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PCSA Stock Soars on Upbeat Clinical Update From Breast Cancer Study
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Key Takeaways
PCSA surged 122.3% after a phase II update from its NGC-Cap breast cancer study.
Processa Pharmaceuticals reported higher exposure to cancer-killing metabolites versus Xeloda monotherapy.
PCSA said tolerability was comparable, with far lower FBAL exposure and only mild side effects.
Shares of Processa Pharmaceuticals (PCSA - Free Report) surged 122.3% on Wednesday after the company provided an encouraging clinical update on its ongoing mid-stage study evaluating its investigational candidate NGC-Cap in patients with advanced or metastatic breast cancer.
NGC-Cap, the combination treatment of PCS6422 and Roche’s (RHHBY - Free Report) oncology drug Xeloda (capecitabine), is Processa Pharmaceuticals’ lead pipeline asset. The phase II study has so far enrolled 19 breast cancer patients who have been randomized to receive either a twice-daily, 150 mg dose of NGC-Cap or a standard dose of Xeloda monotherapy.
The clinical update is from the first 16 advanced or metastatic breast cancer patients in the mid-stage study of NGC-Cap. The data from all 19 patients were not available for this preliminary analysis.
More on the Clinical Update From PCSA’s Breast Cancer Study
Preliminary phase II data from Processa Pharmaceuticals’ ongoing study of NGC-Cap indicate a meaningful pharmacokinetic advantage over standard Xeloda monotherapy in advanced or metastatic breast cancer. Data from the first 16 of 19 enrolled patients show significantly higher exposure to the active, cancer-killing drug metabolites, supporting the potential for improved antitumor activity. This enhanced metabolite exposure aligns with PCSA’s goal of improving the therapeutic index of established chemotherapy backbones.
Importantly, the observed pharmacologic profile suggests that NGC-Cap may enable greater delivery of the most effective components of Roche’s Xeloda without the traditional trade-off of worsening tolerability.
In the past six months, PCSA stock has gained 10.4% compared with the industry’s 6.2% growth.
Image Source: Zacks Investment Research
From a safety perspective, early results from Processa Pharmaceuticals’ phase II breast cancer study indicate that the increased exposure to active metabolites did not translate into more severe toxicity compared with RHHBY’s Xeloda therapy alone. While a higher proportion of patients receiving NGC-Cap experienced side effects related to the active metabolites, the overall severity of these events was comparable between treatment arms, suggesting manageable tolerability despite higher pharmacologic activity.
Notably, patients treated with NGC-Cap showed substantially lower exposure (about ten times less than with Xeloda monotherapy) to the catabolite metabolite FBAL, which is associated with dose-limiting toxicities such as hand-foot syndrome (HFS). Consistent with this reduction, the incidence of HFS was similar across treatment groups, but symptoms in the NGC-Cap arm were limited to mild cases, whereas patients on Roche’s Xeloda monotherapy experienced symptoms of greater severity.
Collectively, these findings support a differentiated safety profile for PCSA’s NGC-Cap that could be attractive if sustained in later-stage analyses.
Processa Pharmaceuticals expects to complete enrollment of the 20-patient cohort for the protocol-defined phase II interim analysis of NGC-Cap for breast cancer by the end of the first quarter of 2026, with full safety and efficacy results from this group anticipated in early 2026.
Apart from NGC-Cap, Processa Pharmaceuticals’ clinical pipeline comprises another investigational candidate, currently undergoing mid-stage development for rare kidney diseases.
PCSA’s Zacks Rank & Stocks to Consider
Processa Pharmaceuticals currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while 2026 EPS estimates have risen from $2.49 to $2.88 over the same period. Shares of CRMD have lost 15.7% over the past six months.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
Over the past 60 days, the loss estimate for Castle Biosciences has narrowed from 64 cents to 34 cents in 2025. Over the same period, loss estimates for 2026 have improved from $1.82 to $1.06. CSTL stock has rallied 109.8% over the past six months.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 66.11%.
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PCSA Stock Soars on Upbeat Clinical Update From Breast Cancer Study
Key Takeaways
Shares of Processa Pharmaceuticals (PCSA - Free Report) surged 122.3% on Wednesday after the company provided an encouraging clinical update on its ongoing mid-stage study evaluating its investigational candidate NGC-Cap in patients with advanced or metastatic breast cancer.
NGC-Cap, the combination treatment of PCS6422 and Roche’s (RHHBY - Free Report) oncology drug Xeloda (capecitabine), is Processa Pharmaceuticals’ lead pipeline asset. The phase II study has so far enrolled 19 breast cancer patients who have been randomized to receive either a twice-daily, 150 mg dose of NGC-Cap or a standard dose of Xeloda monotherapy.
The clinical update is from the first 16 advanced or metastatic breast cancer patients in the mid-stage study of NGC-Cap. The data from all 19 patients were not available for this preliminary analysis.
More on the Clinical Update From PCSA’s Breast Cancer Study
Preliminary phase II data from Processa Pharmaceuticals’ ongoing study of NGC-Cap indicate a meaningful pharmacokinetic advantage over standard Xeloda monotherapy in advanced or metastatic breast cancer. Data from the first 16 of 19 enrolled patients show significantly higher exposure to the active, cancer-killing drug metabolites, supporting the potential for improved antitumor activity. This enhanced metabolite exposure aligns with PCSA’s goal of improving the therapeutic index of established chemotherapy backbones.
Importantly, the observed pharmacologic profile suggests that NGC-Cap may enable greater delivery of the most effective components of Roche’s Xeloda without the traditional trade-off of worsening tolerability.
In the past six months, PCSA stock has gained 10.4% compared with the industry’s 6.2% growth.
Image Source: Zacks Investment Research
From a safety perspective, early results from Processa Pharmaceuticals’ phase II breast cancer study indicate that the increased exposure to active metabolites did not translate into more severe toxicity compared with RHHBY’s Xeloda therapy alone. While a higher proportion of patients receiving NGC-Cap experienced side effects related to the active metabolites, the overall severity of these events was comparable between treatment arms, suggesting manageable tolerability despite higher pharmacologic activity.
Notably, patients treated with NGC-Cap showed substantially lower exposure (about ten times less than with Xeloda monotherapy) to the catabolite metabolite FBAL, which is associated with dose-limiting toxicities such as hand-foot syndrome (HFS). Consistent with this reduction, the incidence of HFS was similar across treatment groups, but symptoms in the NGC-Cap arm were limited to mild cases, whereas patients on Roche’s Xeloda monotherapy experienced symptoms of greater severity.
Collectively, these findings support a differentiated safety profile for PCSA’s NGC-Cap that could be attractive if sustained in later-stage analyses.
Processa Pharmaceuticals expects to complete enrollment of the 20-patient cohort for the protocol-defined phase II interim analysis of NGC-Cap for breast cancer by the end of the first quarter of 2026, with full safety and efficacy results from this group anticipated in early 2026.
Apart from NGC-Cap, Processa Pharmaceuticals’ clinical pipeline comprises another investigational candidate, currently undergoing mid-stage development for rare kidney diseases.
PCSA’s Zacks Rank & Stocks to Consider
Processa Pharmaceuticals currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CorMedix (CRMD - Free Report) and Castle Biosciences (CSTL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while 2026 EPS estimates have risen from $2.49 to $2.88 over the same period. Shares of CRMD have lost 15.7% over the past six months.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
Over the past 60 days, the loss estimate for Castle Biosciences has narrowed from 64 cents to 34 cents in 2025. Over the same period, loss estimates for 2026 have improved from $1.82 to $1.06. CSTL stock has rallied 109.8% over the past six months.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 66.11%.