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Home » Authors » Lee Landenberger

Articles by Lee Landenberger

ASCO 2021: Harpoon’s stock slides despite ‘great progress’ with HNP-424 at interim peek

June 4, 2021
By Lee Landenberger
Updated interim data from the ongoing dose-escalation portion of Harpoon Therapeutics Inc.’s phase I/IIa study of HPN-424 showed the metastatic castration-resistant prostate cancer therapy may move on to a dose expansion.
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Stock prices with loss/gain arrows

Protalix shares drop after releasing phase III data in Fabry

June 2, 2021
By Lee Landenberger
Protalix Biotherapeutics Inc. saw shares dip after releasing initial top-line data from an interim analysis of the phase III Balance clinical trial of pegunigalsidase alfa (PRX-102) to treat Fabry disease. The 24-month, randomized, double-blind, active control study is evaluating the safety and efficacy of 1 mg/kg of PRX-102 dosed every two weeks compared to agalsidase beta (Fabrazyme). Two of the study’s 78 patients dropped out because of treatment emergent adverse events and one left because of a related adverse event.
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Lung cancer illustration

Cstone and Eqrx’s sugemalimab hits primary endpoint in lung cancer study

June 1, 2021
By Lee Landenberger
In reporting positive data from a phase III study of sugemalimab in treating stage III non-small-cell lung cancer (NSCLC), Cstone Pharmaceuticals Co. Ltd. and Eqrx Inc. have the first anti-PD-L1 monoclonal antibody demonstrating progression-free survival in patients with concurrent or sequential chemoradiotherapy. The data built on positive data released in August from another phase III study showing sugemalimab (CS-1001) prolonged PFS when used as a first-line treatment for stage IV squamous and nonsquamous NSCLC plus standard-of-care chemotherapy, hitting the study’s primary endpoint.
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Alkermes’s first oral antipsychotic therapy gets the FDA’s approval

June 1, 2021
By Lee Landenberger
Alkermes plc worked its way through a complete response letter (CRL) issued in late 2020 as the FDA has approved Lybalvi (olanzapine and samidorphan) for treating adults with schizophrenia and bipolar I disorder. The once-daily, oral antipsychotic treatment, the company’s first, is for maintenance monotherapy or acute treatment of manic or mixed episodes and as a monotherapy or adjunct to lithium or valproate. The therapy had a June 1 PDUFA date.
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Lung cancer illustration

Cstone and Eqrx’s sugemalimab hits primary endpoint in lung cancer study

May 28, 2021
By Lee Landenberger
In reporting positive data from a phase III study of sugemalimab in treating stage III non-small-cell lung cancer (NSCLC), Cstone Pharmaceuticals Co. Ltd. and Eqrx Inc. have the first anti-PD-L1 monoclonal antibody demonstrating progression-free survival in patients with concurrent or sequential chemoradiotherapy.
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Antibodies attacking SARS-CoV-2 virus

EUA granted for Glaxosmithkline-Vir COVID-19 treatment

May 27, 2021
By Lee Landenberger
There are now two FDA-backed monoclonal antibody COVID-19 treatments after the agency granted Glaxosmithkline plc (GSK) emergency use authorization (EUA) for single-dose sotrovimab to treat mild to moderate COVID-19 in adults and children as young as 12. Vir Biotechnology Inc. collaborated on the program.
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Larimar’s financing and FA program take a hit

May 26, 2021
By Lee Landenberger
The brakes have now been pumped twice at Larimar Therapeutics Inc. as the FDA placed a clinical hold on its CTI-1601 Friedreich’s ataxia (FA) clinical program, and the company won’t close on a planned $95 million private placement financing. Larimar’s stock (NASDAQ:LRMR) took a battering May 26 as shares slumped 33.46% to close at $8.99.
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Moderna COVID-19 vaccine

Moderna’s COVID-19 vaccine is 100% effective in adolescents

May 25, 2021
By Lee Landenberger
Two weeks after Pfizer Inc.-Biontech SE’s mRNA-based COVID-19 vaccine received emergency use authorization (EUA) for adolescents ages 12 to 15, the first in that age group, Moderna Inc.’s mRNA vaccine has hit the primary immunogenicity endpoint in its phase II/III study of participants ages 12 through 17.
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Liver disease

With a phase II NASH miss, NGM drops the phase III and other developers feel the pain

May 24, 2021
By Lee Landenberger
Missing the primary endpoint in a phase IIb study of aldafermin for treating nonalcoholic steatohepatitis (NASH) has caused NGM Biopharmaceuticals Inc. to halt the program’s development while rattling the company’s share value. But the failure didn’t stop there as other NASH therapy developers felt the reverberations. South Francisco-based NGM’s stock (NASDAQ:NGM) took a battering May 24 as shares closed down 40.77% at $16.81 each. Others in the NASH space rocked by NGM’s negative data on the day included San Francisco-based 89bio Inc., which is prepping BIO89-100, a glycopegylated FGF21 analogue for a phase IIb NASH study. 89bio’s stock (NASDAQ:ETNB) plunged 14.24% to close at $19.40 per share.
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A CHMP thumbs up for the Vir-GSK early COVID-19 treatment

May 21, 2021
By Lee Landenberger
The EMA issued a positive scientific opinion on Glaxosmithkline plc (GSK) and Vir Biotechnology Inc.’s sotrovimab for early COVID-19 treatment. The Committee for Human Medicinal Products (CHMP)’s opinion concerns the monoclonal antibody’s use for adolescents ages 12 and older weighing at least 40 kg (88 pounds), plus adults. All must risk progressing to severe COVID-19 and not require oxygen supplementation.
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