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Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Axsome Symphony phase III plays well in narcolepsy

March 25, 2024
By Randy Osborne
An asset that some investors may have overlooked came through for Axsome Therapeutics Inc., which rolled out phase III data from the trial called Symphony with AXS-12 (reboxetine), which hit the primary endpoint by significantly reducing cataplexy attacks in narcolepsy patients vs. placebo.
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Kidneys

Eledon takes new ‘tac’ with tegoprubart in kidney transplant

March 22, 2024
By Randy Osborne
Eledon Pharmaceuticals Inc.’s tegoprubart, an investigational anti-CD40 ligand antibody, was used as part of the immunosuppressive regimen after the first-ever transplant of a kidney from a genetically modified pig to a human. The tegoprubart procedure was done March 16 at Massachusetts General Hospital on a 62-year-old man with end-stage renal disease.
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Affimed, Seagen soldiers in long SWOG for Hodgkin lymphoma drugs

March 21, 2024
By Randy Osborne
The Hodgkin lymphoma space found itself in the spotlight late last year when Affimed NV rolled out updated data with lead innate cell engager acimtamig when combined with allogeneic natural killer cells. Findings from the investigator-initiated trial became the topic of talk at the American Society of Hematology meeting, when Yago Nieto, professor at the University of Texas MD Anderson Cancer Center – and principal investigator of the study – spoke.
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Cardiovascular illustration

J&J ‘mistake’? Idorsia’s Tryvio wins FDA nod in hypertension

March 20, 2024
By Randy Osborne
About six months after Johnson & Johnson (J&J) returned rights to the compound, oral Tryvio (aprocitentan) won FDA clearance for Idorsia Ltd. Given once daily at a 12.5 mg dose, Tryvio is indicated for hypertension in combination with other blood pressure drugs in patients whose condition is not adequately controlled.
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Crinetics’ kinetics: On the move with phase III acromegaly win

March 19, 2024
By Randy Osborne
Clearing the way for a U.S. regulatory bid in the second half of this year are positive top-line results from Pathfindr-2, the second of two successful phase III studies testing the efficacy and safety of Crinetics Pharmaceuticals Inc.’s oral, once-daily paltusotine for acromegaly.
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IV drips

Adcom CAR T party favors Carvykti in MM, Abecma not so much

March 15, 2024
By Randy Osborne
The U.S. FDA’s Oncology Drugs Advisory Committee, in two separate sessions, took up the matters of Carvykti (ciltacabtagene autoleucel) from Johnson & Johnson and the Bristol Myers Squibb Co. product Abecma (idecabtagene vicleucel) – specifically, whether the benefits of each CAR T therapy outweigh the risks in relapsed or refractory multiple myeloma (MM).
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Kidneys and adrenal glands

CAH-veats abound in Spruce phase II vs. Neurocrine data

March 14, 2024
By Randy Osborne
Spruce Biosciences Inc.’s results from two studies with tildacerfont in adult and pediatric classic congenital adrenal hyperplasia (CAH) spurred Wall Street to speculate – further, again – about the prospect’s odds against a drug in the works from Neurocrine Biosciences Inc.
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Heart with blocked arteries

Silence finds its jams as zerlasiran fosters phase II lipid win

March 13, 2024
By Randy Osborne
Silence Therapeutics plc disclosed positive top-line 36-week data from the Alpacar-360 phase II study with zerlasiran, a short interfering RNA gene muter that targets lipoprotein(a), but also said Mallinckrodt plc has quit development of a separate prospect.
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‘Second’ language speaks well of Regulus phase Ib kidney bid

March 12, 2024
By Randy Osborne
With a second batch of phase Ib data from the trial testing RGLS-8429 in hand from Regulus Therapeutics Inc., Wall Street is looking forward to results from the third cohort in midyear and weighing prospects with the compound in autosomal dominant polycystic kidney disease. Screening of the fourth cohort will start during the second quarter. Meanwhile, the company has begun to mull a pivotal phase II trial that would launch in the middle of next year, and may help with accelerated approval by the U.S. FDA.
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Ear illustration

Sound approach? Sensorion phase IIa wins in hearing loss

March 11, 2024
By Randy Osborne
After a disappointment with the same product in another indication about two years ago, Sensorion SA met the primary endpoint in its proof-of-concept phase IIa trial with SENS-401 for residual hearing preservation after cochlear implant.
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View All Articles by Randy Osborne

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