Becoming the second approved respiratory syncytial virus (RSV) vaccine for the 60 and older crowd, Pfizer Inc.’s Abrysvo (RSVpreF; PF-06928316) received a U.S. FDA nod on May 31 for RSV lower respiratory tract disease. In February, the agency’s Vaccines and Related Biological Products Advisory Committee voted 7-4 that data support both the safety and efficacy of the vaccine. Behind this approval for the senior population is another potential approval, expected in August, for infants via maternal inoculation.
In a deal potentially worth $392 million, C4 Therapeutics Inc. signed with Betta Pharmaceuticals Co. Ltd. to develop and market an orally bioavailable BiDAC degrader for non-small-cell lung cancer (NSCLC).
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.
