Deals involving antibody-drug conjugate (ADC) therapies continue to gain momentum with Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. the latest firms to team up on global development and commercialization activities, as Daiichi offered up rights to three of its potentially first-in-class ADC candidates for $22 billion, making it the largest ADC agreement to date. Under the terms, Rahway, N.J.-based Merck will pay Daiichi $4.5 billion up front for access to the Tokyo-based company’s ADCs, ifinatamab deruxtecan, patritumab deruxtecan and raludotatug deruxtecan. Merck is also offering Daiichi up to an additional $5.5 billion for each ADC if certain sales milestones are met, and it has agreed to foot a further up-front fee of $1 billion, a pro-rated portion of which may be refundable if the programs are terminated early.

Abivax gains US listing, pads coffers with $236M in Nasdaq IPO

French biopharma Abivax SA went public on Nasdaq Oct. 20, raising $235.8 million in an IPO to bolster late-stage clinical work on obefazimod, which it aims to position as an oral treatment option in the lucrative inflammatory bowel disease space. The company issued about 20.3 million new ordinary shares, including 18.7 million American depositary shares (ADSs) and a concurrent offering of 1.6 million ordinary shares outside the U.S., priced at 11.60 per ADS and €10.9864 per ordinary share. Shares of Abivax began trading on Nasdaq under the ticker ABVX and were down $3.20 to $8.40 at midday.

ALK, ROS1 bustling as multiple players advance prospects

This summer’s phase III news from Qilu Pharmaceutical Co. Ltd. with iruplinalkib – an oral inhibitor of ALK and ROS1 tyrosine kinase – reinforced the ongoing interest in the pair of oncology targets, where a handful of developers remain busy. In the queue are such players as Ascentage Pharma Inc. and Bristol Myers Squibb Co. Wall Street lately has been especially energized by news from Nuvalent Inc. in non-small-cell lung cancer.

2023 US FDA approvals rise over last year, yet fall short of earlier years 

The first three quarters of 2023 delivered a mix of approval news, with an uptick in U.S. FDA clearances over the previous year, but still tracking lower than 2017-2021. Global approvals are on a different trajectory, down year over year. Through the third quarter of 2023, FDA approvals were up 8.47% compared to the same period last year. In the first nine months of this year, the FDA granted approval to 128 drugs, including 25 new molecular entities (NMEs). The FDA approved 118 drugs in the corresponding period in 2022. September saw the FDA green-lighting 14 new drugs, including four NMEs.

Celebrating progress: The impact and challenges of the R21 malaria vaccine

The World Health Organization recently endorsed an economical malaria vaccine with a 75% effectiveness rate, which costs less than half of the initial vaccine (RTS,S/AS01) created two years ago. The new vaccine, R21/Matrix-M, developed by the University of Oxford and the Serum Institute of India, marks a significant milestone after decades of scientific research. In 2021, there were 247 million malaria cases and 619,000 deaths, mostly among children under 5, predominantly in Africa.

Also in the news

4moving, Abbvie, Adial, Akeso, Alaya.bio, Arcutis, Aspen, Biomarin, Biontech, Bristol Myers Squibb, Calibrate, Candel, Cephalon, DMK, Exscientia, Flare, Ixaka, Kura, Neurona, Numab, Pfizer, Regulus, SAB, Sail, Senhwa, Skyline, Spago, Sumitomo, Takeda, Telix, Teva, Tourmaline, Vanda, Vaxcyte