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BioWorld - Friday, May 9, 2025
Home » Authors » Randy Osborne

Randy Osborne

Articles

ARTICLES

Pass the SIRPa? Alx sweet on CD47-axis in solid tumors, phase II soon

Feb. 19, 2021
By Randy Osborne
As developers continue their race in the anti-CD47 space, Gilead Sciences Inc. remains high profile with magrolimab, which has reached phase III development for myelodysplastic syndromes. Meanwhile, Alx Oncology Inc., of Burlingame, Calif., is emerging with potentially the first drug targeting the CD47-SIRPa axis to treat solid tumors as well as hematologic malignancies.
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Oral medication

Athenex specs checked as Oraxol awaits PDUFA date

Feb. 18, 2021
By Randy Osborne
Athenex Inc.’s launch of Klisyri (tirbanibulin) likely whetted investor appetite for another prospect coming down the pike: Oraxol, an oral form of paclitaxel for which the Buffalo, N.Y.-based firm has been assigned a PDUFA date of Feb. 28.
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Limb exam

Amicus takes walk-test outcome in stride as Pompe BLA rolls on

Feb. 12, 2021
By Randy Osborne
Amicus Therapeutics Inc.’s results from the phase III trial called Propel with AT-GAA (cipaglucosidase alfa and miglustat) for late-onset Pompe disease (LOPD) met with split opinions, though Wall Street took a decidedly dim view and left shares (NASDAQ:FOLD) to close at $12.57, down $6.16, or 33%.
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Psychiatric disorders illustration

Research making strides even as mystery abounds in schizophrenia

Feb. 12, 2021
By Randy Osborne
Recently published findings in JAMA Psychiatry related to the sharply increased risk of death from COVID-19 in people with schizophrenia put the spotlight on drug development in the space, which has been steadily heating up the past few years.
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Panbela’s phase I pancreatic cancer trial meets visual-disturbance hitch

Feb. 10, 2021
By Randy Osborne
Panbela Therapeutics Inc. hit a speed bump with its phase I trial in the ever-challenging indication of pancreatic cancer (PC), as an independent data safety monitoring board (DSMB) recommended that dosing be held for patients until more safety information is available about polyamine analog SBP-101.
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Swollen face

Kalvista’s angle of HAE attack firms up oral argument in phase II

Feb. 9, 2021
By Randy Osborne
Kalvista Pharmaceuticals Inc.’s chief development officer, Christopher Yea, said the across-the-board positive phase II top-line data with KVD-900 for on-demand use against hereditary angioedema (HAE) attacks will open “a very flexible discussion with regulators” regarding the design and endpoints of the phase III study to come with the oral kallikrein inhibitor. Shares of the Cambridge, Mass.-based firm (NASDAQ:KALV) closed at $33.50, up $17.89, or 115%, after reaching a high of $45, as Wall Street digested the findings.
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Hospital patient wearing pulse oximeter

(Micro)tubular bells chime for Veru with phase II pill against COVID-19 demon

Feb. 8, 2021
By Randy Osborne
CEO Mitchell Steiner said Veru Inc. at first downplayed the prospects of oncology candidate VERU-111 in COVID-19 treatment but now, with positive phase II data in hand, the company has a moral obligation to push onward to late-stage research.
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As investors feel the ‘wait’ of Study 045 fizzle, PTC preparing regulatory case

Feb. 5, 2021
By Randy Osborne
In the wake of Study 045’s failure with Translarna (ataluren) in nonsense mutation Duchenne muscular dystrophy, PTC Therapeutics Inc. is “trying to thread the needle between the notion of getting Study 041 completed in the third quarter of 2022 vs. getting accelerated approval now,” CEO Stuart Peltz said.
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Kidneys

Street hails Cabo, driver of Exelixis; pair fares well in RCC

Feb. 4, 2021
By Randy Osborne
Probably no one was surprised by the FDA’s recent nod for the combination of Alameda, Calif.-based Exelixis Inc.’s tyrosine kinase inhibitor, Cabometyx (cabozantinib), which targets MET, AXL and VEGF, and PD-1 drug Opdivo (nivolumab) from Bristol Myers Squibb Co. as a first-line treatment for advanced renal cell carcinoma (RCC), but investors may feel less confident about the odds for the pairing in a competitive space.
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Cannabidiol

Jazz proves its chops; harmonic rhythm with GW in $7.2B deal

Feb. 3, 2021
By Randy Osborne
Questions about the price tag, the extent of diligence done on intellectual property, and the staying power of Epidiolex (cannabidiol) as well as the potential of other prospects in the acquiree’s pipeline bubbled up during the conference call related to Jazz Pharmaceuticals plc’s whopping takeover of GW Pharmaceuticals plc.
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