ALTEOGEN Inc.

Top 1% investors net purchased Yuhan, Alteogen, and HD Hyundai Heavy Industries as of 1:30 p.m. on the 26th, while net selling Doosan, Korea Electric Power Corp., and Daedong. Yuhan's stock price fell 3.89%, seen as a buying opportunity, and Alteogen's stock price dropped 33%, also attracting buyers.

Merck's Phase 3 trial shows subcutaneous pembrolizumab (KEYTRUDA) with berahyaluronidase alfa is as effective as IV form in metastatic lung cancer, potentially offering a more convenient administration method. This could extend KEYTRUDA's market longevity and mitigate revenue loss post-2028 exclusivity expiry.

Merck announces positive Phase 3 results for subcutaneous pembrolizumab with chemotherapy in metastatic NSCLC, demonstrating noninferior pharmacokinetics compared to IV KEYTRUDA. The trial met primary PK endpoints and showed consistent efficacy and safety. Merck plans to discuss these results with regulatory authorities worldwide.

Merck announces positive Phase 3 trial results for subcutaneous pembrolizumab with berahyaluronidase alfa in metastatic NSCLC, meeting primary pharmacokinetic endpoints and showing noninferiority compared to IV KEYTRUDA.

Merck's Phase 3 study of subcutaneous Keytruda with Alteogen's berahyaluronidase alfa in NSCLC met primary goals, showing non-inferiority to IV Keytruda with chemotherapy.

Merck's subcutaneous Keytruda showed similar characteristics to IV formulation in a Phase 3 trial. The company plans to discuss trial data with FDA and other regulators. Keytruda's U.S. patent expires in 2028, opening the door to biosimilar competitors. Rival Roche has FDA approval for subcutaneous Tecentriq, while Bristol Myers awaits FDA decision on subcutaneous Opdivo. Merck aims to sustain Keytruda's revenue, which reached nearly $22 billion in the first nine months of 2024, by transitioning to a more convenient subcutaneous shot.

Daiichi Sankyo signs $300m exclusive licence agreement with Alteogen to develop subcutaneous version of ADC Enhertu, using Alteogen’s hybrozyme technology ALT-B4. Alteogen to receive $20m upfront and up to $280m in milestones and royalties.

Alteogen Inc. entered an exclusive license agreement with Daiichi Sankyo to use ALT-B4, a novel hyaluronidase, for developing a subcutaneous version of ENHERTU®, a HER2-directed ADC. Alteogen will receive upfront and milestone payments, plus royalties on sales, and will supply ALT-B4 for clinical and commercial use.