Two big pharma firms placed high offers on Dec. 26 to acquire companies focused on radiopharmaceuticals and cell therapies in what Evercore ISI analysts are calling a “good sign for the end of the year.” Bristol Myers Squibb Co., under a definitive merger agreement, will purchase Rayzebio Inc. for $62.50 per share in cash for a total equity value of $4.1 billion, or $3.6 billion net of estimated cash acquired. Meanwhile, a buyout by Astrazeneca plc of Gracell Biotechnologies Inc., of San Diego, Suzhou, China, and Shanghai, is worth up to $1.2 billion, with the pharma firm paying $2 per ordinary share, or $10 per American depositary share (ADS), in cash at closing. The total value also includes a non-tradeable contingent value right for up to 30 cents per ordinary share, or $1.50 per ADS.

Legochem inks landmark $1.7B deal with Janssen for ADC drug

Legochem Biosciences Inc. signed a $1.7 billion licensing deal with Janssen Biotech Inc. for its Trop2-directed antibody-drug conjugate (ADC), closing the biggest technology transfer deal in Korean biotech history after Chong Kun Dang Pharmaceuticals Corp. The news sent Legochem’s stock (KOSDAQ:141080) on the Korea Exchange soaring 10.38%, up ₩5,400 (US$4.17) from its previous close – rising from ₩52,000 (US$40.18) on Dec. 22 to ₩57,400 on Dec. 26. Its stock continued to rally on Dec. 27, rising 6.45% to close at ₩61,100. Under the terms, Legochem stands to gain an up-front payment of $100 million, an option exercise payment of $200 million and potentially $1.422 million in development, regulatory and commercial milestone payments, along with tiered royalties on net sales.

A belated gift: Cytokinetics surges on positive phase III data in cardiomyopathy

Cytokinetics Inc. has received a slightly last minute Christmas gift in the form of positive top-line data from the pivotal phase III study of aficamten in treating symptomatic obstructive hypertrophic cardiomyopathy. Compared to placebo, the selective, small-molecule cardiac myosin inhibitor significantly improved patients’ exercise capacity, including increasing their peak oxygen uptake. Statistically significant (p<0.0001) and clinically meaningful improvements also were found in the study’s 10 secondary endpoints. Aficamten’s competition is Bristol Myers Squibb Co.’s first-in-class agent, Camzyos (mavacamten), the only U.S. FDA-approved cardiac myosin inhibitor for adults in the indication. The often fatal disease is indicated by thickening heart muscles that causes difficulty in breathing, among other symptoms. Cytokinetics stock (NASDAQ:CYTK) was surging at midday with shares trading 77% upward at $81 each.

Lianbio out-licenses Asia rights to Janssen for radioenhancer NBTXR-3 for $30M

Lianbio Co. Ltd. is out-licensing NBTXR-3 to Janssen Pharmaceutical NV to develop and commercialize the radioenhancer in China, South Korea, Singapore and Thailand. Under terms of the agreement with Janssen, Lianbio will receive a one-time payment of $25 million and is eligible to receive a sales milestone payment of $5 million. Following the deal close, Lianbio will support the transition of the asset to Janssen within six months.

Top Trends of 2023: EU pharma reform seeks to provide equitable access; threatens data exclusivity, incentives

As their term in office winds to a close, MEPs in the two main political groupings of the European Parliament still have huge differences of opinion over the proposed reform of the EU pharmaceutical regulation and how best to achieve the stated aims of improving patient access whilst encouraging innovation. At the center of the controversy is a proposal by the European Commission to reduce regulatory data protection from eight years currently to six, with a proviso that this can be extended by two years if a product is launched in all 27 member states within two years of EMA approval.

Top Trends of 2023: Industry, FDA mindset coming around to psychedelics

The long, strange and nowhere-near-concluded trip taken by psychedelic drugs as a therapeutic modality continued in 2023, with regulators in the U.S. and Europe – and, perhaps in greater numbers, investors – warming to prospects in a space that once drew only laughter.

US agencies retain strict conditions in final merger oversight policy

The U.S. Federal Trade Commission and the Department of Justice have issued the final version of their updated merger guidelines for corporations, concluding a process that took a scant six months to complete. As seen in the draft guidelines published earlier this year, any transactions that could increase concentration in a market or eliminate substantial competition between firms could be deemed unacceptable, an approach that seems to offer little breathing room for life science companies seeking efficiencies via these transactions.

US FDA working through guidance to-do list

Drug guidances continue to pour forth from the U.S. FDA as 2023 winds to an end. The latest batch deals with issues as varied as the reformulation of drug products that use carbomers manufactured with benzene, potency assurance for cellular and gene therapies, the development of drugs and biologics for rare diseases, and the quality of topical eye treatments. Citing an immediate public health need to expedite the discontinuation of carbomers manufactured with benzene, which is a known human carcinogen, the FDA said it is implementing the benzene guidance as a final guidance without going through the usual public comment period.

Holiday notice

BioWorld's offices were closed in observance of Christmas. No issues were published Monday, Dec. 25 or Tuesday, Dec. 26.

BioWorld Insider Podcast: Six biopharma executives consider a tough 2023 and are hopeful for a better 2024

One aspect of 2023 our group of executives completely agreed on: the past year was tough financially. And they all foresee a more vibrant year ahead for the market. Giving all of them hope were technological breakthroughs such as artificial intelligence, game changing weight loss drugs, the surging fascination with ADCs and hope for lower interest rates. But uncertainty looms about the upcoming general election in the U.S. and ground-shifting gene therapies. In a preview of the annual Biotech Showcase conference, an investor conference for private and micro- to mid-cap biotech companies Jan. 8-10 in San Francisco, BioWorld spoke with Dave Bearss, CEO of Halia Therapeutics Inc., Vimal Mehta, CEO of Bioxcel Therapeutics Inc., Paul Lammers, CEO at Triumvira Immunologics Inc., Chris Pirie, COO of HDT Bio Corp., Thijs Spoor, CEO of Perspective Therapeutics Inc., and Shelley Hartman, CEO of Aegle Therapeutics Corp. They offered insights brought about by years of hard-won experience.

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Also in the news

Adimab, Algernon, Allovir, Alpha Cognition, Alpine Immune, Arcturus, Atreca, Beigene, Biocytogen, Biovaxys, Cellusion, Cidara, CSL, Codexis, Concentra, CTM, Daiichi Sanyko, Daré, Eli Lilly, Engene, Entera, First Wave, FSD, Galecto, Gilead, Harpoon, Immunome, Innovent, Ionis, Irlab, Kite, Longeveron, Mendus, Merck, Mineralys, Nestlé, Nrx, Olix, Opthea, Point, Sanegene, Sarepta, Takeda, TC, Theseus, Trevena, Vyant, Zealand, Zymeworks