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Home » Authors » Randy Osborne

Articles by Randy Osborne

Keep Kalm and Cara on: Second phase III data due later this year, then NDA submission

May 30, 2019
By Randy Osborne
"We're running as fast as we can to look at other populations," said Cara Therapeutics Inc. CEO Derek Chalmers after the company disclosed positive top-line data from the pivotal phase III trial called Kalm-1 with Korsuva (CR-845/difelikefalin) for injection in hemodialysis (HD) patients with moderate to severe chronic kidney disease (CKD)-associated pruritus (CKD-aP).
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Going all the way, NMDA work sped up as chances weighed for big players

May 24, 2019
By Randy Osborne
Word from the FDA to Axsome Therapeutics Inc. about the effort with its oral N-methyl-D-aspartate (NMDA) receptor antagonist, AXS-05, in depression – and the company's accelerated push with the compound – had Wall Street watching the NMDA space with even more interest than usual.
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Sampler times ahead: HAE oral bid by Biocryst brings 'flexible' try-it-on-us ploy

May 22, 2019
By Randy Osborne
With efficacy that hit the primary endpoint but fell below what Wall Street watched for, Biocryst Pharmaceuticals Inc. hopes a sampling program and BCX-7353's oral route will help gain market share for the once-daily kallikrein inhibitor to prevent hereditary angioedema (HAE).
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Rinri 'stems' hearing loss, $1.7M seed round to fund effort from U of Sheffield

May 21, 2019
By Randy Osborne
"This is just a tiny seed round," Detlev Mennerich, of Boehringer Ingelheim Venture Fund (BIVF), conceded, telling BioWorld however that backers of Rinri Therapeutics Ltd. "have a clear vision" how the firm can use its newly banked £1.4 million (US$1.7 million) to develop chemistry, manufacturing and controls before going back to the market in a year or so for "north of $10 million" in series A money and then taking aim at phase Ib/IIa work.
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Troponin proponents still, analysts like Cytokinetics' reldesemtiv odds in ALS

May 20, 2019
By Randy Osborne
Cytokinetics Inc. CEO Robert Blum said it's "highly unlikely" that the phase III trial planned with fast skeletal muscle troponin activator reldesemtiv, also known as CK-2127107, will begin this year, "just knowing what the tasks in front of us are." But the South San Francisco-based firm, with partner Astellas Inc., of Tokyo, is moving ahead with the candidate in amyotrophic lateral sclerosis (ALS) despite results from the Fortitude-ALS trial showing that the drug missed statistical significance for the primary efficacy analysis after 12 weeks of treatment.
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Abstract painter: ASCO's KRAS rollouts red Haring? Early brushwork pleases

May 17, 2019
By Randy Osborne
With abstracts presaging the customary avalanche of data due from the American Society of Clinical Oncology (ASCO) meeting next month, the mechanism of KRAS inhibition caused an expectedly large share of talk, though efforts remain far from mature, and too fresh for big conclusions.
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Kymera's era: Vertex deal makes degrade, up to $1B+ as Pegasus springs flowing

May 15, 2019
By Randy Osborne

Kymera Therapeutics Inc. CEO Laurent Audoly told BioWorld that his firm's deal with Vertex Pharmaceuticals Inc. "signals to the sector how protein degradation is broadly deployable across many diseases. We're going way beyond oncology and immunology."


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Pop quizartinib grades low as FDA panel puts red mark on OS in Daiichi AML effort

May 15, 2019
By Randy Osborne
As expected, Tokyo-based Daiichi Sankyo Co. Ltd. faced rough sledding in its review by the FDA's Oncologic Drugs Advisory Committee (ODAC) of quizartinib tablets for adults with relapsed or refractory acute myeloid leukemia (AML) that is FMS-like tyrosine kinase (FLT) 3-internal tandem duplication (ITD) positive, as detected by an FDA-approved test.
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Debt-laden Takeda sells Xiidra to Novartis in potential $5.3B deal; Tachosil goes to J&J

May 15, 2019
By Randy Osborne
Novartis AG is buying from Takeda Pharmaceutical Co. Ltd. the dry eye therapy Xiidra (lifitegrast ophthalmic solution) for a $3.4 billion up-front payment, with up to $1.9 billion more if milestones are met, and the Basel, Switzerland-based firm is bringing aboard about 400 employees – mostly based in the U.S. and Canada – associated with the drug, which was approved by the FDA in the summer of 2016.
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All about that Base(camp): Elevatebio meets no treble raising $150M via series A

May 14, 2019
By Randy Osborne
Elevatebio Inc. CEO David Hallal told BioWorld that the five-member syndicate of investors behind his firm's whopper $150 million series A round "all have been on the other side of the table" in cell and gene therapy, and thus understand the potential value of building a portfolio of new companies in both areas by way of partnerships with academic researchers, medical centers and entrepreneurs.
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