Maplight Therapeutics Inc. is betting that the next competitive battleground in schizophrenia will be less about whether muscarinic agonists work and more about whether patients can stay on them and whether they offer benefits beyond psychosis.
Otsuka Pharmaceutical Co. Ltd. will likely look next to expand the label of Simtriyo (centanafadine) into patients with comorbid anxiety, having won the U.S. FDA’s green light as a once-daily extended-release capsule for attention deficit hyperactivity disorder (ADHD) in adults plus pediatrics age 6 years and older who weigh at least 20 kg (about 44 lbs.).
Evogene Ltd. and Eleo Inc. have established a strategic scientific collaboration to discover and develop next-generation oral small-molecule inhibitors targeting the PCSK9 pathway for the treatment of hyperlipidemia and cardiovascular diseases.
Insilico Medicine Cayman Topco has nominated ISM-9528 as a preclinical candidate for pain management. ISM-9528 targets an undisclosed novel mechanism to offer a brain-penetrant, orally available, non-opioid treatment option for pain.
About a week after closing its $10.6 billion acquisition of Nuvalent Inc., GSK plc has reaped the first reward, announcing U.S. FDA approval of zidesamtinib in non-small-cell lung cancer (NSCLC). Branded Jideytro, the ROS1 selective inhibitor is indicated for use in adults with locally advanced or metastatic ROS1-positive disease who have received a prior ROS1 kinase inhibitor.
The decision by Agios Pharmaceuticals Inc. to end work with next-generation oral pyruvate kinase activator tebapivat in sickle cell disease (SCD) put pressure on the company’s first-generation Pyrukynd (mitapivat) and left Novo Nordisk A/S in pole position as the firm advances etavopivat toward an approval bid in the second half of this year.
Another day, another two multibillion-dollar deals with Asian companies, this time involving Dizal Pharmaceutical Co. Ltd. and its EGFR inhibitor for lung cancer, as well as Innovent Biologics Inc. and its anti-CD40L antibody for a chronic fibroinflammatory condition.
Advancell Co. Ltd. has raised an oversubscribed $315 million series D round to accelerate its push to become a fully integrated global radiopharma developer, funding late-stage clinical development alongside isotope supply and manufacturing infrastructure.
Insmed Inc. has delivered further evidence of the advantages of its once-daily pulmonary arterial hypertension (PAH) drug TPIP (treprostinil palmitil inhalation powder), with data from an open-label extension of the phase IIb trial showing patients in the treated arm maintained the benefits over 24 months.
GSK plc’s walk-away from refractory chronic cough prospect camlipixant because of dicey phase III results opened the door wider for Trevi Therapeutics Inc. with Haduvio (oral nalbuphine ER), which yielded positive phase II data in June. Shares of Trevi (NASDAQ:TRVI) closed July 17 at $19.07, up $1.71, or 9.9%. London-based GSK reported findings with camlipixant, a P2X3 receptor antagonist, from the Calm-1 and Calm-2 trials. The first met its primary endpoint, with camlipixant 50 mg twice daily showing statistically significant reductions in 24-hour cough frequency vs. placebo when measured at week 12.