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Home » Authors » Jennifer Boggs

Articles by Jennifer Boggs

Illustration of liver infection

Durect cites ‘midstream’ change in alcohol-associated hepatitis trial miss

Nov. 8, 2023
By Jennifer Boggs
While executives of Durect Corp. plugged “compelling” reduction in mortality from a phase IIb study testing DNMT inhibitor larsucosterol in severe alcohol-associated hepatitis and looked ahead to a potential registrational trial, investors focused on the fact that the study, called Ahfirm, fell short of statistical significance on both primary and secondary endpoints, sending shares (NASDAQ:DRRX) down 79%.
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US FDA clears Santhera’s improved steroid, Agamree, for DMD

Oct. 27, 2023
By Jennifer Boggs and Karen Carey
Less than two weeks after getting a thumbs-up from the EMA’s Committee for Medicinal Products for Human Use, Santhera Pharmaceutical AG’s vamorolone secured U.S. FDA approval for use in patients, 2 and older, with Duchenne muscular dystrophy (DMD). A first-in-class drug, vamorolone, branded Agamree, is expected to offer a safer alternative to the steroid therapy, which the company has said will remain a foundational treatment of DMD, even with the introduction of gene therapies.
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Abivax gains US listing, pads coffers with $236M in Nasdaq IPO

Oct. 20, 2023
By Jennifer Boggs
Abivax SA’s debut on the U.S. market received a somewhat chilly reception Oct. 20, as the firm priced on the low end of its proposed range and ended the first day of trading in the red. But the company managed to pull in about $235.8 million in gross proceeds, the majority of which will support late-stage efforts for obefazimod, an oral candidate with a novel mechanism of action it hopes to advance in the lucrative inflammatory bowel disease space.
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FDA approved icons and medical professional

Approval at last: Ardelyx puts regulatory hitches to rest in US with long-sought CKD nod

Oct. 18, 2023
By Jennifer Boggs
“Finally!” Piper Sandler analysts cheered in a research note on Ardelyx Inc., which after spending three years battling the U.S. FDA, secured approval of Xphozah (tenapanor) for treating hyperphosphatemia in adults with chronic kidney disease (CKD). The company will waste no time getting to market, aiming to have the NHE3 inhibitor available to patients next month, marking the first new treatment class for hyperphosphatemia in 30 years.
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FDA doubts tank Aldeyra stock ahead of PDUFA date for reproxalap in DED

Oct. 16, 2023
By Jennifer Boggs
Investors awaiting the announcement of a partnering deal for RASP modulator reproxalap ahead of the drug’s Nov. 23 PDUFA date were in for a rude awakening, as Aldeyra Therapeutics Inc. disclosed that the U.S. FDA had raised issues with the NDA, putting its imminent approval in dry eye disease in doubt. The update, disclosed in an SEC filing, sent shares (NASDAQ:ALDX) sinking 66%, or $3.60, to close Oct. 16 at $1.83.
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Novo’s CKD trial testing semaglutide stopped early for efficacy

Oct. 11, 2023
By Jennifer Boggs
Novo Nordisk A/S’ semaglutide is making headlines again this week, with a phase IIIb testing the ubiquitous GLP-1 agonist on kidney outcomes halted early for efficacy. The independent data monitoring committee for the trial, dubbed Flow, concluded results from an interim analysis met prespecified efficacy criteria. Final data will read out in the first half of 2024.
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Man scratching arm

Anaptysbio scores phase III win for imsidolimab in GPP

Oct. 9, 2023
By Jennifer Boggs
In what TD Cowen analyst Joseph Thome called an “upside surprise,” Anaptysbio Inc. reported positive top-line data from its phase III Gemini-1 study of imsidolimab, a monoclonal antibody designed to inhibit the interleukin-36 receptor, in patients with generalized pustular psoriasis (GPP), positioning the firm for a potentially productive out-licensing deal.
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‘Maximizing value’: Teva picks Sanofi in $1.5B IBD alliance

Oct. 4, 2023
By Jennifer Boggs
Teva Pharmaceutical Industries Ltd. is partnering with Sanofi SA in a 50-50 collaboration to develop and commercialize its anti-TL1A candidate, TEV ‘574, initially for inflammatory bowel disease (IBD), in a deal that comes with an up-front payment of €469 million (US$500 million) and up to €940 million in development and launch milestones.
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‘Maximizing value’: Teva picks Sanofi in $1.5B IBD alliance

Oct. 4, 2023
By Jennifer Boggs
Teva Pharmaceutical Industries Ltd. is partnering with Sanofi SA in a 50-50 collaboration to develop and commercialize its anti-TL1A candidate, TEV ‘574, initially for inflammatory bowel disease (IBD), in a deal that comes with an up-front payment of €469 million (US$500 million) and up to €940 million in development and launch milestones.
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Acute myeloid leukemia

Ahead in menin inhibitor race, Syndax plans FDA filing in high-risk leukemias this year

Oct. 2, 2023
By Jennifer Boggs
Syndax Pharmaceuticals Inc. is gearing up for a U.S. FDA filing by the end of 2023 on the back of positive data from a pivotal phase I/II study testing menin inhibitor revumenib in adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute myeloid leukemia and acute lymphoid leukemia.
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