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Alias Born | 04/26/2016 |
Thursday, November 02, 2017 3:34:15 PM
AUPH UPDATES:
AURORA LN TRIAL:
-Single Phase 3 trial (Duplicate of Ph2B)
-113 recruiting sites around the world and counting
-Expected completion date 2H-2018 & Top-line results expected 2H-2019
-Rolling NDA Submission 2H-2018 due to Fast Track Approval
-Conservative annual LN revenue: Approx. $1.4 billion
Oct. 20th R&D Day unveiled new exciting catalysts
-FSGS & MCD (Focal Segmental Glomerulonephritis & Minimal Change Disease)
-FSGS & MCD are causes of Nephrotic Syndrome
-Approx. 150,000 patients globally
-No approved treatments
-Reliant on off-label steroids and legacy CNIs (Cyclosporine)
-Ph2 POC trial expected 1H-2018 (Interim data release 2H-2018)
-Nephrotic Syndrome is an important unmet need
VOS (Voclosporin Ophthalmic Solution):
-VOS is a new nanomicellar aimed at treating DES (Dry Eye Syndrome)
-Market size is > 20 million patients in US along
-Improved potency, dosing, and tolerability compared to current standard of care (Restasis)
-Completed Ph1 human trial with small sample but promising efficacy vs. Restasis
-Licensed out VOS for canine use to Merck and completed animal studies
-IP to approx. 2031
-Ph2A trial to be conducted in 1H-2018 (H2H vs. Restasis)
-Low risk high reward opportunity
-2H-2018 AUPH will look to monetize VOS or conduct Ph2B
Recent AUPH News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/20/2024 08:56:55 PM
- Aurinia to Participate in 2024 Cantor Fitzgerald Global Healthcare Conference • Business Wire • 09/13/2024 10:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/12/2024 08:08:25 PM
- Aurinia Announces Board Restructuring • Business Wire • 09/12/2024 08:05:00 PM
- Aurinia Announces First Participant Dosed in AUR200 Single Ascending Dose Trial • Business Wire • 09/05/2024 10:00:00 AM
- Aurinia to Participate in H.C. Wainwright 26th Annual Global Investment Conference • Business Wire • 08/28/2024 10:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/08/2024 08:06:59 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/01/2024 10:07:59 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/01/2024 10:03:38 AM
- Aurinia Pharmaceuticals Reports Second Quarter and Six Months 2024 Financial and Operational Results • Business Wire • 08/01/2024 10:00:00 AM
- Aurinia Pharmaceuticals to Release Second Quarter Financial and Operational Results on August 1, 2024 • Business Wire • 07/19/2024 10:00:00 AM
- Aurinia to Participate in Upcoming Investor Healthcare Conferences • Business Wire • 07/02/2024 10:00:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/14/2024 09:25:28 PM
- Aurinia Announces 2024 Annual General Meeting Results • Business Wire • 06/14/2024 04:16:00 PM
- Aurinia Presents Safety and Efficacy Profile of LUPKYNIS® for People with Lupus Nephritis at European Alliance of Associations for Rheumatology (EULAR) Congress 2024 • Business Wire • 06/05/2024 10:00:00 AM
- Aurinia Addresses Dubious Proposals Put Forth by Lucien Selce • Business Wire • 06/04/2024 09:30:00 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 06/04/2024 09:25:39 PM
- Aurinia Provides Update on Proxy Statement • Business Wire • 06/03/2024 10:30:00 PM
- Aurinia Will Attend 2024 Jefferies Global Healthcare Conference • Business Wire • 05/30/2024 10:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:16:53 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:14:25 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:11:31 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:09:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/22/2024 08:07:15 PM
- Analysis Showing LUPKYNIS® is a Cost-Effective Treatment for Lupus Nephritis Presented at National Kidney Foundation’s Spring Clinical Meeting 2024 • Business Wire • 05/14/2024 10:00:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM