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.
Omeros Corp.’s phase III stumble in the busy immunoglobulin A nephropathy (IgAN) space put a sizeable dent in the stock (NASDAQ:OMER) and caused the Seattle-based firm to end the experiment with narsoplimab. Shares closed Oct. 16 at $1.54, down 73 cents, or 32%, after Omeros reported the interim analysis outcome of the trial called Artemis-IgAN.
Precision cancer biotech Abion Inc. announced a positive interim phase II readout for ABN-401, its novel c-mesenchymal-epithelial transition (c-MET)-targeting tyrosine kinase inhibitor (TKI) for advanced non-small-cell lung cancer (NSCLC), lighting a runway to its next trial as a combination regimen.
Why U.S. FDA-approved Wakix (pitolisant) has worked to treat excessive daytime sleepiness (EDS) in narcolepsy but not in idiopathic hypersomnia (IH) patients is the question that lies before Harmony Biosciences Holdings Inc., and one that the U.S. FDA will take up at a future sit-down.
With an eye on making the U.K. more attractive for clinical trial research, the Medicines and Healthcare products Regulatory Agency took a step Oct. 12 to overhaul its clinical trials regulations by reducing the approval time for the lowest-risk studies.
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.
Tempest Therapeutics Inc. has begun the hunt for a phase III partner to help reach the market with TPST-1120, the oral selective peroxisome-proliferator activated receptor-alpha (PPAR-alpha) antagonist that showed clinical superiority on multiple study endpoints in phase Ib/II as an add-on in first-line unresectable or metastatic hepatocellular carcinoma (HCC).
While Ventyx Biosciences Inc.’s oral S1P1 receptor modulator, VTX-002, achieved primary and secondary endpoints in a phase II ulcerative colitis (UC) trial, the company’s shares (NASDAQ:VTYX) fell 25.9%, or $7.78, closing Oct. 10 at $22.22, possibly due to a higher-than-expected placebo response and a clinical remission rate that was similar to Pfizer Inc.’s etrasimod.
Hopes raised by the phase IIb Harmony study with FGF21 analogue efruxifermin (EFX) in pre-cirrhotic nonalcoholic steatohepatitis (NASH), which appeared in a scientific journal last week, were less than fulfilled as Akero Therapeutics Inc. rolled out disappointing 36-week results from another, same-stage trial called Symmetry in NASH patients with cirrhosis. The company is forging ahead with U.S. FDA talks to figure out how a phase III effort might be designed.
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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