Corcept Shares Rise More Than 60% in Three Months: Here's Why

Puma Biotechnology, Inc. PBYI announced that it has initiated the phase II ALISCA-Breast1 study evaluating its pipeline candidate, alisertib, for the treatment of patients with metastatic breast cancer.

The ALISCA-Breast1 study is investigating alisertib in combination with endocrine therapy for treating hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) recurrent or metastatic breast cancer in patients who have been previously treated with CDK 4/6 inhibitors and have received at least two prior lines of endocrine therapy in the recurrent or metastatic setting.

The main objective of the ALISCA-Breast1 study is to determine the optimal dose of alisertib in combination with a selected endocrine therapy. Initial data from the study is expected in 2025.

Upon finding the optimal dose of alisertib, PBYI plans to meet with global regulatory agencies for the design of a pivotal phase III study on the candidate. The study will evaluate alisertib plus investigator’s choice endocrine therapy compared with placebo plus investigator’s choice endocrine therapy in HER2-negative, HR+ metastatic breast cancer.

PBYI's Stock Performance

Year to date, shares of Puma Biotechnology have plunged 34.4% compared with the industry’s decline of 10.9%.

The primary endpoints of the ALISCA-Breast1 study are to check the objective response rate, duration of response, disease control rate, progression-free survival and overall survival.

The company will evaluate each of these efficacy endpoints within biomarker subgroups to find out whether any biomarker subgroup correlates with response as a secondary endpoint.

PBYI then plans to conduct an initial interim analysis for the investigation of the safety and efficacy of the above study.

Based on the outcomes of the ALISCA-Breast1 study, the company plans to meet with the FDA for a potential approval pathway for alisertib in HER2-negative, HR+ metastatic breast cancer.

PBYI's Development of Alisertib Holds Promise

Puma Biotechnology in-licensed the global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda in 2022.

Apart from breast cancer, the company is conducting ALISCA-Lung1, a phase II study (PUMA-ALI-4201) evaluating alisertib as a monotherapy for the treatment of patients with extensive stage small cell lung cancer. Interim data from this study is expected to be presented in 2025.

Per management, alisertib has huge potential in HR-positive, HER2-negative breast cancer, triple-negative breast cancer, head and neck cancer and small cell lung cancer. If successfully developed for these indications, alisertib has the potential to boost the company’s position in the anticancer drug market.

PBYI's Zacks Rank & Key Picks

Puma Biotechnology currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, Spero Therapeutics, Inc. SPRO and Castle Biosciences, Inc. CSTL, each sporting 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 Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 52.6%.

IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.13. Loss per share estimates for 2025 have narrowed from $1.54 to 54 cents during the same time. Year to date, shares of SPRO have declined 18.3%.

SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 31.8%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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Sage Therapeutics’ SAGE phase II study evaluating its neuropsychiatric candidate, dalzanemdor (SAGE-718), for treating cognitive impairment (CI) associated with Huntington’s Disease (HD) failed to meet the primary endpoint.

The double-blind, placebo-controlled DIMENSION study evaluated the effects of dalzanemdor in participants with CI associated with HD.

Top-line data from the study showed that dalzanemdor failed to demonstrate a statistically significant difference from baseline compared to placebo on the Symbol Digit Modalities Test, a measure of cognitive function, at day 84. This was the primary endpoint of the study.

The stock hit its 52-week low on the pipeline setback. Year to date, shares of Sage Therapeutics have plunged 77.3% compared with the industry’s decline of 8.5%.

More on SAGE's DIMENSION Study

The analyses of secondary endpoints from the DIMENSION study also failed to demonstrate statistically significant or clinically meaningful differences in patients treated with dalzanemdor versus placebo.

Treatment with dalzanemdor was generally well-tolerated and no new safety signals were reported.

Following the disappointing data from the DIMENSION study, SAGE decided to stop further development of dalzanemdor.

The company also decided to stop the ongoing PURVIEW study, which is an open-label safety study evaluating dalzanemdor for treating participants with HD.

An inherited disorder, HD, causes nerve cells (neurons) in brain parts to gradually break down and die. CI is one of the most under-recognized aspects of HD. Currently, no treatment options are available to improve HD-related cognitive effects.

SAGE's Earlier Setback in the Development of Dalzanemdor

Last month, Sage Therapeutics announced that the phase II LIGHTWAVE study, which evaluated dalzanemdor for treating mild cognitive impairment (MCI) and mild dementia in Alzheimer’s Disease (AD), failed to meet the primary endpoint.

Following this, the company decided to stop further development of dalzanemdor for the AD indication.

Previously, dalzanemdor failed in the phase II PRECEDENT study, which investigated the candidate in patients with MCI associated with Parkinson’s disease (PD).

SAGE has stopped further development of dalzanemdor for the PD indication as well.

Owing to the string of pipeline setbacks related to the development of dalzanemdor, SAGE decided to stop the development of the candidate for all the indications.

SAGE's Zacks Rank & Key Picks

Sage Therapeutics currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, Spero Therapeutics, Inc. SPRO and Castle Biosciences, Inc. CSTL, each sporting 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 Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 52.6%.

IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.13. Loss per share estimates for 2025 have narrowed from $1.54 to 54 cents during the same time. Year to date, shares of SPRO have declined 18.3%.

SPRO’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 94.42%.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 31.8%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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GSK plc GSK announced positive headline data from the phase III GLISTEN study, which is evaluating its investigational targeted inhibitor of the ileal bile acid transporter (IBAT), linerixibat, for treating adult patients with cholestatic pruritus associated with primary biliary cholangitis (PBC).

The global GLISTEN study met its primary endpoint by showing that treatment with linerixibat led to a statistically significant improvement in monthly itch score as compared with placebo over 24 weeks.

Per management, if successfully developed, linerixibat has the potential to become the first therapy indicated for treating itch associated with PBC globally.

Year to date, shares of GSK have lost 9.7% compared with the industry’s decline of 11.1%.

More on GSK's GLISTEN Study

The preliminary safety data from the ongoing GLISTEN study were similar to those seen in previous studies on linerixibat.

Full data from the GLISTEN study is expected to be presented at a medical conference in the future.

Cholestatic pruritus (relentless itch) is one of the most common symptoms of PBC, a rare autoimmune disease that might lead to liver failure.

Per the press release, by the year 2030, patients diagnosed with PBC will reach 510,000 globally and over 240,000 people will experience relentless itch, for which there is currently no cure.

Other Players in the PBC Market

Given the high unmet medical need, a few other companies are also developing treatments for PBC, as there remains a high unmet medical need.

In August 2024, the FDA granted accelerated approval to Gilead Sciences’ GILD seladelpar for the treatment of PBC, in combination with ursodeoxycholic acid (UDCA), in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

The candidate was approved under the brand name Livdelzi.

Seladelpar was added to GILD’s portfolio/pipeline through the acquisition of CymaBay Therapeutics Inc. for $4.3 billion in March 2024. The approval of Livdelzi strengthened GILD’s liver disease portfolio.

Small biotech Mirum Pharmaceuticals MIRM is developing its pipeline candidate, volixibat, also an oral IBAT inhibitor, for the treatment of PBC.

The phase IIb VANTAGE study is currently evaluating MIRM’s volixibat for treating PBC.

In June 2024, Mirum announced positive interim data from the VANTAGE study, which showed that treatment with volixibat led to statistically significant improvement in pruritus as well as meaningful reductions in serum bile acids and also an improvement in fatigue.

GSK's Zacks Rank & Key Pick

GSK currently carries a Zacks Rank #4 (Sell).

A better-ranked stock in the biotech sector is Castle Biosciences, Inc. CSTL, 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 Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 29.3%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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