A nearly two-year-old partial clinical hold has been lifted by the U.S. FDA on PTC Therapeutics Inc.’s pivotal phase II study in Huntington’s disease. The agency had paused enrollment in October 2022, saying it wanted more data on PTC-518, an orally bioavailable small-molecule splicing modifier, before enrollment could continue.

Gilead Sciences Inc. tallied a “clear win,” said Barclays analyst Carter Gould, in the phase III interim analysis showing that the Foster City, Calif.-based company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, yielded 100% efficacy as an HIV blocker for cisgender women.

China’s National Medical Products Administration (NMPA) approved Dizal Pharmaceutical Co. Ltd.’s golidocitinib for treating adults with relapsed or refractory peripheral T-cell lymphoma whose disease has progressed or was refractory to at least one prior systemic therapy.

Ionctura SA closed a €80 million (US$86 million) series B round as it prepares to accelerate development of lead asset roginolisib in the treatment of uveal melanoma. That follows publication of phase Ib data showing roginolisib, an orally available allosteric modulator of the delta isoform of PI3K (phosphatidylinositol-4,5-bisphosphate kinase), is distinguished from other drugs in this class, in being well-tolerated over long periods, with patients having been treated for up to 38 months.

Takeda Pharmaceutical Co. Ltd. has signed an option agreement to in-license Ascentage Pharma Group Inc.’s olverembatinib, an oral third-generation BCR-ABL tyrosine kinase inhibitor (TKI). If exercised, the option would allow Takeda to license exclusive global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia.

Chinese artificial intelligence (AI)-driven drug discovery firm Quantumpharm Inc., also known as Xtalpi, began trading on the Hong Kong stock exchange June 13, listing under a new special technology listing track that lured it away from an IPO in the U.S.

Fledgling biotech Ternarx Pty Ltd. has emerged from stealth mode and is the first of its kind in Australia to develop targeted protein degrader technology to destroy disease-causing proteins that cannot be targeted by conventional drugs. The Melbourne-based company will initially develop targeted protein degraders against currently undrugged transcription factors in cancers with significant unmet need, starting with neuroblastoma and prostate cancer.

Marea Therapeutics came out of stealth mode on June 18, after raising a combined $190 million through its series A and B financings. The series A round was led by Third Rock Ventures, and the series B round was led by Sofinnova Investments and co-led by Forbion, Perceptive Xontogeny Venture Fund and Venbio.

The deaths of two cancer patients treated with the small molecule azenosertib has prompted the U.S. FDA to place a partial clinical hold on a phase I study and two phase II studies from Zentalis Pharmaceuticals Inc. The deaths are presumed by Zentalis to be from sepsis. Both patients who died were in the phase II Denali study of platinum-resistant ovarian cancer.

Following a day of deals that collectively bring a potential $3.75 billion into three biopharma companies – namely Ascidian Therapeutics Inc., Belharra Therapeutics Inc. and Mabcare Therapeutics – researchers will be busy discovering new therapies for neurological and immunological diseases, and advancing globally a candidate for solid tumors.