Merck Withdraws I-DXd BLA Citing Insufficient Data

Merck & Co Inc (NYSE: MRK) has withdrawn its Biologics License Application (BLA) for I-DXd, an antibody-drug conjugate aimed at treating extensive-stage small cell lung cancer (ES-SCLC), citing that the submitted data did not meet the criteria for accelerated approval. This decision comes after reviewing the data by the FDA.

Despite this setback, Merck remains committed to advancing I-DXd through ongoing clinical development, including patient enrollment in the pivotal phase 3 IDeate-Lung02 trial comparing I-DXd to standard chemotherapy in relapsed ES-SCLC patients. Two other phase 3 trials are underway exploring I-DXd's efficacy in other cancer indications.

Merck currently offers a dividend yield of 2.31%, but the payout ratio is considered too high at 1.11, raising concerns about long-term sustainability. The stock price is modestly overvalued relative to its intrinsic value estimates, with a GF Value of $120.81 and a current share price of $148.78.