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The US Food and Drug Administration (FDA) has greenlit Eli Lilly’s Alzheimer’s disease drug donanemab, which will be sold under the brand name Kisunla.

Kisunla is an amyloid-targeting therapy intended to treat patients with early symptomatic Alzheimer’s, including those with mild cognitive impairment and those exhibiting mild dementia stages of the disease with confirmed amyloid pathology. 

Treatment with Kisunla runs the risk of infusion-related reactions as well as inducing amyloid-related imaging abnormalities or ARIA—a risk that warranted a black-box warning for Leqembi. 

While the drug is only the second to persuasively demonstrate its potential in delaying cognitive and functional decline, Kisunla will be the only available amyloid-ablating therapy designed to be used in a limited duration treatment regimen that can be discontinued once amyloid plaques are removed. 

A few hours after the news broke, Lilly’s share price increased by almost 1%, before dipping to levels closer to the share value at market open. Eli Lilly has a market cap of $816.4bn.

Aerovate Therapeutics has slashed its workforce by 78%, two weeks after the company announced a Phase IIb trial failure of its pulmonary arterial hypertension (PAH) drug AV-101.  

The Massachusetts-based biotech announced the downsizing in an SEC filing where Aerovate said it expects to incur costs of about $5.6m related to the layoffs. These costs are expected to be incurred in the third and fourth quarters of 2024. The company also added that it expects all of its workforce to be cut in the coming months.   

On 17 June, Aerovate shut down its Phase II/III IMPAHCT trial (NCT05036135) after the Phase IIb section did not meet its primary endpoint for improvement in PAH compared to placebo for any of the studied doses. AV-101—an inhaled version of the drug imatinib—also failed to show meaningful improvements in the secondary endpoint of change in six-minute walk distance.

The US Justice Department has charged 193 people in a major enforcement action, accusing them of participating in healthcare fraud schemes worth $2.75bn.  

The two-week crackdown involved 76 doctors, nurses, and other medical professionals. The defendants are accused of several scams, such as illegally distributing millions of Adderall (amphetamine) pills and other stimulants. 

The crackdown included the arrest of Ruthia He, founder and CEO of San Francisco-based digital technology company Done Global, who was arrested on 13 June. He has been charged with participating in a scheme to distribute Adderall (amphetamine / dextroamphetamine) over the internet and conspired to commit healthcare fraud in connection with the submission of fraudulent claims for reimbursement for the drug and other stimulants.

Novo Nordisk has said it will take a DKr5.7bn ($816m) hit after its acquired drug ocedurenone flopped in the Phase III trial. 

The Phase III CLARION-CKD trial (NCT04968184) failed to meet its primary endpoint in patients with uncontrolled hypertension and moderate or severe (stage 3b/4) chronic kidney disease (CKD). The drug was acquired by the Danish pharma giant from KBP Biosciences last year in a $1.3bn deal. At the time of the acquisition, KBP Biosciences was already conducting the Phase III study. 

The company said that following the trial data, it recognises an impairment loss of $816m related to ocedurenone in Q2 2024. The trial design included a prespecified interim analysis by an independent data monitoring committee after 12 weeks of treatment. The analysis showed that the trial had not met its primary endpoint of change in systolic blood pressure (SBP), leading Novo to terminate the study. 

Merck KGaA (Merck) has discontinued the Phase III TrilynX trial evaluating xevinapant in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN). 

The company stated that its decision was informed by a pre-planned interim analysis performed by the Independent Data Monitoring Committee. It found that the study is “unlikely to meet its primary objective of prolonging event-free survival”. 

Merck licenced xevinapant from Debiopharm International in a deal worth $1.08bn in 2021. Xevinapant is an inhibitor of apoptosis protein (IAP) antagonist designed to restore cancer cell sensitivity to apoptosis. 

Following the news of trial termination, Merck’s stock was down by over 10% in trading on the Frankfurt Stock Exchange.