July 29, 2025

The need-to-know this morning

Merck, AstraZeneca, and Incyte reported earnings for the second quarter.
Novo Nordisk lowered its sales and operating profit forecast for the rest of 2025. The Danish pharma giant also named a new CEO.
Results from a Fulcrum Therapeutics study suggest a pill can treat sickle cell disease, but experts caution the drug's effect was modest and more data will be need to prove patient benefit.
Apellis Pharmaceuticals won approval from the FDA to expand the use of its drug Empaveli to include treatment for patients with C3 glomerulopathy, a rare kidney disease.

biotech

FDA now says Sarepta can ship therapy to young patients

In a reversal, the Food and Drug Administration yesterday cleared the way for Sarepta Therapeutics to resume shipments of its gene therapy for Duchenne muscular dystrophy to younger patients who can walk.

Sarepta last week agreed to suspend shipments of the gene therapy to all patients after a request from the FDA to do so. A senior FDA official told STAT that the biotech faced an "arduous and treacherous" path to getting the product, called Elevidys, back on the market.

The agency's decision to suspend the drug for patients who could still walk angered the Duchenne patient community, and that appears to have played a role in the agency's latest move.

policy

European pharma products to face 15% tariffs

President Trump will implement 15% tariffs on pharmaceuticals coming from the European Union, and they won't go into effect until a national security investigation around pharma imports has been completed, according to a White House official familiar with the plans.

Earlier this year, the U.S. Department of Commerce launched what's known as a Section 232 investigation into drug products. Once that probe is finished and tariffs are levied, the E.U. tariffs will remain at 15%, the person said, though the structure and implementation details remain unknown.

While the levy on European products is far lower than the 200% tariff Trump previously threatened, 15% tariffs are still very steep, Evercore analyst Umer Raffat wrote in a note. How much of a problem they pose for companies will depend on whether Trump gives the industry a grace period so that companies can move their manufacturing to the U.S., as he had suggeted earlier this month he would, Raffat said.

policy

Trump officials consider new patent fees

In other D.C. news, Commerce Secretary Howard Lutnick is considering charging patent holders 1% to 5% of their overall patent value to raise revenue and help narrow the government's budget deficit, the Wall Street Journal reported.

Patents are core to incentivizing innovation across all types of industries, but especially the drug industry. The plan is likely to face strong pushback from business groups.

Patent holders already pay flat fees to the government, but this new plan would lead to much higher costs for some patent holders, according to the Journal.

venture capital

Investors remain cautious as biotechs seek licensing deals

Amid uncertainty in the U.S. economic outlook, venture investors put $4.5 billion in biopharma companies in the second quarter, the lowest amount of second-quarter financing in five years, according to a report published yesterday by J.P. Morgan.

There were 203 fundraising rounds in the first half of the year, and 17% of those were greater than $100 million. This preference for mega-rounds has been an ongoing trend, as investors take a conservative approach and concentrate funding in fewer companies.

With venture funding limited, biotechs have been more willing to out-license drugs. At the same time, pharma companies have been eager to seek deals as they face patent cliffs. In the first half of this year, licensing deals totaled $119.9 billion in value, with 9% of that paid upfront, the highest share since 2020.

Unsurprisingly, there's been a surge in licensing deals around diabetes and drugs, with total deal values and upfront payments reaching record levels.

patents

ARTBio raises $132 million for radiopharmaceuticals

From my colleague Allison DeAngelis: Despite the tough financing environment discussed above, investors are still putting money into radiopharmaceuticals, with ARTBio becoming the fourth company to raise a new investment capital this month.

ARTBio just added $132 million to its coffers, the company announced today, raising money from Sofinnova Investments, B Capital, and others. ARTBio is developing therapies that drop radioactive isotopes onto cancer tumors. The Series B funding will help the startup move its first drug into clinical trials and pick its next drug candidate, while also expanding its supply chain.

The allure of cancer drug development has worn off in recent years. Venture capitalists have turned their attention to other, less saturated fields like metabolic or autoimmune conditions. Interest in radiopharmaceuticals surged two years ago, but has started to level off. "It has certainly been a much different environment to be raising in than 18 months ago or 24 months ago, because all of this is happening in … a very difficult time for all of oncology, especially early-stage oncology," ARTBio CEO Emanuele Ostuni told STAT.

ARTBio ultimately raised more than it had anticipated. More broadly, there has been an uptick in attention this month, with companies Nuclidium, Actithera, and Clarity Pharmaceuticals raising money from private investors.

Radiopharmaceuticals or radioligand therapies are still relatively untapped, scientifically. There are currently only two products on the market, both of which are sold by Novartis and use the same type of radioactive isotope. ARTBio, Nuclidium, and Clarity are developing treatments using new isotopes, which Ostuni said has gotten investors' interest.

More around STAT