The lively antibody-drug conjugate (ADC) space chalked another collaboration as Taipei, Taiwan-based Foreseen Biotechnology Co. Ltd. scored a global licensing agreement worth as much as $1.03 billion with Ipsen SA, of Paris, for antibody-drug conjugate FS-001, which is said to bear first-in-class potential. The drug takes aim at a novel tumor-associated antigen that is overexpressed in many solid tumors and plays a critical role in tumor proliferation and metastasis, the companies said.
The primary-endpoint win by Sensorion SA in a phase II proof-of-concept study with SENS-401 (arazasetron) in hearing loss made public March 11 brought renewed interest in the space, where a number of players are advancing gene therapies. The story marches on, with Montpellier, France-based Sensorion due to discuss the product July 13 at the International Conference on Cochlear Implants and Other Implantable Technologies in Vancouver, British Columbia.
The lively antibody-drug conjugate (ADC) space chalked another collaboration as Taipei, Taiwan-based Foreseen Biotechnology Co. Ltd. scored a global licensing agreement worth as much as $1.03 billion with Ipsen SA, of Paris, for antibody-drug conjugate FS-001, which is said to bear first-in-class potential. The drug takes aim at a novel tumor-associated antigen that is overexpressed in many solid tumors and plays a critical role in tumor proliferation and metastasis, the companies said.
Amylyx Pharmaceuticals Inc.’s acquisition of GLP-1 receptor antagonist avexitide for $35.1 million from Eiger Biopharmaceuticals Inc. could bring the firm “to the forefront of the obesity and diabetes drug landscape in a unique way,” said H.C. Wainwright analyst Andrew Fein. Co-CEO and co-founder Justin Klee said the deal came after Amylyx checked out “hundreds of assets” over the last few years, and its closing brought added attention to phase III-ready, first-in-class avexitide.
Uniqure NV shares (NASDAQ:QURE) closed July 9 at $6.67, up $2.89, or 76%, after the firm made public updated interim data including up to 24 months of follow-up findings from 29 treated patients enrolled in the ongoing U.S. and European phase I/II trials of AMT-130 for Huntington’s disease (HD).
As developers in the oft-troubled TIGIT class forge onward, Roche Holding AG’s Genentech unit provided an unfavorable update July 5 on the phase II/III Skyscraper-06 study testing anti-TIGIT candidate tiragolumab plus Tecentriq (atezolizumab) and chemotherapy vs. Keytruda (pembrolizumab, Merck & Co. Inc.) and chemo as first-line treatment for non-squamous non-small-cell lung cancer (NSCLC).
Argenx SE gained U.S. FDA approval of subcutaneously given Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). The company’s stock (NASDAQ:ARGX) was up 11.7% to $440.59 at the close of trading June 24. About 24,000 people in the U.S. are being treated for CIDP, and patients are generally diagnosed between 40 and 60 years of age.
Sarepta Therapeutics Inc. CEO Douglas Ingram said he expects “ferocious” demand for gene therapy Elevidys (delandistrogene moxeparvovec), granted full approval by the U.S. FDA for Duchenne muscular dystrophy (DMD). Shares of the Cambridge, Mass.-based firm closed June 21 at $16.72, up $37.22, or about 30% on the news.
Gilead Sciences Inc. tallied a “clear win,” said Barclays analyst Carter Gould, in the phase III interim analysis showing that the Foster City, Calif.-based company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, yielded 100% efficacy as an HIV blocker for cisgender women.
Wall Street is mulling Intra-Cellular Therapeutics Inc.’s chances of replicating with Caplyta (lumateperone) the path followed by Abbvie Inc. with Vraylar (cariprazine) in major depressive disorder (MDD), and possibly overtaking the latter in the difficult indication.
