Novo Nordisk and Eli Lilly are asking the FDA to block compounders from making copies of their blockbuster weight-loss drugs, arguing that such versions could be unsafe.

Why it matters: This could slow a medical revolution that promises to reshape America's economy and Americans themselves.

• It also may mean margin compression for telehealth companies like Ro and Hims & Hers, although both also sell branded versions of GLP-1 drugs.

Driving the news: Novo last week nominated semaglutide — the active ingredient in Ozempic and Wegovy — to join a list of drugs that the FDA considers too complex to be made by compounders (e.g., certain biologics).

• This came after a similar (albeit more redacted) filing from Eli Lilly over tirzepatide, the active ingredient in Mounjaro and Zepbound.

The big picture: This is just part of a multi-pronged legal approach by the pharma giants, which claim to be protecting patients. Compounders, on the other hand, argue that the moves are to protect profits.

• Many compounders produce the drugs for around $100 a month, whereas the list price for Novo's Wegovy is more than $1,300.

Zoom in: Beyond safety, there also is a question of shortages.

• Semaglutide injections remain on the FDA's shortages list, which initially enabled compounding.
• Tirzepatide injections were removed from the list earlier this month, before the FDA decided to reevaluate that decision after being sued by the compounders.

Look ahead: If the FDA entertains the safety filings, the subsequent process could take upwards of a year.

• One wildcard would be a Donald Trump victory next week, given his pledge to give medical conspiracy theorist RFK Jr. a say on pharma policy.

The bottom line: We've previously discussed the sea change parallels between GLP-1 drugs and LLM-fueled artificial intelligence.

• Now let's add another: Incumbent calls for more safety guardrails.

Pacific Fusion, a Fremont, Calif.-based nuclear fusion startup, raised over $900 million in Series A commitments led by General Catalyst.

Why it's the BFD: It's a modular approach to fusion, which could help push the technology from science fiction to commercial-scale reality.

Details: The deal is said to include less than $100 million in upfront capital, with the remainder based on pre-defined milestones.

• Other investors include Andrew Forrest, Breakthrough Energy Ventures, Elad Gil, Eric Schmidt, John Doerr, Ken Griffin, Lachy Groom, Leitmotif, Lightspeed, Lowercarbon Capital, Mustafa Suleyman, Patrick Collison, Reid Hoffman, Richard Merkin, and Trousdale Ventures.
• General Catalyst's Hemant Taneja, Eric Schmidt, and Patrick Collison joined Pacific Fusion's board.

Catch up quick: Pacific Fusion is led by geneticist and mathematician Eric Lander, who was President Biden's science adviser before a messy exit.

The bottom line: "Fusion could be the ideal power source, emitting no CO2, requiring far less materials and land than other power sources, and offering billions of years of near-free, globally accessible fuel." — Pacific Fusion's co-founders

🚑 Kivu Bioscience, an SF-based developer of antibody-drug conjugates, raised $92m in Series A funding. Novo Holdings led, and was joined by Gimv, Red Tree Venture Capital, HealthCap and insiders BioGeneration Ventures, M Ventures, and BOM. axios.link/3UtVhJ8

• Simbe Robotics, a South SF-based maker of retail inventory robotics, raised $50m in Series C funding led by Goldman Sachs. axios.link/3AjpUtL

• Fligran, a French threat intelligence platform, raised $35m in Series B funding. Insight Partners led, and was joined by insiders Accel and Moonfire. axios.link/3Umnstu

• Speckle Systems, a London-based AEC data hub, raised $12.5m in Series A funding led by Addition. speckle.systems

• Voze, a Salt Lake City-based sales platform for industrials, raised $12m in Series A funding. Origin Ventures and Mercury co-led, and were joined by insiders Album VC and Pipeline Capital. voze.com

• Fondo, an SF-based accounting platform for startups, raised $7m in seed funding. Money Forward led, and was joined by YC, Motley Fool Ventures, Next Coast Ventures, and Twenty Two. tryfondo.com

• Caldera + Lab, a men's skin care brand, raised $6 million in Series A funding from HighPost Capital, per Axios Pro. axios.link/4fm84Fj

🚑 Pharos, an SF-based hospital quality reporting platform, raised $5m in seed funding. Felicis led, and was joined by General Catalyst, Moxxie, and YC. axios.link/3NDqyp8

• Reactiv, a mobile commerce startup, raised $5m in seed funding, per Fortune. Bonfire Ventures led, and was joined by Foxe Capital, Anthemis, Daher Capital, and Alumni Ventures. reactivapp.com

• Boardy, an AI networking startup, raised $3m in pre-seed funding from HF0, 8VC, Precursor, Afore, FJ Labs, and NextView. axios.link/48os9bM

⚡ Blackstone is in advanced talks to buy around $3.5b of minority stakes in interstate natural gas pipelines owned by EQT Corp. (NYSE: EQT), per Reuters. axios.link/3NI5DRN

• Egen (fka SpringML), a portfolio company of Recognize, agreed to acquire Qarik, a New York-based Google Cloud tech consultancy whose backers include PEAK6 Strategic Capital. qarik.com

• J.C. Flowers & Co. agreed to acquire a control stake in Italian insurance brokerage Consulbrokers. consulbrokers.it

• Permira acquired a minority stake in K-Way, a French premium outerwear brand, from the Boglione family at a €505m enterprise value. axios.link/4eY0bq1

Only two small IPOs are expected on U.S. exchanges this week.

• American National, an insurer owned by Brookfield, hired Jefferies to sell a $1.5b private credit portfolio, per Bloomberg. axios.link/4fmtG4m

• Great Hill Partners sold a majority stake in BigChange, a U.K. field service management software firm, to Simpro Group. bigchange.com

• Lone Star Funds agreed to sell Collierville, Tenn.-based chemicals formulator AOC Resins to Nippon Paint for $2.3b. axios.link/4hg1RNb

• BT (LSE: BT) hired Citigroup to find a buyer for financial services unit Radianz, per the FT. axios.link/3NGMdwA

• DigitalBridge Group (NYSE: DBRG) is seeking to sell Brazil's Scala Data Centers, which cold fetch at least $2b, per Bloomberg.

• DigitaBridge also agreed to buy British data center developer and operator Yondr Group, whose backers include Apollo.

• Slice, an Indian fintech unicorn, completed its merger with North East Small Finance Bank. Slice backers include Tiger Global, Insight Partners and Blume Ventures. axios.link/4eRxJpD

🚑 Solventum (NYSE: SOV), the health-care company spun out of 3M (NYSE: MMM) earlier this year, is seeking to sell its purification and filtration unit, per the WSJ. axios.link/3UumjzV

• TFG, a listed South African fashion and homeware retailer, agreed to U.K. fashion retailer White Stuff. axios.link/4e9tiVP

• Godspeed Capital, a Washington, D.C.-based PE firm focused on the defense and government markets, is raising its third fund, per SEC filings. Its second fund closed on $250m in 2023. godspeedcm.com

• LGT Capital Partners raised over €750m for its sixth small-cap buyout fund. lgtcp.com

🌎 TPG raised nearly $5b for its second climate-focused fund, per an SEC filing.

• John Lancaster (ex-Oyster Creek) joined PE firm Black Bay Partners as a partner, while the firm promoted Matt Schovee and Sam Scofield to partner and principal, respectively. blackbaypartners.com

Boeing today launched one of the largest-ever share sales by a listed company, seeking to raise around $19 billion.

• The aerospace giant, which remains unable to settle a machinist strike, plans to offer 90 million in common stock and another $5 billion in depository shares.
• Boeing shares opened today down nearly 1%.