BAYRY Begins Phase I Study With KQB548 in KRAS-Mutated Cancers

Bayer BAYRY, along with San Diego, CA-based, privately held company, Kumquat Biosciences, announced the initiation of a phase I study evaluating their investigational inhibitor, KQB548 (BAY 3771249), which is being developed for treating KRAS G12D-mutated tumors.

The early-stage dose-escalation study will evaluate the safety and preliminary efficacy of KQB548 as a monotherapy in patients with KRAS G12D-mutated tumors, like pancreatic, colorectal and lung cancer.

Currently, there are no effective treatments that offer durable therapeutic benefits for the majority of patients with KRAS-G12D-mutated tumors. KRAS mutations are found in about 25% of cancers, yet the most common KRAS (G12D) variant still lacks effective treatment.

The initiation of the phase I study on KQB548 in KRAS G12D-mutated tumors marks a significant step forward in addressing an area of high unmet medical need.

In July, the FDA cleared the investigational new drug (IND) for KQB548. The candidate is the lead program under Bayer and Kumquat's exclusive oncology collaboration.

BAYRY Price Performance

Year to date, shares of Bayer have rallied 62.5% compared with the industry’s rise of 7.9%.

BAYRY Ongoing Pipeline Progress

Bayer is making good pipeline progress. The company has expanded its pipeline in new modalities of cell therapy through the acquisition of BlueRock and in gene therapy through the acquisition of AskBio.

Bayer, together with its subsidiaries, BlueRock and AskBio, is developing preclinical and clinical cell and gene therapies for treating various diseases, including retinal disorders, congestive heart failure and Parkinson's disease, among others.

Bayer’s key drugs, Nubeqa for cancer and Kerendia for chronic kidney disease associated with type II diabetes, are fueling growth in its Pharmaceuticals division, making up for the decline in sales of oral anticoagulant Xarelto, which is co-developed with Johnson & Johnson JNJ.

Xarelto is marketed by Johnson & Johnson in the United States. Bayer earns license revenues from JNJ for Xarelto sales in the United States.

Bayer is also working to expand the labels of Nubeqa and Kerendia, which, if successful, can further drive growth.

The company also plans to launch two new drugs in 2025 — elinzanetant, a hormone-free treatment for menopause symptoms, and acoramidis, a drug for the treatment of a specific form of heart disease.

Elinzanetant has been approved for the treatment of moderate-to-severe menopause-related vasomotor symptoms under the brand name Lynkuet in the United Kingdom and Canada.

Approval of new drugs and label expansion of existing drugs should further boost sales from Bayer’s pharma business.

BAYRY's Zacks Rank & Other Stocks to Consider

Bayer currently sports a Zacks Rank #1 (Strong Buy).

Some other top-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP and Exact Sciences EXAS, each sporting a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share have increased from $7.00 to $7.28. Earnings per share estimates for 2026 have increased from $7.48 to $7.78 during the same period. ANIP stock has surged 65.8% year to date.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, the average surprise being 22.66%.

In the past 60 days, estimates for Exact Sciences’ 2025 earnings per share have increased from 29 cents to 36 cents. Earnings per share estimates for 2026 have increased from $1.06 to $1.12 during the same period. EXAS stock has risen 5.5% year to date.

Exact Sciences earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 329.87%.

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This article originally published on Zacks Investment Research (zacks.com).

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