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BioWorld - Monday, December 29, 2025
Home » Topics » Gastrointestinal, BioWorld

Gastrointestinal, BioWorld
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US FDA reduction-in-force delays response to Vanda

April 23, 2025
By Mari Serebrov
A U.S. FDA CDER official is among the first to say the quiet part out loud in proposing a Sept. 12 deadline for the agency to respond to Vanda Pharmaceuticals Inc.’s request for summary judgment or a hearing on CDER’s refusal to approve tradipitant to treat gastroparesis.
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Earendil charts a course with a $1.8B bispecific deal with Sanofi

April 17, 2025
By Lee Landenberger
Earendil Labs will collaborate with Sanofi SA in a $1.8 billion license deal. Earendil, which specializes in artificial intelligence-based R&D for biologics, is getting $125 million up front and $50 million as a near-term payment. In return, Sanofi gets the exclusive global rights to the bispecific antibodies HXN-1002 and HXN-1003.
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Blood glucose chart and monitor, stethoscope, injector pen

Hightide’s HTD-1801 meets phase III endpoints in type 2 diabetes

April 15, 2025
By Tamra Sami
Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met primary and secondary endpoints in the Symphony 1 and Symphony 2 phase III trials in type 2 diabetes in Chinese patients. Based on the data, Shenzhen-based Hightide will submit an NDA to China’s National Medical Products Administration (NMPA) later this year.
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Illustration of intestinal track

Ironwood: FDA nay on PK means another apraglutide study

April 14, 2025
By Randy Osborne
More than a year after Ironwood Pharmaceuticals Inc.’s phase III hitch with apraglutide in short bowel syndrome, the other shoe fell from regulators as did the Boston-based firm’s shares (NASDAQ:IRWD), which ended April 14 at 64 cents, down 29 cents, or 31.5%.
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Single strand RNA

Airna’s $155M series B advances RNA editing drug AIR-001 for AATD

April 1, 2025
By Karen Carey
As it prepares to advance its lead RNA editing candidate, AIR-001, into a phase I/II trial for alpha-1 antitrypsin deficiency, Airna Corp. Inc. closed an oversubscribed $155 million series B financing less than a year after completing its series A round. The company, based in Cambridge, Mass., with research operations in Tübingen, Germany, focuses not only on repairing harmful genetic variants found in rare genetic disorders, but also on introducing beneficial variants that improve health in common conditions.
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Abstract illustration of pig and human with medical motifs
Drug design, drug delivery & technologies

Ten days of normal survival of a pig liver in a human being

March 26, 2025
By Mar de Miguel
Transplanting an animal organ into a human is now a closer reality following the successful xenotransplantation of a genetically modified pig liver into a patient diagnosed with brain death in China. The operation was intended to evaluate organ function over a 10-day period. This is a complex experimental trial that did not involve removing the patient's liver and still requires further study. However, the positive preclinical results suggest this strategy could save the lives of those waiting for a human organ, at least in certain cases.
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Doctor pointing at liver

Hepatic stellate cells shape and control liver function

March 20, 2025
By Coia Dulsat
Researchers at the German Cancer Research Center Deutsches Krebsforschungszentrum (DKFZ) and their collaborators have cast new light on the mechanisms by which hepatic stellate cells control liver metabolism and regeneration. The work builds on the concept of angiocrine signaling, established 15 years ago.
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Microbiome illustration
Infection

Synthetic microbiome prevents Clostridioides difficile recurrences

March 6, 2025
By Coia Dulsat
Investigators at Pennsylvania State University have described a novel approach to combat Clostridioides difficile infection using a synthetic microbiome therapy, which offers an alternative to antibiotics and fecal microbiota transplant (FMT). C. diff, the main cause of antibiotic-related diarrhea, is responsible for an estimated half a million infections annually in the U.S.
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Ayble Health
Patents

Ayble Health’s AI-enabled digital care platform for GI conditions

Jan. 31, 2025
By Simon Kerton
In what represents the first PCT filing emerging in the name of Ayble Health Inc., protection is sought for a system for adaptive, multi-level processing of health data to be used in the individualized management of immune-mediated inflammatory diseases such as inflammatory bowel disease and irritable bowel syndrome.
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Liver over digital lens background

Akero’s EFX reverses cirrhosis in MASH patients in phase IIb trial

Jan. 27, 2025
By Jennifer Boggs
What a difference 60 weeks can make. That’s the lesson Akero Therapeutics Inc. shared with the rollout of what executives called “unprecedented” data from the phase IIb Symmetry trial testing efruxifermin (EFX), its FGF21 receptor agonist, in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). While earlier findings had shown only a trend in improvement at 36 weeks, full 96-week results showed more than doubling of earlier effect size, hitting the primary endpoint and sending shares of Akero (NASDAQ:AKRO) up 97% to close Jan. 27 at $51.71.
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