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FDA Grants Priority Review to Roche's Early-Stage Breast Cancer NDA
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Key Takeaways
Roche's NDA for giredestrant in early-stage ER-positive, HER2-negative breast cancer won Priority Review.
Giredestrant cut invasive disease recurrence or death risk by 30% versus standard endocrine therapy.
Roche also has a second giredestrant NDA under FDA review, with a Dec. 18, 2026, action date.
Roche (RHHBY - Free Report) announced that the FDA has accepted its new drug application (NDA) for its investigational candidate, giredestrant, as an adjuvant treatment for adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I, II, and III breast cancer. The FDA also granted the therapy Priority Review status, potentially accelerating the regulatory review process in the United States. A final decision from the regulatory body is expected by Nov. 30, 2026.
A filing accepted under the FDA’s Priority Review pathway reduces the review period to six months from the standard 10 months. This status is awarded to marketing applications for medicines intended to treat serious conditions and that, if approved, would offer a substantial improvement in safety, effectiveness, prevention, or diagnosis of such conditions.
Giredestrant is an investigational, oral, potent next-generation SERD and full antagonist designed to block estrogen and thereby slow or stop the growth of ER-positive breast cancer cells. Roche is evaluating giredestrant in an extensive clinical development program in five company-sponsored phase III studies that span multiple treatment settings and lines of therapy. The successful development of giredestrant will boost RHHBY’s breast cancer franchise, as ER-positive breast cancer accounts for approximately 70% of cases diagnosed.
Roche’s NDA filing is supported by data from the phase III lidERA Breast Cancer study, which enrolled more than 4,100 patients and compared giredestrant with standard-of-care endocrine therapy (SoC ET).
Year to date, Roche shares have lost 2.6% against the industry’s 2.6% growth.
Image Source: Zacks Investment Research
In the study, giredestrant met its primary endpoint, demonstrating a 30% reduction in the risk of invasive disease recurrence or death compared with SoC ET. At three years, 92.4% of patients treated with giredestrant remained alive and free of invasive disease compared with 89.6% of those receiving SoC ET. The benefit was observed consistently across all clinically relevant patient subgroups.
Overall survival (OS) data remain immature, although an early positive trend was reported. Roche said follow-up for OS will continue in future analyses. The safety profile of giredestrant was consistent with previous studies, with manageable adverse events and a lower treatment discontinuation rate than that of SoC ET (5.3% vs 8.2%).
Additional findings from the broader giredestrant development program were presented recently, further supporting the candidate’s potential across both early-stage and advanced ER-positive breast cancer settings. If approved, giredestrant could represent a significant advancement in endocrine therapy for early-stage breast cancer, an area that has seen limited innovation in recent decades.
RHHBY’s Giredestrant Under FDA Review for Another Indication
Earlier in 2026, the FDA accepted Roche’s NDA for giredestrant in combination with everolimus for the treatment of adult patients with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following progression on prior endocrine therapy. The regulatory body has set a target action date of Dec. 18, 2026.
This NDA submission for giredestrant was supported by data from the phase III evERA breast cancer study, which showed that giredestrant combined with everolimus significantly improved progression-free survival (PFS) compared with SoC ET plus everolimus in patients with ER-positive breast cancer.
Overall survival data showed a favorable trend with further follow-up ongoing, while the regimen demonstrated a manageable safety profile. The evERA study represented the first positive phase III outcome for giredestrant, alongside encouraging results from the phase III lidERA study in early-stage breast cancer.
Roche’s Combo Drug Falls Short in First-Line Breast Cancer
We remind the investors that in March 2026, Roche announced results from a late-stage study evaluating giredestrant in combination with palbociclib for patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. The phase III persevERA Breast Cancer study is evaluating the combo’s efficacy and safety in 992 patients compared with letrozole plus palbociclib in the first-line setting.
Per the data readout, the late-stage study failed to meet its primary endpoint of achieving a statistically significant improvement in PFS compared with the standard regimen of letrozole plus palbociclib in the intent-to-treat population. However, the giredestrant combination showed a numerical improvement in PFS.
Safety findings from the study were broadly consistent with expectations. The adverse events observed with the giredestrant and palbociclib combination were manageable and aligned with the known safety profiles of the individual therapies.
Despite the missed primary endpoint, management expressed confidence in the long-term potential of giredestrant across ER-positive breast cancer settings. The company indicated that it continues to see a development path for the candidate and plans to advance ongoing studies within its broader giredestrant clinical program to identify patient populations that may derive the greatest benefit.
Roche stated that the persevERA study represents the first of two phase III studies evaluating giredestrant in the first-line setting. The second study, pionERA, is assessing giredestrant in combination with a physician’s choice of CDK4/6 inhibitor in patients with endocrine-resistant, ER-positive, HER2-negative breast cancer, with results expected in 2027.
Roche Holding AG Price, Consensus and EPS Surprise
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 70.3% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.10 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.47. INDV shares have lost 2.8% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
The estimate for Immunocore’s 2026 EPS is currently pegged at 6 cents. In the past 60 days, the estimates for its 2027 EPS have increased from 24 cents to 87 cents. IMCR shares have lost 16.1% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
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FDA Grants Priority Review to Roche's Early-Stage Breast Cancer NDA
Key Takeaways
Roche (RHHBY - Free Report) announced that the FDA has accepted its new drug application (NDA) for its investigational candidate, giredestrant, as an adjuvant treatment for adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I, II, and III breast cancer. The FDA also granted the therapy Priority Review status, potentially accelerating the regulatory review process in the United States. A final decision from the regulatory body is expected by Nov. 30, 2026.
A filing accepted under the FDA’s Priority Review pathway reduces the review period to six months from the standard 10 months. This status is awarded to marketing applications for medicines intended to treat serious conditions and that, if approved, would offer a substantial improvement in safety, effectiveness, prevention, or diagnosis of such conditions.
Giredestrant is an investigational, oral, potent next-generation SERD and full antagonist designed to block estrogen and thereby slow or stop the growth of ER-positive breast cancer cells. Roche is evaluating giredestrant in an extensive clinical development program in five company-sponsored phase III studies that span multiple treatment settings and lines of therapy. The successful development of giredestrant will boost RHHBY’s breast cancer franchise, as ER-positive breast cancer accounts for approximately 70% of cases diagnosed.
Roche’s NDA filing is supported by data from the phase III lidERA Breast Cancer study, which enrolled more than 4,100 patients and compared giredestrant with standard-of-care endocrine therapy (SoC ET).
Year to date, Roche shares have lost 2.6% against the industry’s 2.6% growth.
Image Source: Zacks Investment Research
In the study, giredestrant met its primary endpoint, demonstrating a 30% reduction in the risk of invasive disease recurrence or death compared with SoC ET. At three years, 92.4% of patients treated with giredestrant remained alive and free of invasive disease compared with 89.6% of those receiving SoC ET. The benefit was observed consistently across all clinically relevant patient subgroups.
Overall survival (OS) data remain immature, although an early positive trend was reported. Roche said follow-up for OS will continue in future analyses. The safety profile of giredestrant was consistent with previous studies, with manageable adverse events and a lower treatment discontinuation rate than that of SoC ET (5.3% vs 8.2%).
Additional findings from the broader giredestrant development program were presented recently, further supporting the candidate’s potential across both early-stage and advanced ER-positive breast cancer settings. If approved, giredestrant could represent a significant advancement in endocrine therapy for early-stage breast cancer, an area that has seen limited innovation in recent decades.
RHHBY’s Giredestrant Under FDA Review for Another Indication
Earlier in 2026, the FDA accepted Roche’s NDA for giredestrant in combination with everolimus for the treatment of adult patients with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following progression on prior endocrine therapy. The regulatory body has set a target action date of Dec. 18, 2026.
This NDA submission for giredestrant was supported by data from the phase III evERA breast cancer study, which showed that giredestrant combined with everolimus significantly improved progression-free survival (PFS) compared with SoC ET plus everolimus in patients with ER-positive breast cancer.
Overall survival data showed a favorable trend with further follow-up ongoing, while the regimen demonstrated a manageable safety profile. The evERA study represented the first positive phase III outcome for giredestrant, alongside encouraging results from the phase III lidERA study in early-stage breast cancer.
Roche’s Combo Drug Falls Short in First-Line Breast Cancer
We remind the investors that in March 2026, Roche announced results from a late-stage study evaluating giredestrant in combination with palbociclib for patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. The phase III persevERA Breast Cancer study is evaluating the combo’s efficacy and safety in 992 patients compared with letrozole plus palbociclib in the first-line setting.
Per the data readout, the late-stage study failed to meet its primary endpoint of achieving a statistically significant improvement in PFS compared with the standard regimen of letrozole plus palbociclib in the intent-to-treat population. However, the giredestrant combination showed a numerical improvement in PFS.
Safety findings from the study were broadly consistent with expectations. The adverse events observed with the giredestrant and palbociclib combination were manageable and aligned with the known safety profiles of the individual therapies.
Despite the missed primary endpoint, management expressed confidence in the long-term potential of giredestrant across ER-positive breast cancer settings. The company indicated that it continues to see a development path for the candidate and plans to advance ongoing studies within its broader giredestrant clinical program to identify patient populations that may derive the greatest benefit.
Roche stated that the persevERA study represents the first of two phase III studies evaluating giredestrant in the first-line setting. The second study, pionERA, is assessing giredestrant in combination with a physician’s choice of CDK4/6 inhibitor in patients with endocrine-resistant, ER-positive, HER2-negative breast cancer, with results expected in 2027.
Roche Holding AG Price, Consensus and EPS Surprise
Roche Holding AG price-consensus-eps-surprise-chart | Roche Holding AG Quote
RHHBY’s Zacks Rank & Other Stocks to Consider
Roche currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Immunocore (IMCR - 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 Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 70.3% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.10 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.47. INDV shares have lost 2.8% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
The estimate for Immunocore’s 2026 EPS is currently pegged at 6 cents. In the past 60 days, the estimates for its 2027 EPS have increased from 24 cents to 87 cents. IMCR shares have lost 16.1% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.