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Home » Newsletters » BioWorld

BioWorld

May 17, 2023

View Archived Issues
Stock chart with falling red arrow

Intercept tumbles on US FDA concerns ahead of adcom

The U.S. FDA’s release of its briefing document for the upcoming advisory committee meeting on obeticholic acid 25 mg as a fatty liver disease treatment sent Intercept Pharmaceuticals Inc. on a downwards spiral May 17. Soon after the document was released, Intercept stock (NASDAQ:ICPT) dropped as low as $11.41 – down almost 30% from its May 16 close of $16.21. As the day wore on, it regained some of that lost value in heated trading that was more than eight times the company’s average daily volume of 782,285. The rebound helped Intercept close the day at $13.83, down about 15%. Read More

Coming through in PKU: PTC’s sepiapterin weighed against Kuvan post-phase III

With PTC Therapeutics Inc.’s positive results in phase III with sepiapterin for pediatric and adult patients with phenylketonuria (PKU), attention turned to the would-be showdown with Kuvan (sapropterin dihydrochloride), the drug from Biomarin Pharmaceuticals Inc. that was approved in December 2017. Read More
Oral medication

Infection gains build on X4’s WHIM drug promise

Heightening prospects for an oral neutropenia therapy, X4 Pharmaceuticals Inc.’s lead CXCR4 antagonist mavorixafor slashed yearly infection rates in patients with WHIM syndrome by 58% in a pivotal phase III trial, an effect that was statistically significant. Read More
Andy Murray, CEO and co-founder, Sania

Sania targets neural circuit dysfunction with R-scan, Neu-scan

Sania Therapeutics Inc. is setting out its stall at the American Society of Gene & Cell Therapy (ASGCT) conference in Los Angeles this week, after generating proof of concept for its chemogenetics approach to treating motor disorders. The company has engineered adeno-associated viral vectors that can be targeted to specific cell types. It will use these to deliver well-characterized ion channels to dysfunctional motor neurons. The ion channels will then be selectively controlled by an activating drug, which is taken orally. Read More
Older patient receiving shot

Pfizer, Sanofi, and others prep for vast RSV market, behind GSK’s Arexvy

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. Read More

Appointments and advancements for May 17, 2023

New hires and promotions in the biopharma industry, including: Coeptis, Editas, Gilead, Ochre, Orphazyme, Prothena, Strm.Bio, Verismo. Read More

Financings for May 17, 2023

Biopharmas raising money in public or private financings, including: Achieve, Akero, Ani, Indapta, Mendus, Oncosec, Pfizer, Salarius, Satellos. Read More

In the clinic for May 17, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aobiome, Arrowhead, Astrazeneca, Bioxcel, Coya, Dermavant, Immutep, Inhibikase, Iterion, Lynk, Myrtelle, Neogap, Olatec, Orano, Protara, Radiomedix, Regulus, Viking. Read More

Other news to note for May 17, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biofabri, Biosenic, Engene, Forbion, KSQ Siren, Siraomics, Takeda, Zendal. Read More

Regulatory actions for May 17, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aravive, Astellas, Bayer, Bioartic, Bionxt, Biophytis, Cabaletta, Cormedix, Eisai, Kamada, Kimera, Orchard, Phio, Sarepta, Virios, YS. Read More

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