KALA PHARMACEUT. DL-,001 WKN: A2DU77 ISIN: US4831191030 Kürzel: 27F Forum: Aktien Thema: Hauptdiskussion

Kala continues to enroll patients in its ongoing STRIDE 3 (STRIDE – Short Term Relief In Dry Eye) Phase 3 clinical trial, and expects this trial will serve as the basis of its response to the CRL. Kala is targeting topline data from STRIDE 3 by the end of 2019 and resubmission of the NDA during the first half of 2020. The Company believes this resubmission would be subject to a six-month review under the Prescription Drug User Fee Act. Kala initiated STRIDE 3 in July 2018 at the recommendation of the FDA. The STRIDE 3 trial design reflects specific modifications to the inclusion and exclusion criteria of Kala’s previous trials of KPI-121 0.25%, which were implemented to improve the probability of success. https://www.pharmalive.com/kala-pharmaceuticals-receives-fda-crl-for-kpi-121-0-25-nda/

Kala Pharmaceuticals, Inc. (NASDAQ:KALA) announced that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. The FDA indicated that efficacy data from its STRIDE 3 Phase 3 clinical trial are required in order to resubmit the NDA. Data from this trial are due towards the end of this year

Wäre schön wenn es die 4€ hält bis zum approval... es ist ja schon in höherer Dosierung zugelassen. Sollte also nichts im Weg stehen.

3,85€

Autsch ;)

Falls jemand den Earnings Call lesen will: https://seekingalpha.com/article/4282018-kala-pharmaceuticals-kala-ceo-mark-iwicki-q2-2019-results-earnings-call-transcript?source=quotemedia_readmore

Kala Pharmaceuticals Reports Second Quarter 2019 Financial Results We are very pleased with our results in the second quarter. The INVELTYS launch is progressing well, with positive feedback from physicians and strong growth in prescriptions, market share, and revenues compared to the first quarter,” said Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals. “Our experience with INVELTYS provides a strong foundation as we advance KPI-121 0.25%, our product candidate for dry eye disease, which, if approved, we believe will be a promising new therapy for the millions of patients who experience episodic dry eye flares.” The PDUFA action date for KPI-121 0.25% is August 15, 2019. In parallel, Kala continues to enroll the STRIDE 3 trial of KPI-121 0.25% and is targeting topline data by the end of 2019. https://finance.yahoo.com/news/kala-pharmaceuticals-reports-second-quarter-110000571.html

Morgen wird die Bilanz für Q2 veröffentlicht inkl. conference call mit Update. Und nächste Woche PDUFA für KPI-121.

4,61€

+ 5% :)

15.8 pdufa

Ja ok. Jetzt 5,90. Hätte ich doch bei L&S kaufen sollen😂

Hab neulich was über L&S gekauft und die Kosten wären doch erheblicher als angegeben. Deswegen bleibe ich am liebsten bei TG

Ich kenne die Kosten nicht. Bin Consors Kunde

Hallo Nero, du kannst sie doch in Frankfurt kaufen oder am besten direkt an NASDAQ.

Hätte schon längst gekauft würde Tradegate sie handeln.