Incyte Lands EU Backing for First Oral HS Pill

Incyte has won a CHMP positive opinion recommending European Union marketing authorization for Povofortay, an oral JAK1 inhibitor for hidradenitis suppurativa patients who have failed or cannot tolerate anti-TNF biologics. The opinion, adopted 17 September 2026, is povorcitinib's first positive regulatory decision anywhere; the same drug remains under review at FDA, where Incyte has not disclosed a decision date.

Povofortay's opinion in four figures

1,227adults enrolled across the two pivotal STOP-HS1 and STOP-HS2 trials

71.4%reached HiSCR50 response by Week 54 in later-breaking extension data

17 Sep 2026CHMP's positive opinion date — povorcitinib's first regulatory nod anywhere

$5.14BIncyte's total 2025 revenue, led by Jakafi and Opzelura (ruxolitinib)

Figures from Incyte's Phase 3 and extension-data announcements, EMA's CHMP meeting highlights and Incyte's FY2025 results.

A hidradenitis suppurativa market three biologics already split

Hidradenitis suppurativa, a chronic inflammatory skin disease that causes painful nodules and abscesses, has had only injectable options since Humira's approval was extended to the indication in 2015; Cosentyx and Bimzelx followed in 2023 and 2024. Every currently approved HS therapy is a biologic delivered by injection — the gap povorcitinib, an oral pill, is built to fill for patients who fail or can't tolerate anti-TNF therapy specifically, per EMA's own description of the opinion.

A therapeutics market that won't agree on its own size

$881M → $1.39B

Hidradenitis suppurativa treatment market, per two publishers whose base-year figures sit about $260 million apart.

2026 (DelveInsight-style forecast)$881M

2036 (same forecast)$1.39B

2026 (Business Research Insights)$1.14B

2035 (same forecast)$1.65B

Sources: Hidradenitis Suppurativa (HS) Treatment Market to Reach USD 1.39 Billion by 2036 (via OpenPR) · Business Research Insights, Hidradenitis Suppurativa Therapeutics Market Report

Regulatory News outlook

We expect povorcitinib's EU opinion and pending US decision to push oral, non-biologic prescribing toward a meaningful minority of new HS starts within five years, without displacing the three injectable biologics already on the market.

How we got here: Business Research Insights' $1.14 billion 2026 base, compounded at the OpenPR-syndicated forecast's own reported 4.7% annual growth rate for four years, reaches about $1.37 billion by 2030 — the range we use as the market povorcitinib is entering alongside three approved biologics.

Povofortay against HS's three approved biologics

Product	Form	Mechanism	EU/US status
Povofortay (Incyte)	Oral tablet, 45mg or 75mg once daily	JAK1 inhibitor	CHMP positive opinion, Sept 2026 (EU); FDA review ongoing (US)
Humira (adalimumab)	Subcutaneous injection	Anti-TNF biologic	Approved, EU and US (2015)
Cosentyx (secukinumab)	Subcutaneous injection	IL-17A inhibitor	Approved, EU and US (2023)
Bimzelx (bimekizumab)	Subcutaneous injection	IL-17A/IL-17F dual inhibitor	Approved, EU and US (2024)

From each company's own labelling and announcements; not a clinical comparison.

Blocking JAK1 where biologics stop working

Povorcitinib is an oral, selective JAK1 inhibitor — internally coded INCB54707 — that blocks JAK1-dependent signalling from interleukin-6, interleukin-2 and interleukin-22, cytokines EMA credits with driving both skin and systemic inflammation in HS. Where existing biologics neutralize one inflammatory pathway each, a JAK1 inhibitor works further upstream, an approach Incyte already sells for other diseases: its ruxolitinib, sold as Jakafi in oral form and Opzelura as a topical, made up the bulk of the company's $5.14 billion in 2025 revenue.

The CHMP opinion rests on two Phase 3 trials, STOP-HS1 and STOP-HS2, which randomized 1,227 adults with moderate-to-severe, anti-TNF-refractory HS to 45mg or 75mg of povorcitinib once daily, or placebo; both doses met the primary endpoint, HiSCR50 (at least a 50% reduction in inflammatory lesions with no increase in abscesses or draining tunnels), at Week 12 in both trials. In later-breaking data presented at the American Academy of Dermatology's 2026 annual meeting, HiSCR50 response reached as high as 71.4% at Week 54, including in patients who had previously failed anti-TNF therapy.

Three things that set Povofortay apart

01

The first oral option after biologics fail

EMA's own description credits Povofortay as the first oral daily treatment available to HS patients who have responded inadequately to, are intolerant of, or have a contraindication to anti-TNF therapy.

02

A dual-dose regimen with Week 54 data in hand

Both the 45mg and 75mg once-daily doses met their Phase 3 primary endpoint, and later data through Week 54 shows sustained response, including in patients who had already failed a biologic.

03

A pipeline built for more than HS

Povorcitinib is also in Phase 3 testing for vitiligo, with topline data expected in mid-2026, and for prurigo nodularis, expected in the fourth quarter of 2026 — this HS opinion is its first result to reach a regulator.

“Given the limitations of current HS treatments and its impact on patients’ daily lives, there is a critical need for new, well tolerated and effective therapies that provide a rapid reduction in the signs and symptoms of HS, in particular, pain.” Steven Stein, MD, Chief Medical Officer, Incyte — from the March 2025 announcement of the STOP-HS1/STOP-HS2 topline results that underpin this month's CHMP opinion

What CHMP recommended, and what it didn't

CHMP's opinion, adopted at its 14-17 September 2026 meeting, recommends approval specifically for adults with active moderate-to-severe HS who have responded inadequately to, are intolerant of, or have a contraindication to anti-TNF therapy — not a first-line approval, and not yet an approval at all: a European Commission decision, which usually follows a CHMP opinion within about 67 days under EMA's standard process, is still pending.

In the United States, povorcitinib remains under FDA review, with no confirmed decision date disclosed. Incyte's EU opinion arrives without a matching US action, leaving American HS patients without access to a drug European regulators have just recommended for approval.

From a 1991 genomics startup to a fourth approved drug

Povorcitinib's road to its first opinion

1. 1991

   Incyte founded

   Founded as a genomics company in Palo Alto, California; later headquartered in Wilmington, Delaware.

2. 2011-2023

   Jakafi and Opzelura approved

   Ruxolitinib reaches the market first as oral Jakafi, then as topical Opzelura for atopic dermatitis and vitiligo — the JAK-inhibitor franchise that funds Incyte's pipeline.

3. 17 March 2025

   STOP-HS1 and STOP-HS2 topline results

   Both Phase 3 trials meet their HiSCR50 primary endpoint at Week 12, across 1,227 enrolled adults.

4. 2025-2026

   Extension data presented

   24-week data at EADV 2025 and 54-week late-breaking data at AAD 2026 show sustained response, up to 71.4% HiSCR50.

5. 17 September 2026

   CHMP positive opinion adopted

   Povorcitinib's first positive regulatory decision anywhere, recommending EU approval as Povofortay for anti-TNF-refractory HS.

6. Expected late 2026

   European Commission decision

   A final EU marketing-authorization decision typically follows a CHMP opinion within about 67 days.

A positive CHMP opinion is not commercial reality: Incyte has not disclosed EU list pricing, reimbursement negotiations in individual member states, or a launch timeline once the European Commission's decision lands. In the US, the drug's fate depends on an FDA review Incyte has not dated publicly.

• EC decision: typically follows a CHMP opinion within about 67 days under EMA's standard process — a general timeline, not one Incyte has confirmed specifically for this opinion.
• US review: ongoing at FDA; no decision date publicly confirmed as of this writing.
• Pipeline: povorcitinib is also in Phase 3 for vitiligo, with topline data expected mid-2026, and for prurigo nodularis, expected in the fourth quarter of 2026.
• Other markets: Incyte has licensed povorcitinib rights in mainland China, Hong Kong, Macau, Taiwan and Southeast Asia to China Medical System.

What the opinion does not yet settle: EU list pricing, how payers in individual member states will treat an oral JAK1 inhibitor against three already-reimbursed biologics, and whether FDA reaches the same conclusion CHMP did on the same trial data.

Frequently asked questions

What did CHMP recommend for Incyte's Povofortay?

A positive opinion, adopted 17 September 2026, recommending EU marketing authorization for adults with moderate-to-severe hidradenitis suppurativa who have failed or cannot tolerate anti-TNF therapy. A European Commission decision, which typically follows within about 67 days, is still pending.

Is Povofortay approved in the United States?

No. The same drug, povorcitinib, remains under FDA review; Incyte has not disclosed a decision date.

How is Povofortay different from HS's other treatments?

EMA describes it as the first oral daily treatment available to HS patients who fail or can't tolerate anti-TNF biologics; every other currently approved HS therapy — Humira, Cosentyx and Bimzelx — is an injectable biologic.

What trial data supports the opinion?

Two Phase 3 trials, STOP-HS1 and STOP-HS2, enrolling 1,227 adults combined; both met their primary endpoint (HiSCR50) at Week 12, with later data showing responses as high as 71.4% at Week 54.