The decision stands in contrast to the agency’s plans for a would-be rival gene editing treatment from Vertex Pharmaceuticals and CRISPR Therapeutics that is also under a regulatory review. 

The struggling biotech also plans to offload other cell therapy assets, including a multiple myeloma therapy, and focus exclusively on gene editing medicines.

The Japanese drugmaker said it was unable to resolve manufacturing problems that led to a 2019 recall of the drug, which treats hypoparathyroidism.

AstraZeneca paved the way for PARPs in prostate cancer when it won an approval for Lynparza in advanced patients. Now Pfizer may have a combination treatment for earlier-stage disease.

The biotech terminated a Phase 2 study after treatment led to serious liver enzyme elevations in multiple patients with hereditary angioedema.

Chroma Medicine, which launched last year with $125 million in funding, has drawn several high-profile biotech leaders to it, including ex-Alnylam CEO John Maraganore and deal maven George Golumbeski. 

Cellarity is the second Flagship company in as many months to raise a Series C round instead of filing to go public.

The acquisition, Incyte’s first of an entire company, hands the pharmaceutical company a potentially long lasting treatment for the skin disease vitiligo.

The biotech said the proposed offer “significantly undervalues” the company, but that it’s open to considering a higher bid.

Shares in LogicBio had lost nearly all their value since a 2018 IPO, bringing the company to the brink of Nasdaq delisting. The buyout deal represents a premium of over 600%.

Part of a $1 billion alliance the companies formed in 2020, the drug will be tested in a large study of patients who test positive for mutations in a gene called LRRK2.  

The regulator could soon approve medicines from Apellis, Gilead and GSK, and decide whether to pull a controversial preterm birth drug from the market.