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Home » Authors » Randy Osborne

Articles by Randy Osborne

3D illustration of cancer in crosshairs

Dato data lack means upside for Gilead; Padcev 'must-win' does win

Sep. 22, 2023
By Randy Osborne
Upbeat phase III findings outweighed less encouraging late-stage trial news, as big pharma provided a mixed bag of cancer findings – with one data batch to form the basis of global approval bids, as Astrazeneca plc with Daiichi Sankyo Co. Ltd. unveiled interim results from a study called Tropion-Breast01. Targeting trophoblast cell surface antigen 2, datopotamab deruxtecan (dato) hit the mark in progression-free survival for patients with hormone receptor-positive, HER2-low or negative breast cancer in the study called Tropion-Breast01.
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Kidney, pills, bottle

Filspari trips in IgAN phase III; data good enough to Protect against FDA withdrawal?

Sep. 21, 2023
By Randy Osborne
Travere Therapeutics Inc.’s narrow phase III miss in the study called Protect with the approved endothelin and angiotensin II receptor antagonist Filspari (sparsentan) in IgA nephropathy (IgAN) had Wall Street speculating about the fate of the compound, which is available for the indication by way of accelerated approval in the U.S., having been given the nod in February.
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Layoff, shutdown illustration

Amid hard industry times, Histogen gives up as thinner Kinnate hangs on

Sep. 19, 2023
By Randy Osborne
Having cast around for other routes, Histogen Inc. is throwing in the towel, its board having adopted a shutdown plan that includes the distribution of remaining cash to stockholders after a wind-down of operations. One of the company’s West Coast peers, Kinnate Biopharma Inc., had news, too. The firm disclosed the layoff of 70% of its workforce, including all employees at the Shanghai-based subsidiary Kinnjiu Biopharma Inc., leaving the outfit with 28 full timers.
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Gold dollar sign inside gold cog

Pass the (molecular) glue: Magnet school teaches new way with $50M series A

Sep. 19, 2023
By Randy Osborne
Magnet Biomedicine Inc. emerged from stealth mode and pulled down a $50 million series A round co-led by founding investor Newpath Partners alongside Arch Venture Partners. The firm is advancing molecular glue discovery by way of rational selection and design, looking past known protein-protein interactions and what Magnet calls “tangential” degradation approaches to analyze the broader protein landscape and ultimately pair targets with rationally chosen presenters in the tissue where the disease manifests.
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Let there Belite: Alkeus, Kubota help in Stargardt orals genesis

Sep. 18, 2023
By Randy Osborne
Iveric Bio Inc.’s regulatory win Aug. 4 drew attention to the already hot eye-disease space, where intriguing new developments include the possibility of an oral therapy for Stargardt disease. Belite Bio Inc. in late July finished enrollment of a phase III study with once daily tinlarebant, a retinol binding protein 4 antagonist for Stargardt’s. Data from 90 adolescent subjects in the study called Dragon are due in mid-2024.
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Boy in wheelchair, scenic overlook

Repeat defender: PTC to appeal Translarna case in Europe – again

Sep. 15, 2023
By Randy Osborne
“We’re going to battle,” PTC Therapeutics Inc. CEO Matthew Klein said, responding to a surprise negative opinion from the EMA’s Committee for Medicinal Products for Human Use on converting the conditional marketing authorization to full status for Translarna (ataluren) in the treatment of nonsense mutation Duchenne muscular dystrophy. The opinion applies to the renewal of the existing conditional authorization, too.
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Lungs

The more the Mereo as AATD lung space keeping busy

Sep. 14, 2023
By Randy Osborne
Though data won’t be available for a few years, the disclosure in mid-July that Grifols SA completed enrollment in the phase III study called Sparta caused some ears to perk up in the alpha-1-antitrypsin deficiency (AATD) space, where a number of contenders are busy.
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Red arrow down on money background

Eiger scraps phase III but delta force deploying in hepatitis

Sep. 13, 2023
By Randy Osborne
One hepatitis delta virus player (HDV) has dropped out after Eiger Biopharmaceuticals Inc.’s phase III effort with peginterferon lambda turned up safety issues, while others remain busy in a space highlighted during last November’s meeting of the American Association for the Study of Liver Diseases. Shares of Palo Alto, Calif.-based Eiger (NASDAQ:EIGR) closed Sept. 13 at 41 cents, down 28 cents, or 40.6%, on word that the company is stopping the Limt-2 study in patients with chronic HDV.
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Kidneys and adrenal glands

Neurocrine win juices Spruce; CAH phase III ‘most difficult’ ever

Sep. 12, 2023
By Randy Osborne
Neurocrine Biosciences Inc.’s positive top-line data from the phase III study called Cahtalyst in classic congenital adrenal hyperplasia (CAH) further whetted Wall Street’s appetite for soon-to-come results in the same indication from Spruce Therapeutics Inc.
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Vaccine wizard Moderna taking $1.7B shot in cancer with Immatics

Sep. 11, 2023
By Randy Osborne
Moderna Inc. has more than COVID-19 vaccines in the hopper, and the company aims to add still more oomph by way of an oncology deal with Immatics NV that could be worth more than $1.7 billion for the latter, which banks $120 million up front and stands to collect research funding as well.
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