With the latest data from the phase II Sequel study, Cognition Therapeutics Inc. added new physiological evidence for the neuroprotective effect of CT-1812 in mild to moderate Alzheimer’s disease (AD) bolstering earlier results related to target engagement and the compound’s impact on cognitive changes. But the results failed to hit statistical significance, and shares of New York-based Cognition (NASDAQ:CGTX) closed June 28 at $2.18, down 32 cents, almost 13%.
Less than a week after Eli Lilly and Co.’s $2.4 billion, IL-17-based buyout of Dice Therapeutics Inc., Moonlake Immunotherapeutics Inc. offered more news in the space by way of data from the global phase II trial called Mira evaluating the efficacy and safety of the Nanobody sonelokimab in moderate to severe hidradenitis suppurativa (HS).
As earlier-stage efforts in oncology continue with BMF-219, Biomea Fusion Inc. rolled out new clinical data June 23 from the first two cohorts of patients with type 2 diabetes enrolled in the phase II part of its ongoing phase I/II study called Covalent-111 testing the same compound, an oral covalent menin inhibitor.
A recent population study in Morocco reinforced the importance of early diagnosis in handling – at best physicians can – Prader-Willi syndrome (PWS) and served, at least indirectly, to remind investors of the potentially lucrative space, where the lone drug labeled for the indication is a growth hormone.
Just over a month after expressing “substantial doubt that the company can continue as a going concern,” Aeglea Biotherapeutics Inc. came back from the brink with a deal to take over Spyre Therapeutics Inc. in a stock-for-stock transaction, signed concurrently with an agreement to raise $210 million via the sale of series A preferred shares.
For the second time in a week, measures of serum neurofilament light chain (NfL) took center stage, this time as Denali Therapeutics Inc. unveiled interim data from the open-label, single-arm phase I/II study testing DNL-310 in children with mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.
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.
