After reaching a height in 2021, seed and series A rounds have fallen in recent years, and 2024 is no exception, although amounts raised are tracking slightly ahead of last year. On July 23, the numbers were given a boost when two new companies – namely Dover, Del.-based Brenig Therapeutics Inc. and Boston-based Third Arc Bio Inc. – raised $65 million and $165 million, respectively, in series A financings. A third new company, Abiologics, also received $50 million in early funding. That brings the series A total for 2024 to $3.98 billion through 64 transactions.

Flagship puts $50M into Abiologics for Synteins

Flagship Pioneering introduced Abiologics Inc., which is developing a new class of supranatural and programmable medicines called Synteins. The compounds are computationally generated and synthesized with novel building blocks. Flagship has invested $50 million to the Cambridge, Mass.-based firm, which will first focus on oncology and immunology indications.

Gan & Lee’s long-acting GLP-1 shows weight loss in phase IIb

Gan & Lee Pharmaceuticals’ long-acting GLP-1 receptor agonist (GLP-1 RA), GZR-18, achieved as much as 17.29% weight loss in a phase IIb trial in obese and overweight Chinese patients. Developed independently by Shanghai-based Gan & Lee, GZR-18 is a once-weekly or potentially biweekly GLP-1 RA being developed to treat adults with type 2 diabetes and for weight management for obese or overweight patients.

Merck’s RSV antibody for infants hits late-stage study endpoints

Many respiratory syncytial virus (RSV) disease vaccines are for older adults but Merck & Co. Inc.’s monoclonal antibody MK-1654 (clesrovimab), which just produced positive top-line phase IIb/III data, aims at a far younger market. Data for protecting healthy preterm and full-term infants from RSV disease show the double-blind, randomized, placebo-controlled clinical trial hit all its primary efficacy and safety endpoints, including the incidence of RSV-associated medically attended lower respiratory infection for 150 days compared to placebo. Pfizer Inc.’s RSV prophylactic Abrysvo (RSVpreF) to protect newborns up to age 6 months against RSV for the first time was approved by the U.S. FDA in August 2023. Abrysvo comprises two antigens from RSV A and B strains, the two primary RSV subtypes. It administered at 32 through 36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by RSV.

House Oversight hearing on PBMs another blame game session

Noting that the median price of new drugs that entered the U.S. market last year hit $300,000, senior officials of the three biggest pharmacy benefit managers (PBMs) in the country once again denied responsibility for drug prices as they testified today before the House Oversight Committee. Instead, they continued pointing their fingers at big pharma and the patent thickets drugmakers build around blockbuster drugs. Just before the hearing began, committee Chair James Comer (R-Ky.) released a staff report that he said includes evidence showing “how PBMs inflate prescription drug costs and interfere with patient care for their own financial benefit.” The report echoed many of the findings of an interim FTC report on PBM practices that was issued earlier this month.

FDA approves second Soliris biosimilar

Samsung Bioepis Co. Ltd., of Incheon, South Korea, gained U.S. FDA approval of Epysqli (eculizumab-aagh) as the second biosimilar product to Alexion Pharmaceuticals Inc.’s Soliris (eculizumab) to treat two rare diseases. The regulatory clearance July 22 grants use of Epysqli to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) — two rare hematologic- and kidney-related disorders known to affect about 50,000 and 5,000 patients in the U.S., respectively. Soliris, first developed by Astrazeneca plc’s Alexion subsidiary, is an injectable recombinant humanized monoclonal antibody and anti-C5 complement inhibitor.

BioWorld Insider Podcast – The cost of delays in development and sales: It’s probably not what you think

Two costs of developing drug candidates have been upended by new research from the Tufts University School of Medicine’s Center for the Study of Drug Development. New data have produced some very different numbers than you might expect in the cost of a single day of a clinical trial and of missing a day to generate prescription drugs sales. The center’s director, Ken Getz, spoke to the BioWorld Insider podcast about updating the outdated numbers and what it means for companies and investors.

Also in the news

Addex, Apollo, Bridgebio, Cannamore, Certa, Destiny, Evotec, Immutep, Johnson & Johnson, Leo, Mei, Metrion, Moderna, Mymd, Ovid, Pharmaessentia, Pharma Two B, Precision Neuroscience, Rani, Samsung Bioepis, Scilex, Synaptixbio, TME, Valneva, Vedanta, Zymeworks