In a bit of déjà vu, the U.S. FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee once again voted that Makena (hydroxyprogesterone caproate) should be withdrawn from the U.S. market while a second confirmatory trial is designed and conducted. But today’s 14-1 vote was much more decisive than the committee’s 9-7 vote in 2019. If the FDA follows the adcom’s advice and goes forward with its proposal to withdraw the drug, which received accelerated approval in 2011 to reduce the risk of preterm birth, it will be up to Covis Pharma BV to determine if it’s the end of the road for the drug. Adcom members and the FDA alike encouraged the company to study the drug in high-risk populations.

Jazz swoops for Zymeworks ADC zanidatamab in deal worth up to $1.76B

Jazz Pharmaceuticals plc in-licensed regional rights to Zymeworks Inc.’s HER2- targeted cancer drug zanidatamab in a deal potentially worth $1.76 billion, plus royalties. Jazz wants to expand its oncology portfolio with the deal, which covers the U.S., Europe, Japan and all other territories except Asia Pacific markets previously licensed by Zymeworks to Beigene Ltd.

Nucleome secures £37.5M to help illuminate non-coding gene functions

Nucleome Therapeutics Ltd. is poised to shed some light on the dark matter of the genome after raising £37.5 million (US$42.3 million) in an oversubscribed series A expected to support commercialization of its technology for deciphering non-coding genes.

Radiopharm’s radiotracer F-18 Pivalate shows high uptake in brain metastases in phase II trial

Radiopharm Theranostics Ltd.’s phase II F-18 Pivalate positron emission tomography trial in brain metastases saw positive results with high uptake regardless of the origin of primary tumors, showing that Pivalate could be used to monitor brain metastases.

FDA puts PTC's US Huntington’s disease study enrollment on hold

The U.S. FDA wants more data on PTC-518 before PTC Therapeutics Inc.'s phase II study of Huntington’s disease can continue enrollment. While stopped in the U.S., the study of the oral, small-molecule splicing modifier still is enrolling participants at sites in several European countries and in Australia. PTC said it plans to share data from the study in the first half of 2023. The phase II clinical trial has an initial 12-week placebo-controlled phase, to be followed by a nine-month placebo-controlled phase. The compounds are designed to broadly lower the levels of mutant huntingtin protein in both the brain and the periphery by affecting its splicing. Shares in PTC (NASDAQ:PTCT) fell 7.5% by midday.

Eucure out-licenses anti-OX40 mAb to Syncromune for intratumoral immunotherapy

Biocytogen Pharmaceuticals Co. Ltd. subsidiary Eucure Biopharma Co. Ltd. has formed a partnership with Syncromune Inc. to combine Eucure’s YH-002 and two other active ingredients with Syncromune’s Syncrovax platform technology in a deal the partners said could be worth “hundreds of millions of U.S. dollars,” including an up-front cash payment of undisclosed value.

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