http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Thu, 23 Jul 2026 03:30:18 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html <p>Lundbeck announced that the U.S. Food and Drug Administration has granted Fast Track designation to Lu AH69593, an investigational oral orexin 2 receptor agonist being developed for the treatment of narcolepsy.</p> <p>Lu AH69593, discovered by Lundbeck, is currently in Phase 1b clinical development. The compound targets the orexin 2 receptor, which is involved in wake-promoting signaling and sleep-wake regulation. Lundbeck said it is evaluating the drug's safety, tolerability, pharmacokinetic, and pharmacodynamic profile in the ongoing trial.</p> <p>Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and disrupted sleep-wake regulation. Symptoms can include sleep attacks, fragmented nighttime sleep, sleep paralysis, and http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html Thu, 23 Jul 2026 03:30:18 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html <p>Lundbeck announced that the U.S. Food and Drug Administration has granted Fast Track designation to Lu AH69593, an investigational oral orexin 2 receptor agonist being developed for the treatment of narcolepsy.</p> <p>Lu AH69593, discovered by Lundbeck, is currently in Phase 1b clinical development. The compound targets the orexin 2 receptor, which is involved in wake-promoting signaling and sleep-wake regulation. Lundbeck said it is evaluating the drug's safety, tolerability, pharmacokinetic, and pharmacodynamic profile in the ongoing trial.</p> <p>Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and disrupted sleep-wake regulation. Symptoms can include sleep attacks, fragmented nighttime sleep, sleep paralysis, and http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html Thu, 23 Jul 2026 03:30:18 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html <p>Lundbeck announced that the U.S. Food and Drug Administration has granted Fast Track designation to Lu AH69593, an investigational oral orexin 2 receptor agonist being developed for the treatment of narcolepsy.</p> <p>Lu AH69593, discovered by Lundbeck, is currently in Phase 1b clinical development. The compound targets the orexin 2 receptor, which is involved in wake-promoting signaling and sleep-wake regulation. Lundbeck said it is evaluating the drug's safety, tolerability, pharmacokinetic, and pharmacodynamic profile in the ongoing trial.</p> <p>Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and disrupted sleep-wake regulation. Symptoms can include sleep attacks, fragmented nighttime sleep, sleep paralysis, and http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html Thu, 23 Jul 2026 03:30:18 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html <p>Lundbeck announced that the U.S. Food and Drug Administration has granted Fast Track designation to Lu AH69593, an investigational oral orexin 2 receptor agonist being developed for the treatment of narcolepsy.</p> <p>Lu AH69593, discovered by Lundbeck, is currently in Phase 1b clinical development. The compound targets the orexin 2 receptor, which is involved in wake-promoting signaling and sleep-wake regulation. Lundbeck said it is evaluating the drug's safety, tolerability, pharmacokinetic, and pharmacodynamic profile in the ongoing trial.</p> <p>Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and disrupted sleep-wake regulation. Symptoms can include sleep attacks, fragmented nighttime sleep, sleep paralysis, and http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html Thu, 23 Jul 2026 03:30:18 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html <p>Lundbeck announced that the U.S. Food and Drug Administration has granted Fast Track designation to Lu AH69593, an investigational oral orexin 2 receptor agonist being developed for the treatment of narcolepsy.</p> <p>Lu AH69593, discovered by Lundbeck, is currently in Phase 1b clinical development. The compound targets the orexin 2 receptor, which is involved in wake-promoting signaling and sleep-wake regulation. Lundbeck said it is evaluating the drug's safety, tolerability, pharmacokinetic, and pharmacodynamic profile in the ongoing trial.</p> <p>Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and disrupted sleep-wake regulation. Symptoms can include sleep attacks, fragmented nighttime sleep, sleep paralysis, and http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html Thu, 23 Jul 2026 03:30:18 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html <p>Lundbeck announced that the U.S. Food and Drug Administration has granted Fast Track designation to Lu AH69593, an investigational oral orexin 2 receptor agonist being developed for the treatment of narcolepsy.</p> <p>Lu AH69593, discovered by Lundbeck, is currently in Phase 1b clinical development. The compound targets the orexin 2 receptor, which is involved in wake-promoting signaling and sleep-wake regulation. Lundbeck said it is evaluating the drug's safety, tolerability, pharmacokinetic, and pharmacodynamic profile in the ongoing trial.</p> <p>Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and disrupted sleep-wake regulation. Symptoms can include sleep attacks, fragmented nighttime sleep, sleep paralysis, and http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html Thu, 23 Jul 2026 03:30:18 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html <p>Lundbeck announced that the U.S. Food and Drug Administration has granted Fast Track designation to Lu AH69593, an investigational oral orexin 2 receptor agonist being developed for the treatment of narcolepsy.</p> <p>Lu AH69593, discovered by Lundbeck, is currently in Phase 1b clinical development. The compound targets the orexin 2 receptor, which is involved in wake-promoting signaling and sleep-wake regulation. Lundbeck said it is evaluating the drug's safety, tolerability, pharmacokinetic, and pharmacodynamic profile in the ongoing trial.</p> <p>Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and disrupted sleep-wake regulation. Symptoms can include sleep attacks, fragmented nighttime sleep, sleep paralysis, and http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html Thu, 23 Jul 2026 03:30:18 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html <p>Lundbeck announced that the U.S. Food and Drug Administration has granted Fast Track designation to Lu AH69593, an investigational oral orexin 2 receptor agonist being developed for the treatment of narcolepsy.</p> <p>Lu AH69593, discovered by Lundbeck, is currently in Phase 1b clinical development. The compound targets the orexin 2 receptor, which is involved in wake-promoting signaling and sleep-wake regulation. Lundbeck said it is evaluating the drug's safety, tolerability, pharmacokinetic, and pharmacodynamic profile in the ongoing trial.</p> <p>Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and disrupted sleep-wake regulation. Symptoms can include sleep attacks, fragmented nighttime sleep, sleep paralysis, and http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html Thu, 23 Jul 2026 03:30:18 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html <p>Lundbeck announced that the U.S. Food and Drug Administration has granted Fast Track designation to Lu AH69593, an investigational oral orexin 2 receptor agonist being developed for the treatment of narcolepsy.</p> <p>Lu AH69593, discovered by Lundbeck, is currently in Phase 1b clinical development. The compound targets the orexin 2 receptor, which is involved in wake-promoting signaling and sleep-wake regulation. Lundbeck said it is evaluating the drug's safety, tolerability, pharmacokinetic, and pharmacodynamic profile in the ongoing trial.</p> <p>Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and disrupted sleep-wake regulation. Symptoms can include sleep attacks, fragmented nighttime sleep, sleep paralysis, and http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html Thu, 23 Jul 2026 03:30:18 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html <p>Lundbeck announced that the U.S. Food and Drug Administration has granted Fast Track designation to Lu AH69593, an investigational oral orexin 2 receptor agonist being developed for the treatment of narcolepsy.</p> <p>Lu AH69593, discovered by Lundbeck, is currently in Phase 1b clinical development. The compound targets the orexin 2 receptor, which is involved in wake-promoting signaling and sleep-wake regulation. Lundbeck said it is evaluating the drug's safety, tolerability, pharmacokinetic, and pharmacodynamic profile in the ongoing trial.</p> <p>Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and disrupted sleep-wake regulation. Symptoms can include sleep attacks, fragmented nighttime sleep, sleep paralysis, and http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html Thu, 23 Jul 2026 03:30:18 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html <p>Lundbeck announced that the U.S. Food and Drug Administration has granted Fast Track designation to Lu AH69593, an investigational oral orexin 2 receptor agonist being developed for the treatment of narcolepsy.</p> <p>Lu AH69593, discovered by Lundbeck, is currently in Phase 1b clinical development. The compound targets the orexin 2 receptor, which is involved in wake-promoting signaling and sleep-wake regulation. Lundbeck said it is evaluating the drug's safety, tolerability, pharmacokinetic, and pharmacodynamic profile in the ongoing trial.</p> <p>Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and disrupted sleep-wake regulation. Symptoms can include sleep attacks, fragmented nighttime sleep, sleep paralysis, and http://www.streetinsider.com/FDA/FDA+grants+Lundbeck+Fast+Track+status+for+narcolepsy+drug+candidate/26803317.html Thu, 23 Jul 2026 03:30:18 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/Press+Releases/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/PRNewswire/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/PRNewswire/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/PRNewswire/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/PRNewswire/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344 http://www.streetinsider.com/PRNewswire/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html <div class="xn-content"> <ul type="disc"><li>The <location value="LC/us" idsrc="xmltag.org" >U.S</location>. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy</li><li>The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation</li><li>Lu AH69593 is currently in Phase 1b development for patients with narcolepsy</li><li>The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders</li></ul><p><span class="legendSpanClass">VALBY, <location value="LC/dk" idsrc="xmltag.org" >Denmark</location></span>, <span class="legendSpanClass"><chron>July 23, 2026</chron></span> /PRNewswire/ -- Lundbeck today announced that the <span value="ACORN:0682203466" idsrc="xmltag.org" >U.S. Food and Drug Administration</span> http://www.streetinsider.com/PRNewswire/Lundbeck+receives+FDA+Fast+Track+designation+for+Lu+AH69593%2C+an+investigational+orexin+2+receptor+agonist+for+narcolepsy/26803316.html Thu, 23 Jul 2026 03:29:00 -0400 A.06822034 HLUN-A HLUN-B HLUNA.CO HLUNB.CO LUN LUN.CO O.20026344