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Home » Newsletters » BioWorld

BioWorld

June 21, 2023

View Archived Issues
Stock chart with falling red arrow

Uniqure stock drops 40% as Huntington’s disease data fail to convince

Shares in Uniqure NV fell sharply on inconclusive interim data from a U.S. phase I/II trial of its gene therapy for Huntington’s disease. The stock (NASDAQ:QURE) hit a six-year low during trading on June 21, ending the day at $11.62, down 40%. Read More

Vyvgart Hytrulo wins U.S. FDA approval for generalized myasthenia gravis

Following a three-month delay, the U.S. FDA approved under priority review a subcutaneous formulation of Argenx SE’s efgartigimod, offering patients a much more convenient way to treat generalized myasthenia gravis (gMG). Read More
Eye and financial charts

No studies, no data, no approval: Aldeyra gets a CRL

In its newly issued complete response letter (CRL) to Aldeyra Therapeutics Inc., the U.S. FDA said there’s just not enough evidence of efficacy right now to approve ADX-2191, an injectable vitreous-compatible formulation of methotrexate to treat primary vitreoretinal lymphoma (PVRL). Read More
Pipet, test tubes, chemical structures

Applying power of genetics to chemistry, Flagship’s Empress emerges from stealth with $50M

Empress Therapeutics Inc., a Flagship Pioneering firm, has come out of stealth with $50 million in initial funding, a new chief scientific officer and an ambitious plan to file multiple INDs for novel small-molecule compounds over the next two years. Read More
Illustration of intestines with inflammation

Scientists behind LANCL2 target launch with phase III-ready drug

Many of the available treatments for the autoimmune conditions ulcerative colitis (UC) and Crohn’s disease come with drawbacks such as safety issues or inconvenient dosing regimens. Describing itself as a biomarker-driven immunoregulatory therapeutics company, Nimmune Biopharma Inc. is striving to fulfil what it perceives as a high need for safer, more effective options with candidates that target the lanthionine synthetase C-like 2 (LANCL2) pathway. Read More

PhRMA suit: IRA negotiations also a ‘taking’ from patients, providers

The floodgates have opened for challenges to the new U.S. drug price negotiation process laid out in the Inflation Reduction Act (IRA) that was narrowly passed last year. Read More

SK Bioscience strives for ‘equal access’ to Korean COVID-19 vaccine with WHO approval

The World Health Organization (WHO) recently gave an emergency use listing (EUL) for SK Bioscience Ltd.’s COVID-19 vaccine called Skycovione, a self-assembled nanoparticle vaccine that targets the SARS-CoV-2 spike protein. Read More

China greenlights Salubris’ HIF-PH inhibitor for anemia

Shenzhen Salubris Pharmaceuticals Co. Ltd. received marketing approval from China’s NMPA for enarodustat as a treatment for anemic patients with chronic kidney disease (CKD) that are not on dialysis. Read More

Appointments and advancements for June 21, 2023

New hires and promotions in the biopharma industry, including: Alentis, Kyowa, Maplight, Noema, Organicell, Rgenta, Versameb, Virpax. Read More

Financings for June 21, 2023

Biopharmas raising money in public or private financings, including: Artbio, Clene, Diamedica and Neural. Read More

In the clinic for June 21, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Argenx, Bavarian Nordic, Bridgebio, Citius, Clarity, Curevac, Curocell, Cytokinetics, Delix, Denali, Enanta, Escient, HMNC Brain Health, Icosavax, Longbio, Maia, Merck, Milestone, Minghui, Nodthera, Seagen, Takeda, Timber, Tracon. Read More

Other news to note for June 21, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: GSK, Neogap, Novo Nordisk, Ose, Scynexis, Veru, Virpax. Read More

Regulatory actions for June 21, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aardvark, Advantage, Agepha, Akebia, Aldeyra, Amarin, Amgen, Arcellx, Argenx, Aridis, ARS, Biologix, Boehringer Ingelheim, Geron, Pfizer, Precigen, Replay, Sonnet. Read More

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