es nur noch 📈 gehen
Kommt anscheinend wieder in Schwung
Lol wie blöd kann man sein. CLSD microinjector Einsatz war ein zweifellos voller Erfolg. Nur weil das Medikament von RGNX leichte Tendenz zu Entzündungen gezeigt hatte ist CLSD Kurs ebenfalls eingebrochen. CLSD ist doch nur bei Verabreichungsform involviert und die hat zu keinerlei Problemen geführt nur der Wirkstoff mit dem CLSD nichts zu tun hat zeigt nicht ganz ideale Ergebnisse hat aber noch Chancen Studie wird weitergeführt.
In den Potentialabschätzungen der CLSD Aktie war zum Teil das Microinjektor Geschäft noch überhaupt nicht eingepreist. Daher alle die geschmissen haben tut mir leid das war Bockmist. Für CLSD ist kein Schaden entstanden, selbst wenn alles super gewesen wäre ist der eigentliche Wert/Gewinn des Verkaufs der Injektoren vernachlässigbar klein gewesen bei dieser Möglichkeit des Zusatzeinkommens uuund es waren geradezu great News, die Verabreichungsmethode wurde nochmals geadelt d.h. im Gegenteil die News war für CLSD ein absoluter Erfolg.
In den Potentialabschätzungen der CLSD Aktie war zum Teil das Microinjektor Geschäft noch überhaupt nicht eingepreist. Daher alle die geschmissen haben tut mir leid das war Bockmist. Für CLSD ist kein Schaden entstanden, selbst wenn alles super gewesen wäre ist der eigentliche Wert/Gewinn des Verkaufs der Injektoren vernachlässigbar klein gewesen bei dieser Möglichkeit des Zusatzeinkommens uuund es waren geradezu great News, die Verabreichungsmethode wurde nochmals geadelt d.h. im Gegenteil die News war für CLSD ein absoluter Erfolg.
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