FDA9/10/2007, 5:30:00 AM
Anda approvalFDA10/22/2007, 5:30:00 AM
Anda approvalFDA3/14/2008, 5:30:00 AM
Anda approvalFDA3/18/2008, 5:30:00 AM
Anda approvalFDA9/10/2008, 5:30:00 AM
Anda approvalFDA9/19/2008, 5:30:00 AM
Anda approvalFDA10/6/2008, 5:30:00 AM
Anda approvalFDA3/9/2009, 5:30:00 AM
Anda approvalFDA3/27/2009, 5:30:00 AM
Anda approvalFDA6/17/2009, 5:30:00 AM
Anda approvalFDA7/6/2009, 5:30:00 AM
Anda approvalFDA7/31/2009, 5:30:00 AM
Anda approvalFDA8/7/2009, 5:30:00 AM
Anda approvalFDA9/30/2009, 5:30:00 AM
Anda approvalFDA9/30/2009, 5:30:00 AM
Anda approvalFDA11/5/2009, 5:30:00 AM
Anda approvalFDA11/17/2009, 5:30:00 AM
FDA approvalFDA4/6/2010, 5:30:00 AM
Anda approvalFDA5/5/2010, 5:30:00 AM
Anda approvalFDA6/17/2010, 5:30:00 AM
Anda approvalFDA6/21/2010, 5:30:00 AM
Anda approvalFDA8/18/2010, 5:30:00 AM
Anda approvalFDA11/15/2010, 5:30:00 AM
Anda approvalFDA2/2/2011, 5:30:00 AM
Anda approvalFDA5/3/2011, 5:30:00 AM
FDA approvalFDA6/21/2011, 5:30:00 AM
Anda approvalFDA7/18/2011, 5:30:00 AM
Anda approvalFDA7/25/2011, 5:30:00 AM
Anda approvalFDA7/26/2011, 5:30:00 AM
Anda approvalFDA8/16/2011, 5:30:00 AM
Anda approvalFDA8/30/2011, 5:30:00 AM
Anda approvalFDA10/28/2011, 5:30:00 AM
Anda approvalFDA12/7/2011, 5:30:00 AM
Anda approvalFDA12/30/2011, 5:30:00 AM
Anda approvalFDA2/24/2012, 5:30:00 AM
Anda approvalFDA3/27/2012, 5:30:00 AM
Anda approvalFDA5/10/2012, 5:30:00 AM
Anda approvalFDA5/17/2012, 5:30:00 AM
Anda approvalFDA5/23/2012, 5:30:00 AM
Anda approvalFDA7/13/2012, 5:30:00 AM
FDA label expansionFDA7/16/2012, 5:30:00 AM
Anda approvalFDA1/31/2013, 5:30:00 AM
Anda approvalFDA2/4/2013, 5:30:00 AM
Anda approvalFDA3/18/2013, 5:30:00 AM
Anda approvalFDA4/3/2013, 5:30:00 AM
Anda approvalFDA7/1/2013, 5:30:00 AM
Anda approvalFDA9/9/2013, 5:30:00 AM
Anda approvalFDA9/13/2013, 5:30:00 AM
Anda approvalFDA9/13/2013, 5:30:00 AM
Anda approvalFDA12/11/2013, 5:30:00 AM
Anda approvalFDA12/23/2013, 5:30:00 AM
Anda approvalFDA1/23/2014, 5:30:00 AM
FDA approvalFDA1/28/2014, 5:30:00 AM
FDA approvalFDA2/12/2014, 5:30:00 AM
Anda approvalFDA2/14/2014, 5:30:00 AM
Anda approvalFDA4/8/2014, 5:30:00 AM
Anda approvalFDA4/23/2014, 5:30:00 AM
Anda approvalFDA4/23/2014, 5:30:00 AM
Anda approvalFDA6/10/2014, 5:30:00 AM
Anda approvalFDA7/18/2014, 5:30:00 AM
FDA label expansionFDA7/18/2014, 5:30:00 AM
FDA label expansionFDA9/11/2014, 5:30:00 AM
Anda approvalFDA9/16/2014, 5:30:00 AM
FDA label expansionFDA10/30/2014, 5:30:00 AM
FDA label expansionFDA12/18/2014, 5:30:00 AM
Anda approvalFDA1/29/2015, 5:30:00 AM
Anda approvalFDA5/21/2015, 5:30:00 AM
Anda approvalFDA6/5/2015, 5:30:00 AM
Anda approvalFDA7/24/2015, 5:30:00 AM
FDA approvalFDA8/17/2015, 5:30:00 AM
Anda approvalFDA11/30/2015, 5:30:00 AM
Anda approvalFDA12/3/2015, 5:30:00 AM
Anda approvalFDA12/30/2015, 5:30:00 AM
Anda approvalFDA1/29/2016, 5:30:00 AM
Anda approvalFDA2/17/2016, 5:30:00 AM
FDA label expansionFDA4/8/2016, 5:30:00 AM
FDA approvalFDA4/20/2016, 5:30:00 AM
Anda approvalFDA5/12/2016, 5:30:00 AM
FDA label expansionFDA7/19/2016, 5:30:00 AM
Anda approvalFDA8/1/2016, 5:30:00 AM
Anda approvalFDA8/5/2016, 5:30:00 AM
Anda approvalFDA9/28/2016, 5:30:00 AM
Anda approvalFDA1/3/2017, 5:30:00 AM
Anda approvalFDA1/4/2017, 5:30:00 AM
FDA label expansionFDA1/24/2017, 5:30:00 AM
Anda approvalFDA6/8/2017, 5:30:00 AM
Anda approvalFDA7/21/2017, 5:30:00 AM
Anda approvalFDA8/7/2017, 5:30:00 AM
Anda approvalFDA9/7/2017, 5:30:00 AM
Anda approvalFDA9/18/2017, 5:30:00 AM
FDA label expansionFDA11/16/2017, 5:30:00 AM
Anda approvalFDA12/19/2017, 5:30:00 AM
FDA label expansionFDA4/6/2018, 5:30:00 AM
Anda approvalFDA4/16/2018, 5:30:00 AM
Anda approvalFDA4/30/2018, 5:30:00 AM
Anda approvalFDA5/22/2018, 5:30:00 AM
FDA approvalFDA7/16/2018, 5:30:00 AM
FDA approvalFDA7/20/2018, 5:30:00 AM
Anda approvalFDA8/14/2018, 5:30:00 AM
FDA approvalFDA8/21/2018, 5:30:00 AM
Anda approvalFDA9/12/2018, 5:30:00 AM
FDA approvalFDA10/9/2018, 5:30:00 AM
Anda approvalFDA10/11/2018, 5:30:00 AM
Anda approvalFDA10/12/2018, 5:30:00 AM
Anda approvalFDA11/5/2018, 5:30:00 AM
Anda approvalFDA11/26/2018, 5:30:00 AM
Anda approvalFDA11/30/2018, 5:30:00 AM
Anda approvalFDA12/18/2018, 5:30:00 AM
FDA approvalFDA1/4/2019, 5:30:00 AM
Anda approvalFDA1/7/2019, 5:30:00 AM
Anda approvalFDA1/8/2019, 5:30:00 AM
FDA label expansionFDA1/25/2019, 5:30:00 AM
Anda approvalFDA2/6/2019, 5:30:00 AM
Anda approvalFDA2/15/2019, 5:30:00 AM
Anda approvalFDA2/21/2019, 5:30:00 AM
Anda approvalFDA3/13/2019, 5:30:00 AM
Anda approvalFDA3/26/2019, 5:30:00 AM
Anda approvalFDA3/27/2019, 5:30:00 AM
FDA label expansionFDA3/28/2019, 5:30:00 AM
Anda approvalFDA4/24/2019, 5:30:00 AM
Anda approvalFDA4/26/2019, 5:30:00 AM
Anda approvalFDA5/1/2019, 5:30:00 AM
Anda approvalFDA5/13/2019, 5:30:00 AM
FDA label expansionFDA5/21/2019, 5:30:00 AM
Anda approvalFDA5/22/2019, 5:30:00 AM
FDA label expansionFDA5/28/2019, 5:30:00 AM
Anda approvalFDA6/21/2019, 5:30:00 AM
Anda approvalFDA7/1/2019, 5:30:00 AM
Anda approvalFDA7/9/2019, 5:30:00 AM
Anda approvalFDA7/19/2019, 5:30:00 AM
FDA approvalFDA7/23/2019, 5:30:00 AM
Anda approvalFDA8/19/2019, 5:30:00 AM
Anda approvalFDA8/29/2019, 5:30:00 AM
FDA approvalFDA9/20/2019, 5:30:00 AM
FDA label expansionFDA11/5/2019, 5:30:00 AM
FDA approvalFDA11/5/2019, 5:30:00 AM
Anda approvalFDA11/14/2019, 5:30:00 AM
Anda approvalFDA11/20/2019, 5:30:00 AM
Anda approvalFDA11/20/2019, 5:30:00 AM
Anda approvalFDA11/29/2019, 5:30:00 AM
Anda approvalFDA12/4/2019, 5:30:00 AM
Anda approvalFDA12/10/2019, 5:30:00 AM
FDA label expansionFDA12/26/2019, 5:30:00 AM
Anda approvalFDA1/2/2020, 5:30:00 AM
Anda approvalFDA1/8/2020, 5:30:00 AM
FDA label expansionFDA1/9/2020, 5:30:00 AM
Anda approvalFDA2/3/2020, 5:30:00 AM
FDA label expansionFDA2/25/2020, 5:30:00 AM
FDA label expansionFDA4/17/2020, 5:30:00 AM
FDA label expansionFDA5/4/2020, 5:30:00 AM
Anda approvalFDA5/21/2020, 5:30:00 AM
FDA label expansionFDA6/15/2020, 5:30:00 AM
Anda approvalFDA6/24/2020, 5:30:00 AM
FDA label expansionFDA6/30/2020, 5:30:00 AM
Anda approvalFDA8/26/2020, 5:30:00 AM
FDA approvalFDA9/16/2020, 5:30:00 AM
FDA label expansionFDA9/17/2020, 5:30:00 AM
FDA label expansionFDA9/25/2020, 5:30:00 AM
FDA label expansionFDA10/26/2020, 5:30:00 AM
Anda approvalFDA11/30/2020, 5:30:00 AM
Anda approvalFDA12/21/2020, 5:30:00 AM
FDA label expansionFDA12/31/2020, 5:30:00 AM
Anda approvalFDA1/15/2021, 5:30:00 AM
Anda approvalFDA1/29/2021, 5:30:00 AM
Anda approvalFDA2/1/2021, 5:30:00 AM
FDA label expansionFDA2/18/2021, 5:30:00 AM
Anda approvalFDA2/26/2021, 5:30:00 AM
Anda approvalFDA4/13/2021, 5:30:00 AM
Anda approvalFDA4/14/2021, 5:30:00 AM
Anda approvalFDA7/1/2021, 5:30:00 AM
Anda approvalFDA7/23/2021, 5:30:00 AM
FDA label expansionFDA8/16/2021, 5:30:00 AM
Anda approvalFDA1/28/2022, 5:30:00 AM
FDA label expansionFDA3/17/2022, 5:30:00 AM
Anda approvalFDA3/18/2022, 5:30:00 AM
FDA label expansionFDA3/24/2022, 5:30:00 AM
FDA label expansionFDA4/7/2022, 5:30:00 AM
FDA label expansionFDA5/11/2022, 5:30:00 AM
Anda approvalFDA5/26/2022, 5:30:00 AM
Anda approvalFDA8/30/2022, 5:30:00 AM
Anda approvalFDA9/30/2022, 5:30:00 AM
Anda approvalFDA10/7/2022, 5:30:00 AM
Anda approvalFDA12/9/2022, 5:30:00 AM
FDA label expansionFDA2/8/2023, 5:30:00 AM
Anda approvalFDA3/6/2023, 5:30:00 AM
Anda approvalFDA3/9/2023, 5:30:00 AM
FDA label expansionFDA5/2/2023, 5:30:00 AM
Anda approvalFDA7/18/2023, 5:30:00 AM
FDA label expansionFDA7/31/2023, 5:30:00 AM
Anda approvalFDA7/31/2023, 5:30:00 AM
Anda approvalFDA8/4/2023, 5:30:00 AM
FDA label expansionFDA8/4/2023, 5:30:00 AM
FDA label expansionFDA8/4/2023, 5:30:00 AM
FDA label expansionFDA8/4/2023, 5:30:00 AM
FDA label expansionFDA8/4/2023, 5:30:00 AM
FDA label expansionFDA8/4/2023, 5:30:00 AM
FDA label expansionFDA8/9/2023, 5:30:00 AM
Anda approvalFDA8/18/2023, 5:30:00 AM
FDA label expansionFDA8/18/2023, 5:30:00 AM
FDA label expansionFDA8/22/2023, 5:30:00 AM
FDA label expansionFDA8/22/2023, 5:30:00 AM
FDA label expansionFDA10/19/2023, 5:30:00 AM
Anda approvalFDA3/20/2024, 5:30:00 AM
FDA label expansionFDA9/24/2024, 5:30:00 AM
FDA label expansionFDA9/27/2024, 5:30:00 AM
FDA approvalFDA10/9/2024, 5:30:00 AM
FDA label expansionFDA2/12/2025, 5:30:00 AM
FDA label expansionFDA2/20/2025, 5:30:00 AM
Anda approvalFDA3/18/2025, 5:30:00 AM
Anda approvalFDA8/26/2025, 5:30:00 AM
Anda approvalFDA4/6/2026, 5:30:00 AM
Anda approvalFDA5/13/2026, 5:30:00 AM
FDA label expansionFDA6/3/2026, 5:30:00 AM
Anda approvalBSE6/11/2026, 2:30:00 PM
Dividend actionBSE6/11/2026, 8:01:46 PM
Dividend actionBSE6/12/2026, 4:26:47 AM
Dividend actionFDA6/12/2026, 5:30:00 AM
FDA label expansionBSE6/20/2026, 5:30:00 PM
Ma announcedBSE6/20/2026, 10:53:15 PM
Ma announcedBSE7/10/2026, 9:17:59 PM
Earnings releaseBSE7/15/2026, 12:03:38 AM
Earnings releaseBSE7/24/2026, 2:20:33 PM
Ma announcedBSE7/27/2026, 9:30:08 PM
BSE announcement materialBSE7/30/2026, 3:30:17 AM
Anda approvalBSE7/31/2026, 7:58:56 PM
Earnings releaseBSE7/31/2026, 11:30:00 PM
Earnings releaseBSE7/31/2026, 11:49:07 PM
BSE announcement materialBSE8/1/2026, 1:41:25 AM
Earnings releaseBSE8/1/2026, 2:04:19 AM
BSE announcement materialBSE8/6/2026, 10:34:30 PM
Earnings releaseBSE8/7/2026, 2:04:51 AM
BSE announcement materialFDA8/11/2026, 5:30:00 AM
FDA label expansionFDA8/11/2026, 5:30:00 AM
FDA label expansionCTGOV8/23/2026, 5:05:40 AM
Trial registeredCTGOV8/23/2026, 5:05:41 AM
Trial registeredCTGOV8/23/2026, 5:05:41 AM
Trial registeredCTGOV8/23/2026, 5:05:42 AM
Trial registeredCTGOV8/23/2026, 5:05:47 AM
Trial registeredCTGOV8/23/2026, 5:05:47 AM
Trial registeredCTGOV8/23/2026, 5:05:48 AM
Trial registeredCTGOV8/23/2026, 5:05:48 AM
Trial registeredCTGOV8/23/2026, 5:05:49 AM
Trial registeredCTGOV8/23/2026, 5:05:49 AM
Trial registeredCTGOV8/23/2026, 5:05:50 AM
Trial registeredCTGOV8/23/2026, 5:05:50 AM
Trial registeredCTGOV8/23/2026, 5:05:51 AM
Trial registeredCTGOV8/23/2026, 5:05:53 AM
Trial registeredCTGOV8/23/2026, 5:05:54 AM
Trial registeredCTGOV8/23/2026, 5:05:57 AM
Trial registeredCTGOV8/23/2026, 5:05:57 AM
Trial registeredCTGOV8/23/2026, 5:05:58 AM
Trial registeredCTGOV8/23/2026, 5:05:58 AM
Trial registeredCTGOV8/23/2026, 5:05:59 AM
Trial registeredCTGOV8/23/2026, 5:05:59 AM
Trial registeredCTGOV8/23/2026, 5:06:00 AM
Trial registeredCTGOV8/23/2026, 5:06:00 AM
Trial registeredCTGOV8/23/2026, 5:06:03 AM
Trial registeredCTGOV8/23/2026, 5:06:03 AM
Trial registeredCTGOV8/23/2026, 5:06:04 AM
Trial registeredCTGOV8/23/2026, 5:06:08 AM
Trial registeredCTGOV8/23/2026, 5:06:08 AM
Trial registeredCTGOV8/23/2026, 5:06:09 AM
Trial registeredCTGOV8/23/2026, 5:06:09 AM
Trial registeredCTGOV8/23/2026, 5:06:10 AM
Trial registeredCTGOV8/23/2026, 5:06:10 AM
Trial registeredCTGOV8/23/2026, 5:06:11 AM
Trial registeredCTGOV8/23/2026, 5:06:13 AM
Trial registeredCTGOV8/23/2026, 5:06:13 AM
Trial registeredCTGOV8/23/2026, 5:06:14 AM
Trial registeredCTGOV8/23/2026, 5:06:14 AM
Trial registeredCTGOV8/23/2026, 5:06:19 AM
Trial registeredCTGOV8/23/2026, 5:06:19 AM
Trial registeredCTGOV8/23/2026, 5:06:20 AM
Trial registeredCTGOV8/23/2026, 5:06:20 AM
Trial registeredCTGOV8/23/2026, 5:06:21 AM
Trial registeredCTGOV8/23/2026, 5:06:21 AM
Trial registeredCTGOV8/23/2026, 5:06:23 AM
Trial registeredCTGOV8/23/2026, 5:06:24 AM
Trial registeredCTGOV8/23/2026, 5:06:24 AM
Trial registeredCTGOV8/23/2026, 5:06:25 AM
Trial registeredCTGOV8/23/2026, 5:06:25 AM
Trial registeredCTGOV8/23/2026, 5:06:28 AM
Trial registeredFDA8/26/2026, 5:30:00 AM
FDA approvalCTGOV8/30/2026, 5:09:58 AM
Trial registeredCTGOV8/30/2026, 5:10:02 AM
Trial registeredCTGOV8/30/2026, 5:10:03 AM
Trial registeredCTGOV8/30/2026, 5:10:03 AM
Trial registeredCTGOV8/30/2026, 5:10:04 AM
Trial registeredCTGOV8/30/2026, 5:10:04 AM
Trial registeredCTGOV8/30/2026, 5:10:05 AM
Trial registeredCTGOV8/30/2026, 5:10:05 AM
Trial registeredCTGOV8/30/2026, 5:10:06 AM
Trial registeredCTGOV8/30/2026, 5:10:08 AM
Trial registeredCTGOV8/30/2026, 5:10:08 AM
Trial registeredCTGOV8/30/2026, 5:10:14 AM
Trial registeredCTGOV8/30/2026, 5:10:14 AM
Trial registeredCTGOV8/30/2026, 5:10:15 AM
Trial registeredCTGOV8/30/2026, 5:10:15 AM
Trial registeredCTGOV8/30/2026, 5:10:16 AM
Trial registeredCTGOV8/30/2026, 5:10:17 AM
Trial registeredMARKET8/31/2026, 5:30:00 AM
Unusual moveMARKET8/31/2026, 5:30:00 AM
Unusual moveCTGOV9/2/2026, 5:09:57 AM
Trial eligibility change| eligibility_criteria | Inclusion Criteria:
1. Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines
2. Age ≥ 18 years of age at the time of signing consent
3. Diagnosis of moderate to severe psoriasis of the genital area at Screening and baseline defined as modified sPGA-G score of ≥3.
4. Presence of non-genital plaque psoriasis (BSA ≥1%) at both Screening and Baseline.
5. Presence of psoriasis of the genital area that is inadequately controlled with topical therapy or the subject is intolerant to topical therapy
6. Negative evaluation for TB within 4 weeks before initiating IMP, defined as a negative QuantiFERON test. Subjects with a positive QuantiFERON test or 2 successive indeterminate
QuantiFERON tests are allowed if they have all of the following:
* no history of active tuberculosis (TB) or symptoms of TB,
* a posteroanterior chest radiograph (with associated report available at the site) performed within 3 months of Screening with no evidence of active TB ( or of any other pulmonary infectious diseases),
* if prior latent TB infection, must have history of adequate prophylaxis (per local standard of care),
* if presence of latent TB is established, then treatment according to local country guidelines must have been followed for 4 weeks, prior to dosing in the study at Visit 2-Week 0.
A maximum of 2 QuantiFERON tests of no more than 3 weeks apart are allowed. A re-test is only permitted if the first is indeterminate; the result of the second test will then be used
Exclusion Criteria:
1. Predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis.
2. Planned surgical intervention between Baseline and the Week 16 evaluation for a pre-treatment condition.
3. Active infection or history of infections as follows:
* any active infection (bacterial, fungal or viral) for which systemic anti-infectives were used within 28 days prior to first investigational medicinal product (IMP) dose, with the last dose having been received within 7 days of Screening,
* a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infectives within 8 weeks prior to the first IMP dose, with the last dose having been received within 7 days of Screening,
* recurrent or chronic infections, e.g., chronic pyelonephritis, chronic osteomyelitis, bronchiectasis, or other active infection that, in the opinion of the Investigator, might cause participation in this study to be detrimental to the subject.
4. Any concurrent medical condition or uncontrolled, clinically significant systemic disease ( e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could jeopardize subject safety or compliance with the protocol. |
CTGOV9/2/2026, 5:09:57 AM
Trial endpoint change| primary_outcomes | [object Object] | → | [object Object] |
CTGOV9/4/2026, 11:39:34 AM
Trial registeredCTGOV9/4/2026, 11:39:34 AM
Trial registeredCTGOV9/4/2026, 11:39:35 AM
Trial registeredCTGOV9/4/2026, 11:39:35 AM
Trial registeredCTGOV9/4/2026, 11:39:36 AM
Trial registeredCTGOV9/4/2026, 11:39:36 AM
Trial registeredCTGOV9/4/2026, 11:39:37 AM
Trial registeredCTGOV9/4/2026, 11:39:37 AM
Trial registeredCTGOV9/4/2026, 11:39:38 AM
Trial registeredCTGOV9/4/2026, 11:39:38 AM
Trial registeredCTGOV9/4/2026, 11:39:42 AM
Trial registeredCTGOV9/4/2026, 11:39:43 AM
Trial registeredCTGOV9/4/2026, 11:39:43 AM
Trial registeredCTGOV9/4/2026, 11:39:44 AM
Trial registeredMARKET9/18/2026, 5:30:00 AM
Unusual moveNSE9/28/2026, 8:20:40 AM
Licensing dealNSE10/1/2026, 5:47:03 PM
Phase3 readout positiveNSE10/12/2026, 8:05:00 PM
Board changeNSE10/12/2026, 8:34:43 PM
Executive departureNSE10/13/2026, 5:54:34 PM
BSE announcement materialNSE10/26/2026, 12:30:34 PM
Debt issuance