On May 13, 2022 Ontada, a McKesson business focused on provider technology and actionable real-world research, education and evidence in oncology, reported the acceptance of seven abstracts for presentation at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) (Press release, McKesson, MAY 13, 2022, View Source [SID1234614537]). The leading global conference for health economics and outcomes research, ISPOR 2022 will take place in Washington, D.C., and virtually from May 15-18, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The acceptance of these studies showcases the critical role Ontada’s real-world data and evidence solutions play in our life science partners’ ability to accelerate the development and commercialization of oncology therapies," said Susan Shiff, Ph.D., president of Ontada. "The studies highlight a wide range of innovative ways to gain insight into treatment patterns and outcomes. These are critical to support drug development and the advancements of new medicines designed to improve patient care."

In an oral abstract session on Tuesday, May 17 from 4:30 to 5:30pm ET, results will be presented from the study, "Feasibility of Using Oncology Specific Electronic Health Records (EHR) Data to Emulate Clinical Trial Inclusion and Exclusion Criteria." Assessing the utility of both structured and unstructured data from oncology-specific EHR systems, the study examined eligibility criteria of oncology clinical trials to assess the degree to which real-world data can be used to retrospectively replicate the information needed in trials.

"These results demonstrate that oncology-specific EHR data can be leveraged to emulate inclusion and exclusion criteria of clinical trials, which offers the ability to evaluate treatment options using external controls in cases where a randomized clinical trial may not be feasible," said Nicholas Robert, M.D., study co-author and chief medical officer of Ontada. "Complementing clinical trials by capturing data on the effectiveness of drugs with real-world evidence will ultimately improve our understanding of how drugs perform in broader patient groups."

Ontada’s data scientists and researchers leveraged our real-world data and analytics capabilities in additional poster studies to be presented at this year’s ISPOR:

A Proposed Framework for Evaluating Continuity of Data Coverage in Electronic Health Record and Administrative Claims Data in Real-World Evidence (RWE) Studies
Application of Medication History for Comorbidity Assessment in Cancer Patients
HER2 and Other Biomarker Testing Patterns Among Patients with Advanced Gastric Cancer (GC) or Gastric Esophageal Junction Cancer (GEJC)
Lack of Standardization in Quantitative Evaluations of the Efficacy-Effectiveness Gap (EEG) for Cancer Therapies: A Targeted Literature Review (TLR)
Frequency of and Testing Patterns for Microsatellite Instability High (MSI-H) and Deficient Mismatch Repair (dMMR) Among Solid Tumors in a US Community Oncology Setting
Integrating Data from Disparate Sources to Create a Comprehensive Patient Journey: A Case Study in Prostate Cancer
The full schedule of presentations, including timing and author information, can be found here. For more information or to interview a trial investigator, contact Ryan Mathre at 651.335.2338 or [email protected].

On May 13, 2022 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between chronic, low-grade inflammation and age-related diseases, reported financial results and recent business highlights for its first quarter ended March 31, 2022 (Press release, HCW Biologics, MAY 13, 2022, View Source [SID1234614522]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to successfully execute our clinical development strategy which is based on our unique approach toward inflammaging," stated Hing C. Wong, Founder and CEO of HCW Biologics Inc. "HCW Biologics is developing immunotherapeutics that do not treat a single indication or symptom. Our approach is to treat a patient systemically to remove the underlying problems causing a condition."

Dr. Wong continued, "Our plan is to use difficult-to-treat cancer indications as the gateway for clinical development of our lead product candidate, HCW9218. In preclinical studies, we have demonstrated that HCW9218 can effectively reduce therapy-induced cancer and normal tissue cellular senescence to augment the anti-tumor activities of chemotherapies and alleviate their side effects. In addition, HCW9218 has been shown to significantly enhance anti-tumor activity of immune checkpoint therapies in a preclinical setting."

Dr. Wong further stated, "We believe that HCW9218 also has potential as a treatment for a broad range of age-related pathologies beyond cancer, through our discovery that HCW9218 can reduce accumulated senescent cells due to the naturally aging process or metabolic dysfunction, leading to the improvement of health span of experimental animals."

Business Highlights:

At the 105th Annual Meeting of the American Association of Immunologists held on May 6 -10, 2022, HCW Biologics showcased two novel groups of fusion molecules invented with the Company’s proprietary and versatile TOBI discovery platform. Two posters were presented which are available on the Company’s website:

A "kick and expand" strategy to generate large numbers of CIML NK cells for adoptive cell therapy for the treatment of cancer using novel fusion proteins HCW9201 and HCW9206.

Robust human regulatory T cell expansion with fusion proteins HCW9302 and HCW9213 circumvents need for magnetic-bead or feeder cell approaches for adoptive cell therapy.

On April 19, 2022, Dr. Hing Wong presented, "Bifunctional Immunotherapeutic HCW9218 for Cancer and Inflammaging," at the Third Annual International Conference on Cell and Experimental Biology. Dr. Wong presented preclinical data for the first time that showed results of the Company’s investigational work related to the treatment of inflammaging indications in naturally-aged mice. The Company believes these results demonstrate the potential of HCW9218 to fundamentally change the treatment of a broad range of diseases and conditions associated with aging, even aging itself, by enhancing health span that has been diminished with aging.

First Quarter 2022 Financial Results:

Cash and cash equivalents: On March 31, 2022, the Company’s cash balance was $18.1 million, short-term investments were $17.0 million and long-term investments were $9.8 million. Investments are all U.S. Treasury bills or notes. The Company estimates that the current cash balance is sufficient to fund operations through the end of 2023.

Revenues: Revenues were $3.1 million for the three-month period ended March 31, 2022, and there were no revenues in the three-month period ended March 31, 2021. Revenues were derived from the sale of clinical development material to our licensee, Wugen.

Research and development (R&D) expenses: R&D expenses were $1.8 million for the three-month period ended March 31, 2022, as compared to $2.3 million for the three-month period ended March 31, 2021. The 22% decrease in R&D expenses was driven primarily by a decrease in manufacturing and materials expenses and preclinical expenses.

General and administrative expenses (G&A): G&A expenses were $1.9 million for the three-month period ended March 31, 2022, as compared to $1.1 million for the three-month period ended March 31, 2021. The 73% increase reflects higher salaries, benefits and related expenses as a result of stock-based compensation expense associated with an equity award to the Company’s CEO upon completion of the Company’s IPO and an increase for Board compensation under our non-employee director compensation program, with a partial offset resulting from a decrease in performance-related bonuses.

Net loss: Net loss was $2.1 million for the three-month period ended March 31, 2022, compared to $2.8 million for the three-month period ended March 31, 2021.

On May 13, 2022 PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), a diversified commercial-stage medical technology company, and its majority-owned subsidiary Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid"), a commercial-stage cancer prevention medical diagnostics company, reported that PAVmed and Lucid Chairman & Chief Executive Officer Lishan Aklog, M.D. was selected as one of the Top 50 Healthcare Technology CEOs of 2022 by The Healthcare Technology Report (Press release, PAVmed, MAY 13, 2022, View Source [SID1234614538]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I am so fortunate to work with a rapidly growing team of the best and brightest in the industry, who all share a passion to serve patients through technology and to drive long-term shareholder value through strategic execution."

"I would like to thank The Healthcare Technology Report for this honor," said Dr. Aklog. "I am so fortunate to work with a rapidly growing team of the best and brightest in the industry, who all share a passion to serve patients through technology and to drive long-term shareholder value through strategic execution."

The Healthcare Technology Report described this year’s awardees as "some of the most cultivated, intelligent executives in the healthcare and technology industry." Their "leadership and innovation remain crucial in the development of industry leading medical devices, next generation software platforms, cutting-edge drugs and therapeutics, and advanced diagnostics, among other technologies" all while making "momentous contributions and improvements across the globe."

The editors carefully evaluated hundreds of CEOs across the fields of healthcare, medical devices, biotech, healthcare software, and more. The list includes CEOs from industry leaders such as Medtronic, Edwards Lifesciences and ResMed. Like Dr. Aklog, many of the recipients are founders or co-founders of their organizations.

About Lishan Aklog, M.D.
Dr. Lishan Aklog is Chairman & CEO of PAVmed Inc. (Nasdaq: PAVM), a diversified, commercial-stage medical technology company which he co-founded, and its majority-owned subsidiary Lucid Diagnostics Inc., a cancer prevention medical diagnostics company (Nasdaq: LUCD). He also serves on the board of the leading medtech industry group, AdvaMed, and as an independent public company director. He previously co-founded a medtech holding company which founded four medical device companies and led one of its portfolio companies which commercialized one of his life-saving inventions, AngioVac. Dr. Aklog has consulted for leading medtech companies and is an inventor on dozens of patents. The Healthcare Technology Report previously recognized him as a Top Healthcare Technology CEO of 2021. Prior to entering the life sciences industry as an entrepreneur and executive, Dr. Aklog had a distinguished career as an innovator in cardiac surgery, serving on the faculty of leading academic medical centers including Harvard Medical School and Mount Sinai Medical Center, and in professional society leadership positions. He was recognized as an America’s Top Doctor for over a decade. He received his undergraduate degree in Physics, magna cum laude, and M.D., cum laude, from Harvard University. He completed his training at Harvard teaching hospitals and leading medical centers in London and Paris.

On May 13, 2022 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported recent corporate highlights and financial results for its fiscal second quarter ended March 31, 2022 (Press release, Outlook Therapeutics, MAY 13, 2022, View Source [SID1234616059]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent Corporate Highlights

Successfully submitted a BLA for ONS-5010, an investigational therapy which, if approved, will be branded as LYTENAVA (bevacizumab-vikg), for the treatment of wet age-related macular degeneration (wet AMD);
Expanded commercial team with the appointment of Joel Prieve as Senior Vice President, Commercial Operations, in February 2022; and
Further expanded commercial team with appointment of Alicia Tozier as Senior Vice President, Marketing and Market Access, in March 2022.
"This past quarter was marked by the achievement of the most important milestone to date for Outlook Therapeutics – the submission of our BLA for ONS-5010. In anticipation of potentially providing an on-label, FDA-approved alternative for wet AMD patients in the United States, we are ramping up our pre-commercial launch activities. To support these efforts, we have continued to add to the expertise of our commercial team to build momentum among partners, payors and the retina community. We are focused on positioning ourselves to unlock the full potential of ONS-5010," commented C. Russell Trenary III, President and Chief Executive Officer of Outlook Therapeutics.

ONS-5010 / LYTENAVA (bevacizumab-vikg) Development Updates

Outlook Therapeutics’ wet AMD clinical program for ONS-5010 consists of three completed clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE. With the successful completion of these clinical trials, Outlook Therapeutics submitted its BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in March 2022. If the BLA is approved, it is expected to result in 12 years of marketing exclusivity for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD.

As previously announced, if ONS-5010 receives FDA approval, Outlook Therapeutics plans to submit a supplementary application (sBLA) for approval to provide the product in a pre-filled, silicone oil-liquid free syringe that meets the FDA’s strict specifications for ophthalmic use. To support the anticipated submission of this sBLA, Outlook Therapeutics is conducting its NORSE SEVEN clinical trial to compare the safety of ONS-5010 in vials versus pre-filled syringes. NORSE SEVEN is expected to enroll approximately 120 subjects with visual impairment due to retinal disorders. Patients will be treated for three months and the enrollment of patients in the arm of the study receiving ONS-5010 in vials has already been completed.

Pre-Launch Commercial Planning Underway

According to the National Eye Institute (NEI), use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for at least 50% of all wet AMD injections in the United States each year. Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases.

In anticipation of potential FDA marketing approval in early 2023, Outlook Therapeutics has begun commercial launch planning, including best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Biopharma Services for finished drug product. The Company also is actively building out its distribution and commercial team structures.

To bring ONS-5010 to market in a way that benefits all stakeholders – patients, clinicians and payors – Outlook Therapeutics has been in collaborative discussions with payors and the retina community. Outlook Therapeutics is also developing registration documents on a parallel path for approvals in Europe and expects to submit them in the fourth quarter of calendar 2022. Outlook Therapeutics continues to explore potential strategic commercialization partners, such as the current partnership with Syntone Biopharma JV in China. Outlook Therapeutics expects ONS-5010, if approved, to be a safe and cost-effective choice for patients, clinicians, and payors worldwide for retinal indications.

In addition to the clinical development program evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for a planned registration clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO), NORSE FOUR, and two planned registration clinical trials evaluating the drug candidate for the treatment of diabetic macular edema (DME), NORSE FIVE and NORSE SIX.

Upcoming Anticipated Milestones

Receive PDUFA date from FDA;
Continued progress with ongoing pre-launch commercial preparations in anticipation of potential approval for ONS-5010 in early 2023; and
Completion in calendar 2022 of the NORSE SEVEN study evaluating Outlook Therapeutics’ vial delivery system versus a pre-filled syringe of ONS-5010.
Financial Highlights for the Fiscal Second Quarter Ended March 31, 2022

For the fiscal second quarter ended March 31, 2022, Outlook Therapeutics reported a net loss attributable to common stockholders of $19.7 million, or $0.09 per basic and diluted share, compared to a net loss attributable to common stockholders of $13.1 million, or $0.09 per basic and diluted share, for the same period last year.

At March 31, 2022, Outlook Therapeutics had cash and cash equivalents of $58.4 million, compared to $70.2 million at December 31, 2021. Outlook Therapeutics’ cash and cash equivalents on hand are expected to provide funding into the first calendar quarter of 2023.

"We believe Outlook Therapeutics is in a strong financial position," stated Lawrence A. Kenyon, Chief Financial Officer of Outlook Therapeutics. "We have successfully accessed capital via our ATM program and plan to continue using this financing option, subject to market conditions. Also, we have initiated discussions with the holders of our unsecured notes to extend the maturity of these notes until 2024 after we begin generating revenue from LYTENAVA, if approved. With these steps, we believe we have charted a path that would allow Outlook Therapeutics to launch LYTENAVA without the need to raise significant additional capital."

About ONS-5010 / LYTENAVA (bevacizumab-vikg)

ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 can replace the need to use unapproved repackaged IV bevacizumab from compounding pharmacies for the treatment of wet AMD.

Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

On May 13, 2022 UroGen Pharma Ltd. (Nasdaq: URGN) reported that highlighted four presentations of interest featuring data on JELMYTO (mitomycin) for pyelocalyceal solution for patients with low-grade upper tract urothelial cancer (LG-UTUC) and investigational agent UGN-102 (mitomycin) for intravesical solution in Phase 3 clinical development as primary non-surgical therapy for low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC) at the upcoming 2022 American Urological Association (AUA) Annual Meeting, May 13-16 in New Orleans, Louisiana (Press release, UroGen Pharma, MAY 13, 2022, View Source [SID1234614523]). The presentations will be published in the June 2022 issue of The Journal of Urology and will be accessible via the AUA website.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details on AUA Presentations:

Podium Presentation
Abstract #: PD26-08
Session: Low-grade urothelial carcinoma recurs at a tempo that naturally accelerates from Adagio to Allegro
Presenter: Alex Sankin, M.D., Associate Professor Department of Urology, Albert Einstein College of Medicine
Date and Time: Saturday, May 14, 2022 at 2:10-2:20 PM CT
Location: Room 252

ICU Theater
Session: Chemoablation as primary treatment: Transforming the paradigm for low grade UTUC with JELMYTO
Presenter: Jennifer Linehan, M.D. Associate Professor of Urology and Urologic Oncology at the Saint John’s Cancer Institute
Date and Time: Sunday, May 15, 2022 at 12:00-1:00 PM CT
Location: S&T Hall: Booth 1043

Moderated Poster
Abstract #: MP54-06
Session: Longitudinal Health-Related Quality of Life Outcomes in Adults with Non-Muscle-Invasive Bladder Cancer Receiving a Chemoablative Gel as a Primary Treatment (Optima II: Phase 2b, single arm, open-label trial)
Presenter: Angela Smith, M.D., M.S. Associate Professor at the University of North Carolina (UNC) Department of Urology in Chapel Hill, North Carolina
Date and Time: Monday, May 16, 2022 at 8:45-10:00 AM CT
Location: Room 228

Podium Presentation
Abstract #: PD58-06
Session: Antegrade Administration of Reverse Thermal Mitomycin Gel for Primary Chemoablation of Upper Tract Urothelial Carcinoma via Percutaneous Nephrostomy Tube: a Multi-Institutional Real-World Experience
Presenter: Kyle Rose, M.D., Urologic Oncology Fellow at Moffitt Cancer Center in Tampa, Fla.
Date and Time: Monday, May 16, 2022 at 1:50-2:00 PM CT
Location: Room 252

UroGen will be hosting Booth #837 at the Ernest N. Morial Convention Center during AUA 2022.

About JELMYTO

JELMYTO (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for primary chemoablative treatment of LG UTUC in adults. 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 U.S. Food and Drug Administration. 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.