Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Public Company Edition: Septerna, Apimeds, CAMP4 and Upstream filed paperwork with the SEC aiming to take advantage of renewed investor interest in IPOs. Also, Biohaven closed a $287.5m offering and Grifols subsidiary GigaGen obtained up to $135m from BARDA.

Recent changes in the industry include changes at the top at Prothena and 180 Life Sciences, plus Cantargia acquires chief business officer from Ultimovacs.

Plus deals involving Jiangsu Alphamab/CSPC, Zydus/CDRI, Junshi/JSIAMA, Repair/Genevant, Sanofi/I-Mab, Novartis/Mitem and BioAtla/Context.

Judo Bio, incubated for three years by Atlas Venture to deliver siRNA and other genetic medicines to the kidney, came out of stealth mode with $100m and new CEO Rajiv Patni.

CEO Chris Cargill talks to Scrip about Sosei Heptares’ new identity as Nxera, the ups and downs of being big pharma’s go-to small-molecule drug hunter and its move into commercialization in Japan.

The Swiss group’s head of cardiovascular, renal and metabolism aims to speed its incretins to market, and tackle the plateauing of weight loss and muscle wastage through combinations.

The German group is spinning off from Eckert & Ziegler and listing in Frankfurt, though a leap to the NASDAQ will likely follow once it has more data on a lymphoma theranostic.

Lilly’s Mounjaro to Pfizer’s Paxlovid, the WuXi group has been part of pharma majors’ sourcing chain. How big is the hole clients are to fill when the proposed BIOSECURE Act comes into effect? Here’s a Scrip infographic using Evaluate Pharma data.

After 10 years of promised investment following its Nobel Prize for iPS cell research, Japan is cautiously narrowing regulations around the conditional approval of cell therapies and cutting some reimbursement prices. Commercial success remains mixed and some products have been withdrawn from the market.

Lilly and Novo Nordisk were top performers among large-cap pharma stocks, while the stock prices of Bristol Myers and Gilead declined the most.

Six biopharma companies have filed to list their shares on US exchanges so far this year, but the sums they are seeking are small.

The US International Trade Commission looks set to ban the importation of Ascletis's THRβ agonist into the US for use in clinical trials due to an initial legal determination on potential infringement of trade secrets related to Viking's same-class candidate VK2809.

Judo Bio, incubated for three years by Atlas Venture to deliver siRNA and other genetic medicines to the kidney, came out of stealth mode with $100m and new CEO Rajiv Patni.

Phase III success positions Scholar Rock’s selective myostatin inhibitor for regulatory filings in early 2025. Analysts see a blockbuster opportunity for additive therapy in spinal muscular atrophy.

The FDA has placed zetomipzomib on clinical hold a year after Kezar decided to focus solely on the product.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Public Company Edition: Septerna, Apimeds, CAMP4 and Upstream filed paperwork with the SEC aiming to take advantage of renewed investor interest in IPOs. Also, Biohaven closed a $287.5m offering and Grifols subsidiary GigaGen obtained up to $135m from BARDA.

PD-1 inhibitor Opdivo has obtained US FDA approval for pre- and post-surgical treatment in operable non-small cell lung cancer, but Merck and AstraZeneca got there first.

Once the deal with Sanofi closes, the rare disease drug will become one of Recordati’s fastest forecast sellers.

CEO Chris Cargill talks to Scrip about Sosei Heptares’ new identity as Nxera, the ups and downs of being big pharma’s go-to small-molecule drug hunter and its move into commercialization in Japan.

Gilead strikes voluntary licensing agreements with six generic manufacturers for lenacapavir but health groups seek clarity on pricing and seeming API supply restrictions. All eyes are also on the patent opposition case in India.

All big pharmas have proprietary artificial intelligence or machine learning platform or are partnering with third parties, according to a survey by S&P Global. Their deep pockets and early adoption are locking in a competitive advantage.

Big pharmas, biotechs and the US government look to partner with artificial intelligence and machine learning firms for discovery efforts across therapeutic areas and modalities.