H. Lundbeck A/S is to acquire Longboard Pharmaceuticals Inc. in an all-cash deal valuing the epilepsy specialist at $2.6 billion. The agreed price of $60 per share is a 54% premium to the closing price of Longboard stock (NASDAQ:LBPH) on Oct. 11 and represents the biggest deal in Lundbeck’s 110-year history. The acquisition will give the Copenhagen, Denmark-based pharma company ownership of bexicaserin, which in September entered phase III development in Dravet syndrome. The 5-HT_2C agonist has the potential to treat this and other rare developmental and epileptic encephalopathies, for most of which there are no approved therapies.

Pfizer notches another hemophilia approval 

The U.S. FDA has approved the second hemophilia drug in nearly six months from Pfizer Inc. This one, Hympavzi (marstacimab), is for preventing or reducing bleeding in those age 12 and older with hemophilia A and B. Those with hemophilia A should be without factor VIII inhibitors and those with hemophilia B should be without factor IX inhibitors, which are neutralizing antibodies. The anti-tissue factor pathway inhibitor’s BLA had a PDUFA date in the fourth quarter. Pfizer’s Beqvez (fidanacogene elaparvovec) won FDA approval in late April for use in adults with hemophilia B, making it the second adeno-associated viral vector-based gene therapy available for patients in the U.S.

China’s NMPA approves Junshi’s PCSK9 ongericimab

China’s National Medical Products Administration (NMPA) has given the thumbs up to Junshi Biosciences Co. Ltd.’s NDA for ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody (MAb), marking the third PCSK9 inhibitor to be cleared in China. As previously reported by BioWorld, Innovent Biologics Inc.’s PCSK9 inhibitor, Sintbilo (tafolecimab), was the first locally developed PCSK9 MAb to be approved in China and was cleared in August 2023. Akeso Pharmaceuticals Inc.’s PCSK9 inhibitor, ebronucimab, scored the second approval in September 2024. Branded as Junshida – and available as an injectable pre-filled 150-mg syringe and a 150-mg auto-injector – Junshi’s ongericimab is indicated for dietary control in combination with statins or statins and ezetimibe for treatment of adults with primary hypercholesterolemia (non-familial) and mixed dyslipidemia, who fail to achieve low-density lipoprotein cholesterol (LDL-C) goals after receiving moderate or higher doses of statins. The approval marks Shanghai-based Junshi’s fifth commercialized product.

Jasper rises on promising early briquilimab data in urticaria 

Shares of Jasper Therapeutics Inc. (NASDAQ:JSPR) shot up 30% early Oct. 14 as the company reported promising preliminary data from the phase Ib/IIa Spotlight study testing briquilimab in chronic inducible urticaria (CIndU). In the two most prevalent CIndU subtypes, cold urticaria or symptomatic dermographism, 14 of 15 patients (93%) achieved a clinical response within six weeks. It’s the latest win for briquilimab, an antibody therapy targeting c-Kit (CD117), across a range of mast cell and stem cell diseases, including Fanconi anemia, acute myeloid leukemia, myelodysplastic syndromes and severe combined immunodeficiency.

Akeso raises $250M to expand global pipeline

Akeso Pharmaceuticals Inc. raised $250 million via a public offering that will allow the company to accelerate clinical development of its internally developed drugs in both China and international markets. The offering consists of 31.7 million shares priced at HKD$61.28 (US$7.88) per share and marks the second successful placement in 2024 for Guangdong, China-based Akeso. Following the offering, the company's cash on hand is expected to be $1.064 billion. Akeso raised HKD$1.17 billion in March 2024 to expedite development of its PD-1/CTLA4 bispecific antibody Kailani (cadonilimab), and ligufalimab (AK-117), a humanized IgG4 anti-CD47 monoclonal antibody for potential treatment of solid tumors; and to commercialize ivonescimab (AK-112), its PD-1/VEGF bispecific antibody.

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