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Ventyx (VTYX) Down Despite Positive Ulcerative Colitis Study Data
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Shares of Ventyx Biosciences, Inc. (VTYX - Free Report) were down 25.9% on Tuesday, even though the company announced positive top-line data from the phase II study evaluating its novel oral therapy, VTX002, for treating moderate-to-severely active ulcerative colitis (UC), a chronic inflammatory bowel disease.
The double-blind, placebo-controlled phase II study evaluated the safety and efficacy of once-daily, two oral doses of S1P1 receptor modulator, VTX002 (30 mg and 60 mg), in the given patient population.
Data from the study showed that 28% of the patients treated with the 60mg dose and 24% of patients who received the 30 mg dose of VTX002 achieved clinical remission at week 13 compared with only 11% on placebo. Clinical remission was the primary endpoint of the study.
Also, 29% of the patients who received the 60mg dose and 21% of the patients who were administered the 30mg dose of VTX002 achieved complete endoscopic remission versus 7% of patients who received placebo at week 13. Complete endoscopic remission was the secondary endpoint of the study.
Importantly, both doses of VTX002 were generally safe and well-tolerated, with no serious side effects being observed in the given patient population.
Despite the study meeting the primary endpoint of clinical remission rate with a high rate of complete endoscopic remission (VTX002 60 mg), shares of Ventyx tanked as the data failed to impress investors.
Shares of Ventyx have plunged 32.2% so far this year compared with the industry’s decline of 19.8%.
Image Source: Zacks Investment Research
We note that VTX002, if successfully developed and upon potential approval, is likely to face competition from Bristol-Myers’ (BMY - Free Report) S1P receptor modulator, Zeposia, which was approved as an oral medicine for treating moderately to severely active UC in 2021.
BMY also markets Zeposia for the treatment of adults with relapsing forms of multiple sclerosis.
Another pharma giant Pfizer (PFE - Free Report) is also developing its pipeline candidate, etrasimod, an S1P receptor modulator for treating moderately to severely active UC. Etrasimod is currently under review in the United States and in Europe for treating UC. A decision from regulatory bodies in the United States and in Europe countries is expected later in 2023 and in the first half of 2024, respectively.
PFE is also developing etrasimod eta for Crohn’s disease, eosinophilic esophagitis, alopecia areata and atopic dermatitis.
We remind investors that apart from VTX002, Ventyx is also developing its lead pipeline candidate, VTX958, in three ongoing phase II studies for treating moderate-to-severe plaque psoriasis, Crohn’s disease and active psoriatic arthritis.
Other candidates in Ventyx’s pipeline include VTX2735 and VTX3232, which are being developed in mid to early-stage studies for treating various inflammatory and autoimmune disorders.
Ventyx has no approved product in its portfolio at the moment. Therefore, the successful development of its pipeline remains the company’s key focus.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2023 earnings per share has moved up from $4.98 to $5.09. During the same period, the estimate for Ligand’s 2024 earnings per share has moved up from $4.26 to $4.56. Year to date, shares of LGND have lost 9.6%.
LGND’s earnings beat estimates in three of the trailing four quarters and missed the mark on the other occasion, delivering an average surprise of 52.47%.
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Ventyx (VTYX) Down Despite Positive Ulcerative Colitis Study Data
Shares of Ventyx Biosciences, Inc. (VTYX - Free Report) were down 25.9% on Tuesday, even though the company announced positive top-line data from the phase II study evaluating its novel oral therapy, VTX002, for treating moderate-to-severely active ulcerative colitis (UC), a chronic inflammatory bowel disease.
The double-blind, placebo-controlled phase II study evaluated the safety and efficacy of once-daily, two oral doses of S1P1 receptor modulator, VTX002 (30 mg and 60 mg), in the given patient population.
Data from the study showed that 28% of the patients treated with the 60mg dose and 24% of patients who received the 30 mg dose of VTX002 achieved clinical remission at week 13 compared with only 11% on placebo. Clinical remission was the primary endpoint of the study.
Also, 29% of the patients who received the 60mg dose and 21% of the patients who were administered the 30mg dose of VTX002 achieved complete endoscopic remission versus 7% of patients who received placebo at week 13. Complete endoscopic remission was the secondary endpoint of the study.
Importantly, both doses of VTX002 were generally safe and well-tolerated, with no serious side effects being observed in the given patient population.
Despite the study meeting the primary endpoint of clinical remission rate with a high rate of complete endoscopic remission (VTX002 60 mg), shares of Ventyx tanked as the data failed to impress investors.
Shares of Ventyx have plunged 32.2% so far this year compared with the industry’s decline of 19.8%.
Image Source: Zacks Investment Research
We note that VTX002, if successfully developed and upon potential approval, is likely to face competition from Bristol-Myers’ (BMY - Free Report) S1P receptor modulator, Zeposia, which was approved as an oral medicine for treating moderately to severely active UC in 2021.
BMY also markets Zeposia for the treatment of adults with relapsing forms of multiple sclerosis.
Another pharma giant Pfizer (PFE - Free Report) is also developing its pipeline candidate, etrasimod, an S1P receptor modulator for treating moderately to severely active UC. Etrasimod is currently under review in the United States and in Europe for treating UC. A decision from regulatory bodies in the United States and in Europe countries is expected later in 2023 and in the first half of 2024, respectively.
PFE is also developing etrasimod eta for Crohn’s disease, eosinophilic esophagitis, alopecia areata and atopic dermatitis.
We remind investors that apart from VTX002, Ventyx is also developing its lead pipeline candidate, VTX958, in three ongoing phase II studies for treating moderate-to-severe plaque psoriasis, Crohn’s disease and active psoriatic arthritis.
Other candidates in Ventyx’s pipeline include VTX2735 and VTX3232, which are being developed in mid to early-stage studies for treating various inflammatory and autoimmune disorders.
Ventyx has no approved product in its portfolio at the moment. Therefore, the successful development of its pipeline remains the company’s key focus.
Ventyx Biosciences, Inc. Price
Ventyx Biosciences, Inc. price | Ventyx Biosciences, Inc. Quote
Zacks Rank and Stock to Consider
Ventyx currently carries a Zacks Rank #3 (Hold).
A top-ranked stock in the biotech sector is Ligand Pharmaceuticals Incorporated (LGND - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2023 earnings per share has moved up from $4.98 to $5.09. During the same period, the estimate for Ligand’s 2024 earnings per share has moved up from $4.26 to $4.56. Year to date, shares of LGND have lost 9.6%.
LGND’s earnings beat estimates in three of the trailing four quarters and missed the mark on the other occasion, delivering an average surprise of 52.47%.