In a deal that could exceed $1 billion for Ochre Bio Ltd., the U.K.-based liver disease therapy developer will collaborate with Boehringer Ingelheim GmbH. In the meantime, Hepion Pharmaceuticals Inc. shut down its lead candidate’s phase IIb study while looking for a lifeline.
South Korea’s Eubiologics Co. Ltd. said it gained the World Health Organization’s (WHO) prequalification designation on April 16 for its simplified oral cholera vaccine, approved as Euvichol-S.
Microbiome specialist Enterobiotix Ltd. has raised £27 million (US$34.2 million) in a series B round as it starts a phase II trial of EBX-102-02 in the treatment of irritable bowel syndrome.
The possibility for expanding Bristol Myers Squibb Co.’s S1P modulator, Zeposia (ozanimod), into Crohn’s disease took a hit on disappointing data from the initial analysis of its Yellowstone study, the first of two phase III trials. Results showed the study failed to meet the primary endpoint, defined as clinical remission as measured by the Crohn’s Disease Activity Index at week 12.
Benevolentai Ltd. is betting on its oral phosphodiesterase 10 inhibitor BEN-8744 as having first-in-class potential for moderate to severe ulcerative colitis, after healthy volunteers in a phase Ia trial remained free of central nervous system-associated side effects.
China’s National Medical Products Administration has cleared China Grand Pharmaceutical and Healthcare Holdings Ltd. to advance radiopharmaceutical agent ITM-11 (177Lu-edotreotide) to phase III trials in gastroenteropancreatic-neuroendocrine tumors
PYC Therapeutics raised AU$40 million of an anticipated AU$74 million (US$48.6 million) capital raise to advance three candidates, including lead candidate VP-001, which could potentially be the first treatment for retinitis pigmentosa type 11 (RP11), which causes blindness that begins in childhood and ultimately leads to legal blindness by middle age.
Two sNDAs, one from Bristol Myers Squibb Co. (BMS) and the other from Mirum Pharmaceuticals Inc., have received U.S. FDA approval to further expand their treatment indications.
As widely expected, Madrigal Pharmaceuticals Inc.’s resmetirom picked up the first U.S. FDA approval for treating nonalcoholic steatohepatitis (NASH), an advanced form of nonalcoholic fatty liver disease that has been steadily increasing in global prevalence. Branded Rezdiffra, the liver-directed THR-beta agonist gained accelerated approval for use in conjunction with diet and exercise to treat adults with noncirrhotic NASH with moderate to advanced liver fibrosis, specifically stages F2 and F3.
Akero Therapeutics Inc.’s phase IIb data with FGF21 analogue efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) kept interest alive in the face-off between the company and 89bio Inc. with pegozafermin, another FGF21 drug targeting MASH, for which a phase III study is planned.
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