The FDA’s approval of Genentech Inc.’s Gavreto (pralsetinib) for treating adults with metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) follows the FDA’s May approval of Eli Lilly and Co.’s Retevmo for patients whose tumors have a RET alteration. Gavreto will be commercialized in the U.S. by Genentech, part of the Roche Group, along with Blueprint Medicines Corp., which developed the once-daily oral therapy. Outside the U.S., Roche will handle commercialization.
Lixte Biotechnology Holdings Inc., a small OTC-listed company developing inhibitors of protein phosphatases to be used alone and in combination with cytotoxic agents and/or x-ray and immune checkpoint blockers for treating cancer, has filed to raise $10.7 million in a public offering of shares on Nasdaq.
A nearly $2 billion global development and commercialization deal with Abbvie Inc. and a $418 million private placement have bolstered I-Mab Biopharma Co. Ltd.’s position globally. I-Mab framed the deal as being the largest out-licensing and global partnership transaction ever executed by a China-based biotech.
With the PDUFA date for relugolix against prostate cancer growing nearer and data in castration resistance-free patients closer still, Myovant Sciences GmbH aims to wring more from the oral, once-daily gonadotropin-releasing hormone receptor antagonist, studying it in uterine fibroids and endometriosis.
In its second acquisition of the past four weeks, Lodo Therapeutics Corp., acquired Hibiskus Biopharma Inc. plus exclusive worldwide rights from the University of California Riverside and Michigan State University to preclinical proteasome and immunoproteasome inhibitors developed by Hibiskus’ two co-founders.
Researchers at City of Hope have used a combination of oncolytic virus and CD19-targeting CAR T cells to first force expression of CD19 on tumor cells and then hunt down those cells, eradicating tumors in immunocompetent mouse models and endowing them with immunity to later re-administration of tumor cells.
Rain Therapeutics Inc., a California company developing targeted cancer therapies with a biomarker-based strategy, has raised a $63 million series B round led by Boxer Capital to support its development of the small-molecule MDM2 inhibitor RAIN-32 (milademetan) for the potential treatment for liposarcoma and other cancers.
The massive deal Jounce Therapeutics Inc. has cut with Gilead Sciences Inc., an agreement that could eventually add up to about $805 million, will strengthen Jounce’s ability to develop its pipeline and choose new partners, the company’s CEO and president told BioWorld.
Two days ahead of its Sept. 3 PDUFA date, Bristol Myers Squibb Co. received the FDA’s approval for Onureg, an oral form of azacitidine, for continuing treatment of adults with acute myeloid leukemia (AML). The indication is specifically for patients achieving first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy. BMS said Onureg is the first and only FDA-approved continued AML treatment for patients in complete remission.
DUBLIN – Shares in Polyphor AG gained as much as 12% during early trading Aug. 31 on news of a deal in China for its lead drug, balixafortide, which is currently undergoing a phase III trial in HER2-negative locally recurrent or metastatic breast cancer.
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