Though Pyxis Oncology Inc.’s preliminary phase I data with antibody-drug conjugate (ADC) PYX-201 in solid tumors were characterized as positive, findings sent the Boston-based firm’s stock (NASDAQ:PYXS) into a tailspin. Shares dropped from $3.82 to $2.01 between Nov. 20 and the morning of Nov. 21, even as experts along with Wall Street agreed that the compound shows particular promise in head and neck squamous cell carcinoma – a space where developers aplenty remain busy.
From local drug discovery to global innovation, economic uncertainty is taking a toll on China’s innovative biotech system, forcing local companies to weather unpredictable storms, investors said during the Chinabio Partnering Forum in Shanghai in September.
In a deal worth up to $1 billion, Ideaya Biosciences Inc. is in-licensing Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s SHR-4849, a phase I DLL3-targeting opo-I-payload antibody-drug conjugate (ADC). Under terms of the deal, San Francisco-based Ideaya will develop and commercialize SHR-4849 worldwide outside of greater China, and Shanghai-based Hengrui is eligible to receive up to $1.04 billion that includes a $75 million up-front fee, $200 million in development and regulatory milestone payments, and commercial success-based milestone payments. Hengrui is also eligible to receive royalties on net sales outside of greater China.
China's National Medical Products Administration (NMPA) approved Innovent Biologics Inc.’s NDA for Dovbleron (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for treating adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
A year after Generate Biomedicines Inc. pulled off its $273 million series C financing round, the Flagship Pioneering-spawned and AI-powered protein therapeutics firm drew investment of an undisclosed amount from the Samsung Life Science Fund Dec. 18.
The BioWorld Biopharmaceutical Index (BBI) closed November with a modest 3.58% gain for the year, a sharp decline from its 16.92% rise in September and peak of 25.19% in August. The BBI has now fallen behind the Nasdaq Biotechnology Index, which posted a 6.27% year-to-date gain, and the Dow Jones Industrial Average, up 19.16% at the end of the month.
Onconic Therapeutics Inc., a subsidiary of Jeil Pharmaceutical Co. Ltd., saw its shares (KOSDAQ:476060) ascend for two consecutive days after debuting with a ₩20.15 billion (US$13.89 million) IPO on the Korea Exchange Dec. 19. Seoul, South Korea-based Onconic’s Kosdaq IPO offered about 1.55 million shares at ₩13,000 each, which was lowered from its original price band of ₩16,000 to ₩18,000 per share after demand forecasting.
A principal investigator and a former biopharma executive are the latest to reach settlements with the SEC to resolve charges of insider trading involving drug companies. Sai-Hong Ignatius Ou, of the University of California Irvine, agreed to a judgment ordering him to disgorge more than $1.5 million and to pay a civil penalty of the same amount. In a separate, unrelated settlement, Curt Dewitz, a former executive of an undisclosed biopharma company, agreed to disgorge about $70,383 in unlawful profits.
Ottimo Pharma Ltd. is equipped to file an IND and take its lead bifunctional antibody into phase II development, after closing a $140 million series A. The round will accelerate development of jankistomig, which targets the PD-1 immune checkpoint whilst inhibiting tumor angiogenesis by neutralizing vascular endothelial growth factor (VEGF).
A Chinese player entered the U.S. non-small-cell lung cancer (NSCLC) arena as the U.S. FDA cleared Xcovery Holdings Inc.’s Ensacove (ensartinib) as a first-line therapy for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic disease who have not previously received an ALK-inhibitor. Xcovery, of Palm Beach Gardens, Fla., is a subsidiary of Betta Pharmaceuticals Co. Ltd, of Hangzhou, China.
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