Bayer AG BAYRY announced that it will acquire rights to the late-stage specialty cardiovascular biopharmaceutical company Cytokinetics, Incorporated’s CYTK pipeline candidate aficamten in Japan.

Aficamten, a cardiac myosin inhibitor, is being evaluated for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM).

Year to date, shares of Bayer have lost 41.9% against the industry’s growth of 3.1%.

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BAYRY’s Collaboration With CYTK

Bayer entered into a collaboration and license agreement with Cytokinetics for the exclusive development and commercialization of aficamten in Japan.

As per the joint development plan, Bayer plans to conduct a phase III study in Japanese patients with obstructive HCM. On the other hand, Cytokinetics will expand ACACIA-HCM, the ongoing global late-stage study of aficamten in patients with non-obstructive HCM, into Japan. This study is intended to support the potential marketing authorization of aficamten in Japan for Bayer. CYTK will also expand CEDAR-HCM, its ongoing study for pediatric patients with obstructive HCM.

Please note that aficamten was granted Breakthrough Therapy designations by the FDA and the National Medical Products Administration in China for the treatment of symptomatic obstructive HCM.

Per the financial terms of the agreement, Cytokinetics will receive an upfront payment of €50 million and an additional €90 million upon achieving milestones through commercial launch, including €20 million, which are near-term. In addition, Cytokinetics is eligible to receive up to €490 million in commercial milestone payments upon achieving certain sales milestones by Bayer and tiered royalties on net sales of aficamten in Japan.

Cytokinetics also submitted a new drug application (NDA) to the FDA in the third quarter of 2024 and plans to submit a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) in the ongoing quarter.

BAYRY’s Efforts to Expand Pharmaceuticals Portfolio

Successful drug development is imperative to Bayer amid multiple challenges. The failure of a late-stage study on asundexian was a major setback for the company.

BAYRY is also working to expand the labels of its key drugs, Nubeqa and Kerendia, which should boost growth.

Bayer acquired marketing rights for the cardiovascular candidate, acoramidis, in Europe from BridgeBio.

An NDA for acoramidis has been filed with the FDA, and the regulatory body has set a target action date of Nov. 29, 2024, for the same.

Bayer is also working on the label expansion of its approved drugs.

BAYRY also submitted an MAA to the EMA for its pipeline candidate, elinzanetant.

The MAA is seeking approval of the candidate for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause or adjuvant endocrine therapy.

The FDA also accepted the company’s new drug application for elinzanetant, seeking approval for the treatment of moderate-to-severe VMS.

BAYRY’s Zacks Rank & Stock to Consider

BAYRY currently carries a Zacks Rank #3 (Hold).

A better-ranked large-cap pharma stock is Pfizer PFE, which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.85 to $2.92. PFE’s shares have lost 12.9% year to date.

Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.


 

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