With high hopes for its LPA1R antagonist program, Contineum Therapeutics Inc. has priced an IPO of 6.9 million shares of its class A common stock at $16 per share as it seeks to generate $110 million in gross proceeds. The San Diego-based company began trading on Nasdaq under the ticker CTNM on April 5, opening at $14.50. Of the net proceeds, the firm plans to put about $66 million toward completing a phase Ib study and phase II trials of its lead, small-molecule drug candidate, PIPE-791, in idiopathic pulmonary fibrosis and progressive multiple sclerosis.

BMS, 2seventy win broader label for Abecma in MM

The U.S. FDA gave its go-ahead to expand the label for Abecma (idecabtagene vicleucel) to include adults with relapsed or refractory multiple myeloma (r/r MM) after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The label of the B-cell maturation antigen-directed, genetically modified autologous CAR T cell immunotherapy includes a boxed warning that notes the risks of cytokine release syndrome, neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, prolonged cytopenia, and secondary hematological malignancies. Abecma was first cleared for r/r MM in March 2021. The drug was developed by Bristol Myers Squibb Co. and 2seventy Bio Inc. Shares of the latter (NASDAQ:TSVT) were trading at $5.79, up 78 cents, or 15%.

Curbing ‘financial toxicity’ key to biotech success, expert says

“A biotech company cannot survive on ‘drug efficacy’ alone,” former Korea Drug Development Fund (KDDF) CEO Hyunsong Muk said recently, “because novel drug development is not just a scientific problem.” Financial toxicity is, in fact, a major obstacle for biotech companies trying to advance preclinical candidates to early stage clinical trials, Muk said at Novo Nordisk A/S’ Partnering Day and Symposium on April 4 in Seoul, South Korea, making it a key aspect of the novel drug development process in Korea and worldwide.

Ascletis quits development of farnesoid X receptor agonist ASC-42

After reviewing data from its phase II trial of farnesoid X receptor (FXR) agonist ASC-42 in primary biliary cholangitis (PBC), Ascletis Pharma Inc. said it was quitting development of the molecule in all indications. Ascletis, of Hangzhou, China, said it made a strategic decision not to pursue further clinical trials of ASC-42 for the PBC indication because the efficacy and safety data from the 12-week phase II trial “did not show competitiveness to new PBC drug candidates currently in development and registrational stages.” The phase II trial had consisted of three ASC-42 active treatment arms (5 mg, 10 mg and 15 mg QD) and one placebo control arm. The company also quit development of its ASC-42 clinical trials in nonalcoholic steatohepatitis and hepatitis B virus.

Better drugs for neurodegeneration will take more research, better biomarkers

At a recent meeting on “Research priorities for preventing and treating Alzheimer’s disease and related dementias” (ADRD), convened by the National Academies, one consensus priority on ADRD research was that there needs to be more of it at every stage. Several speakers presented stark numbers on the relative volume of research in cancer and neurodegeneration. Bart De Strooper told the committee that “The elephant in the room is the lack of knowledge in our field … we need much more research” to understand the disease.

Industry seeks clarity on EU’s joint clinical assessment plan

With nine months to go before their introduction, the industry is flagging many uncertainties around the proposed guidelines for implementing joint clinical assessments (JCAs). These assessments of the clinical effectiveness of new therapies vs. current treatments are the key feature of new pan-European regulations on health technology assessment (HTA) that come into effect in January 2025. Guidelines for how to conduct JCAs have been drawn up by 13 national HTA bodies in consultation with multiple stakeholders. These were put out for public comment by the European Commission in a consultation that ended on April 2. With the outcome unknown, the industry is now both pointing to shortcomings in the proposed guidelines as they stand, and pushing for them to be finalized so that companies can plan accordingly.

CMS rule gives faster access to Part D biosimilars

In finalizing its 2025 Medicare Advantage and Part D rule, the U.S. Centers for Medicare & Medicaid Services (CMS) all but did away with the coverage differences between biosimilars and interchangeables.

Also in the news

AB Science, Achilles, ADC, Aethon, Basilea, Biora, Candel, Caris, Curevac, Effector, Gain, Iaso, Iecure, Macrogenics, Merck, Mina, Nippon Shinyaku, Noxopharm, Odyssey, Oncozenge, Panther, Partner, Poltreg, Revolution Medicines, Tempest, UCB