Eli Lilly and Co. aired positive top-line data from the phase III trial called Achieve-1 testing orforglipron vs. placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The drug is the first oral small molecule GLP-1 receptor agonist – taken without food and water restrictions – to finish a late-stage trial with results that were satisfying enough to push the firm’s already-hefty stock (NYSE:LLY) up 13%, or $99.32, to trade at $834.22. Orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by an average of 1.3% to 1.6% from a baseline of 8%. Officials said they are confident that if the drug wins approval, Lilly could carry out a worldwide launch without supply constraints.

Budget woes ahead for US life sciences sector?

The next major shock wave to hit the U.S. biopharma and med-tech industries could be the fiscal 2026 federal budget. Nearly one-third of the discretionary budget for the Department of Health and Human Services could be wiped out, Puneet Souda, a Leerink Partners LLC analyst, said, citing a White House preliminary budget document for HHS. About half of the department’s nearly $40 billion cut would sweep the NIH, which could see its budget drop from more than $47 billion currently to less than $27 billion, Souda said. In real dollars, that would set the NIH back to 1999 funding levels. The FDA would fare better with proposed cuts of about 10%. Given how those cuts would be distributed throughout the agency, the “impact may be less than many had feared across [the] drugs, biologics and medical device divisions,” said Brian Abrahams, head of global healthcare research at RBC Capital Markets LLC.

Telix’s brain cancer radiotherapy shows phase II survival benefit

Telix Pharmaceuticals Ltd.’s glioblastoma theranostic, TLX-101, is showing promising overall survival in a phase II trial in recurrent high-grade glioma. The targeted radiation therapy, combined with external beam radiation therapy, demonstrated a median overall survival of 12.4 months from treatment initiation and 32.2 months from initial diagnosis. The results significantly outperform the 9.9-month median survival typically observed with radiation therapy alone in recurrent glioblastoma patients.

Earendil in a $1.8B bispecific deal with Sanofi

Earendil Labs will collaborate with Sanofi SA in a $1.8 billion license deal. Earendil, which specializes in artificial intelligence-based R&D for biologics, is getting $125 million up front and $50 million as a near-term payment. Sanofi gets the exclusive global rights to the bispecific antibodies HXN-1002 and HXN-1003. Their development will be with Earendil’s platform that uses predictive protein modeling and high-throughput biology. The two are being developed to treat autoimmune and inflammatory bowel diseases. HXN-1002 targets α4β7 and TL1A to treat moderate to severe ulcerative colitis and Crohn's disease. HXN-1003 targets TL1A and IL23 for treating patients who are refractory to existing therapies.

Brink’s recombinase enzymes offer new gene editing approach

Newco Brink Therapeutics SAS is poised to work on the next chapter in genome editing after raising €3.5 million (US$4 million) in seed funding to discover and develop programmable recombinase enzymes. The company said these will be more efficient and specific than the current generation of nucleases, and can be tailored for in vivo use in humans. The initial target will be recombinases that are programmed for the endogenous modification of T cells into CAR T cells, in the treatment of hematological cancers.

Glycomine snags $115M to advance its PMM2-CDG treatment

Glycomine Inc. secured $115 million in a series C financing round to support the advancement of GLM-101 into a phase IIb study in patients with phosphomannomutase-2 congenital disorder of glycosylation (PMM2-CDG). The round was led by CTI Life Sciences Fund, funds managed by Abrdn Inc. and Advent Life Sciences. Existing investors Novo Holdings, Sanofi Ventures, Abingworth, Rivervest Venture Partners, Sanderling Ventures, Chiesi Ventures, Remiges Ventures and Asahi Kasei Ventures also participated in the round.

Biopharma M&As plunge in Q1, while $66.86 in deals beats 2024 average

Biopharma deal value declined compared to the previous quarter but remained above the 2024 quarterly average of $57.63 billion. In Q1, biopharma deals totaled $66.86 billion across 330 transactions, a decrease from $80.65 billion in Q4 2024, which saw 372 deals. However, this was a significant value increase from Q1 2024, when deals amounted to $44.32 billion across 376 transactions.

Holiday notice

BioWorld's offices will be closed in observance of Good Friday. No issue will be published April 18.

Also in the news

Addgene, Airna, Arrowhead, Belhaven, Bioarctic, Bluebird, Briacell, Cara, Concept, Conduit, Decoy, Eisai, Elix, Geovax, Innocare, Madrigal, Neurelis, Neuronos, Oncopeptides, Organon, Phathom, Prism Biolab, Protara, Recordati, Telix, Tvardi