regulatory_update

Uppsala, Sweden – September 04, 2026 -- Orexo AB has reached a non-binding agreement in principle with the US Department of Justice to pay USD 4 million in installments over several years, closing a federal investigation that began in 2020.

Orexo agrees to capped contingent payment tied to 2030-2031 sales thresholds

Beyond the fixed USD 4 million payment, Orexo would accept a capped contingent payment equal to five percent of net sales, triggered only if certain sales-related thresholds are met in 2030 and 2031 and Orexo's commercial products perform successfully in the market. The company is in the final stages of negotiating the settlement but cautions there is no assurance the deal will be finalized on these terms.

Uppsala, Sweden – September 04, 2026 -- Orexo AB has struck a non-binding agreement in principle with the US Department of Justice to settle a federal investigation that has run since 2020, the Swedish pharmaceutical company said.

Orexo to pay $4 million in installments over several years

Under the tentative terms, Orexo would pay USD 4 million in installments spread across multiple years. The company would also accept a capped contingent payment equal to five percent of net sales, triggered only if certain sales thresholds are met in 2030-2031 and contingent on Orexo's commercial products performing well in the market.

Minneapolis – September 04, 2026 -- The American Academy of Neurology (AAN) and American Headache Society (AHS) have issued a joint update to their 2012 clinical practice guideline on migraine prevention medications for adults, published simultaneously in Neurology and Headache journals on August 31, 2026.

Guideline sets clear treatment threshold for clinicians

The update recommends preventive treatment for patients experiencing four or more migraine days per month, four or more moderate-to-severe headache days per month, or migraine that impairs their ability to work or complete daily tasks. It distinguishes between chronic migraine, defined as 15 or more headache days a month with at least eight showing migraine features, and episodic migraine, which occurs on fewer days per month.

STOCKHOLM – September 04, 2026 -- Canada's Drug Agency (CDA-AMC) has issued a final recommendation supporting public reimbursement of Leqembi (lecanemab) for patients with mild cognitive impairment or mild dementia due to early Alzheimer's disease, BioArctic AB's partner Eisai announced.

Final recommendation follows agency reconsideration process

The decision comes after CDA-AMC reconsidered its position on the drug, marking a step toward broader patient access in Canada. Negotiations will now proceed through the pan-Canadian Pharmaceutical Alliance, followed by individual reimbursement decisions from public drug plans across Canada's provinces and territories.

WASHINGTON – September 03, 2026 -- The National Petroleum Council (NPC) has issued nine recommendations urging Congress and federal agencies to launch a coordinated national program to assess America's subsurface energy and mineral resources, warning that over 80% of the country's energy needs depend on assets that remain largely unmapped for decades.

The report, titled "American Resources for a Secure Future: A National Cooperative Subsurface Assessment Program," was commissioned by U.S. Secretary of Energy Chris Wright and developed by roughly 80 experts spanning state government, Tribal organizations, industry, and academia. It was approved by a full vote of NPC membership.

SOUTH SAN FRANCISCO, Calif. -- September 01, 2026 -- IDEAYA Biosciences said its FDA Type C meeting on IDE849, a DLL3-targeting antibody drug conjugate, produced agreement on a Phase 3 registrational trial design for extensive stage small cell lung cancer (ES-SCLC). The Nasdaq-listed company (IDYA) plans to enroll roughly 400 patients who have already received tarlatamab, randomizing them 1:1 between IDE849 monotherapy and an investigator's choice control arm of topotecan and amrubicin. IDEAYA is targeting trial initiation by year-end 2026.