INCY Announces New Late-Stage Data on Skin Disease Drug

Incyte INCY announced new 24-week interim data from the STOP-HS program on pipeline candidate, povorcitinib (INCB54707), in adult patients with moderate to severe hidradenitis suppurativa (HS).

The data will be presented at the European Association of Dermatology and Venereology (“EADV”) 2025 Congress.

Povorcitinib is an oral small-molecule JAK1 selective inhibitor. HS is a chronic inflammatory skin disease. It is characterized by painful nodules and abscesses that can lead to irreversible tissue destruction and scarring.

The new data will support the planned regulatory submissions for povorcitinib in HS in Europe and the United States in 2025 and early 2026, respectively.

Year to date, shares of the company have gained 21.5% compared with the industry’s growth of 4.5%.

More on INCY’s STOP-HS Program

The STOP-HS clinical trial program includes two phase III studies, STOP-HS1 (NCT05620823) and STOP-HS2 (NCT05620836). These studies are evaluating the efficacy and safety of povorcitinib in adult patients with moderate to severe HS. Both studies include a 12-week double-blind, placebo-controlled treatment period, followed by a 42-week extension period and 30-day safety follow-up.

New data from both these studies showed that povorcitinib treatment resulted in continued clinically meaningful and statistically significant improvements for patients with active moderate to severe HS through week 24.

Nearly 60% of efficacy-evaluable patients among both povorcitinib treatment groups (45 mg and 75 mg) achieved Hidradenitis Suppurativa Clinical Response (HiSCR)50 at week 24.

Additionally, across STOP-HS1 and STOP-HS2, povorcitinib treatment in both dosing groups resulted in continued improvements at week 24 in endpoints associated with higher thresholds of response.

Data also showed that patients treated with povorcitinib achieved HiSCR75, HiSCR90 and HiSCR100 through week 24.

Patients treated with povorcitinib also achieved greater improvements in skin pain by the first visit (week 3) through week 24, with 62-70% achieving mild or no pain at week 24.

Incyte had earlier reported that both STOP-HS1 and STOP-HS2 studies met their primary endpoint at each tested dose (45 mg and 75 mg). A significantly higher proportion of patients treated with povorcitinib once daily versus placebo achieved HiSCR, a ≥50% reduction from baseline in the total abscess and inflammatory nodule count at week 12, with no increase from baseline in abscess or draining tunnel count.

The overall safety profile of povorcitinib is consistent with previous data and both doses were well tolerated. However, treatment-emergent adverse events occurred in 42.4–54.3% of patients who transitioned from placebo to povorcitinib at week 12, and in 70.2–78.7% of patients who were initially randomized to povorcitinib through week 24. Serious adverse events and adverse events of special interest were observed in 2.9-4.8% and 0-1.4% of patients, respectively.

We note that the candidate is currently being evaluated in phase III studies for HS, vitiligo and prurigo nodularis, as well as phase II trials for asthma and chronic spontaneous urticaria.

Pipeline/Regulatory Updates Boost INCY Stock

Incyte’s efforts to develop new drugs to diversify its portfolio and add an incremental stream of revenues are impressive.

The successful development of povorcitinib will be a significant boost for INCY’s revenue base.

While the uptake of recently approved drugs has been good (Pemazyre, Monjuvi and Tabrecta) and a potential approval of the additional drugs should diversify its portfolio, INCY is heavily dependent on lead drug Jakafi for its top-line growth.

Incyte’s lead drug, Jakafi, is a JAK1/JAK2 inhibitor approved for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.

Jakafi is marketed by Incyte in the United States and by Novartis NVS as Jakavi in ex-U.S. markets. Incyte earns royalties from NVS on sales outside the country.

The FDA’s approval of the cream formulation of ruxolitinib for the treatment of mild to moderate atopic dermatitis, under the brand name Opzelura, has been a significant boost for the company. The drug has also been approved for the topical treatment of non-segmental vitiligo in adult and pediatric patients aged 12 years and above.

INCY’s Zacks Rank & Stocks to Consider

INCY currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP and CorMedix CRMD, each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share have moved up from $6.53 to $7.25. Earnings per share estimates for 2026 have increased from $7.07 to $7.74 during the same period. ANIP stock has soared 76.7% year to date.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, the average surprise being 22.66%.

In the past 60 days, estimates for CorMedix’s 2025 earnings per share have moved up from $1.10 to $1.52. Earnings per share estimates for 2026 have increased from $1.46 to $2.12 during the same period. CRMD stock has surged 59.7% year to date.

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