The first and only calcitonin gene-related peptide receptor antagonist nasal spray for migraine has reached the market in the hands of Pfizer Inc., which won U.S. FDA clearance for Zavzpret (zavegepant). Set to launch in July, the compound gained the regulators’ go-ahead thanks to data from two phase III trials. Pricing was not immediately disclosed. Shares of Pfizer (NYSE:PFE) were trading midday at $39.53, up 7 cents.

Newco news: Flagship puts $50M toward targeted tissue-homing tech startup

In an ideal world, when a patient takes a medicine, it acts only at the specific site of disease in the human body whilst sparing healthy tissues. But it almost goes without saying that with many drug regimens, side effects or complications are part of the package. Working behind the scenes to address this limitation over the past couple of years, Massachusetts-based venture capital company Flagship Pioneering is now publicizing its platform of “programmable medicines” that directly and precisely target diseased tissue, funnelling $50 million of investment in the technology and recognizing its achievements formally by launching Ampersand Biomedicines.

AB2 Bio completes enrollment in pivotal pediatric trial for ultra-rare inflammatory disease 

Swiss orphan biotech AB2 Bio Ltd. has completed enrollment in a pivotal phase III trial for its recombinant interleukin-18-binding protein (IL-18BP) drug tadekinig alfa for an inherited form of the ultra-rare condition hemophagocytic lymphohistiocytosis (HLH) that results in an excess of the pro-inflammatory cytokine IL-18. If left untreated, primary monogenetic IL-18-driven HLH – a pediatric disease of variable severity that only came to be described seven to eight years ago – can lead to multiple organ failure, with death occurring in roughly a quarter of cases, although the average overall life expectancy is not yet known. There are no approved therapies for this specific form of HLH. 

Insider trading settled over profits from Audentes/Astellas merger

A California man agreed to settle insider trading charges related to Tokyo-based Astellas Pharma Inc.’s buyout offer of San Francisco-based Audentes Therapeutics Inc. in December 2019 for $3 billion. Mahmoud Abdelkader’s wife worked for Audentes and allegedly determined from “facts he learned from his wife, that there was a high likelihood of Audentes being acquired,” the SEC’s complaint said. He then purchased short-term, out-of-the-money Audentes call options on Oct. 17 and Oct. 18, 2019, about six weeks before the merger was announced. 

Fumarate accumulation moderates inflammation through mitochondrial genetic material

A deficiency in fumarate metabolism could be behind a new mechanism of inflammation mediated by mitochondrial DNA and RNA. Two independent and simultaneous studies described how the accumulation of fumarate in the mitochondria released the genetic material of this organelle through vesicles, activating an inflammatory signaling pathway. Investigators at Trinity College observed fumarate hydratase (FH) dysfunction in macrophages associated with systemic lupus erythematosus (lupus) or sepsis. Scientists at the University of Cambridge reached the same conclusions about FH focusing on kidney cancer cells.

Also in the news

Alligator, Allorion, Alnylam, Areteia, Astellas, Astrazeneca, Avenue, Bergenbio, Biocryst, Bionomics, Clene, CNS, Diamyd, Eli Lilly, Endo, Estrella, First Wave, F-Star, Genfleet, Gensight, Invox, Janssen, Lantern, Leo, Medicinova, Medison, Microbion, Myovant, Novelion, Novo Nordisk, Olema, Orchard, Owkin, Pact, Qiagen, Ribon, Scisparc, Seelos, Servier, Soligenix, Springworks, Sumitovant, TG, Tracon, Twist, Vaccinex, Vertex