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Home » Authors » Randy Osborne

Articles by Randy Osborne

Minerva whacked as hack slacks roluperidone tack, but is firm's MDD bid 'Sage-like'?

Oct. 2, 2019
By Randy Osborne
Minerva Neurosciences Inc. CEO Rémy Luthringer said his firm knew about the cyberattack on a contractor helping with the roluperidone phase III trial in schizophrenia "toward the end of the summer," when "the provider was trying to solve the problem" and ultimately did. But the attack still meant an enrollment delay, and Wall Street reacted accordingly. Despite imminent, possibly transforming data in major depressive disorder (MDD), investors pushed Minerva shares (NASDAQ:NERV) down $2.04, or 26.3%, Tuesday to close at $5.71.
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Leave that apabetalone? Resverlogix: Please stay for AHA six weeks away

Oct. 1, 2019
By Randy Osborne
Wall Street will have to wait until the American Heart Association (AHA) meeting next month in Philadelphia for full data from Resverlogix Inc.'s phase III BETonMACE trial with apabetalone, but disclosure of the endpoint miss was enough to send investors fleeing.
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Laying on GAS, Aravive spins early ovarian AXL; will the wheels stay on?

Sep. 30, 2019
By Randy Osborne
Aravive Inc.'s chief medical officer, Gail McIntyre, told BioWorld that a "very clever mechanism" designed by researchers at Stanford University helped lead to positive data from the first 12 patients of the ongoing phase Ib part of the phase Ib/II experiment with AVB-500 against notoriously hard-to-beat ovarian cancer.
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The Artara deal crafting: Merger includes $42.5M for post-blowup Proteon

Sep. 25, 2019
By Randy Osborne
Proteon Therapeutics Inc.'s inventorying of options after the phase III failure with vonapanitase in chronic kidney disease (CKD) ended in a merger deal with Artara Therapeutics Inc., a startup that has hung its main hat on TARA-002, a therapy for lymphatic malformations (also called lymphangiomas) that has already gained validation by way of a similar product in Japan.
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Early bird causing squirm: Avadel narcolepsy timing has Jazz Pharmaceuticals dancing faster?

Sep. 24, 2019
By Randy Osborne
Investor-pleasing news from the FDA regarding Dublin-based Avadel Pharmaceuticals plc's pivotal phase III trial testing once-nightly sodium oxybate (FT-218) for narcolepsy sparked Wall Street speculation regarding what the update might mean for Jazz Pharmaceuticals plc, also of Dublin, which markets twice-nightly Xyrem (sodium oxybate) in the space.
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Rybelsus 'Pioneering' oral GLP-1 diabetes therapy paradigm

Sep. 23, 2019
By Randy Osborne
Bagsvaerd, Denmark-based Novo Nordisk A/S' chief medical officer, Todd Hobbs, told BioWorld it "won't be too much longer" – probably a week or so – before the firm sets pricing of oral once-daily Rybelsus (semaglutide) in type 2 diabetes, approved Friday thanks to a priority review voucher that guaranteed a greased path for the first non-injected glucagon-like peptide (GLP-1) receptor protein therapy.
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TRuCs overtaking CARs? Mesothelin tumor effort by TCR2 early, auspicious

Sep. 23, 2019
By Randy Osborne
During its second-quarter earnings report, Cambridge, Mass.-based TCR2 Therapeutics Inc. touted the start of a phase I/II trial with TC-210 to treat patients with mesothelin-positive tumors of various types, and interest continues to grow in the company's approach.
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HIF HIF hooray: Heartfelt faith in CKD anemia class, Street sorts market odds

Sep. 18, 2019
By Randy Osborne
With the NDA target date of October approaching for roxadustat, Fibrogen Inc.'s hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for anemia in chronic kidney disease (CKD), watchers of the space are handicapping the prospects for competitor Akebia Therapeutics Inc., developing vadadustat in the same class.
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Fund-hunting startups hear VC strategy hints, counsel on timing of pharma deals

Sep. 16, 2019
By Randy Osborne
BOSTON – Panelists at Biopharm America debated strategies for early stage financing as they weighed the importance of a prestigious board, the wisdom of small deals by startups with pharma firms, and the likelihood (or not) that angel investors will help make the case with other backers yet to come.
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Guts, glory: 'Seres' of tries in microbiome may yield success yet, experts insist

Sep. 13, 2019
By Randy Osborne
BOSTON – The gut microbiome and its prospects for drug development have been matters of debate for a while, sharpened by the high-profile phase II failure of Seres Therapeutics Inc.'s candidate, SER-109, in the summer of 2016. A panel at Biopharm America surveyed the space in light of developments since the stumble with that candidate, composed of about 50 species of firmicutes spores derived from stool specimens from healthy donors, against recurrent Clostridium difficile infection. 
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