Corxel Pharmaceuticals Ltd. completed a $287 million series D round to advance its lead compound, an oral small-molecule GLP-1 receptor agonist, CX-11, for obese and overweight patients.
Hyperactivity of the transmembrane adaptor protein STING, which normally helps the cell respond to infection and injury, has been implicated in several autoimmune or inflammatory diseases, including systemic lupus erythematosus and amyotrophic lateral sclerosis.
Lexicon Pharmaceuticals Inc. announced that it received no objections from the U.S. FDA to move pilavapadin, its non-opioid candidate for diabetic peripheral neuropathic pain, into phase III study, pushing company shares up near 20% on the day.
Erasca Inc. priced an upsized public offering to raise $225 million to fund development of its therapies for patients with RAS/MAPK pathway-driven cancers.
Six months shy of the PDUFA date for its oral, selective glucocorticoid receptor antagonist relacorilant to treat platinum-resistant ovarian cancer, Corcept Therapeutics Inc. reported a 35% reduction in the risk of death, meeting the second primary endpoint of overall survival after reaching statistical significance with progression-free survival last March.
After selling off amyotrophic lateral sclerosis therapeutics last month, Tanabe Pharma America Inc. emerged a forerunner in another rare disease space with positive top-line phase III data of dersimelagon (MT-7117) for erythropoietic protoporphyria/X-linked protoporphyria.
After passing on one skinny label case a few years ago, the U.S. Supreme Court agreed to delve into the dark hole the Federal Circuit has dug for drug label carveouts that allow generic drugs and biosimilars to come to market even though some indications of the reference drug may still be protected by exclusivities or patents. The high court granted cert Jan. 16 to Hikma Pharmaceuticals v. Amarin Pharma Inc., which revolves around Hikma’s marketing of its generic version of Amarin’s blockbuster drug, Vascepa (icosapent ethyl).
China’s National Medical Products Administration has accepted for review Grand Pharmaceutical Group Ltd./Telix Pharmaceuticals Ltd.’s NDA for TLX-591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate for diagnosing prostate cancer.
Corvus Pharmaceuticals Inc. rolled out new positive data to prove its thesis on the value of blocking IL-2-inducible T-cell kinase in atopic dermatitis (AD), and the company’s first-in-class approach “could shake up cancer and autoimmune disorders,” Wainwright analyst Swayampakula Ramakanth said when he started coverage Jan. 2.
Two former Spero Therapeutics Inc. executives are on the hook for a total of $187,500 in civil penalties in a settlement resolving U.S. SEC allegations of issuing misleading statements centered on the FDA’s evaluation of Spero’s lead drug candidate that resulted in a 64% stock drop in May 2022.
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