Regenerative medicine company Mesoblast Ltd.’s stock was trading down 60% at midday on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval.
340B stakeholders find common ground in pointing a finger at PBMs
When it comes to recommending reforms for the U.S.’ 30-year-old 340B Drug Discount Program, there’s one thing drug manufacturers and hospitals agree on – pharmacy benefit managers (PBMs) and other middlemen should not be profiting from a program that’s intended to help uninsured and vulnerable patients gain access to affordable prescription drugs or other health care services. But that’s where the agreement ends between the two industries in their responses to a Senate working group looking for bipartisan 340B solutions.
Biologic cancer drug developer Sunho targets HK IPO
On Aug. 3, Sunho Biologics Inc., filed to list on the Hong Kong stock exchange, armed with its antibody and immunocytokine drug pipeline and post-investment valuation of ¥1.41 billion (US$196 million).
Newco news: Nexo emerges with $60M series A, takes aim at ‘elusive’ targets
When looking for a name, the founders of startup Nexo Therapeutics Inc., which recently emerged from stealth mode with a $60 million series A financing and a research collaboration with the University of Texas MD Anderson Cancer Center, sought a moniker that truly captured its approach to drug development. “We’re excited by opportunities that exist at the intersection of things,” said CEO Andy Phillips. But that “intersection,” goes beyond what the company asserts on its website, to operate at the “nexus of biology and chemistry.”
Newco news: With $26M in funding, RNA editing firm Amber Bio targets diverse mutations
New company Amber Bio emerged on Aug. 3 with $26 million in seed funding that will help advance an RNA-based gene editing platform that leverages Cas-based systems to create safer medicines. Through the company’s platform, a single drug can be used to treat diseases with high allelic diversity. The company plans to develop its own genetic medicines internally, while also licensing out the technology to expand its reach. “The reality is our platform has really far-reaching implications in the ways we treat genetic disorders,” said Jacob Borrajo, cofounder and CEO of the San Francisco-based company.
Also in the news
180 Life Sciences, Aardvark, ABM, Aravive, Arbele, Areteia, Askbio, Assertio, Blue Water, Bolt, Cage, Catalent, Celsius, CNS, Deciphera, Evox, Galapagos, Immutep, Innocan, Ionis, Kiora, Merck, Mindmed, Mithra, Neurobo, Orchard, Oxford Biodynamics, Perfuse, Regeneron, Structure, Taiho, Terns, Ultimovacs, Vertex, Xilio, Xylocor