CSL Behring has licensed global rights to Uniqure NV's late-stage hemophilia B gene therapy candidate, AMT-061, for $450 million up front, plus up to $1.6 billion in potential milestone payments and royalties. Uniqure positioned the deal as a boon for its broader gene therapies pipeline, anchored by a Huntington's disease (HD) program. But the move appeared to sour investors hoping for a rumored near-term M&A takeout, sending company shares (NASDAQ:QURE) falling 21.8% to $49.22 on June 25. Despite the market reception, analyst reaction was largely supportive of the move, embracing CSL as a natural fit for the program and, in the words of SVB Leerink analyst Joseph Schwartz, appreciating the transfer of "any potential remaining risk in hemophilia B to CSL Behring as QURE rings the cash register." Read More
LONDON – Sosei Heptares has attracted a third pharma partner to its G protein-coupled receptor (GPCR) discovery platform, signing a potential $1 billion-plus deal with Abbvie Inc. in inflammatory and autoimmune diseases. Read More
Nearly a week after filing for a $115 million IPO that it had put off for more than a year, and two months after dosing the first patient in its phase I trial in metastatic castration-resistant prostate cancer, Poseida Therapeutics Inc. has closed on a $110 million series D to continue its CAR T-cell therapy programs. Read More
LONDON – Enterome SA has raised €46.3 million (US$52.6 million) in a mixture of debt and equity, enabling it to take a new type of cancer vaccine, based on microbiome-derived antigens that mimic neoantigens expressed on tumor cells, into the clinic. Read More
At a session of the American Association for Cancer Research Virtual Annual Meeting II, multiple FDA regulators gave presentations on various topics to help drug companies understand the ever-evolving oncology regulation. Read More
Biotech companies with COVID-19 vaccine candidates are collaborating with Indonesian companies for overseas trials and to ensure wider availability when approved. Sinovac Biotech Co. Ltd., for example, is collaborating with Indonesia’s PT Bio Farma to test and manufacture its vaccine candidate there. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: EMD Serono, Genprex, Medivir, Merck, Sinovac, Tizona, Viracta. Read More
