Strong top-line results from Immunovant Inc.’s phase IIa clinical trial of IMVT-1401 in treating moderate to severe generalized myasthenia gravis increased the competition with Momenta Pharmaceuticals Inc. and Argenx SE in the crowded anti-FcRn space.
Novartis AG won FDA clearance for the anti-CD20 monoclonal antibody Kesimpta (ofatumumab) in relapsing forms of multiple sclerosis (MS) in adults, with a label that includes clinically isolated syndrome and relapsing-remitting as well as active secondary progressive disease.
Sanofi SA is acquiring Principia Biopharma Inc. in a $3.68 billion deal that brings Sanofi three clinical-stage BTK inhibitors and simplifies a partnership that began three years ago. Paris-based Sanofi plans to acquire all outstanding Principia common stock shares for $100 each at a $3.36 billion enterprise value. Sanofi will get SAR-442168 (PRN-2246), the brain-penetrant candidate at the heart of the deal. The agreement now gives Sanofi full control of the program, bringing a three-year partnership between the two companies to an end
The FDA’s go-ahead for Roche Holding AG’s Enspryng (satralizumab-mwge) in anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder had watchers of the space weighing its market odds against two therapies approved earlier: Soliris (eculizumab) from Boston-based Alexion Pharmaceuticals Inc., and the more recently cleared Uplizna (inebilizumab-cdon) from Viela Bio Inc., of Gaithersburg, Md.
Adopting a new strategy in food allergies and others, South San Francisco-based Iggenix Inc. launched with a $10 million series A round to fund work that CEO Bruce Hironaka told BioWorld puts the company “at the front of the wave.” Companies in the allergy space generally “have not taken full advantages of the developments that we’ve seen in the biotech industry over the last 20 or 30 years,” he said.
The matter of how adhesion of its Viaskin Peanut allergy patch relates to efficacy became a major problem for DBV Technologies SA, which drew a complete response letter (CRL) for the once-daily epicutaneous (EPIT) product. Shares of the Montrouge, France-based firm (NASDAQ:DBVT) closed Aug. 4 at $2.34, down $1.76, or 43%, in reaction to the CRL for the patch, designed to protect children ages 4 to 11. The FDA wants DBV to modify the patch, which means a new human-factor study; officials also are requiring clinical data for the modified patch.
Novartis AG didn’t say why the FDA has put off action until September – a delay of three months – on the sBLA for multiple sclerosis (MS) prospect Arzerra (ofatumumab, OMB-157), first cleared in October 2009 for chronic lymphocytic leukemia, but the holdup brought renewed attention to the bustling space, and Immunic Inc. – which held its R&D Day on May 27 – is coming on strong.
LONDON – Enthera Pharmaceuticals Srl has announced the largest international series A to date for an Italian biotech, closing a €28 million (US$32.9 million) round, to take programs in type 1 diabetes and inflammatory bowel disease (IBD) into phase I development.
HONG KONG – Looking to boost its R&D capacity, China’s Sunshine Guojian Pharmaceutical (Shanghai) Co. Ltd. launched an IPO on July 22 that raised ¥1.7 billion (US$240 million) on Shanghai’s STAR market. Shares (SSE:688336) almost doubled in value on the first day of trading, closing at ¥54.10, for a gain of 92%.
DUBLIN – Roche Holding AG has joined Jnana Therapeutics Inc. in its quest to drug the human repertoire of solute carrier (SLC) metabolite transporters as a means of tackling a swath of immune-mediated and neurological diseases. The Basel, Switzerland-based pharma is paying Boston-based Jnana $40 million up front and could pay over $1 billion more in research funding, preclinical, development and commercial milestones, as well as sales royalties, in a multitarget deal.