Based on a preliminary data analysis, Moderna Inc. said it plans to ask the FDA to approve its second and newest COVID-19 booster candidate, mRNA-1273.214. The vaccine contains mRNA-1273 (Spikevax) and a vaccine candidate targeting omicron. New phase II/III results showed it hitting all the study’s primary endpoints when compared to Moderna’s original vaccine, mRNA-1273. CEO Stéphane Bancel said he would like the booster to be available in late summer. Astrazeneca plc also posted strong COVID-19 data as Evusheld (tixagevimab/cilgavimab) demonstrated clinically and statistically significant protection against progression to severe COVID-19 or death from any cause when compared to placebo. The phase III study’s participants were non-hospitalized adults with mild to moderate COVID-19 and had been symptomatic for seven days or less.

Rigel probing geographical differences in ‘confounding’ phase III failure in wAIHA

Pointing to an anomalously high placebo response rate at eastern European trial sites in its Forward phase III trial testing fostamatinib in warm autoimmune hemolytic anemia (wAIHA), Rigel Pharmaceuticals Inc. executives maintain confidence for the SYK inhibitor in treating the rare blood disorder despite the overall statistical miss. “We believe the product does have benefit in these patients,” said President and CEO Raul Rodriguez, adding the firm would be conducting further analyses before taking its case to the U.S. FDA. Investors, however, were less sanguine, sending shares of South San Francisco-based Rigel (NASDAQ:RIGL) falling more than 50% at midday.

US FTC to open the black box on PBM dealings

News that the U.S. FTC is finally going to examine the role of pharmaceutical benefit managers (PBMs) and their impact on prescription drug prices and availability is playing to applause from several sectors that have been complaining for years about PBM practices. After stepping back from such an investigation earlier this year, the FTC announced yesterday that it was launching an inquiry into the six largest PBMs, which together account for about 90% of the U.S. market. Commending the FTC for taking a step “toward a more transparent and understandable prescription drug market,” Sen. Chuck Grassley (R-Iowa) said, “PBMs clearly play an enormous role in what Americans pay for their medicine, and much of that role is opaque and inscrutable.”

Hua Medicine’s dorzagliatin could be first drug to restore glucose homeostasis in type 2 diabetics

Hua Medicine Ltd. presented findings from two phase III trials of its first-in-class dual-acting glucokinase activator (GKA) dorzagliatin that show the drug significantly improved early-phase insulin secretion and glucose sensitivity in patients with type 2 diabetes, thereby restoring glucose homeostasis to treat the underlying cause of diabetes.

Mineralys raises $118M ahead of key phase II readout for hypertension drug MLS-101

Philadelphia’s Mineralys Therapeutics Inc. has secured a further $118 million to develop MLS-101, a potential hypertension drug in-licensed from Mitsubishi Tanabe Pharma Corp. The series B fundraiser follows a $40 million series A round in 2021, which the company used to finance a phase II proof-of-concept study. The firm plans to use proceeds to potentially take MLS-101, a highly selective aldosterone synthase inhibitor that MTPC off-loaded following a strategic review in 2019, into the final stages of clinical development.

Ariceum raises €25M to advance targeted radiotherapy program

Ariceum Therapeutics GmbH is picking up where Ipsen SA left off and taking forward the targeted radiopharmaceutical drug satoreotide, developed by the French pharma to phase II but subsequently divested when it ditched its radiation therapy portfolio. Ipsen transferred satoreotide and all corresponding rights to Ariceum in 2021 and now the startup has raised €25 million (US$26.7 million) in a series A round to restart work on the somatostatin type 2 derivative receptor antagonist.

Synklino secures €29.8M series A financing for CMV-fighter

Synklino A/S has raised €29.8 million (US$31.8 million) in a series A round to take forward SYN-002, a treatment for cytomegalovirus (CMV) infections in both donated organs and patients undergoing hematopoietic stem cell and solid organ transplants. The candidate, a fusion toxin protein, selectively targets CMV infected cells, completely removing both lytic and latent virus over a treatment period of 2 to 3 weeks.

Insilico raises $60M to invest in AI platform and IPF program

AI-enabled drug discovery company Insilico Medicine Ltd. has raised $60 million in a series D round to support expansion of its pipeline. The Hong Kong-based company will use the proceeds to support clinical testing of its lead asset, a potential treatment for idiopathic pulmonary fibrosis, as well as the advancement of its Pharma.AI platform. The funds will also back its global expansion and strategic initiatives, including an automated, AI-driven robotic drug discovery lab and a “biological data factory.”

The BioWorld Insider Podcast: New therapies vie to change fatal course of amyotrophic lateral sclerosis

As multidisciplinary care extends survival and improves the quality of life for people with amyotrophic lateral sclerosis (ALS), can a host of new ALS drugs vying to slow its progression make a difference? A surprise extension of the U.S. FDA review for Amylyx Pharmaceuticals Inc.’s AMX-0035 to review new data, plus near-term readouts from a major ALS platform trial may soon provide answers. Join the BioWorld Insider podcast as we talk with executives from Amylyx and Clene Inc., and a key Penn State ALS expert on what the future of medicine may hold for ALS patients.

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Alvotech, Anagenex, Anavex, Eiger, Emergent, Imaginab, Implant, Johnson and Johnson, Kadimastem, Lead, Multitude, Nosopharm, Oaktree, Oncusp, Oxeltis, Oxurion, Pharnext, Resverlogix, Roche, Stealth, TC, Tiziana