Eli Lilly and Co. disclosed its plan to buy collaborator Sigilon Therapeutics Inc., bringing aboard SIG-002, the type 1 diabetes drug on which the pair has been working since 2018. The news sent shares of Cambridge, Mass.-based Sigilon (NASDAQ:SGTX) on a rocket ride, trading midday at $25.39, up $21.48, or 549%. Lilly will commence a tender offer to acquire all outstanding shares of Sigilon for $14.92 per share in cash (a total of about $34.6 million) payable at closing, plus one non-tradeable contingent value right per share that entitles the holder to up to $111.64 per share more in cash, which brings the total potential payout as high as $126.56 per share in cash without interest – an aggregate of up to about $309.6 million, excluding shares held by Lilly, of Indianapolis.

Alvotech Humira biosimilar not at US starting gate yet

One of the companies that had hoped to be part of the upcoming launch of Humira biosimilars is instead exploring options to raise additional capital so it can continue advancing its biosimilar pipeline in the near-term. Alvotech Holdings SA was expecting FDA approval June 28 for AVT-02, developed as both an interchangeable and biosimilar to the high-concentration formulation of Abbvie Inc.’s blockbuster autoimmune drug. But instead of an approval, the FDA sent the company a complete response letter June 28 noting deficiencies at the company’s Reykjavik facility that must be satisfactorily resolved.

Bioxcel’s BXCL-502 shows promise for Alzheimer’s acute agitation, but shares plunge on FDA warning letter

Although the highest dose of Bioxcel Therapeutics Inc.’s BXCL-501 hit the primary endpoint in the phase III Tranquility II trial for acute agitation in Alzheimer’s disease, shares fell dramatically on June 29 by 64% when investors learned the company received an FDA warning letter over infractions at a trial site. The New Haven, Conn.-based company’s stock (NASDAQ:BXCL) was trading at $6.31, down $11.36 at midday. It issued a press release on the phase III results, showing statistical significance with the 60-mcg dose, but it also filed an 8-K with the SEC disclosing the receipt of an FDA Form 483 in December. The warning pointed out problems with the principal investigator at the site, which enrolled 40% of the Tranquility II trial participants.

Celltrans’ type 1 diabetes treatment receives FDA approval

Two years after a U.S. FDA advisory committee agreed the risk-benefit profile of Celltrans Inc.’s pancreatic islet cellular therapy was favorable, the agency has approved Lantidra (donislecel) for treating adults with type 1 diabetes. The therapy is made from deceased donor pancreatic cells and is for those who cannot approach their target glycated hemoglobin level because of severe hypoglycemia that cannot be properly managed. The FDA said Lantidra’s primary mechanism of action is believed to be the secretion of insulin by the infused allogeneic islet beta cells. Privately held Celltrans developed Lantidra at the University of Illinois-Chicago.

Singapore’s Lion TCR raises $40M in series B round to advance cell therapy for HBV-related liver cancer

Lion TCR Pte. Ltd raised $40 million in series B funding that will see the company advance its clinical trial program for its hepatitis B virus (HBV)-specific T-cell receptor (TCR) cell therapy for HBV-related liver cancer. Lion TCR of Singapore, and Guangzhou, China, was cleared by the FDA to begin a phase Ib/II international multicenter trial for lead compound, Liocyx-M (LioCyx-M004), and enrollment has begun. The company is conducting trials in Asia, including sites in Singapore and China. It is the first international multicenter trial testing the TCR-T therapy for HBV-related liver cancer.  

Vesalius closes €95M fund IV, with 60% going to drug development

Vesalius Biocapital Partners Sàrl has called a first close on its fourth fund at €95 million (US$103 million) and now is targeting a total of €150 million, with new investors to be accepted on a "rolling closing" basis until the final close in 2024. Fund IV has been backed both by investors in Vesalius’ previous funds and by new investors. It will support a portfolio of 10 to 15 startups, with 60% going to drug development and 40% to digital health companies. Returning investors include the EU’s European Investment Fund, which put €30 million into fund III and has upped this to €40 million in fund IV.

Also in the news

Abbvie, Acorda, Alloy, Amplifica, Anavex, Appili, Astellas, Atossa, Bayer, Black Diamond, Blue Earth, Caliway, Carisma, Checkpoint, Cognition, Corcept, Cormedix, Eiger, Emergex, First Wave, Foghorn, Genmab, Immunome, Ironwood, Karyopharm, Kineta, Lumos, Meletios, Microba, Morphimmune, Navidea, Neuren, Panbela, Prothena, Rapport, Regeneron, Rezolute, Rivus, Sangamo, Sanofi, Sellas, Spago, Taysha Gene Therapies, Tme, Vectivbio, Verona, Vir, Viracta