Clene Inc. plans to sit down in the third quarter of this year with the U.S. FDA for talks about approval for gold nanocrystal suspension CNM-Au8, bolstered by favorable biomarker findings in amyotrophic lateral sclerosis (ALS) from the phase II/III Healey ALS platform trial – along with a sizeable time-to-event and survival data package that should drive the conversation.
Eli Lilly and Co.’s phase II data with LY-3462817 (peresolimab), a monoclonal antibody (MAb) that functions as a PD-1 agonist for rheumatoid arthritis (RA), juiced hopes for the approach being tried by a handful of firms.
With the drug already under review by the U.S. FDA for dry eye disease (DED), Aldeyra Therapeutics Inc.’s reproxalap hit statistical significance in the second phase III study for allergic conjunctivitis (AC), and the firm is mulling what CEO Todd Brady called the “high-class problem” of how to best commercialize the product. A partner may help puzzle that out.
Since late 2006, when hiked levels of aldosterone and increases in blood pressure foiled Pfizer Inc.’s torcetrapib, researchers have been wary of cholesteryl ester transfer protein (CETP) inhibitors. But not all researchers. Among the still-hopeful is Newamsterdam Pharma NV, which recently rolled out positive phase II data with obicetrapib, and the company is forging ahead despite other CETPs that have not fared well in late-stage testing after performing nicely in phase II, including candidates from Merck & Co. Inc. and Eli Lilly and Co.
Disc Medicine Inc.’s positive phase II data from an ongoing, open-label trial called Beacon with oral bitopertin in erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) whetted investor appetite for the results of the other mid-stage Disc experiment known as Aurora with the compound, due early next year.
Standing as one of the more prominent among incurable conditions, Parkinson’s disease (PD) still hasn’t met a medicine or surgical intervention that can slow or stop progression, despite efforts of many drug developers testing new strategies.
Standing as one of the more prominent among incurable conditions, Parkinson’s disease (PD) still hasn’t met a medicine or surgical intervention that can slow or stop progression, despite efforts of many drug developers testing new strategies.
Having banked almost $775 million since its inception in 2019, Eikon Therapeutics Inc. closed three transactions to beef up its pipeline and raised nearly $106 million in a series C round. And the dealmaking will continue, said Alfred Bowie, chief financial officer. “We still have well over a half-billion in cash on our balance sheet,” he told BioWorld. “We’re active.” The new funds “add more fuel to the fire,” and let the company “make sure we aren’t cannibalizing some of the funding we’ve raised to help push forward the internal pipeline,” which is “advancing very nicely.”
With rising rates of disease and established guidelines for treatment, officials at Lexicon Pharmaceuticals Inc. have “the wind at our backs” as they go about commercializing Inpefa (sotagliflozin) for heart failure (HF), after the drug was cleared late May 26 by the U.S. FDA, said CEO Lonnel Coats. Shares of The Woodlands, Texas-based Lexicon (NASDAQ:LXRX), which had risen significantly after hours on word of the Inpefa go-ahead, closed May 30 at $2.90, down 28 cents. Regulators gave their nod to the inhibitor of renal sodium-glucose co-transporter 2 (SGLT2) and intestinal SGLT1 with a broad label across the full range of left ventricular ejection fraction, including HFpEF and HFrEF, and for patients with or without diabetes.
