This week, Roche RHHBY announced that it will acquire its existing partner, Poseida Therapeutics PSTX for $9 per share in cash, representing a total equity value of approximately $1.0 billion. Merck MRK and AstraZeneca’s AZN late-stage studies, evaluating the expanded use of their new drugs, met their respective goals. The European Commission approved Novartis’ NVS breast cancer drug Kisqali (ribociclib) for a broad population in early breast cancer.

Here's a recap of the week’s most important stories.

MRK’s Study of Winrevair in Advanced PAH Succeeds

Merck announced positive top-line data from a phase III study, ZENITH, evaluating its pulmonary arterial hypertension (“PAH”) drug, Winrevair (sotatercept), for more advanced disease – those with WHO Group 1 functional class (FC) III or IV at high risk of mortality. The study met its primary endpoint of time to first morbidity or mortality event, which could be either all-cause death, lung transplantation or PAH hospitalizations. In the study, treatment with Winrevair added to background PAH therapy led to a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality events compared to placebo.

Based on the overwhelming efficacy seen in the study, an independent data monitoring committee (DMC) recommended the study be stopped early. The DMC also recommended that patients with this advanced form of PAH be offered the opportunity to get Winrevair through an open-label extension study.

Winrevair was approved to treat PAH WHO Group 1 in the United States in March based on data from the STELLAR study.

NVS’ Kisqali Gets EU Nod for Early Breast Cancer 

The European Commission (EC) granted approval to Novartis’ breast cancer drug Kisqali (ribociclib) for a broader patient population. Kisqali can now be prescribed in the EU in combination with an aromatase inhibitor (AI) for the adjuvant treatment of adults with HR+/HER2- early breast cancer (EBC) at a high risk of disease recurrence. The approval is based on data from the phase III NATALEE study. Kisqali was approved for EBC patients in the United States by the FDA in September 2024. Kisqali is already approved for the treatment of metastatic breast cancer (MBC) in several countries.

Roche to Buy CAR-T Cell Therapy Maker Poseida 

Roche announced a definitive agreement to acquire Poseida Therapeutics, a biotech making allogeneic pre-clinical and clinical-stage CAR-T therapies across areas like hematological malignancies, solid tumors and autoimmune disease. Roche and Poseida already have a collaboration deal to develop off-the-shelf CAR-T cell therapies for hematological malignancies. Roche will acquire Poseida for $9.00 per share in cash at closing plus a non-tradeable contingent value right (CVR) for up to an aggregate of $4.00 per share in cash, adding up to a deal value of approximately $1.5 billion. The transaction is expected to close in the first quarter of 2025, subject to customary closing conditions.

Roche also announced that its phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq in a non-small cell lung cancer (NSCLC) indication, did not achieve its primary endpoint of overall survival at the final analysis.

AZN’s Truqap Combo Improves PFS in Prostate Cancer Study

AstraZeneca’s phase III study evaluating Truqap in combination with J&J’s Zytiga (abiraterone) and androgen deprivation therapy (ADT) in PTEN-deficient metastatic hormone-sensitive prostate cancer met its primary endpoint of radiographic progression-free survival(rPFS). Data from the CAPItello-281 study showed that the Truqap combination led to a statistically significant and clinically meaningful improvement in rPFS compared to abiraterone and ADT with placebo in patients suffering from this aggressive form of prostate cancer. Truqap is presently approved for treating HR-positive (or ER-positive), HER2-negative locally advanced or metastatic breast cancer.

The NYSE ARCA Pharmaceutical Index rose 3.7% in the past five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return

Here’s how the eight major stocks performed in the previous five trading sessions.

Image Source: Zacks Investment Research

In the last five trading sessions, all the stocks were in the green. AbbVie rose the most (9.1%).

In the past six months, while AbbVie rose the most (17.2%), Novo Nordisk declined the most (20.0%).

(See the last pharma stock roundup here: Pharma Stock Roundup: EU Nod for PFE’s Hympavzi, NVS Ups Sales View)

What's Next in the Pharma World?

Watch this space for regular pipeline and regulatory updates next week.

AstraZeneca, Novartis, Merck and Roche have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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AstraZeneca PLC (AZN) : Free Stock Analysis Report

Novartis AG (NVS) : Free Stock Analysis Report

Roche Holding AG (RHHBY) : Free Stock Analysis Report

Merck & Co., Inc. (MRK) : Free Stock Analysis Report

Poseida Therapeutics, Inc. (PSTX) : Free Stock Analysis Report

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