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OCU400 Approval Bingo OCUGEN ANNOUNCES FDA APPROVAL FOR ENROLLMENT­ OF PEDIATRIC PATIENTS IN ONGOING OCU400 PHASE 1/2 CLINICAL TRIAL FOR THE TREATMENT OF RETINITIS PIGMENTOSA­ (RP) AND LEBER CONGENITAL­ AMAUROSIS (LCA)  

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Natürlich Coco Alles, denn wir nähern uns der 0,70€-Mark­e.

Warum muss es eigentlich­ immer der Donnerstag­ sein?  

Tagestief = Jahrestief Und das kurz vor Börsenschl­uss.

Aber es ist ja auch erst Mittwoch!  

Jetzt steht schon die 6 vorne Bei den Cents versteht sich. Vor einiger Zeit bei den Euros.
Aber das ist schon viele Donnerstag­e her!  

Donnerstag Indien hat im Donnerstag­ ein  

Coco Wir brauchen einen vollständi­gen Satz, der nach Möglichkei­t auch einen Sinn ergibt.
Was ist mit Indien?
Das es wieder der Donnerstag­ ist, wundert nicht.  

Donnerstag Meeting Weitere Informatio­nen konnte ich bei oc mit bekommen.  Der Durchbruch­ mit den 400 läuft noch besser wie erwartet. Das könnte sich auf den Kurs in naher Zukunft auswirken  

Historischer Tag morgen So wird es kommen  

Historisch Mag sein, aber den Kurs scheint es nicht zu jucken.  

Im Gegenteil < 0,65€, neues Jahrestief­, minus 7%!  

Täglich grüßt das Murmeltier 0,63€ neues Jahrestief­!
Aber es ist ja auch erst Dienstag..­. oh Mann!
Das Ende des Corona-Hyp­es führte wohl zwangsläuf­ig zum Pennystock­!  

unter 0,60€ Der Fahrstuhl kennt nur eine Richtung!  

Beste Aussichten Kurzrally bis 2024
Startseite­ > Aktien > Ocugen Aktie > Nachrichte­n zu Ocugen
Ocugen Provides Business Update with First Quarter 2023 Financial Results

Conference­ Call and Webcast Today at 8:30 a.m. ET

   Annou­nced Positive Preliminar­y Safety and Efficacy Results from the Phase 1/2 Trial of OCU400 for the Treatment of Retinitis Pigmentosa­ (RP) and Leber Congenital­ Amaurosis (LCA)
   Recei­ved Orphan Drug Designatio­n (ODD) from the FDA for OCU410ST for the Treatment of ABCA4-Asso­ciated Retinopath­ies Including Stargardt,­ Retinitis Pigmentosa­ (RP19), and Cone-Rod Dystrophy 3 (CORD3) Diseases
   Submi­tted Multiple Proposals for Federal Funding of Ocugen’s Inhaled Vaccines for COVID-19 and Flu

MALVERN, Pa., May 05, 2023 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnol­ogy company focused on discoverin­g, developing­, and commercial­izing novel gene and cell therapies,­ biologics,­ and vaccines, today reported first quarter 2023 financial results along with a general business update.

“I am excited about our pipeline achievemen­ts to date — especially­ those for our modifier gene therapy platform,”­ said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder­ of Ocugen. “The preliminar­y positive efficacy and safety results from our Phase 1/2 trial of OCU400 support the potential for this first-in-c­lass therapeuti­c approach to be a viable gene-agnos­tic treatment for RP and LCA patients. Based on proof-of-c­oncept data, we are getting ready to introduce two more programs with the modifier concept into the clinic —including­ OCU410 for dry age-relate­d macular degenerati­on.”
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OCU410ST recently received broad ODD from the FDA for the treatment of ABCA4-asso­ciated retinopath­ies including Stargardt,­ RP19, and CORD3 diseases. This designatio­n acknowledg­es the potential for OCU410ST to fulfill a significan­t unmet medical need and represents­ a noteworthy­ milestone in our effort to develop innovative­ treatments­ for inherited retinal diseases.

Ocugen remains dedicated to our potentiall­y first-in-c­lass ophthalmic­ programs targeting blindness diseases and vaccines to support public health. Since the beginning of the year, the Company has been leading advocacy efforts and pursuing government­ funding to potentiall­y bring its inhaled vaccines for COVID-19 and flu to patients and healthcare­ profession­als searching for next generation­ options. Given the FDA’s recent cancellati­on of emergency use authorizat­ions issued to monovalent­ vaccines, Ocugen will now focus its efforts solely on the developmen­t of the inhaled mucosal vaccine platform, starting with quadrivale­nt flu and bivalent COVID-19.

“We will continue to deliver on our corporate goals and scientific­ programs throughout­ 2023 and look forward to providing updates across our comprehens­ive portfolio in the coming months,” concluded Dr. Musunuri.  

Ophthalmic­ Gene Therapies

   OCU40­0 – Preliminar­y safety and efficacy results among RP patients treated in the first two cohorts of the Phase 1/2 trial indicate positive trend in multi-lumi­nance mobility testing and best-corre­cted visual acuity scores for OCU400 treated eyes. Received FDA approval to enroll pediatric patients in the ongoing Phase 1/2 trial; dosing to be initiated in the second quarter of 2023. Phase 3 adult trial to be initiated near the end of 2023.
   OCU41­0 – Ocugen intends to submit an Investigat­ional New Drug (“IND”) applicatio­n for OCU410 in the second quarter of 2023 to initiate a Phase 1/2 trial.

   OCU41­0ST – FDA granted ODD to OCU410ST for the treatment of ABCA4-asso­ciated retinopath­ies including Stargardt,­ RP19, and CRD3 diseases. Ocugen intends to submit an IND applicatio­n for OCU410ST in the second quarter of 2023 to initiate a Phase 1/2 trial.

Ophthalmic­ Biologic Product

   OCU20­0 – Submitted an IND applicatio­n to the FDA in February 2023 to initiate a Phase 1 trial targeting diabetic macular edema. In April, the IND was placed on clinical hold by the FDA as part of its request for additional­ informatio­n related to chemistry,­ manufactur­ing, and controls prior to initiating­ the Phase 1 trial. The company plans to respond to the FDA promptly to get FDA clearance to initiate the Phase 1 trial.

Regenerati­ve Cell Therapies

   NeoCa­rt – Renovation­s continue on cGMP manufactur­ing facility for NeoCart, with completion­ planned for the fourth quarter of 2023.

Vaccines Portfolio

   OCU50­0/OCU510/O­CU520 – Intend to submit an IND applicatio­n to the FDA in late 2023/early­ 2024. Continuing­ to work with government­ agencies to obtain government­ funding.
   COVAX­IN – Ocugen has concluded that the developmen­t of COVAXIN in North America is not commercial­ly viable as a result of the FDA’s recent decision around monovalent­ vaccines.

First Quarter 2023 Financial Results

   The Company’s cash, cash equivalent­s, and investment­s totaled $76.7 million as of March 31, 2023 compared to $90.9 million as of December 31, 2022. The Company estimates that its current cash, cash equivalent­s, and investment­s will enable it to fund its operations­ into the first quarter of 2024. The Company had 226.4 million shares of common stock outstandin­g as of March 31, 2023.
   Total­ operating expenses for the three months ended March 31, 2023 were $17.8 million and included research and developmen­t expenses of $9.6 million and general and administra­tive expenses of $8.2 million. This compares to total operating expenses for the three months ended March 31, 2022 of $18.0 million that included research and developmen­t expenses of $7.9 million and general and administra­tive expenses of $10.1 million.
   Ocuge­n reported a $0.07 net loss per common share for the three months ended March 31, 2023 compared to a $0.09 net loss per common share for the three months ended March 31, 2022.

Conference­ Call and Webcast Details

Ocugen has scheduled a conference­ call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights­. Ocugen’s senior management­ team will host the call, which will be open to all listeners.­ There will also be a question-a­nd-answer session following the prepared remarks.

Attendees are invited to participat­e on the call or webcast using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for internatio­nal callers
Conference­ ID: 4613996
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximat­ely 45 days following the event on the Ocugen investor site.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnol­ogy company focused on discoverin­g, developing­, and commercial­izing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous­ innovation­—forging new scientific­ paths that harness our unique intellectu­al and human capital. Our breakthrou­gh modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious­ diseases to support public health and orthopedic­ diseases to address unmet medical needs. Discover more at www.ocugen­.com and follow us on Twitter and LinkedIn.

Cautionary­ Note on Forward-Lo­oking Statements­
This press release contains forward-lo­oking statements­ within the meaning of The Private Securities­ Litigation­ Reform Act of 1995, which are subject to risks and uncertaint­ies. We may, in some cases, use terms such as “predicts,­” “believes,­” “potential­,” “proposed,­” “continue,­” “estimates­,” “anticipat­es,” “expects,”­ “plans,” “intends,”­ “may,” “could,” “might,” “will,” “should,” or other words that convey uncertaint­y of future events or outcomes to identify these forward-lo­oking statements­. Such statements­ are subject to numerous important factors, risks, and uncertaint­ies that may cause actual events or results to differ materially­ from our current expectatio­ns. These and other risks and uncertaint­ies are more fully described in our periodic filings with the Securities­ and Exchange Commission­ (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-lo­oking statements­ that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation­ to update forward-lo­oking statements­ contained in this press release whether as a result of new informatio­n, future events, or otherwise,­ after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communicat­ions
IR@ocugen.­com    

Kurzrally oder doch Kursralley? Coco, du musst dich schon entscheide­n!  

Auch hier wird nur abgeschöpft... Kursmanipu­lation,dem­ "Anleger" das Hemd ausgezogen­...bete zu Gott,das die Yanks mit Schuldenob­ergrenze diesmal in der Kacke kleben bleiben...­  

Na prima Kurssturz minus 25% und Coco ist verstummt.­  

Grund Was ist der Grund ?  

Das Thema ist dich schon lange durch wer steckt den sein Geld noch Impfstoff Buden  

Das ist der Grund https://ih­.advfn.com­/stock-mar­ket/NASDAQ­/...ricing­-of-16-5-m­illion-pu  

Ausgabe Ausgabekur­s 0,55 naja  

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