Eqrx Inc., a startup co-founded by serial biotech entrepreneur and investor Alexis Borisy to deliver new medicines for cancer and other conditions at "radically lower prices," is poised to raise up to $1.8 billion via a merger with the special purpose acquisition company (SPAC) CM Life Sciences III Inc. The transaction, which would bring Eqrx to Nasdaq, includes a fully committed and upsized PIPE of $1.2 billion led by Softbank Group's SB Management Ltd. as well as SPAC sponsors Casdin Capital LLC and Corvex Management LP, plus $550 million of cash and trust held by the SPAC itself. Read More
Hong Kong Exchanges and Clearing Ltd. (HKEX) has taken the first step towards allowing listings on the market via special purpose acquisition companies (SPACs), also known as “blank check” companies. The move has left biotech companies wondering if the change could provide the next big opportunity to join the market after pre-revenue companies were first allowed to list there under a 2018 main board listing rule paved the path for them to do so. Read More
A three-month delay proved to be of no concern for Nexviazyme (avalglucosidase alfa-ngpt, neoGAA), Sanofi SA’s long-term enzyme replacement therapy (ERT), which gained FDA approval for intravenous infusion to treat patients 1 and older with late-onset Pompe disease. Read More
Akeso Inc. became the fifth company to score an approval for a homegrown PD-1 antibody in China, with penpulimab cleared for relapsed or refractory (r/r) classic Hodgkin’s lymphoma (cHL). The company is seeking more approvals for nasopharyngeal and lung cancers in both China and the U.S. to stand out in the increasingly competitive PD-1 space. Read More
While Aprea Therapeutics Inc.’s data disclosed July 21 from the phase II trial with eprenetapopt – also known as APR-246, a reactivator of mutant tumor suppressor protein p53 – plus azacitidine (AZA) whetted interest in taking aim at the “guardian of the genome,” the company’s fortune took an unexpected turn when the FDA smacked a partial clinical hold on work with the duo. Read More
Sierra Oncology Inc. has swooped in on an early stage BET inhibitor from Astrazeneca plc, paying just $8 million up front for the myelofibrosis drug – a price that raises questions about the $1.7 billion Morphosys AG stumped up to buy Constellation Pharmaceuticals and its class rival. Read More
Novavax Inc. now says it plans to submit an emergency use authorization (EUA) to the FDA for its highly efficacious COVID-19 vaccine, NVX-CoV2373, sometime in the fourth quarter, backing off previous plans of a second-quarter and then a third-quarter filing. Read More
Manufacturing deficiencies were cited in the FDA’s complete response letter (CRL) for Spectrum Pharmaceuticals Inc.’s Rolontis (eflapegrastim), a decision that will further delay to market in the U.S. what could be the *first novel G-CSF drug in more than 15 years to treat chemotherapy-induced neutropenia. Read More
For the first time this year, the amount of money raised by the biopharma industry has dropped below the amount collected during the same timeframe last year, even though the number of transactions has climbed by nearly 10%. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Biovie, Clene, Exicure, Imara, Merck, Monopar, Noema, Portage, RDIF, Regeneron, Sanofi, Stemedica, Takeda, Telix, Ultimovacs. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Eczac?ba??-Pharmaceuticals Marketing, Glaxosmithkline, Kadmon, Mymd, Paratek, Pharmaxis, Praxis Bioresearch, Recode, Roche, Sesen, Sorrento, Synaptogenix, Syros, Teva, Transcode, Vaxcyte, Verseon. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apexigen, China Pharma, Eiger, Everest, Exelixis, Merck, Therapeutic Solutions. Read More
