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.
Foundation Medicine Inc.’s string of 2020 wins continues, with the U.S. FDA giving its thumbs up to Foundationone Liquid CDx, the company’s comprehensive pan-tumor liquid biopsy test.
Nearly a week after filing for a $115 million IPO that it had put off for more than a year, and two months after dosing the first patient in its phase I trial in metastatic castration-resistant prostate cancer, Poseida Therapeutics Inc. has closed on a $110 million series D to continue its CAR T-cell therapy programs.
BEIJING – Androgen receptor (AR)-related disease specialist Kintor Pharmaceutical Ltd., of Suzhou, China, raised $240 million on the Hong Kong Stock Exchange (HKEX) on May 22 by issuing 92.3 million shares at HK$20.15 apiece. The IPO was oversubscribed by 551 times, showing the city’s biotech fever.
BEIJING – Androgen receptor (AR)-related disease specialist Kintor Pharmaceutical Ltd., of Suzhou, China, raised $240 million on the Hong Kong Stock Exchange (HKEX) on May 22 by issuing 92.3 million shares at HK$20.15 apiece. The IPO was oversubscribed by 551 times, showing the city’s biotech fever.
Just days after Clovis Oncology Inc.'s Rubraca (rucaparib) became the first PARP inhibitor approved by the FDA to treat certain cases of metastatic prostate cancer (mCPRC) in third-line care, the agency granted an even broader label in the indication to its first-in-class competitor, Lynparza (olaparib). Endorsement of second-line use of Lynparza in mCPRC and an overall survival (OS) benefit listed in its updated label will help rapidly establish it as "the drug of choice in the [second] line, leaving little commercial opportunities for Rubraca downstream," SVB Leerink analyst Andrew Berens said.
LONDON – Ibex Medical Analytics is preparing for commercial rollout in Europe after receiving CE-IVD marking for its artificial intelligence (AI) decision support system for automated interpretation of prostate cancer biopsies. Galen Prostate, trained on more than 60,000 samples from multiple institutions, is intended to give a second opinion on digitized slides, following initial assessment by a pathologist.
Citing what it called poor study design and execution coupled with a lack of follow-up data, the FDA’s Oncologic Drugs Advisory Committee voted 13-2 against recommending approval of Steba Biotech SA’s NDA for Tookad (padeliporfin dipotassium) for injection in men with localized early stage prostate cancer.
Houston-based Nanospectra Biosciences Inc. has kicked off a pivotal U.S. study of its Aurolase therapy in the targeted destruction of prostate tumors using nanomedicine technology. The IDE study, with an estimated completion date of December 2022, will support a de novo 510(k) submission to the U.S. FDA. The first two patients were treated at the University of Michigan, which also participated in the first-in-human pilot study of Aurolase.
Nearly 70% of men with locally recurrent prostate cancer who received radiation therapy initially could delay androgen deprivation therapy (ADT) for at least five years following stereotactic body radiation therapy (SBRT) with Accuray Inc.’s Cyberknife system, according to a study published in the International Journal of Radiation Oncology • Biology • Physics.
