Shares of Iterum Therapeutics plc fell 40% July 26 after disclosing that the FDA issued a complete response letter (CRL) for its NDA for sulopenem etzadroxil/probenecid (oral sulopenem), an anti-infective compound, for urinary tract infections (UTIs). The agency determined the NDA cannot be approved in its present form.
In a deal that could bring Arvinas Inc. a potential $2.4 billion, the company will collaborate with Pfizer Inc. to develop and commercialize an oral estrogen receptor protein degrader. In addition to a potential $400 million in approval milestones and a possible $1 billion in commercial milestones, Arvinas will be paid $650 million up front by Pfizer, which will also make an equity investment of $350 million in Arvinas while receiving about 3.5 million newly issued Arvinas common stock shares. With the deal, Pfizer will have a 7% equity share in Arvinas. The two plan to equally divide development and commercialization costs as well as any profits.
DUBLIN – Anocca AB raised $47 million in a series B round to advance its T-cell-based immunotherapies expressing recombinant T-cell receptors (TCRs) toward clinical trials in cancer and to build out its manufacturing capacity at its base in Södertälje, Sweden.
Jiangsu Hengrui Medicine Co. Ltd. reported positive interim data from its phase III trial for SHR-3680, an androgen receptor antagonist, demonstrating that it reduced the risk of disease progression or death in metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
French biotech Pep-Therapy SAS is taking its potentially first-in-class cancer cell penetrating peptide technology into the clinic, after raising €5.4 million (US$6.4 million) in an extended series A funding round. The series A fundraiser initially brought in €2.6 million, but the extension brought in a further €1.6 million in equity from Anaxago, i&i Prague and Badge as well as a €1 million loan from Bpifrance.
Having created a profitable preclinical services business, Biocytogen Pharmaceuticals Co. Ltd. is now working to develop its own pipeline of antibody therapeutics, recently inking a partnership with China Resources Biopharmaceutical Co. Ltd to develop drugs for oncology and immunology indications and raising “tens of millions of dollars” in a new financing round to support the development of its antibody drugs.
PERTH, Australia – Suda Pharmaceuticals Ltd. saw its stock shoot up nearly 44% on the heels of an oversubscribed AU$3.65 million (US$2.71 million) capital raise after acquiring a new invariant natural killer T (iNKT) cell therapy platform for oncology.
China’s Center for Drug Evaluation has released the guideline on developing oncology drugs with a clinical value-oriented approach, part of its ongoing efforts to encourage the development of truly innovative oncology drugs in China.
The China NMPA’s Center for Drug Evaluation accepted Lepu Biopharma Co. Ltd.’s new drug application (NDA) for anti-PD-1 antibody candidate HX-008 (pucotenlimab). That comes after the company filed for an IPO in Hong Kong.
Innovent Biologics Inc. and Ascentage Pharma Group Corp. Ltd. inked a three-component collaboration that comes with joint commercialization of an NDA-stage Bcr-Abl inhibitor and co-development of combination therapies, as well as Innovent taking a stake in Ascentage. The collaboration involves a deal worth up to $145 million and a $50 million investment.
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