Form 8-K - Current report
November 06 2024 - 8:01AM
Edgar (US Regulatory)
false 0001668243 0001668243 2024-11-06 2024-11-06
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 6, 2024
UROGEN PHARMA LTD.
(Exact name of registrant as specified in its charter)
|
|
|
|
|
| Israel |
|
001-38079 |
|
98-1460746 |
| (State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
|
|
|
| 400 Alexander Park Drive, 4th Floor Princeton, New Jersey |
|
08540 |
| (Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including area code: +1 (646) 768-9780
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
|
|
|
|
| Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange on which registered |
| Ordinary Shares, par value NIS 0.01 per share |
|
URGN |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 |
Results of Operations and Financial Condition. |
On November 6, 2024, UroGen Pharma Ltd. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1.
The information in this Item 2.02, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 9.01 |
Financial Statements and Exhibits. |
(d)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
|
| Date: November 6, 2024 |
|
|
|
UROGEN PHARMA LTD. |
|
|
|
|
|
|
|
|
By: |
|
/s/ Chris Degnan |
|
|
|
|
|
|
Chris Degnan |
|
|
|
|
|
|
Chief Financial Officer |
Exhibit 99.1
UroGen Pharma Reports 2024 Third Quarter Financial Results and Business Highlights, Including the Potential Launch of
UGN-102 in 2025
| |
• |
|
New Drug Application for UGN-102 accepted by US FDA; PDUFA target
action date set for June 13, 2025 |
| |
• |
|
JELMYTO® achieved net product sales
of $25.2 million in Q3 2024, compared to $20.9 million in Q3 2023 |
| |
• |
|
$254.2 million in cash, cash equivalents and marketable securities as of
September 30, 2024 |
| |
• |
|
Conference call and webcast to be held today at 10:00 AM ET |
PRINCETON, N.J. November 6, 2024— UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and
commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the third quarter ended September 30, 2024, and provided an overview of recent developments.
“The recent FDA acceptance of our New Drug Application for UGN-102 marks a significant milestone in our mission
to deliver breakthrough treatments to patients,” said Liz Barrett, President and Chief Executive Officer of UroGen. “Supported by robust clinical evidence, we believe UGN-102 has the potential
to redefine the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer and provide longer treatment-free intervals for patients that currently face
the burden of repetitive surgeries under general anesthesia. We look forward to a potential FDA approval by the PDUFA target action date of June 13, 2025. If approved, we believe UGN-102 will represent a
paradigm shift in care, addressing a total market opportunity of over $5 billion. Our team is fully focused on preparing for a successful commercial launch of UGN-102, if approved, in 2025.”
Q3 2024 and Recent Business Highlights:
UGN-102 (mitomycin) for intravesical solution:
| |
• |
|
In October 2024, the U.S. Food and Drug Administration (FDA) accepted UroGen’s New Drug Application (NDA)
for investigational drug UGN-102 (mitomycin) for intravesical solution as a treatment for low-grade intermediate risk non-muscle
invasive bladder cancer (LG-IR-NMIBC). The FDA granted a Prescription Drug User Fee Act (PDUFA) target action date of June 13, 2025. |
| |
• |
|
The NDA for UGN-102 is supported by a comprehensive development program
which demonstrated a clinically meaningful complete response rate and a strong duration of response across three late phase clinical trials and an acceptable safety profile. The Phase 3 ENVISION trial successfully met its primary endpoint by
demonstrating that patients treated with UGN-102 had a 79.6% (95% CI, 73.9%, 84.5%) complete response (CR) rate at three months following the first instillation of
UGN-102. More recently, durability data from ENVISION showed that UGN-102 demonstrated an 82.3% (95% CI, 75.9%, 87.1%) 12-month
duration of response (DOR) by Kaplan-Meier estimate in patients who had achieved a complete response at three months after the first instillation of UGN-102. This is the highest DOR ever reported in this
patient population. The ENVISION trial demonstrated that UGN-102 has an acceptable safety profile that is consistent with the side effect profile observed in previous clinical trials. |
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper
tract urothelial cancer (LG-UTUC):
| |
• |
|
Generated net product revenue of $25.2 million in the third quarter of 2024, compared to
$20.9 million in the third quarter of 2023, primarily driven by strong underlying demand growth and also reflecting non-patient purchases. |
Next-generation novel mitomycin-based formulation for urothelial cancers
| |
• |
|
In October 2024, the first patient was dosed in the Phase 3 UTOPIA clinical trial of investigational drug UGN-103 (mitomycin) for intravesical solution in patients with LG-IR-NMIBC. UGN-103 is a next
generation product that combines UroGen’s RTGel® technology with a novel mitomycin formulation licensed from medac GmbH. UGN-103 is planned to
follow the potential FDA approval and launch of UGN-102 for LG-IR-NMIBC. UroGen plans to initiate a Phase 3 study early next
year to explore the safety and efficacy of UGN-104, its next generation product for the treatment of LG-UTUC. To learn more about the UTOPIA trial, refer to
clinicaltrials.gov/NCT06331299. |
| |
• |
|
In September 2024, UroGen received a Notice of Allowance from the United States Patent and Trademark Office for a
patent application covering, among other things, the use of UGN-103 in the treatment of LG-IR-NMIBC. The U.S. patent,
once issued, will have an expiration date in December 2041. |
Corporate
| |
• |
|
In October 2024, UroGen appointed Chris Degnan as Chief Financial Officer. Mr. Degnan brings broad expertise
in financial strategy, investor relations, SEC reporting, accounting and compliance, having previously held CFO roles at Galera Therapeutics and Verrica Pharmaceuticals. He replaced Don Kim who left the Company to pursue other
opportunities. |
Third Quarter 2024 Financial Results
JELMYTO Revenue: JELMYTO net product revenues were $25.2 million and $20.9 million for the three months ended
September 30, 2024, and 2023, respectively.
R&D Expense: Research and development expenses for the third quarter of 2024
were $11.4 million, including non-cash share-based compensation expense of $0.6 million as compared to $10.2 million, including non-cash
share-based compensation expense of $0.4 million, for the same period in 2023.
SG&A Expense: Selling, general and administrative
expenses for the third quarter of 2024 were $28.9 million, including non-cash share-based compensation expense of $2.9 million. This compares to $21.8 million, including non-cash share-based compensation expense of $1.8 million, for the same period in 2023.
Financing on Prepaid Forward Obligation: UroGen reported
non-cash financing expense related to the prepaid forward obligation to RTW Investments of $5.9 million in the third quarter of 2024, compared to $5.5 million in the same period in 2023.
Interest Expense on Long-Term Debt: Interest expense related to the outstanding $125 million term loan facility with funds managed by Pharmakon
Advisors was $2.7 million in the third quarter of 2024, compared to $3.8 million in the same period in 2023.
Net Loss: UroGen reported a
net loss of $23.7 million or ($0.55) per basic and diluted share in the third quarter of 2024 compared with a net loss of $21.9 million or ($0.68) per basic and diluted share in the same period in 2023.
Cash & Cash Equivalents: As of September 30, 2024, cash, cash equivalents and marketable securities totaled
$254.2 million.
For further details on the Company’s financials, including results for the 9-month
period ended September 30, 2024, refer to Form 10-Q, filed with the SEC.
2024 Revenue, Operating Expense,
and RTW Expense Guidance: With respect to the Company’s previously provided full-year 2024 JELMYTO revenue guidance, the Company expects full-year revenues to be below the low end of the guidance range. The Company does expect JELMYTO to
achieve low double-digit year-over-year revenue growth for the full year 2024. With respect to the Company’s previously provided full-year 2024 operating expenses guidance, the Company expects to be toward the midpoint of the guidance range,
including non-cash share-based compensation expense of $9 to $13 million, subject to market conditions. The anticipated full year 2024 non-cash
financing expense related to the prepaid obligation to RTW Investments is unchanged and expected to be in the range of $21 to $26 million. The rate for the cash component of the RTW obligation will be 13% of global net product
sales of JELMYTO in 2024.
Conference Call & Webcast Information: Members of UroGen’s management team will host a live
conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.
The live
webcast can be accessed by visiting the Investors section of the Company’s website at http://investors.UroGen.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be
needed to access the webcast.
UROGEN PHARMA LTD.
SELECTED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
| |
|
September 30,
2024 |
|
|
December 31,
2023 |
|
| Cash and cash equivalents and marketable securities |
|
$ |
254,217 |
|
|
$ |
141,470 |
|
| Total assets |
|
$ |
301,943 |
|
|
$ |
178,311 |
|
| Total liabilities |
|
$ |
276,428 |
|
|
$ |
243,523 |
|
| Total shareholders’ equity (deficit) |
|
$ |
25,515 |
|
|
$ |
(65,212 |
) |
UROGEN PHARMA LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Three months ended
September 30, |
|
|
Nine months ended
September 30, |
|
| |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
| Revenue1 |
|
$ |
25,204 |
|
|
$ |
20,852 |
|
|
$ |
65,833 |
|
|
$ |
59,183 |
|
| Cost of revenue |
|
|
2,543 |
|
|
|
2,367 |
|
|
|
6,410 |
|
|
|
7,075 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Gross profit |
|
|
22,751 |
|
|
|
18,485 |
|
|
|
59,423 |
|
|
|
52,108 |
|
| Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Research and development expenses |
|
|
11,355 |
|
|
|
10,230 |
|
|
|
42,251 |
|
|
|
34,312 |
|
| Selling, general and administrative expenses |
|
|
28,941 |
|
|
|
21,755 |
|
|
|
86,296 |
|
|
|
68,723 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Total operating expenses |
|
|
40,296 |
|
|
|
31,985 |
|
|
|
128,547 |
|
|
|
103,035 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Operating loss |
|
|
(17,545 |
) |
|
|
(13,500 |
) |
|
|
(69,124 |
) |
|
|
(50,927 |
) |
| Financing on prepaid forward obligation |
|
|
(5,915 |
) |
|
|
(5,479 |
) |
|
|
(17,348 |
) |
|
|
(16,047 |
) |
| Interest expense on long-term debt |
|
|
(2,721 |
) |
|
|
(3,815 |
) |
|
|
(8,629 |
) |
|
|
(11,129 |
) |
| Interest and other income, net |
|
|
2,599 |
|
|
|
906 |
|
|
|
5,922 |
|
|
|
1,941 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Loss before income taxes |
|
$ |
(23,582 |
) |
|
$ |
(21,888 |
) |
|
$ |
(89,179 |
) |
|
$ |
(76,162 |
) |
| Income tax expense |
|
|
(91 |
) |
|
|
9 |
|
|
|
(183 |
) |
|
|
(66 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net loss |
|
$ |
(23,673 |
) |
|
$ |
(21,879 |
) |
|
$ |
(89,362 |
) |
|
$ |
(76,228 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net loss per ordinary share basic and diluted |
|
$ |
(0.55 |
) |
|
$ |
(0.68 |
) |
|
$ |
(2.36 |
) |
|
$ |
(2.89 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weighted average shares outstanding, basic and diluted |
|
|
43,100,237 |
|
|
|
32,298,182 |
|
|
|
37,797,492 |
|
|
|
26,358,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 1. |
JELMYTO net revenues include $2.6 million and $1.1 million in CREATES Act sales during the three
months ended September 30, 2024, and 2023 respectively. |
About JELMYTO
JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel
containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with LG-UTUC. It is recommended for primary treatment of biopsy-proven LG-UTUC in
patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the
urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper
urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.
APPROVED USE FOR JELMYTO
JELMYTO® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper
Tract Urothelial Cancer (LG-UTUC).
IMPORTANT SAFETY INFORMATION
You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
Before receiving JELMYTO, tell your healthcare provider about all your
medical conditions, including if you:
| |
• |
|
are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during
treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use
effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you
should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose. |
| |
• |
|
are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not
breastfeed during treatment with JELMYTO and for 1 week after the last dose. |
| |
• |
|
Tell your healthcare provider if you take water pills (diuretic). |
How will I receive JELMYTO?
| |
• |
|
Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO
treatment. |
| |
• |
|
You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that
you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up
to an additional 11 monthly doses. |
| |
• |
|
JELMYTO is given to your kidney through a tube called a catheter. |
| |
• |
|
During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how
you take your current medicines. |
After receiving JELMYTO:
| |
• |
|
JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine
for at least 6 hours. |
| |
• |
|
To urinate, males and females should sit on a toilet and flush the
toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water. |
| |
• |
|
Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
|
JELMYTO may cause serious side effects, including:
| |
• |
|
Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric
obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your
healthcare provider right away if you develop side pain or fever during treatment with JELMYTO. |
| |
• |
|
Bone marrow problems. JELMYTO can affect your bone marrow and
can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need
to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO. |
| |
• |
|
The most common side effects of JELMYTO include: urinary tract infection, blood in your urine,
side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain. |
You are encouraged to report
negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You
may also report side effects to UroGen Pharma at 1-855-987-6436.
Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.
About Upper Tract Urothelial Cancer (UTUC)
Urothelial
cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively
referred to as upper tract urothelial cancers (UTUC). In the U.S., there are approximately 6,000—7,000 new or recurrent low-grade UTUC patients annually. Most cases are diagnosed in patients
over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can
lead to a high rate of recurrence and relapse.
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently under
regulatory review for approval in the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel®
technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. An NDA for UGN-102 is currently under review by the FDA with a potential decision expected by June 13, 2025. The U.S. market for LG-IR-NMIBC
that UGN-102 can address, if approved, is valued at approximately $5 billion.
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients
deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s
sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat
low-grade upper tract urothelial cancer and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with LG-IR-NMIBC are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel.
Visit www.UroGen.com to learn more or follow us on X (Twitter), @UroGenPharma.
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without
limitation, statements regarding: the potential timing for a decision from the FDA on the UGN-102 NDA; the potential launch timing for UGN-102, if approved; the
potential patient benefits and opportunities for UGN-102, if approved; the estimated size of the U.S. market that could be addressed by UGN-102, if approved; the plans
for UGN-103 to follow the potential FDA approval and launch of UGN-102; the timing for the planned Phase 3 trial of UGN-103 and UGN-104 and the potential approval of both product candidates; the anticipated intellectual property protection for UGN-103; 2024 financial guidance; the estimated patient
population and demographics for UTUC; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs; and the potential of UroGen’s sustained release technology to make local delivery more
effective as compared to other treatment options. Words such as “anticipate,” “believe,” “expect,” “if,” “plan,” “potential,” “will,” or other words that convey uncertainty of
future events or outcomes to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials and potential safety
and other complications thereof; unforeseen delays that may impact the timing of progressing clinical trials and reporting data; results from the ENVISION Phase 3 trial may not be sufficient to support an NDA submission for UGN-102; even though the NDA for UGN-102 has been accepted by the FDA, there is no guarantee that such NDA will be sufficient to support approval of UGN-102 on the timeframe expected, or at all; the PDUFA target action date may be delayed due to various factors outside UroGen’s control; the FDA may schedule an advisory committee meeting for UGN-102, and the impact of any such advisory committee meeting or recommendation on the approval decision by the FDA is uncertain; the ability to obtain and maintain adequate intellectual property rights and
adequately protect and enforce such rights; past results are not necessarily indicative of results that may be seen in the future, including in larger patient populations; the ability to
obtain and maintain regulatory approval within the timeframe expected, or at all; complications associated with commercialization activities; the labeling for any approved product; competition in
UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s ability to attract or retain key management, members of the board of directors and other
personnel; UroGen’s RTGel technology may not perform as expected; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and UroGen’s financial condition and need for
additional capital in the future. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for
the quarter ended June 30, 2024, filed with the SEC on August 13, 2024, as well as in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q being filed with the SEC later
today (which is available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or
implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
INVESTOR CONTACT:
Vincent Perrone
Senior Director, Investor Relations
vincent.perrone@UroGen.com
609-460-3588 ext. 1093
MEDIA CONTACT:
Cindy Romano
Director, Corporate Communications
cindy.romano@UroGen.com
609-460-3583 ext. 1083
Source: UroGen Pharma Ltd.
v3.24.3
| X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
| Name: |
dei_AmendmentFlag |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
| Name: |
dei_DocumentPeriodEndDate |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:dateItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
| Name: |
dei_DocumentType |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:submissionTypeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
| Name: |
dei_EntityAddressAddressLine1 |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionAddress Line 2 such as Street or Suite number
| Name: |
dei_EntityAddressAddressLine2 |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- Definition
+ References
+ Details
| Name: |
dei_EntityAddressCityOrTown |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionCode for the postal or zip code
| Name: |
dei_EntityAddressPostalZipCode |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionName of the state or province.
| Name: |
dei_EntityAddressStateOrProvince |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:stateOrProvinceItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityCentralIndexKey |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:centralIndexKeyItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionIndicate if registrant meets the emerging growth company criteria. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityEmergingGrowthCompany |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
| Name: |
dei_EntityFileNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:fileNumberItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
| Name: |
dei_EntityIncorporationStateCountryCode |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarStateCountryItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityRegistrantName |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityTaxIdentificationNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:employerIdItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionLocal phone number for entity.
| Name: |
dei_LocalPhoneNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
| Name: |
dei_PreCommencementIssuerTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
| Name: |
dei_PreCommencementTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTitle of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
| Name: |
dei_Security12bTitle |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:securityTitleItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionName of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
| Name: |
dei_SecurityExchangeName |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarExchangeCodeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Section 14a
-Number 240
-Subsection 12
| Name: |
dei_SolicitingMaterial |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
| Name: |
dei_TradingSymbol |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:tradingSymbolItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
| Name: |
dei_WrittenCommunications |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
UroGen Pharma (NASDAQ:URGN)
Historical Stock Chart
From Nov 2024 to Dec 2024
UroGen Pharma (NASDAQ:URGN)
Historical Stock Chart
From Dec 2023 to Dec 2024
