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BioWorld - Saturday, May 9, 2026
Home » Topics » North America » U.S.

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Mobia Medical Vivistim system

Mobia debuts on Nasdaq to bring stroke therapy to more patients

May 8, 2026
By Shani Alexander
No Comments
Mobia Medical Inc. began trading on Nasdaq under the ticker MOBI on May 8. The company priced its IPO at the midpoint of its proposed $14 to $16 range, selling 10 million shares at $15 each and raising approximately $150 million. The stock closed at $11.75 its first day of trading, down 21.7%.
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IPO, coins, financial chart

Odyssey’s IPO, placement brings $304M to lead drugs in IBD, lupus

May 8, 2026
By Karen Carey
No Comments
Raising $279 million in an IPO and another $25 million in a concurrent private placement, Odyssey Therapeutics Inc. is advancing its lead phase II asset, OD-001, in ulcerative colitis, with plans to bring its SLC15A4 program into the clinic for lupus.
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Illustration of antibodies attacking nerve cells

Budo judo moves aplenty for Climb in autoimmune

May 8, 2026
By Randy Osborne
No Comments
Climb Bio Inc. outlined May 5 an enticing data spill ahead this year with Fc-enhanced monoclonal antibody budoprutug (budo) in autoimmune diseases. Mizuho analyst Joseph Catanzaro appreciated in his report Wellesley Hills, Mass.-based Climb’s “conviction that CD19 represents a best-in-class pan-B-cell depletion target across antibody-mediated autoimmune diseases – a relative white space for conventional mAbs.”
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Close up of bow of cruise ship
Infection

Hantavirus is ‘sentinel’ more than acute pandemic threat

May 8, 2026
By Anette Breindl
No Comments
News of eight infections and three deaths so far due to an emerging zoonotic virus has brought back unhappy memories of the early days of SARS-CoV-2. At a press conference on Thursday, officials from the WHO did their best to calm the public’s fears that the MV Hondius, the ship currently heading to the Canary Islands with its remaining passengers plus assorted medical, WHO and European Center for Disease Prevention and Control staff, is the 2026 version of the Diamond Princess.
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Close up of bow of cruise ship

Hantavirus is ‘sentinel’ more than acute pandemic threat

May 8, 2026
By Anette Breindl
No Comments
News of eight infections and three deaths so far due to an emerging zoonotic virus has brought back unhappy memories of the early days of SARS-CoV-2. At a press conference on Thursday, officials from the WHO did their best to calm the public’s fears that the MV Hondius, the ship currently heading to the Canary Islands with its remaining passengers plus assorted medical, WHO and European Center for Disease Prevention and Control staff, is the 2026 version of the Diamond Princess.
Read More

Atara rises on new FDA pathway for Ebvallo resubmission

May 7, 2026
No Comments
Atara Biotherapeutics Inc.’s allogeneic T-cell immunotherapy, Ebvallo (tabelecleucel), for Epstein-Barr virus-positive post-transplant lymphoproliferative disease isn’t out of the running yet. Despite grim predictions in the wake of the U.S. FDA’s second complete response letter for the drug in January, Atara and partner Pierre Fabre Pharmaceuticals Inc. reached agreement with the regulator on a path for resubmitting the BLA.
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FDA logo on textured paper

FDA slowdown on Tzield sBLA underlines CNPV questions

May 7, 2026
By Mari Serebrov
No Comments
Reports that Sanofi SA has asked to withdraw its sBLA for Tzield (teplizumab) from the U.S. FDA’s Commissioner’s National Priority Voucher (CNPV) program is once again raising questions about whether leadership skepticism is overruling approval decisions at the agency.
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Bladder

Phase II Engene trouble: NMIBC detalimogene data throttle stock

May 7, 2026
By Randy Osborne
No Comments
Hopes piqued last November for detalimogene voraplasmid in bladder cancer took a hit from the latest word from the study, as did shares of Engene Therapeutics Inc. (NASDAQ:ENGN), which closed May 7 at $1.72, down 80.6%, or $7.13.
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Red arrow pointing downward on a stock market ticker

Entrada sinks on mixed DMD data with ENTR-601-44

May 7, 2026
By Karen Carey
No Comments
A lower-than-expected increase in dystrophin over baseline in the first and lowest-dose cohort of a phase I/II study of ENTR-601-44 in Duchenne muscular dystrophy (DMD) caused shares of Entrada Therapeutics Inc. to plunge more than 57%, despite the cohort meeting the safety and tolerability primary objective.
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Roche building

Roche to acquire Pathai for up to $1.05B

May 7, 2026
By Shani Alexander
No Comments
Roche Holding AG has agreed to acquire Pathai Inc. for up to $1.05 billion in a bid to strengthen its position in digital pathology and enhance its biopharma services. The move builds on a partnership established between the two companies in 2021, and expanded in 2024, to include the development of AI-enabled companion diagnostic algorithms.
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