Amgen ends autoimmune alliance with Kyowa Kirin; TEPEZZA subQ Ph3 success; Imdelltra EU CHMP win; M&A momentum builds
Key Questions
What happened to Amgen's autoimmune alliance with Kyowa Kirin?
Amgen ended its autoimmune alliance with Kyowa Kirin, with the term concluding on March 16. This follows the Phase 3 readout for rocatinlimab on March 23.
What were the key results from Amgen's subcutaneous TEPEZZA Phase 3 trial?
The Phase 3 trial for subcutaneous TEPEZZA in moderate-to-severe active thyroid eye disease met primary and key secondary endpoints, achieving a 76.7% response rate and -3.17mm proptosis reduction. Results were comparable to the intravenous version, positioning it as a simpler delivery option.
How did Viridian Therapeutics (VRDN) stock react to Amgen's TEPEZZA data?
Viridian shares dropped 19% following Amgen's positive Phase 3 TEPEZZA data in April 2022. The data highlighted Amgen's competitive edge in thyroid eye disease treatment.
What do analysts say about Amgen after the TEPEZZA Phase 3 success?
Seeking Alpha upgraded Amgen to Buy, citing its superior thyroid eye disease data over Viridian. William Blair remains bullish, reiterating its strong market position with $36.75 billion in revenue.
What is the latest on Imdelltra's regulatory progress?
Imdelltra received a positive EU CHMP opinion, demonstrating a 40% reduction in death risk and potential $627M in sales. Zai Lab is advancing it in a Phase 1b trial.
What is the Dark Blue AML deal mentioned?
Amgen announced an $840M deal for Dark Blue AML therapeutics on March 22, signaling ongoing M&A momentum in its pipeline.
What issues arose with Prolia biosimilars?
A Prolia biosimilar was blocked, potentially extending Amgen's market exclusivity for the osteoporosis drug.
How does MariTide factor into Amgen's future outlook?
MariTide, an obesity drug, is expected to offset patent expirations (LOE), supporting Amgen's FY26 revenue pivot to $37-38.4 billion.
Kyowa term (03-16), rocatinlimab Ph3 (03-23). TEPEZZA subQ Ph3: 76.7% response/-3.17mm crushes VRDN (-19% Apr22; Seeking Alpha Buy upgrade, William Blair bullish). $840M Dark Blue AML (03-22). Imdelltra CHMP (40% death cut, $627M); Zai Ph1b. Tavneos alert; Prolia biosim blocked. MariTide obesity offsets LOE; $37-38.4B FY26 pivot.