As Novo Nordisk A/S and Eli Lilly and Co. go head-to-head in the U.S. and Chinese glucagon-like peptide-1 receptor agonists (GLP-1RA) market for diabetes and obesity, Novo Nordisk is in innovator gear once more with leading studies of GLP-1s in Alzheimer’s disease (AD). Sparking intense debate of the potential of GLP-1 in neurodegenerative diseases were findings from Novo Nordisk’s Elad study, which demonstrated significantly improved clinical and cognitive scores in AD patients treated with liraglutide (Victoza/Saxenda) at one year. The study had enrolled 204 patients with mild AD from 24 clinics in the U.K., of which around half (n=102) received up to 1.8 mg of daily subcutaneous liraglutide.

Intercept faces a skeptical FDA in rare liver disease adcom

Intercept Pharmaceuticals Inc. made its case this morning to the U.S. FDA’s Gastrointestinal Drugs Advisory Committee for full approval of Ocaliva (obeticholic acid) to treat the rare disease primary biliary cholangitis (PBC). Intercept is attempting to convince the committee and ultimately a skeptical FDA that the drug’s benefit as a second-line PBC treatment outweighs its risks. The farnesoid X receptor agonist now has a post-approval boxed warning and a restricted indication. In a confirmatory study, Ocaliva failed to demonstrate efficacy on a primary composite endpoint of liver transplantation, death and liver-related outcomes in PBC subjects with chronic disease. The FDA, which is not required to follow the adcom’s guidance, has set an Oct. 15 PDUFA date for Ocaliva’s sNDA.

Immuneering soars on early phase IIa pancreatic data

Shares of Immuneering Corp. (NASDAQ:IMRX) were trading at $2.19, up 76 cents, or 53% on word of positive initial response data from the first five patients treated with IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first line pancreatic cancer as part of the Cambridge, Mass.-based firm’s ongoing phase IIa trial. Results in five patients showed an overall response rate of 40% (2/5), including one complete response, and a disease control rate of 80% (4/5). Mizuho analyst Graig Suvannavejh said in a report that although development is “still in the early innings, we're highly encouraged by these initial data.” More results are coming from at least one of the other four arms of the study by the end of this year.

New biotech M&A alliance to bolster China, US cross-investment

Despite heightened political tensions, both Chinese and U.S. industry officials are working to strengthen ties in the health care and biotech sector, including launching strategic initiatives to foster Sino-U.S. biotech investment and M&A deals. As one of the initiatives, representatives from Hong Kong, China and the U.S. convened at the Bio Hong Kong 2024 conference to launch a global health care M&A and financial investment alliance, along with fostering company and talent growth in Hong Kong.

MBX joins Bicara and Zenas in trio of IPO pricings

Three biopharma IPOs priced on Sept. 13, raising a combined $703 million for two Massachusetts-based companies focused on bifunctional antibodies for autoimmune diseases and cancer, and one midwestern firm developing peptide therapies for endocrine and metabolic disorders. Gross proceeds were $315 million to Boston-based Bicara Therapeutics, $225 million to Waltham, Mass.-based Zenas Biopharma Inc., and $163.2 million to Carmel, Ind.-based MBX Biosciences Inc. It is the highest amount raised for the industry through IPOs in a single month since February. So far in 2024, 21 biopharma companies have debuted, raising $5.58 billion total.

2024 remains a record-breaker for biopharma deal value, M&A values double

Biopharma deal values reached $14.88 billion in August, declining from July’s $20.86 billion but improving over June’s $12.79 billion. With a total of $135.17 billion raised through the first eight months, 2024 continues to hold the record for the highest year-to-date deal value in BioWorld's records.

Also in the news

Allarity, Aprinoia, Aura, Bicara, Biovaxys, Curevac, Emergent, Encell, Epitopea, F2G, Fulcrum, Gilead, Innovent, ITM, Leyden Laboratories, Lucy, Kazia, Merck, Monopar, Nkgen, Oncopeptides, Oncternal, Ono, Orano, Oruka, Pila, QL Biopharm, Radiomedix, Sanofi, Scbio, Seres, Sernova, Summit, Turbine, Ultimovacs, Viridian, Vyne