All Clarivate websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.
Providing no details, Mirati Therapeutics Inc. failed to meet its overall survival primary endpoint in the phase III Sapphire trial with sitravatinib. The receptor tyrosine kinase inhibitor was tested in combination with anti-PD-1 checkpoint inhibitor Opdivo (nivolumab, Bristol Myers Squibb Co.) vs. docetaxel in patients with second- or third-line advanced nonsquamous non-small-cell lung cancer. According to Mirati, this patient population consists of about 70,000 people in the U.S. and Europe who have derived prior benefit from a PD-(L)1 inhibitor.
Launching with a $300 million series A financing, Renagade Therapeutics Inc. has set out to target disease on a large scale – at every point throughout the human body where disease forms – through its RNA platform designed to deliver, code, edit and insert genetic information. The round, led by founding investors MPM Bioimpact and F2 Ventures, is the largest venture capital (VC) round for a U.S.-based biopharma company this year, and it is among the top series A rounds for the industry to date.
Right on schedule the U.S. FDA gave its blessing for Krystal Biotech Inc.’s topical gene therapy, Vyjuvek (beremagene geperpavec, or B-VEC), an orphan drug, to become the first approved treatment for the rare skin condition dystrophic epidermolysis bullosa (DEB).
Four years after its founding, Myeloid Therapeutics Inc. raised $73 million to advance mRNA immunotherapy technology that targets and activates myeloid cells. Proceeds from the financing will go toward MT-101, the company’s first autologous CAR monocyte, which is in a phase I/II trial for T-cell lymphoma. It also will accelerate development of MT-302, a potentially first-in-class TROP2-FcA mRNA lipid nanoparticle candidate, which is ready for a phase I/II study for TROP2-expressing solid tumors.
With GSK plc’s Arexvy approved in the U.S. as the first respiratory syncytial virus (RSV) vaccine, several other developers are lining up for what in five years could be a $10 billion market. Their aim is to provide lasting protection for those most susceptible to the endemic virus, particularly young children and those older than 60. Behind GSK is Pfizer Inc. with PF-06928316, which has a U.S. FDA PDUFA date set for this month, and Sanofi SA’s nirsevimab, for which FDA action is expected in the third quarter.
On its May 10 PDUFA date, the U.S. FDA approved serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s dementia, marking the first approved treatment for the indication.
On its May 10 PDUFA date, the U.S. FDA approved serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s dementia, marking the first approved treatment for the indication.
Roche AG acquired global rights to Zion Pharma Ltd.’s lead program, ZN-A-1041, an orally administered selective tyrosine kinase inhibitor that is designed to penetrate the blood-brain barrier and can prevent and treat brain metastases in HER2-positive metastatic breast cancer patients.
The idea for a new company, Ten63 Therapeutics Inc., started in 2015, when Gilda Szacher Frenkel passed away at age 62 from pancreatic cancer. After sequencing her tumor, her son Marcel discovered that her cancer was driven by mutations to key proteins that regulate cellular processes – all the “usual suspects,” he said. At the time, he remembers they were initially encouraged by the discovery and excited to search for developed drugs that could help her. “Here was this blueprint telling us what was wrong,” Marcel Frenkel said, “but, unfortunately, those mutations were unactionable. There were no drugs to modulate the main oncologic drivers.”
In what has been described as one of the slowest, closed-window public markets in recent years, Acelyrin Inc. priced an upsized IPO, raising $540 million, the fifth highest amount for a U.S. IPO by a traditional biopharma company to date. Despite industry IPOs raising only $628 million throughout the first four months of 2023 – the lowest amount in 10 years, Acelyrin’s IPO suggests that there is still a strong investor appetite ready and waiting for innovative technologies with solid data.
