Risankizumab Achieves Primary and All Secondary Endpoints in Phase 3 Induction Study in Patients With Ulcerative Colitis

A significantly higher proportion of patients with moderately to severely active ulcerative colitis treated with risankizumab achieved the primary endpoint of clinical remission ^a (per Adapted Mayo Score) compared to placebo at week 12 in the Phase 3 INSPIRE induction study
All secondary endpoints, including clinical, endoscopic and histologic outcomes, were met
Safety results in this study were consistent with the known safety profile of risankizumab, with no new safety risks observed ¹
Building on AbbVie's growing gastroenterology portfolio, risankizumab is an IL-23 inhibitor being evaluated as a treatment for adults with moderate to severe ulcerative colitis and approved for Crohn's disease, psoriatic arthritis, and psoriasis ¹

ABBVie (NYSE: ABBV) today announced positive top-line results from INSPIRE, a Phase 3 induction study, showing risankizumab (SKYRIZI ® ,1200 mg intravenous [IV], at weeks 0, 4 and 8) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 12, as well as all secondary endpoints in adult patients with moderately to severely active ulcerative colitis. 1 In the study, 20.3% of patients receiving risankizumab achieved clinical remission compared to 6.2% of patients receiving placebo (p

"Our commitment to people living with gastroenterological conditions continues to grow," said Roopal Thakkar , M.D., senior vice president, development, regulatory affairs and chief medical officer, AbbVie. "These encouraging results help support the potential risankizumab has to improve clinical, endoscopic and histologic outcomes in patients with ulcerative colitis."

A significantly greater proportion of patients treated with risankizumab achieved endoscopic improvement at week 12 compared to placebo (36.5% vs 12.1%; p 1 Furthermore, 24.5% of patients treated with risankizumab achieved histologic-endoscopic mucosal improvement at week 12 vs 7.7% of those receiving placebo (p 1

"It is impressive to see the meaningful responses that were achieved in the INSPIRE study, which demonstrates the potential of risankizumab to serve as an option across inflammatory bowel diseases," said Edouard Louis , M.D., Ph.D., professor and head of the department of gastroenterology, University Hospital CHU of Liège Belgium , INSPIRE study investigator. "These results suggest that risankizumab may help patients coping with the challenging symptoms of ulcerative colitis, which include abdominal pain, bowel urgency and fecal incontinence."

*Efficacy Results at Week 12 ^,**¹
	Risankizumab 1200 mg IV (n=650)	Placebo (n=325)
Clinical Remission (Adapted Mayo Score) ^a	20.3 %	6.2 %
Clinical Response (Adapted Mayo Score) ^b	64.3 %	35.7 %
Endoscopic Improvement ^c	36.5 %	12.1 %
Histologic-Endoscopic Mucosal Improvement ^d	24.5 %	7.7 %

^* Primary endpoint was clinical remission (per Adapted Mayo Score). Clinical response (per Adapted Mayo Score), endoscopic improvement and histologic-endoscopic mucosal improvement were secondary endpoints. Not all secondary endpoints are shown. All primary and secondary endpoints in this study achieved statistical significance under the overall type I error rate at 0.05 (2-sided).

^a Clinical remission per Adapted Mayo Score is defined as stool frequency subscore (SFS) ≤1 and not greater than baseline, rectal bleeding subscore (RBS) of 0 and endoscopic subscore ≤1 without friability.

^b Clinical response per Adapted Mayo Score is defined as a decrease from baseline in the Adapted Mayo score ≥2 points and ≥30% from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1.

^c Endoscopic improvement is defined as endoscopic subscore ≤1 without friability.

^d Histologic-endoscopic mucosal improvement is defined as Geboes score ≤3.1 and endoscopic subscore ≤1 without friability.

During the 12-week, double-blind, placebo-controlled period, the safety profile of risankizumab 1200 mg IV was consistent with the safety profile observed in previous studies across other indications, with no new safety risks observed. ¹ The most common adverse events observed in the risankizumab group were COVID-19, anemia and arthralgia. Serious adverse events occurred in 2.3% of patients in the risankizumab 1200 mg IV group compared to 10.2% of patients in the placebo group. ¹ Rates of serious infections were 0.6% in those treated with risankizumab 1200 mg IV and 1.2% in patients who received placebo. ¹ There was one death in the risankizumab 1200 mg group due to COVID-19 pneumonia on study day 33. There were no adjudicated major adverse cardiac events (MACE), no adjudicated anaphylactic reaction events and no malignancy events reported in the risankizumab group. ¹

Use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities. The maintenance study for ulcerative colitis is ongoing.

Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

About Ulcerative Colitis

Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon. ^2,3 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence. ^3,4 The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or complications, including cancer or death. ^4,5 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease. ⁶

About INSPIRE ¹

INSPIRE is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of risankizumab 1200 mg IV administered every four weeks as induction therapy in subjects with moderately to severely active ulcerative colitis.

The primary endpoint is clinical remission (per adapted Mayo Score , defined as SFS ≤1 and not greater than baseline, RBS of 0 and endoscopic subscore ≤1 without friability) at week 12. Secondary endpoints include clinical response (decrease from baseline in the Adapted Mayo score ≥2 points and ≥30% from baseline, plus a decrease in RBS ≥1 or an absolute RBS ≤1), endoscopic improvement (endoscopic subscore ≤1 without friability), and histologic endoscopic mucosal improvement (HEMI, endoscopic subscore of 0 or 1 without friability and Geboes score ≤3.1) at week 12. More information can be found on www.clinicaltrials.gov (NCT03398148).

About Risankizumab (SKYRIZI ^® )

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. ⁷ IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases. ⁸ SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis and Crohn's disease. Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing. ^8,9,10

U.S. Indications and Important Safety Information about SKYRIZI ^® (risankizumab-rzaa) ¹¹ SKYRIZI is a prescription medicine used to treat adults with:

moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
active psoriatic arthritis (PsA).
moderate to severe Crohn's disease.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)?

SKYRIZI is a prescription medication that may cause serious side effects, including:

Serious Allergic Reactions:
Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:

Fainting, dizziness, feeling lightheaded (low blood pressure)
Swelling of your face, eyelids, lips, mouth, tongue, or throat
Trouble breathing or throat tightness
Chest tightness
Skin rash, hives
Itching

Infections: SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.

Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:

fever, sweats, or chills
muscle aches
weight loss
cough
warm, red, or painful skin or sores on your body different from your psoriasis
diarrhea or stomach pain
shortness of breath
blood in your mucus (phlegm)
burning when you urinate or urinating more often than normal

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you:

have any of the conditions or symptoms listed in the section " What is the most important information I should know about SKYRIZI? "
have an infection that does not go away or that keeps coming back.
have TB or have been in close contact with someone with TB.
have recently received or are scheduled to receive an immunization (vaccine). Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine.
are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.
become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?"

Liver problems in people with Crohn's disease: A person with Crohn's disease who received SKYRIZI by intravenous infusion developed changes in liver blood tests with a rash that led to hospitalization. Your doctor will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with SKYRIZI if you develop liver problems. Tell your doctor right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach(abdominal) pain, tiredness(fatigue), loss of appetite, yellowing of the skin and eyes (jaundice) and dark urine.

The most common side effects of SKYRIZI in people treated for Crohn's Disease include : upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, and urinary tract infection.

The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections.

These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects.

Use SKYRIZI exactly as your healthcare provider tells you to use it.

SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a 600mg/10mL intravenous infusion, and a 360mg/2.4mL single-dose prefilled cartridge with on-body injector.

This is the most important information to know about SKYRIZI. For more information, talk to your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click here for Full Prescribing Information and Medication Guide for SKYRIZI.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Gastroenterology

With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html .

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , LinkedIn or Instagram .

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

AbbVie. Data on file: ABVRRTI75696.
Gajendran M, Loganathan P, Jimenez G, et al. A comprehensive review and update on ulcerative colitis. Dis Mon . 2019 Dec;65(12):100851. doi: 10.1016/j.disamonth.2019.02.004
The facts about inflammatory bowel diseases. Crohn's & Colitis Foundation of America. Accessed March 8 , 2023. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
Ulcerative colitis. Mayo Clinic. Accessed March 3, 2023 . https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326
Monstad, I, Hovde O, Solberg IC, A Moum B. Clinical course and prognosis in ulcerative colitis: results from population-based and observational studies. Ann Gastroenterol . 2014; 27(2): 95–104.
Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care . 2016;22(3 Suppl):s51-60.
Duvallet E, Sererano L, Assier E, Falgarone G, Boissier MC. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med . 2011;43(7):503-11. doi:10.3109/07853890.2011.577093
Pipeline. AbbVie. 2021. Accessed March 3, 2023 . https://www.abbvie.com/our-science/pipeline.html
A study comparing risankizumab to placebo in participants with active psoriatic arthritis including those who have a history of inadequate response or intolerance to biologic therapy(ies) (KEEPsAKE2). ClinicalTrials.gov. Updated February 28, 2023 . Accessed March 3, 2023 . https://clinicaltrials.gov/ct2/show/NCT03671148
A multicenter, randomized, double-blind, placebo controlled induction study to evaluate the efficacy and safety of risankizumab in participants with moderately to severely active ulcerative colitis. ClinicalTrials.gov. Updated March 10, 2023 . Accessed March 12, 2023 . https://clinicaltrials.gov/ct2/show/record/NCT03398148
SKYRIZI [package insert]. North Chicago, IL : AbbVie Inc.; 2022.

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Health Canada Approves AbbVie's RINVOQ® for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis

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AbbVie (NYSE: ABBV), today announced that Health Canada has approved RINVOQ ® (upadacitinib, 15 mg), the first oral, once-daily selective and reversible JAK inhibitor for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have had an inadequate response to a biologic disease modifying anti-rheumatic drug (DMARD) or when use of those therapies is inadvisable.

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European Medicines Agency (EMA) has adopted a positive opinion
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(NASDAQ: BIIB) and AbbVie (NYSE:
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subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
“For people with relapsing forms of MS (RMS) and active disease,
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profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
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action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
“Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
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About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of 1995.
The words “believe,” “expect,” “anticipate,” “project” and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie’s operations is
set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent events
or developments, except as required by law.

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Abstract Title	Presentation Details All times CDT
Crohn's Disease
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Safety Profile of Risankizumab in Crohn's Disease Patients by Age: Post-hoc Analysis of the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies	Poster #Tu1717 IBD: Controlled Clinical Trials in Humans (Poster Session) May 9, 2023 12:30 – 1:30 PM
Functional Constipation
Efficacy and Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: a Phase 3 Pivotal Randomized Placebo-Controlled Trial	Oral Presentation: #145 AGA Pediatric Functional and Motility Disorders (Research Forum) May 6, 2023 10:15 – 10:30 AM
Time to Response of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: Data from a Phase 3 Randomized Placebo-Controlled Trial	Poster #Mo2008 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Efficacy of Linaclotide in Treating Symptoms of Incomplete Evacuation and Straining in Pediatric Patients with Functional Constipation	Poster #Mo2007 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Long-term Safety of Linaclotide in Treating Functional Constipation in Pediatric Patients aged 6-17 years: Interim Analysis of an Open Label, Phase 3, Extension Trial	Poster #Mo2016 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Safety of Linaclotide in Pediatric Patients with Functional Constipation: A Pooled Analysis of Placebo-Controlled, Randomized Controlled Trials	Poster #Mo2015 AGA Pediatric Functional and Motility Disorders (Poster Session) May 8, 2023 12:30 – 1:30 PM
Exocrine Pancreatic Insufficiency
Development, Generalizability of a Clinical Screening Tool for Exocrine Pancreatic Insufficiency (EPI) in Patients with Definite Chronic Pancreatitis	Poster #Mo1419 AGA Exocrine Pancreatic Diseases and Diabetes (Poster Session) May 8, 2023 12:30 – 1:30 PM
Disease State
Patients with Crohn's Disease and Ulcerative Colitis Cycle Through Multiple Medications Prior To Starting Advanced Therapy: A Retrospective Study	Poster #Sa1814 May 6, 2023 12:30 – 1:30 PM
Food Security in Hispanics with IBD: A Barrier to Dietary Management	Poster #EP141 AGA Diet and IBD (ePoster section) May 6, 2023 9:30 AM – 4:00 PM
Incidence Rates of Gastrointestinal Perforation Among Patients with Inflammatory Bowel Disease: Real-world Evidence from a Large US Nationwide Claims Database	Poster #Su1769 IBD: Diagnostics in IBD (Poster Section) May 7, 2023 12:30 – 1:30 PM

Risankizumab Achieves Primary and All Secondary Endpoints in Phase 3 Induction Study in Patients With Ulcerative Colitis

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1. Vertex Pharmaceuticals (NASDAQ:VRTX)

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5. BioNTech (NASDAQ:BNTX)

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