STAT6 stat sig? Kaken, J&J $1.2B-plus deal adds oomph to space
Kaken Pharmaceutical Co. Ltd.’s license agreement with Johnson & Johnson (J&J) for signal transducer and activator of transcription (STAT)6 inhibitor KP-723 could presage further deals in STAT6, where a number of developers are active. Kaken’s arrangement with J&J involves the global development, manufacturing and sale of KP-723, which has reached the preclinical stage. Tokyo-based Kaken will take the drug through phase I trials, after which J&J takes over.

STAT6 stat sig? Kaken, J&J $1.2B-plus deal adds oomph to space
Kaken Pharmaceutical Co. Ltd.’s license agreement with Johnson & Johnson (J&J) for signal transducer and activator of transcription (STAT)6 inhibitor KP-723 could presage further deals in STAT6, where a number of developers are active. Kaken’s arrangement with J&J involves the global development, manufacturing and sale of KP-723, which has reached the preclinical stage. Tokyo-based Kaken will take the drug through phase I trials, after which J&J takes over.
Certa expands GPR68 platform via acquisition of Occurx
Certa Therapeutics Pty Ltd. has acquired Occurx Pty Ltd. in a move to strengthen its pipeline to target multiple fibrotic diseases as both companies share a focus on targeting GPR68, a defined G protein-coupled receptor (GPCR) receptor that mediates signaling pathways associated with inflammation and fibrosis and is thought to be a master switch of fibrosis.
Year in review 2024: Top financings
IPOs, follow-ons, private placements and VCs in 2024.
Today's news in brief
BioWorld briefs for Dec. 27, 2024.
European VC improves in 2024, driven by ADCs and CNS, inflammatory drugs
After the funding feast sparked by the pandemic, European biotech has emerged from the famine that followed, with venture capital raised this year finally exceeding the 2020 total.After the funding feast sparked by the pandemic, European biotech has emerged from the famine that followed, with venture capital raised this year finally exceeding the 2020 total.
GLP-1 receptor agonists continue their global victory tour
2024 was another banner year for GLP-1 receptor agonists (GLP-1RAs) on multiple fronts. They continued to expand into new indications, and provide their developers with both rich remuneration and scientific acclamation. There are now seven approved GLP-1RAs. Commercially, the most successful one so far is semaglutide, sold under the brand name Wegovy or Ozempic depending on the indication.
Money raised by biopharma
Total raised in public, private and other financings of biopharma companies, comparing 2019-2024.
Biopharma money raised: Jan. 1-Dec. 26, 2024
Year-to-date money raised in public, private and other financings of biopharma companies.
Holiday notice
BioWorld's offices were closed in observance of Christmas. No issues were published Wednesday, Dec. 25 or Thursday, Dec. 26.

BioWorld Insider Podcast

Karen Carey, BioWorld’s managing editor and chief analyst, and the managing editor of Bioworld Science, Anette Breindl, join this episode of the BioWorld Insider podcast to talk about the business and the science of women’s health.

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Analysis and data insight

Court cases, new US Congress could reshape Rx negotiations
Regulatory
The first round of the U.S.’ Medicare negotiations accounted for a lot of digital ink and headlines in 2024. Next year is sure to bring more of the same as Medicare is to announce up to 15 Part D drugs to be negotiated in the second round by Feb. 1, even as several constitutional challenges to the...
Bridgebio’s Attruby FDA nod boosts stock; 10 November approvals
Regulatory
The U.S. FDA approved 10 drugs in November, down from 15 in October, 24 in September and 22 in August. Four new molecular entities were approved by the agency in the month, bringing the year-to-date total to 42.
Biopharma stocks fall but remain above water amid approvals, data, deals
Cancer
The BioWorld Biopharmaceutical Index (BBI) closed November with a modest 3.58% gain for the year, a sharp decline from its 16.92% rise in September and peak of 25.19% in August. The BBI has now fallen behind the Nasdaq Biotechnology Index, which posted a 6.27% year-to-date gain, and the Dow Jones...
November’s 10 billion-dollar deals cap 2024 as record year
Deals and M&A
Biopharma deal activity in November reached $29.18 billion, up from $22.29 billion in October. Year-to-date deal values have increased 3.6%, from $194.13 billion in the first 11 months of 2023 to $201.19 billion through November this year, overtaking 2023 to be the highest year on record through...

Financings

Flagship’s Generate Bio scores investment from Samsung fund
Cancer
A year after Generate Biomedicines Inc. pulled off its $273 million series C financing round, the Flagship Pioneering-spawned and AI-powered protein therapeutics firm drew investment of an undisclosed amount from the Samsung Life Science Fund Dec. 18.

Science

The map for a journey to the center of the brain
Neurology/psychiatric
In the 1970s, scientists from several countries proposed to reconstruct, one by one, all the neurons in the brain as they appear under an electron microscope. They started with a small worm. Caenorhabditis elegans has only 302 neurons. It took 16 years. How much time would be required to repeat...

Cell mapping yields clues to metabolic health in obese individuals
Endocrine/metabolic
Researchers at the University of Leipzig and ETH Zurich have used single-cell sequencing to identify differences between fat tissue of obese individuals who are metabolically unhealthy, and those who were in good metabolic health. The findings, which were published online Dec. 17, 2024, in Cell...
Second insulin receptor offers new therapeutic avenues
Endocrine/metabolic
Investigators at the Helmholtz Institute have shown that inceptor, an inhibitor of the insulin signaling pathway, acted by binding insulin and targeting it for degradation. “Insulin was discovered 100 years ago, and the insulin receptor was discovered 50 years ago,” Heiko Lickert told BioWorld....

Newco news

Alloplex’s Suplexa reawakens immune cells to fight cancer
Cancer
When it comes to cell therapy, Alloplex Biotherapeutics Inc. CEO Frank Borriello said he believes that autologous, personalized therapy is the only thing that makes sense. “The allure of an off-the-shelf therapy has been such a magnet. It sucked in a lot of companies into that dream, and I'm sorry...
Freya adds $11.8M for microbial immunotherapies in women’s health
Financings
Vaginal microbiome specialist Freya Bioscience ApS has added $11.8 million to its series A, bringing the total for the round to $50 million. Of the additional $11.8 million, $10.4 million comes from the Gates Foundation and is designated for the development of vaginal microbiome-based...
Next Generation Gene pioneers gene therapy approach with China data
Clinical
Gene therapy faces complexities in delivering treatments due to persistent safety concerns and daunting immune responses, but Next Generation Gene Therapeutics Inc. has found a way around this issue using dual-functional vectors to simultaneously remove harmful, mutated genes and replace them with...
Hope for endometriosis as HMI-115 reduces pelvic pain by 50%
Clinical
Hope Medicine Inc. reported positive interim results for monoclonal antibody HMI-115 in a phase II endometriosis trial that saw the mean non-menstrual pelvic pain score reduced by 50%. “HMI-115 is a prolactin receptor blocker, and we're using it to treat endometriosis and some other diseases. It is...
Seaport sailing to the clinic with a $225M series B
Financings
Seaport Therapeutics Inc. has followed up its recent fundraiser with an oversubscribed $225 million series B financing that will help set it on the path to a phase IIb study in major depressive disorder. The company’s lead candidate is allopregnanolone, an endogenous neurosteroid that is taken...

U.S.

Uncertainty builds at US FDA with retirements, CR questions
Regulatory
The end of the year will be the end of an era at the FDA, as Bob Temple shuts his door at CDER for the last time Dec. 31. After more than half a century at the FDA’s drug center, Temple has become the backbone of CDER’s new drug program, providing expertise and stability as other personnel have...

Europe

Danish regulators question possible Ozempic link to rare eye condition
Regulatory
The Danish Medicines Agency is to ask the EMA’s pharmacovigilance committee to investigate a potential increased risk of an acute eye condition in diabetic patients being treated with the glucagon-like peptide-1 receptor agonist Ozempic (semaglutide).

Teva-Sanofi upbeat on ‘best-in-class’ duvakitug bowel disease data
Clinical
The potential for TL1A-targeting duvakitug to impact unmet needs of patients with ulcerative colitis (UC) and Crohn’s disease (CD), and to provide antifibrotic effects for a host of other diseases, boosted shares of Teva Pharmaceutical Industries Ltd. and Sanofi SA by 26.5% and 6.7%, respectively,...
Welireg, Emcitate among drugs EMA recommends for approval
Regulatory
The EMA’s Committee for Medicinal Products for Human Use recommended 17 drugs for approval at its December meeting, bringing the total for 2024 to 114. That is up from the 77 drugs recommended for approval in 2023, of which 39 were novel.

Clinical

Enhanced Cognition: Lewy body dementia phase II pumps stock
Neurology/psychiatric
Investors will get more details during the International Lewy Body Dementia Conference in Amsterdam late next month, but Wall Street is already buzzing about Cognition Therapeutics Inc.’s data from the phase II study with CT-1812 in dementia with...
Caliway’s CBL-514 meets endpoints in reducing abdominal fat
Endocrine/metabolic
Caliway Biopharmaceuticals’ lipolysis candidate, CBL-514, met all the primary and secondary efficacy endpoints in a phase IIb study for subcutaneous fat reduction, paving the way for the company to begin a global pivotal phase III study in 2025.
Happier new year? Tenaya to raise HCM gene therapy dose
Cardiovascular
Wall Street must wait until 2025 for data from the higher-dose cohort in Tenaya Therapeutics Inc.’s phase Ib/II study with gene therapy TN-201 for MYBPC3-linked hypertrophic cardiomyopathy (HCM), but shares (NASDAQ:TNYA) closed Dec. 17 at $1.41,...
Recce moves to pivotal trials in Indonesia for diabetic foot ulcers
Infection
Recce Pharmaceuticals Ltd. is progressing synthetic antibiotic Recce-327 to pivotal phase III trials in Indonesia for the treatment of diabetic foot infections. The trial, which is assessing Recce-327 as a topical gel (R327G), is expected to begin...
Puretech’s modified pirfenidone impresses in phase IIb IPF trial
Respiratory
Puretech Health plc has announced phase IIb data showing its reformulation of pirfenidone has improved the tolerability and increased the efficacy of the marketed antifibrotic in the treatment of idiopathic pulmonary fibrosis. The tweak on the...
New cancer data from Bicycle precedes stock drop
Conferences
Mixed results for three of Bicycle Therapeutics plc’s zelenectide pevedotin development programs preceded a strong drop in the company’s stock. Bicycle shares (NASDAQ:BCYC) dropped 31.3% on Dec. 13 to close at $13.81 each, the stock’s lowest price...

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