July 14, 2026

The need-to-know this morning

AstraZeneca is spending $600 million upfront to pick up global rights for the lung cancer drug Zegfrovy from the Chinese firm Dizal Pharmaceutical Co. The drug, an EGFR inhibitor, is approved in the U.S. and China for patients with a type of advanced or metastatic non-small cell lung cancer that has certain mutations, and is under review by regulatory agencies as a first-line therapy. AstraZeneca said the drug fit with its other products for EGFR-mutated lung cancer.

biotech

Akero team, backed by Fairmount, launches new immunology company

The former executive team of Akero Therapeutics, recently sold to Novo Nordisk, has partnered with the investment firm Fairmount, one of the sector's most prolific company creators, to launch a publicly traded biotech centered around a long-acting immunology drug plucked from a Chinese firm.

The new company, called Avere Therapeutics, is led by Andrew Cheng, Kitty Yale, and William White, the team that ran Akero Therapeutics and developed a drug for the fatty liver disease MASH that was sold to Novo for $5 billion. Now, they will work to develop an oral IL-23 targeted drug for psoriasis, ulcerative colitis, and other immunological conditions.

The drug, called AVR-001, was licensed from China's Hansoh Pharmaceutical Group. It has the potential to be dosed weekly, and could compete against AbbVie's injectable blockbuster Skyrizi and a new oral, daily pill from Johnson & Johnson, called Icotyde.

Avere's foundational investor, Fairmount, has also been the primary financial backer of a group of biotechs developing other long-acting immunology drugs, including Apogee, Spyre, and Oruka. In June, AbbVie said it would acquire Apogee for $11 billion.

Avere is going public Tuesday via a reverse merger with the biotech company NextCure and will be backed by an additional $320 million in private placement financing, led by Fairmount and other investors.

alzheimer's

FDA approves injectable starting dose of Leqembi

The FDA said yesterday it approved the Alzheimer's drug Leqembi to be given as an at-home injection from the start of treatment, making it more accessible to patients.

The drug, sold by Eisai and Biogen, was initially developed as an IV infusion. It was an inconvenient regimen — once every two weeks for the first 18 months of treatment, patients would have to travel to infusion centers and sit for roughly an hour during the administration.

Last year, the FDA approved then injectable version of Leqembi, but only for maintenance dosing after patients received 18 months of IV treatment. Now, patients can choose to only get the injection through their entire treatment course.

regulation

Another post-Makary reversal

The FDA will convene an advisory committee meeting to discuss Sydnexis' investigational treatment for pediatric myopia, the biotech said yesterday. It's another instance of the agency reversing a decision made under former Commissioner Marty Makary.

Last year, during Makary's tenure, the FDA had asked Sydnexis to prepare for an advisory committee meeting, but later said a meeting was no longer necessary and proceeded to reject the drug, saying the company's efficacy data were not “clinically meaningful.”

The latest reversal is one of several that have occurred under acting Commissioner Kyle Diamantas, who took over from Makary in May. Under Diamantas, the agency has changed course on decisions related to UniQure's treatment for Huntington's disease and Regenxbio's gene therapy for Hunter syndrome.

regulation

FDA psychedelic guidance expands on unblinding, durability data

The FDA yesterday released final guidance on psychedelic drug development, providing more recommendations on trial design than in earlier draft guidance posted in 2023.

Since psychedelics can lead to intense perceptual changes, experts and regulators worry that participants and researchers will be effectively unblinded and be aware of the treatment they received, increasing the risk of bias in their responses.

In the final guidance, the FDA said drugmakers can minimize biases by using questionnaires to ask both participants and researchers whether they think an active treatment was used, as well as separate questionnaires to ask participants about their expectations for drug effects before and after treatment.

The final guidance also said that trials should not include an overrepresentation of people who have had prior psychedelic experience, since they're more likely to recognize the effects of the drugs, raising the risk of unblinding.

While the draft guidance said drugmakers should follow participants in open-label extensions for a year after randomized trials, the new guidance, said the most informative trial designs would incorporate blinded one-year follow-ups, adding that if data suggest regular redosing is warranted, then the drugmaker should study the recommended dosing intervals.

The agency will also hold a public hearing in September about the therapeutic use of psychedelic drugs.

neuroscience

Alzheimer's Association invests in GLP-1 research

From STAT's “AAIC in 30 minutes” newsletter: The Alzheimer’s Association said yesterday it will put up $100 million for a global study that will test whether combining lifestyle interventions and metabolic drugs — like GLP-1 obesity medicines — can reduce the risk of cognitive decline and dementia.

The association framed the study as a new approach as prevention efforts get greater attention and funding. It’s an effort to merge takeaways from lifestyle studies into risk reduction with research into the connection between cardiometabolic health and dementia.

“By testing a combined approach that targets both lifestyle and biology, we have the opportunity to better understand how to meaningfully reduce the risk of cognitive decline before symptoms begin,” Maria Carrillo, the association’s chief science officer, said in a statement.

The study will be called PROTECT-Cog, a riff on “prevention of risk for cognitive decline through combined therapy.” It will enroll older adults at elevated risk for cognitive decline and follow them for three years.

In its announcement, the association cited “emerging evidence” suggesting GLP-1 drugs have the potential to reduce dementia risk quite substantially compared to other diabetes treatments, noting that experts think the health benefits of the treatments come from not just regulating appetite, but also from reducing inflammation.

One note of caution: Novo Nordisk ran two placebo-controlled trials of its drug semaglutide (the key ingredient in Wegovy and Ozempic) to test whether it could slow the progression of Alzheimer’s versus placebo, and both studies failed.

“There is clearly a need to better understand the timing and use of these therapies in prevention,” the association said.

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