Arcutis Biotherapeutics' supplemental NDA for Zoryve (roflumilast) cream 0.3% to treat plaque psoriasis in children ages 2–5 carries an 83.5% market-implied approval probability ahead of its June 29, 2026 PDUFA target date. The FDA accepted the filing in November 2025 with no apparent safety or efficacy issues flagged. Traders point to Arcutis' recent success securing multiple Zoryve label expansions, including atopic dermatitis clearance for the identical pediatric cohort in October 2025 and prior psoriasis approvals down to age 6. Supporting Phase 3 data, the drug's established topical PDE4 mechanism, and lack of competing red flags underpin the strong consensus, though standard FDA review risks such as labeling negotiations remain until the decision window closes.
Polymarket डेटा का संदर्भ देने वाला प्रयोगात्मक AI-जनरेटेड सारांश। यह ट्रेडिंग सलाह नहीं है और इस बाज़ार के समाधान में कोई भूमिका नहीं निभाता। · अपडेट किया गयाहाँ
$4,981 वॉल्यूम
$4,981 वॉल्यूम
29 जून, 2026
हाँ
$4,981 वॉल्यूम
$4,981 वॉल्यूम
29 जून, 2026
As of market creation, the FDA's expected decision date for the specified application is June 29, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Arcutis's Zoryve cream as a treatment for plaque psoriasis in children aged 2 to 5 by July 13, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application
The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.
If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.Arcutis Biotherapeutics' supplemental NDA for Zoryve (roflumilast) cream 0.3% to treat plaque psoriasis in children ages 2–5 carries an 83.5% market-implied approval probability ahead of its June 29, 2026 PDUFA target date. The FDA accepted the filing in November 2025 with no apparent safety or efficacy issues flagged. Traders point to Arcutis' recent success securing multiple Zoryve label expansions, including atopic dermatitis clearance for the identical pediatric cohort in October 2025 and prior psoriasis approvals down to age 6. Supporting Phase 3 data, the drug's established topical PDE4 mechanism, and lack of competing red flags underpin the strong consensus, though standard FDA review risks such as labeling negotiations remain until the decision window closes.
As of market creation, the FDA's expected decision date for the specified application is June 29, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Arcutis's Zoryve cream as a treatment for plaque psoriasis in children aged 2 to 5 by July 13, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application
The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.
If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Arcutis's Zoryve cream as a treatment for plaque psoriasis in children aged 2 to 5 by July 13, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application
The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.
If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
बाज़ार खुला: Jun 4, 2026, 3:38 PM ET
वॉल्यूम
$4,981समाप्ति तिथि
29 जून, 2026बाज़ार खुला
Jun 4, 2026, 3:38 PM ETResolver
0x65070BE91...परिणाम प्रस्तावित: हाँ
कोई विवाद नहीं
अंतिम परिणाम: हाँ
As of market creation, the FDA's expected decision date for the specified application is June 29, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Arcutis's Zoryve cream as a treatment for plaque psoriasis in children aged 2 to 5 by July 13, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application
The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.
If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.Arcutis Biotherapeutics' supplemental NDA for Zoryve (roflumilast) cream 0.3% to treat plaque psoriasis in children ages 2–5 carries an 83.5% market-implied approval probability ahead of its June 29, 2026 PDUFA target date. The FDA accepted the filing in November 2025 with no apparent safety or efficacy issues flagged. Traders point to Arcutis' recent success securing multiple Zoryve label expansions, including atopic dermatitis clearance for the identical pediatric cohort in October 2025 and prior psoriasis approvals down to age 6. Supporting Phase 3 data, the drug's established topical PDE4 mechanism, and lack of competing red flags underpin the strong consensus, though standard FDA review risks such as labeling negotiations remain until the decision window closes.
As of market creation, the FDA's expected decision date for the specified application is June 29, 2026.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Arcutis's Zoryve cream as a treatment for plaque psoriasis in children aged 2 to 5 by July 13, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application
The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.
If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Arcutis's Zoryve cream as a treatment for plaque psoriasis in children aged 2 to 5 by July 13, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) application
The following constitute qualifying approvals:
Standard approval (traditional approval based on clinical benefit), Accelerated approval (based on surrogate endpoints), Approval with Risk Evaluation and Mitigation Strategy (REMS), Approval with restricted distribution or indication limitations, except compassionate use/expanded access programs
The following do not constitute qualifying approvals:
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately.
If the listed drug is approved before the end of the specified period, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
वॉल्यूम
$4,981समाप्ति तिथि
29 जून, 2026बाज़ार खुला
Jun 4, 2026, 3:38 PM ETResolver
0x65070BE91...परिणाम प्रस्तावित: हाँ
कोई विवाद नहीं
अंतिम परिणाम: हाँ
Arcutis Biotherapeutics' supplemental NDA for Zoryve (roflumilast) cream 0.3% to treat plaque psoriasis in children ages 2–5 carries an 83.5% market-implied approval probability ahead of its June 29, 2026 PDUFA target date. The FDA accepted the filing in November 2025 with no apparent safety or efficacy issues flagged. Traders point to Arcutis' recent success securing multiple Zoryve label expansions, including atopic dermatitis clearance for the identical pediatric cohort in October 2025 and prior psoriasis approvals down to age 6. Supporting Phase 3 data, the drug's established topical PDE4 mechanism, and lack of competing red flags underpin the strong consensus, though standard FDA review risks such as labeling negotiations remain until the decision window closes.
Polymarket डेटा का संदर्भ देने वाला प्रयोगात्मक AI-जनरेटेड सारांश। यह ट्रेडिंग सलाह नहीं है और इस बाज़ार के समाधान में कोई भूमिका नहीं निभाता। · अपडेट किया गया
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