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Home » Authors » Randy Osborne

Articles by Randy Osborne

Bempeg goose egg likely not, but Nektar hitch nips stock as more clarity due

Aug. 12, 2019
By Randy Osborne
Analysts had questions aplenty for Nektar Therapeutics Inc. about cancer drug candidate bempegaldesleukin ("bempeg," NKTR-214) after the firm made known some apparent manufacturing problems with the compound, a CD122-preferential interleukin-2 pathway agonist designed to stimulate the patient's own immune system and fight various cancer types.
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Winning the hunger game: Rhythm NDA pace well set with POMC, LEPR findings

Aug. 8, 2019
By Randy Osborne
As expected, Rhythm Pharmaceuticals Inc. rolled out positive top-line results from two pivotal, phase III trials evaluating setmelanotide, the company's melanocortin-4 receptor (MCR4R) agonist, for the treatment of pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesities. 
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Gastro drub? Leap combo results digested by Street; biomarker bid paying off

Aug. 7, 2019
By Randy Osborne
Leap Therapeutics Inc. said its anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with the anti-PD-1 antibody Keytruda (pembrolizumab, Merck & Co. Inc.), turned up higher survival and objective response outcomes in patients with advanced gastroesophageal junction and gastric cancer (GEJ/GC) whose tumors expressed high levels of DKK1 (DKK1-high).
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Daiichi's Turalio go-ahead casts CSF1R into spotlight; 'headroom' for Deciphera

Aug. 7, 2019
By Randy Osborne
Deciphera Pharmaceuticals Inc. CEO Steven Hoerter told BioWorld Asia the FDA approval of Turalio (pexidartinib) from Daiichi Sankyo Co. Ltd. last week "leaves a lot of headroom for efficacy," given the response rate of about 40%. "One of the most significant concerns that the FDA had was hepatotoxicity, which is an off-target effect," he added, so the approval came with "some fairly onerous monitoring requirements." 
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FDA makes Daiichi's Turalio first approved therapy for rare cancer

Aug. 7, 2019
By Randy Osborne
Tokyo-based Daiichi Sankyo Co. Ltd.'s Turalio (pexidartinib) won FDA clearance for adults with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.
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Daiichi's Turalio go-ahead casts CSF1R into spotlight; 'headroom' for Deciphera

Aug. 6, 2019
By Randy Osborne
Deciphera Pharmaceuticals Inc. CEO Steven Hoerter told BioWorld the FDA approval of Turalio (pexidartinib) from Daiichi Sankyo Co. Ltd. last week "leaves a lot of headroom for efficacy," given the response rate of about 40%.
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FDA makes Daiichi's Turalio first approved therapy for rare cancer

Aug. 5, 2019
By Randy Osborne
Tokyo-based Daiichi Sankyo Co. Ltd.'s Turalio (pexidartinib) won FDA clearance for adults with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.
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Star VOCalist with Pfizer, Glycomimetics may Reset expectations in SCD study

Aug. 5, 2019
By Randy Osborne
With data from the phase III, 341-patient Reset trial due soon, investors in Glycomimetics Inc. eagerly await the findings to be unveiled by partner Pfizer Inc. with rivipansel to treat vaso-occlusive crisis (VOC) in sickle cell disease (SCD).
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Not a moment too spoon: Aztherapies drug 'in dish,' AD reaching critical mast?

Aug. 2, 2019
By Randy Osborne

Not a moment too spoon: Aztherapies drug 'in dish,' AD reaching critical mast?

Aug. 2, 2019
By Randy Osborne
Aztherapies Inc.'s new phase III approach in Alzheimer's disease (AD), ALZT-OP1, combines two well-characterized small molecules in optimized form – inhaled mast cell stabilizer cromolyn and orally given ibuprofen – for a multimodal attack of the condition at an early stage, tamping down "the big fire that's burning in the brain," Chief Medical Officer (CMO) Karen Reeves told BioWorld. Formerly with New York-based Pfizer Inc., Reeves was not the first to characterize AD as a "ticking time bomb."
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