The U.S. FDA has approved Sun Pharmaceutical Industries Ltd.’s Leqselvi (deuruxolitinib), a JAK1 and JAK2 inhibitor for adults with severe alopecia areata, a chronic autoimmune disease. The twice-daily, oral treatment will be targeting a company-estimated market of about 300,000 people in the U.S. JAK inhibitors are a familiar presence in the space. Eli Lilly and Co.’s once-daily JAK inhibitor pill Olumiant (baricitinib) was approved for adults in June 2022, followed in June 2023 by Pfizer Inc.’s severe alopecia areata treatment Litfulo (ritlecitinib), a once-daily oral JAK3 kinase inhibitor and TEC kinase family inhibitor. Litfulo is the first and only treatment for adolescents aged 12 years and older. Mumbai, India-based Sun acquired Concert Pharmaceuticals Inc. in March 2023 for $576 million to get deuruxolitinib.

Eisai to ask for re-exam after negative opinion on lecanemab in AD

Biogen Inc. and partner Eisai Co. Ltd. said the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing bid for lecanemab in early Alzheimer’s disease (AD) and mild AD. The humanized anti-soluble aggregated amyloid-beta monoclonal antibody is approved in the U.S., Japan, China, South Korea, Hong Kong and Israel, and is being sold in the U.S., where it’s branded Leqembi, as well as Japan and China. Eisai, of Tokyo, will ask the CHMP to re-examine the matter. Cambridge, Mass.-based Biogen’s shares (NASDAQ:BIIB) overnight July 25 fell from $227.44 to $211.55, and were trading midday July 26 at $213.13, down $14.31, or 6%.

Confo's €60M series B targets GPCR, endocrine/metabolic disorders

GPCR drug discovery and development specialist Confo Therapeutics NV has closed a €60 million (US$65.2 million) series B round that will fund a significant expansion of the inhouse portfolio while it continues to turn the handle on its technology platform to generate more compounds for partnering. The underlying technology, in which GPCRs are locked in pharmacologically relevant conformations by single domain VHH nanobodies, opening the way for fragment based-discovery, is proving to be very productive, and with the new money the Ghent, Belgium-based company plans to complete two phase I programs and to take two others to the point of being ready for an IND filing. “What is different is that we can really increase sensitivity toward the pharmacology of interest… hence we don’t lose time working on compounds that don’t have the right pharmacology,” said Cedric Ververken, CEO.

From Day One, Ipsen gains ex-US rights to tovorafenib for $461M

Ipsen SA, of Paris, struck a $461 million deal with Day One Biopharmaceuticals Inc. for ex-U.S. rights to tovorafenib, an oral drug for pediatric brain tumor that gained U.S. FDA accelerated approval April 23 as Ojemda (tovorafenib). Tovorafenib is an oral, once-weekly type II RAF inhibitor that is the first to be FDA approved as a second-line treatment for pediatric patients 6 months and older with relapsed or refractory low-grade glioma with V600 mutation – the most common alteration that affects up to 75% of those diagnosed. Under the terms announced July 25, Ipsen agreed to pay Day One $111 million up front, including $71 million in cash and a $40 million equity investment at a premium, and up to approximately $350 million in potential launch and sales milestone payments. Upon successful commercialization, Day One is eligible to receive tiered double-digit royalties starting at the mid-teens percentage on sales.

Ensho debuts to target gut inflammation with oral α4β7 inhibitors

Ensho Therapeutics Inc. launched in July after licensing a pipeline of four oral α4β7 inhibitors for inflammatory and gastrointestinal disorders, including inflammatory bowel disease (IBD), from EA Pharma Co. Ltd. “Millions of people worldwide are living with IBD,” Ensho founder, president and executive chair Neena Bitritto-Garg recently told BioWorld, “and while there are a number of approved medications to address the symptoms of IBD, it remains a difficult-to-treat disease with high relapse rates for a considerable proportion of patients.”

The BioWorld Insider podcast: The first half of 2024 was strong as M&As and financings dominate

Karen Carey, BioWorld managing editor and chief analyst, takes a look at the numbers from the first half of 2024. She finds the first six months to be healthy for the biopharma market while the rest of the year is populated with question marks that include the U.S. presidential election and potential interest rate cuts.

Also in the news

Ac Immune, Aquestive, Biomarin, Checkpoint, Chemomab, Consynance, Day One, Fortress, Immunome, Ipsen, Mira, Mirum, Nectin, OS Therapies, Ractigen, Roche, Scpharmaceuticals, Tonix, Vigil Neuroscience, Zymeworks