Friday, November 14, 2025 4:23:49 PM
Yes that has happened...ZS Pharma for example .
There are a range of possibilities over the next 2 yrs ...... from worst to best
Worst case scenario ...another CRL
Delayed resubmission but OLC approved in July . Net effect is that TDAPA process is delayed so Co does a capital raise ,
Early resubmission ,approved in June , get the first tranche of $ make the July TDAPA submission and no capital raise necessary .
Early re submission , approved in June , gets first tranche , make July TDAPA filing , Co starts process for approval in the EU , Korea , UK and maybe Japan
Same as above but Kidney Patient Act passed in Congress allowing 3 yrs in TDAPA plus 65% reimbursement after 3 yrs .
Jan 2027 ....fully reimbursed in the US and soon approved in the EU followed by UK, Korea and Japan . Major interest from Vifor to replace their Velphoro ...ie they buy UNCY
Best case scenario ....2027 ...Stumblebum regrets taking $36 a share since OLC is now the go to pho lowering drug for roughly the 1 m dialysis patients that need it in US , EU, UK , Japan and Korea
Kiwi
PS Pill burden is a huge issue for these patients .
RMB ...while my wife gets that Vascepa or DHA/EPA fish oil reduces CV risk she said ...trying to get my patients to take an additional 4 caps of a drug on top of the dozen or so drugs they already take each day ...is probably unrealistic
OLC is one small pill , SWALLOWED with each meal , fully covered by Medicare for at least the first 2 yrs AND dispensed in the dialysis clinic from MD direct to patient .
My wife complains often about the scripts she writes that never get picked up ...delays at pharmacy or patient just didn't want to wait for it to..
That won't happen with OLC
Recent UNCY News
- Form SCHEDULE 13G/A - Statement of Beneficial Ownership by Certain Investors: [Amend] • Edgar (US Regulatory) • 02/10/2026 06:15:05 PM
- Unicycive shares gain as FDA accepts resubmitted OLC NDA • IH Market News • 01/29/2026 03:01:58 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/14/2025 10:10:14 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 11/14/2025 10:09:13 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/12/2025 02:12:01 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/12/2025 11:39:29 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/28/2025 11:30:13 AM
- UNCY Investors Have Opportunity to Lead Unicycive Therapeutics, Inc. Securities Fraud Lawsuit • PR Newswire (US) • 10/14/2025 06:55:00 AM
- Unicycive Therapeutics, Inc. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - UNCY • PR Newswire (US) • 10/02/2025 12:04:00 PM
- The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Unicycive Therapeutics, Inc.(UNCY) Shareholders • PR Newswire (US) • 09/29/2025 12:45:00 PM
- Unicycive Therapeutics, Inc. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights – UNCY • Business Wire • 09/25/2025 07:19:00 PM
- The Gross Law Firm Notifies Shareholders of Unicycive Therapeutics, Inc.(UNCY) of a Class Action Lawsuit and an Upcoming Deadline • PR Newswire (US) • 09/25/2025 12:45:00 PM
- Lost Money on Unicycive Therapeutics, Inc.(UNCY)? Join Class Action Suit Seeking Recovery - Contact The Gross Law Firm • PR Newswire (US) • 09/22/2025 12:45:00 PM
- Shareholders of Unicycive Therapeutics, Inc. Should Contact The Gross Law Firm Before October 14, 2025 to Discuss Your Rights - UNCY • PR Newswire (US) • 09/18/2025 12:45:00 PM
Exxe Group Advances Platform Strategy and Share Structure Reduction Following Strategic Meetings • AXXA • Mar 11, 2026 1:03 PM
DRCR Pushes Forward With Implementation of 2026 Business Plan • DRCR • Mar 11, 2026 12:26 PM
Record Gold Prices Reshape Opportunities for Emerging Producers • LFLR • Mar 11, 2026 9:00 AM
C2 Blockchain Reports 803 Million DOG (Bitcoin) Holdings Following Strategic Accumulation of Bitcoin-Native Digital Assets • CBLO • Mar 10, 2026 8:00 AM
RENI Completes Due Diligence on Target Acquisition; Confirms Strong Asset Base and Operational Performance • RENI • Mar 5, 2026 10:15 AM
BlackStar Engages in Talks with U.S. Senate Banking Committee Team Covering the Digital Asset Market Clarity Act • BEGI • Mar 4, 2026 4:47 PM
