Two years after signing a $1.6 billion partnership with Marengo Therapeutics Inc., Paris-based Ipsen SA is back at it again, this time teaming up for two additional assets that target “cold” tumors in a deal that could bring privately held Marengo $1.2 billion. The Cambridge, Mass.-based biotech will provide its next-generation, precision T-cell engager (TCE) technology, Tristar, designed to overcome limitations of traditional TCEs in treating cold tumors for which the immune system fails to mount an adequate immune response due to poor T-cell quality and exhaustion. Tristar TCEs redirect highly activated memory Vβ T cells to the tumor. The deal includes an up-front payment and potential milestone payments up to $1.2 billion total, as well as tiered royalty payments on sales.

Geron’s telomerase strategy validated at last with Rytelo nod

Geron Corp., a company founded more than three decades ago, is finally celebrating its first U.S. FDA approval. The agency cleared imetelstat, branded Rytelo, for use in transfusion-dependent anemia in adults with low- to intermediate-risk myelodysplastic syndromes, specifically those requiring four or more red blood cell units over eight weeks who have failed or no longer respond to erythropoiesis-stimulating agents (ESA) or who are not eligible for ESA treatment. The approval, coming about a week ahead of the June 16 PDUFA date, comes with a label that includes broad use across ESA-ineligible and relapsed/refractory patients, as well as for patients who are ring sideroblast (RS)-positive or RS-negative. Shares of Geron (NASDAQ:GERN) were trading up 20% at midday.

Biomea’s full clinical hold in diabetes stifles the stock

The U.S. FDA clamped a full clinical hold Biomea Fusion Inc.‘s phase I/II study of BMF-219, a covalent menin inhibitor for treating types 1 and 2 diabetes. The FDA said the hold was based on possible drug-induced elevated liver enzymes in the type 2 diabetes patients who had completed the dose-escalation portion of the study. Biomea said the potential causes might be diet, medical history and concomitant medications. The company was referring to participants in the higher-dose range, up to 400 mg, of the Covalent-111 study. The company’s stock (NASDAQ:BMEA) was taking it on the chin at midday, with shares going for $4.16 each, a 63% drop since Friday’s opening bell. On June 8, 2023, shares closed at $41.80 each, the crest for the past 12 months.

IPO nets $136M for CNS-focused Rapport

Rapport Therapeutics Inc. was set to begin trading today (NASDAQ:RAPP) after pricing its IPO of 8 million shares at $17 each to raise $136 million. With offices in Boston and San Diego, Rapport is developing drugs for central nervous system disorders. The offering is expected to close June 10. Goldman Sachs, Jefferies, TD Cowen and Stifel acted as joint bookrunners on the deal. The underwriters have been granted a 30-day option to purchase an additional 1.2 million shares.

Telix announces $200M Nasdaq IPO to bolster radiopharma pipeline

Australian radiopharmaceutical company Telix Pharmaceuticals Ltd. announced its IPO on the Nasdaq to raise $200 million to advance its late-stage radiopharma candidates. Headquartered in Melbourne, Telix has operations in the U.S., Europe (Belgium and Switzerland) and Japan. Telix has an extensive pipeline of theranostic radiopharmaceutical candidates with a focus in urologic oncology (prostate and kidney), neuro-oncology (glioma), musculoskeletal oncology (sarcoma) and bone marrow conditioning.

IPO drought continues in May as biopharma financings up overall

Biopharma financings rebounded in May, reaching $9.15 billion and marking a 48% increase from $6.18 billion in April. However, value is down from the $13.84 billion in financings seen in March and $22.3 billion in February. This year’s monthly average of $12.52 billion reflects an 112% increase from the average of $5.91 billion per month in 2023.

Also in the news

4DMT, Abbvie, Accelerated, Agathos, Agomab, Alchemab, Annexon, Anthos, Bio-Path, Boston, Cirius, Elsie, Exscientia, GSK, Intercept, Kiromic, Madrigal, Micurx, Moderna, Nuclera, Plus, Replimune, Structure