Tezspire effective for chronic rhinosinusitis; Gilead lowers Trodelvy valuation

AstraZeneca and Amgen recently reported that their drug, Tezspire, demonstrated significant efficacy in reducing nasal congestion and the size of nasal polyps compared to a placebo in a Phase 3 clinical trial. This study included participants with a specific type of chronic rhinosinusitis. These findings, which the companies intend to present at an upcoming medical conference, could potentially broaden the use of Tezspire beyond its current approvals for asthma in the United States and over sixty other countries. Additionally, Tezspire may soon compete with GSK's depemokimab, another drug that has shown promise in treating the same condition in two Phase 3 trials.

Jazz Pharmaceuticals is planning to initiate an early-stage clinical trial for an experimental narcolepsy treatment called JZP441 in the first half of next year. The drug was previously tested in a different Phase 1 trial but was paused due to reports of visual disturbances and cardiovascular side effects. JZP441 targets orexins, proteins that play a crucial role in regulating wakefulness, arousal, hunger, and mood. According to Robert Iannone, Jazz's head of research and development, this upcoming study will be critical in determining whether to continue with JZP441 and will also provide valuable insights for the company's backup programs.

Geron Corporation has secured substantial funding through agreements with Royalty Pharma and funds managed by Pharmakon Advisors. The deal includes selling tiered royalty rights on U.S. net sales of Rytelo, a newly approved drug for anemia associated with myelofibrosis, in exchange for $125 million. Additionally, Geron obtained a five-year senior secured term loan of up to $250 million from Pharmakon-related funds, with half of the amount already drawn. These funds have been partially utilized to repay existing loans from Hercules Capital and Silicon Valley Bank. Geron plans to use the remaining funds to launch Rytelo and conduct further testing.

Aditum Bio, a venture firm, and China-based Leads Biolabs have established a new company, Oblenio Bio, to develop a tri-specific T cell engager aimed at treating autoimmune diseases. Oblenio Bio has been granted an exclusive global development option for the drug, with Leads receiving $35 million in upfront and near-term fees and also gaining an equity stake in the new company. Oblenio Bio is the 13th company to be spun out by Aditum Bio.

Gilead Sciences has decided to cease the development of its antibody-drug conjugate Trodelvy for second-line non-small cell lung cancer. This decision follows consultations with regulatory authorities after unfavorable results from a lung cancer study conducted earlier this year. Consequently, Gilead will record a $1.8 billion write-down on the value of its ongoing research and development activities. Despite this, the company continues to pursue the development of Trodelvy for first-line lung cancer treatment, as it is already approved for certain types of breast tumors.

Avid Bioservices, a contract drug manufacturing company, is set to be acquired by GHO Capital Partners and Ampersand Capital Partners for approximately $1.1 billion. The investors will pay $12.50 per share of Avid, representing nearly a 14% premium on the stock's closing price. This acquisition coincides with Ampersand's recent purchase of a Nektar Therapeutics drug manufacturing facility for $70 million in cash. The move aligns with a broader trend of contract development and manufacturing organizations being taken private in recent years.