As its name suggests, Superluminal Medicines Inc. is aiming for speed. The startup, which closed a $33 million seed round led by RA Capital Management, is combining a biology-focused approach with a generative AI platform it says has the potential to create candidate-ready compounds in a matter of months, with its initial sights set on G protein-coupled receptor targets.
The narrative of TIGIT-targeting immunotherapy development, beset by negative news in recent months, has found a positive plotline again, thanks to what Roche Holding AG referred to as “an inadvertent disclosure” of a second interim analysis from the phase III Skyscraper-01 study testing anti-TIGIT candidate tiragolumab with anti-PD-L1 antibody Tecentriq (atezolizumab) in non-small-cell lung cancer.
The impact of a black box warning on Neurocrine Biosciences Inc.’s expanded U.S. label for Ingrezza (valbenazine) to treat chorea associated with Huntington’s disease (HD) appears up for debate, following FDA approval late Aug. 18. But analysts agree that it is unlikely to affect sales of the VMAT2 inhibitor in tardive dyskinesia, for which the company recently raised 2023 guidance as high as $1.82 billion.
Six years of collaboration is ending in a buyout, as Decibel Therapeutics Inc. agreed to be acquired by Regeneron Pharmaceuticals Inc. in a deal valued at up to $213 million, including $109 million in equity, with additional payments via contingent value rights linked to clinical and regulatory milestones for DB-OTO, the lead gene therapy program targeting hearing loss.
When Nektar Therapeutics Inc. decided to push ahead with development of Treg stimulator rezpegaldesleukin (rezpeg) in atopic dermatitis despite what appeared to be middling early stage data, investors weren’t exactly jumping up and down. But it turns out those data are more promising than originally thought.
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.
Citius Pharmaceuticals Inc.’s retooled version of withdrawn cancer drug Ontak (denileukin diftitox) is not quite ready for prime time, according to the U.S. FDA, which issued a complete response letter (CRL) for the interleukin-2-diphtheria toxin fusion protein known as Lymphir. The agency is asking for Citius to incorporate enhanced product testing and additional controls but did not raise any concerns regarding safety and efficacy, the company said.
Nearly five years after submitting its first NDA seeking U.S. approval for Vanflyta (quizartinib) for treating a subset of patients with acute myeloid leukemia (AML), Daiichi Sankyo Co. Ltd. finally cleared the last hurdle. The FDA on July 20 approved the FLT3 inhibitor for use in combination with cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed disease that is FLT3 ITD-positive.
Nearly five years after submitting its first NDA seeking U.S. approval for Vanflyta (quizartinib) for treating a subset of patients with acute myeloid leukemia (AML), Daiichi Sankyo Co. Ltd. finally cleared the last hurdle. The FDA on July 20 approved the FLT3 inhibitor for use in combination with cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed disease that is FLT3 ITD-positive.
While the 12-month data from Bridgebio Pharma Inc.’s phase III ATTRibute-CM study testing acoramidis in transthyretin amyloid cardiomyopathy were deemed “puzzling” in late 2021, the 30-month results reported July 17 proved far more pleasing to investors. The trial hit all its endpoints and showed promising results on exploratory markers, sending company shares (NASDAQ:BBIO) up 76%, to close at $32.04, up $13.82.
