Lundbeck Secures the US FDA Fast Track designation for Lu AH69593 to Treat Narcolepsy

Shots: The US FDA has granted Fast Track designation to Lu AH69593 for the treatment of patients with narcolepsy Lu AH69593 is a small-molecule orexin 2 receptor agonist being developed by Lundbeck for narcolepsy to regulate arousal, wakefulness, & sleep-wake stability Lu AH69593 is being evaluated in a P-Ib clinical program, with Lundbeck continuing to…

ByRidhi RastogiJuly 24, 2026

NEWS

Lundbeck Reports the P-IIb (PROCEED) Trial Data on Bocunebart for Migraine Prevention at AHS 2026

Shots: Lundbeck has reported primary P-IIb (PROCEED) trial data assessing bocunebart (Lu AG09222, QM, SC or IV) vs PBO as a preventive treatment in pts with 1-4 prior preventive migraine treatment failures In the IV group (n=429), bocunebart met its 1EP, reducing monthly migraine days over Wks. 1-12, with a mean reduction of 4.24 vs…

ByRidhi RastogiJune 5, 2026

NEWS

Lundbeck Partners with Cradle to Accelerate AI-Driven Biotherapeutics Discovery

Shots: Lundbeck and Cradle entered a partnership to leverage AI-powered protein engineering for the discovery and optimization of biotherapeutics, with an initial focus on 2 antibody programs targeting CNS diseases Lundbeck will deploy Cradle’s generative AI platform in its first end-to-end AI-guided protein engineering workflow, using iterative feedback from experimental data to discover & optimize…

ByRidhi RastogiJune 4, 2026

TOP 20

Top 20 Biopharma Deal Terminations of 2025

Shots: Biopharma dealmaking in 2025 continued to face significant headwinds, with collaborations frequently collapsing due to strategic reprioritization, fierce competitive pressures, unfavorable clinical readouts, and failure to meet key closing conditions highlighting the inherent uncertainty and capital risk embedded in innovation-driven partnerships The year underscored a clear dominance of R&D-focused collaborations and licensing agreements,…

ByPrince GiriApril 24, 2026

NEWS

Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

Shots: Lundbeck has reported P-IIb (PROCEED) trial results evaluating bocunebart (SC/IV; QM for 3mos.) vs PBO in migraine patients with prior failure of 1-4 preventive therapies, with the IV arm randomizing 431 pts across 14 countries Trial met its 1EP in the multiple IV dosing arm, showing a statistically significant reduction in monthly migraine days…

ByRidhi RastogiFebruary 16, 2026

NEWS

Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Shots: The Japanese MHLW has accepted an NDA of Vyepti for the treatment of pts living with migraine, who are eligible for preventive therapy; regulatory review is also ongoing in China & South Korea The NDA was supported by extensive clinical data, incl. the P-III (SUNRISE) trial of Vyepti (100 or 300mg, IV) vs PBO…

ByRidhi RastogiNovember 14, 2025

NEWS

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Shots: The EC has approved Rxulti (brexpiprazole) to treat schizophrenia in pts (≥13yrs.) following CHMP’s positive opinion in Jan 2025 Approval was based on P-III trial assessing Rxulti (2 to 4mg/day, PO, QD) vs PBO vs Aripiprazole in adolescents (n=316) for 6wks. that showed greater reduction in symptom severity compared to PBO as measured by…

ByRidhi RastogiMarch 13, 2025

VIEWPOINTS

Marija Geertsen, Vice President, U.S. Medical Affairs, Lundbeck Shares Insights from 12 Abstracts Presented at AAN 2023

Shots: Marija spoke about the data on Migraine and Brain Health presented at the 75th Annual Meeting of the AAN 2023. The 12 abstracts included the data from post-hoc and real-world analyses of VYEPTI She also talked about a medical symposium sponsored by the company “Migraine: Your Patient, Your Partner. Proactive care for high-frequency, worsening…

BySenior EditorAugust 14, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in May 2023

Shots: The US FDA approved 15 NDAs and 3 BLA in May 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 54 novel products in 2023 In May 2023, the major highlights drugs were, Ayvakit approval for Indolent Systemic Mastocytosis, Rinvoq for Active Crohn's Disease PharmaShots has…

BySenior EditorJune 21, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in April 2023

Shots: The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023 In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…

BySenior EditorMay 17, 2023

Lundbeck Secures the US FDA Fast Track designation for Lu AH69593 to Treat Narcolepsy

Lundbeck Reports the P-IIb (PROCEED) Trial Data on Bocunebart for Migraine Prevention at AHS 2026

Lundbeck Partners with Cradle to Accelerate AI-Driven Biotherapeutics Discovery

Top 20 Biopharma Deal Terminations of 2025

Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Otsuka and Lundbeck Receive the EC’s Approval for Rxulti to Treat Schizophrenia in Adolescents

Marija Geertsen, Vice President, U.S. Medical Affairs, Lundbeck Shares Insights from 12 Abstracts Presented at AAN 2023

Insights+: The US FDA New Drug Approvals in May 2023

Insights+: The US FDA New Drug Approvals in April 2023

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