Biopharma financings in 2023 – at $49.3 billion raised through the third quarter (Q3) – are tracking ahead of or only slightly behind several years since 2011, except for the two outlier years of 2020 and 2021 when there was a flurry of investments in response to the COVID-19 pandemic. Take those two years out of the equation and financings are not doing too badly, showing a 7.8% increase over 2022, with a total of 876 transactions. The volume itself is an increase of 13.3% over last year. That said, the number of financings and amounts raised through venture capital – the place where new, private innovators get early funding – is declining, albeit slightly when compared to last year, but it may explain the industry-wide frustration over financial struggles. Not only is VC funding falling, but the number of new startups appear to be increasing, creating a wider pool from which investors can choose to place their money. During Q3, biopharma IPOs, follow-on offerings, private placements and other public financings each raised more than either of the two previous quarters, while VC amounts fell by 14.8% from the second quarter.

Chasing Karuna, Cerevel prices an underwritten offering

In a race with Karuna Therapeutics Inc. to get its schizophrenia drug to market, Cerevel Therapeutics Holdings Inc. has priced an underwritten public offering at $22.81 per share. The offering is worth of about $450 million, with the company estimating sales of the 19.7 million shares will yield net proceeds of about $433.6 million. Cerevel stock (NASDAQ:CERE) rallied 5% at midday, with shares at $24. The offering will close around Oct. 16. The company is developing emraclidine, a targeted muscarinic therapy to treat schizophrenia. A phase II data readout remains on track for the first half of 2024. In late September, Karuna Therapeutics Inc. submitted an NDA to the FDA for Karxt (xanomeline-trospium), a muscarinic antipsychotic for treating schizophrenia that acts similarly to Cerevel’s therapy.

Astria licenses Ichnos OX40 portfolio in potential $320M deal

Astria Therapeutics Inc. signed an agreement with Ichnos Sciences Inc. to bring aboard the latter’s OX40 portfolio for atopic dermatitis (AD) as well as other allergic and immunological diseases. Under the terms, Astria will pay Ichnos an up-front license fee of $15 million. Astria is also obligated to pay Ichnos up to $305 million if milestones are met, of which up to $20 million relates to clinical development in as many as three indications, and $285 million are related to regulatory approval and commercial sales goals for all licensed products in the indications. Ichnos could bank tiered mid-single digit to low-double digit royalties based on annual net sales, subject to reduction in specified circumstances. The lead AD candidate, called STAR-0310, is a monoclonal antibody OX40 antagonist that incorporates YTE half-life extension technology.

BioJapan 2023: Japan invests in bio clusters to foster global innovation

Japan’s economy has remained stagnant for the last few decades, and Prime Minister Fumio Kishida has heralded the biotech industry as a strategic industry to attract global partners, which was also one of the expectations for the BioJapan 2023 conference this week in Yokohama, drawing attendees from more than 37 countries and was the first live biotech industry event that welcomed foreigners since the COVID-19 pandemic. Drug discovery has undergone a major transformation, as exhibited by the recent mRNA vaccines that helped break the grip of the COVID-19 pandemic, and Japan’s leaders are committed to growing the industry through various bio ecosystems, said Minoru Yoshida, chairperson for the Japan Bioindustry Association.

EU orders Illumina to sell Grail or face further fines

The European Commission (EC) has ordered Illumina Inc. to sell Grail Inc. after it closed the acquisition without approval from EU regulators. The EC said that if Illumina fails to comply with the order, the company faces fines of up to 5% of its daily aggregate revenue or up to 10% of its annual worldwide revenue. The EC had previously prohibited the deal over concerns that the merger would stifle innovation and reduced choice in the emerging market for blood-based early cancer detection tests. However, Illumina, completed the $7.1 billion acquisition of cancer diagnostic test maker Grail while the EC's review of the deal was going on.

UK to halve approval time for lowest-risk trials

With an eye on making the U.K. more attractive for clinical trial research, the Medicines and Healthcare products Regulatory Agency (MHRA) took a step today to overhaul its clinical trials regulations by reducing the approval time for the lowest-risk studies. Under the new scheme, the MHRA will process initial applications for the lowest-risk phase III and IV trials within 14 days instead of the statutory 30 days – so long as the trial meets the agency’s criteria, including confirmation that there are no known safety issues with the drug being investigated.

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