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Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Praxis makes perfect? Bid to sharpen MDD drug targeting has banked $100M so far

May 4, 2020
By Randy Osborne
Praxis Precision Medicines Inc. CEO Marcio Souza told BioWorld that the line figuratively walked by PRAX-114, a GABAA positive allosteric modulator in major depressive disorder (MDD), means upside relief without the downside of adverse effects.
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Man piecing together a puzzle

AD astra: Axsome’s agitation candidate shines bright in phase III, FDA talks next

May 1, 2020
By Randy Osborne
With regard to agitation in Alzheimer’s disease (AD), doctors “are in a very difficult position right now,” said Axsome Therapeutics Inc. CEO Herriot Tabuteau. That’s because the products currently used off-label are antipsychotics – all of which carry an FDA black box warning “specifically against their use in elderly patients with dementia, including AD,” since they double the risk of stroke and of mortality.
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Rosana Kapeller, CEO, Rome Therapeutics
Newco news

Repeatome defender: $50M series A lets Rome ransack ‘junk DNA’

May 1, 2020
By Randy Osborne
CEO and co-founder Rosana Kapeller told BioWorld that Rome Therapeutics Inc.’s $50 million series A will fund early work in an “exploding” new area of biology: the repeatome – “the dark genome” or “junk DNA,” as many previously deemed the roughly 60% of the human genome that consists of repetitive sequences of nucleic acids.
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Hit or miss in mimesis? Albeit early, Neoleukin lookin’ good

April 30, 2020
By Randy Osborne
Seattle-based Neoleukin Therapeutics Inc. is targeting the end of 2020 for an IND submission related to prospective cancer immunotherapy NL-201, described as an engineered, hyperstable agonist of interleukin-2 (IL-2) and IL-15. It’s meant to eliminate alpha receptor binding and thereby overcome the problems with native IL-2.
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Wall Street hails Chimerix viral load; COVID-19, smallpox bids forge onward

April 29, 2020
By Randy Osborne
A pair of good-news items from Chimerix Inc. pushed the Durham, N.C.-based company’s stock (NASDAQ:CMRX) to $2.15, closing up 64 cents, or 42%, higher as backers reacted to near-term NDA plans for smallpox countermeasure brincidofovir (BCV) and the start of a phase II/III trial with dociparstat sodium (DSTAT) in COVID-19 patients with acute lung injury (ALI).
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TNBC news rating well for shares of Immunomedics; Trodelvy soon goes live

April 23, 2020
By Randy Osborne
With accelerated approval in hand for Trodelvy (sacituzumab govitecan-hziy) to treat metastatic triple-negative breast cancer (mTNBC), Immunomedics Inc. is looking ahead to data related to the next indication for the antibody-drug conjugate (ADC) – urothelial tumors – “in the near future,” Chairman Behzad Aghazadeh told investors during a conference call.
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FDA Approved stamp with pills

Immunomedics’ Trodelvy wins FDA nod for triple-negative breast cancer

April 22, 2020
By Randy Osborne
Immunomedics Inc. gained accelerated FDA clearance for Trodelvy (sacituzumab govitecan-hziy) to treat patients with metastatic triple-negative breast cancer (TNBC) who have undergone at least two prior therapies. It’s the first antibody-drug conjugate (ADC) given the go-ahead specifically in relapsed/refractory TNBC and the first anti-Trop-2 ADC bound for the market. Trodelvy, which was granted breakthrough therapy designation and priority review, moved along faster thanks to the objective response rate (ORR) and duration of response (DoR) turned up by Morris Plains, N.J.-based Immunomedics in a single-arm, multicenter phase II study. Continued approval may be contingent on verifying clinical benefit in the confirmatory phase III experiment called Ascent, recently halted by the independent data safety monitoring committee due to compelling evidence of efficacy across multiple endpoints.
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Will to Prevail in FTD-GRN Proclaimed, phase I/II gene therapy start near

April 22, 2020
By Randy Osborne
The acceptance by the FDA of Prevail Therapeutics Inc.’s IND for the one-time, fast-tracked gene therapy PR-006 provided hope for 50,000 to 60,000 people in the U.S beset by frontotemporal dementia with the GRN mutation (FTD-GRN), and the New York-based company is moving ahead with a phase I/II experiment called Proclaim.
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Cara package delivers investor relief, Korsuva filing in second half

April 21, 2020
By Randy Osborne
Despite the higher placebo response than a previous, identically designed experiment turned up, Cara Therapeutics Inc.’s Kalm-2 phase III study Korsuva (CR-845/difelikefalin) for injection handily reached its primary endpoint in hemodialysis patients with moderate to severe chronic kidney disease-associated pruritus (CKD-aP).
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Future imperfect: CBER head weighs good-enough options in virus war

April 20, 2020
By Randy Osborne
Looking ahead to COVID-19 strategies, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said vaccine studies might be done not in clinics but in the streets. “By definition, we’re probably not going to be able to vaccinate everyone simultaneously,” he noted.
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View All Articles by Randy Osborne

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