Bayer Obtains Full FDA Approval for Oncology Drug Vitrakvi

Bayer BAYRY announced that the FDA has granted full approval to oncology drug, Vitrakvi (larotrectinib), a first-in-class TRK inhibitor.The drug is now fully approved in the United States for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation that has spread or for those who are not eligible for surgery. The drug was approved for patients who did not have any satisfactory alternative treatment or whose disease progressed following treatment.Please note that Vitrakvi was first granted accelerated approval by the FDA in November 2018.More on BAYRY's VitrakviThe full FDA approval was based on the results of confirmatory trials that support Vitrakvi as a potential new standard of care treatment option for NTRK gene fusion-positive tumors in adult and pediatric patients.Vitrakvi, a first-in-class oral TRK inhibitor, was exclusively designed to inhibit against the TRK family of proteins (TRKA, TRKB and TRKC).Pooled efficacy results from three multicenter, open-label, single-arm clinical trials — LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687), and NAVIGATE (NCT02576431) — showed an overall response rate of 60% with a complete response rate of 24% and a partial response rate of 36%.Bayer obtained the exclusive licensing rights for the global development and commercialization of Vitrakvi following the acquisition of Loxo Oncology by Eli Lilly and Company in February 2019.Bayer Looks to Solidify Portfolio2025 is likely to be another challenging year for this German pharma giant as it expects earnings to decline and sales to grow modestly. The uncertainty caused by ongoing Roundup litigation is also a major hangover on the stock.Sales growth was encouraging in the Pharmaceutical division in 2024. New products, Nubeqa and Kerendia, retained their impressive momentum and offset the negative impact of a decline in Xarelto sales. The company is working to expand the labels of its key drugs, Nubeqa and Kerendia, which should boost growth.Successful development of additional drugs is imperative for Bayer amid multiple challenges. BAYRY expects to launch two new drugs — elinzanetant, a hormone-free treatment for menopause symptoms, and acoramidis, a drug for the treatment of a certain type of heart disease.Shares of BAYRY have surged 15.4% year to date against the industry’s decline of 8.2%.Image Source: Zacks Investment ResearchThe company also aims to strengthen its pharmaceutical pipeline. In 2021, Bayer acquired clinical-stage biopharmaceutical company Vividion Therapeutics to expand into precision small-molecule therapeutics, primarily in oncology and immunology.BAYRY has expanded its pipeline in new modalities of cell therapy, through the acquisition of BlueRock, and gene therapy, through the acquisition of AskBio.The company recently announced a licensing agreement with Suzhou Puhe BioPharma Co., a clinical-stage biotechnology company.Suzhou Puhe BioPharma is focused on the research and development of innovative small-molecule precision therapeutics.Bayer’s Zacks Rank & Other Key PicksBAYRY currently carries a Zacks Rank #2 (Buy).A couple of other top-ranked stocks in the pharma/biotech sector are Amicus Therapeutics, Inc. FOLD and ANI Pharmaceuticals, Inc. ANIP, both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.Amicus TherapeuticsIn the past 60 days, estimates for Amicus’ earnings per share (EPS) have increased from 43 cents to 52 cents for 2025. During the same time frame, EPS estimates for 2026 have increased from 71 cents to 79 cents.FOLD’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 45.42%.ANI PharmaceuticalsIn the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $5.54 to $6.34 for 2025. During the same period, EPS estimates for 2026 have increased from $6.90 to $7.13. Year to date, shares of ANIP have rallied 14%.ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 17.32%. Zacks Names #1 Semiconductor StockIt's only 1/9,000th the size of NVIDIA which skyrocketed more than +800% since we recommended it. NVIDIA is still strong, but our new top chip stock has much more room to boom.With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $803 billion by 2028.See This Stock Now for Free >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bayer Aktiengesellschaft (BAYRY): Free Stock Analysis Report Amicus Therapeutics, Inc. (FOLD): Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks