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

Der Abgesang ist hoffentlich noch zu früh. Eine weitere Studie 3 ist ja bereits gestartet gewesen und ist Ende vom Jahr fertig, danach kann der NDA erneut eingereicht werden. Mit etwas Glück ist alles nur um 6 Monate verschoben. Die Analysten halten noch an ihren Einschätzungen fest, im Mittel 12$ in der Spitze 51$.

Ist Kala nun tot oder was? Eigentlich denke ich für 3,50- schon interessant für nen Zock, oder? Also auf Sicht von ein paar Monaten nun

Danke für die Info!

The Market Is Sour On Kala Pharmaceuticals Despite Insider Support Summary Kala Pharmaceuticals received a CRL for KPI-121 0.25%, but already dropped a lot leading up to its PDUFA date. The company adeptly predicted the negative outcome and already has a follow-up trial in place with data expected at the end of the year. Cash runway is good to Q3 2020, and if everything goes to plan, a second NDA would be submitted by then. Kala has very heavy insider support; two directors invested $45 million in the company's $8.25 secondary last October https://seekingalpha.com/article/4284840-market-sour-kala-pharmaceuticals-despite-insider-support?source=quotemedia_readmore

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😂