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Home » Authors » Randy Osborne

Articles by Randy Osborne

Business, data, dollars illustration

The knight of the living dead Fc, Alx on march with $105M round for CD47

Feb. 12, 2020
By Randy Osborne
Alx Oncology Inc. pulled down a $105 million series C equity financing to support the expansion into phase II trials with ALX-148, described as a next-generation CD47 myeloid checkpoint inhibitor, paired with other cancer therapeutics. ALX-148 uses a “dead” Fc domain that does not bind to macrophages, thus reducing cytopenia and other toxicities associated with the class.
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Reactants ignite, China syndrome melts down FDA drug-quality meeting

Feb. 11, 2020
By Randy Osborne
A half-day open meeting intended to examine “how the public perceives and values pharmaceutical quality,” convened by the Robert J. Margolis Center for Health Policy at Duke University in cooperation with the FDA, included a rundown of the agency’s oversight program, results of surveys to measure viewpoints of patients and providers – and tart commentary from a two-member “reactant panel.”
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Diabetes glucose monitor

Vtv scores phase II TD in T1D as Alzheimer’s bid RAGEs against dying of light

Feb. 10, 2020
By Randy Osborne
With the Simpliciti-T1 phase II trial testing new-mechanism TTP-399 as adjunct therapy in type 1 diabetes (T1D), High Point, N.C.-based Vtv Therapeutics Inc. nailed the HbA1c endpoint with none of the safety concerns foiling developers of type 2 diabetes (T2D) drugs who sought to broaden their labels.
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Metabolic: Inclisiran, Rybelsus

Novartis’ high ‘steaks’ with inclisiran in FH; optimism for Rybelsus in diabetes

Feb. 10, 2020
By Randy Osborne

The less-frequent dosing regimen of Basel, Switzerland-based Novartis AG’s cholesterol therapy, inclisiran, under development in the hands of subsidiary The Medicines Co., positions the small interfering RNA (siRNA) drug to take on marketed proprotein convertase subtilisin/kexin type 9 (PCSK9)-targeting antibodies as well as statins in the busy therapeutic space. Statins are the gold standard now, but about 80% of patients don’t reach their lipid goals.


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Electrical activity of the brain

Epidiolex un-hexed, Zogenix vexed post-phase III LGS win

Feb. 7, 2020
By Randy Osborne
Emeryville, Calif.-based Zogenix Inc.’s positive top-line data from the phase III study with Fintepla (fenfluramine oral solution) in Lennox-Gastaut syndrome (LGS) failed to charm Wall Street, which by day’s end trimmed the shares (NASDAQ:ZGNX) by $20.50, or 39%, putting the final price at $32.12.
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Close-up of eye with digital focus

Biotime streamlined as Lineage came, thaw, conquered in dry AMD cell therapy

Feb. 6, 2020
By Randy Osborne
Lineage Cell Therapeutics Inc. CEO Brian Culley told BioWorld that concerns about the pace of the company’s dry age-related macular degeneration (AMD) phase I/IIa trial have been alleviated after an independent data safety monitoring board (DSMB) decreed that the study’s protocol-mandated treatment stagger can be removed.
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Reactants ignite, China syndrome melts down FDA drug-quality meeting

Feb. 5, 2020
By Randy Osborne
A half-day open meeting intended to examine “how the public perceives and values pharmaceutical quality,” convened by the Robert J. Margolis Center for Health Policy at Duke University in cooperation with the FDA, included a rundown of the agency’s oversight program, results of surveys to measure viewpoints of patients and providers – and tart commentary from a two-member “reactant panel.”
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DPP1 bid requited, Insmed wears no green Willow; ‘Goldilocks’ bid wins chair at NCFBE table

Feb. 3, 2020
By Randy Osborne
Shares of Bridgewater, N.J.-based Insmed Inc. (NASDAQ:INSM) closed at $28.88, up $8.34, or 40.6%, on positive top-line results from the global, randomized, double-blind placebo-controlled phase II study called Willow, testing INS-1007 once daily in adults with non-cystic fibrosis bronchiectasis (NCFBE).
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EU panel CHMPions varied batch of prospective new therapies

Jan. 31, 2020
By Randy Osborne
The EMA’s Committee for Medicinal Products for Human Use (CHMP) looked with favor on a bucketload of would-be drugs, issuing positive opinions for the European Commission to consider across a range of indications.
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IPO, coins, upward arrow

Carbon dating: Black Diamond IPO woos backers, draws $201M in upsized deal

Jan. 30, 2020
By Randy Osborne
Wall Street’s enthusiasm ran high for Cambridge, Mass.-based Black Diamond Therapeutics Inc. (BDT), shares of which (NASDAQ:BDTX) closed 108% higher at $39.48, after the company priced its upsized IPO of about 10.5 million shares at $19 each, for gross proceeds of about $201 million. As recently as December, the company pulled down $85 million in a series C financing. BDT’s lead product candidates target oncogenic driver mutations of the ErbB kinases in EGFR and HER2. At the time, the firm noted that it had raised $194 million thus far. With the IPO, which first set sights on 8.9 million shares in the range of $16 to $18 each, the picture grows even brighter.
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