Acorda Therapeutics Inc. has filed for bankruptcy and agreed to sell its assets, including rights to its three commercialized drugs, to German biopharma Merz Therapeutics GmbH for $185 million. Palo Alto, Calif.-based Eiger Biopharmaceuticals Inc. also filed for bankruptcy.
Yes, even a phase III protocol for a “failed” trial can constitute prior art, the U.S. Court of Appeals for the Federal Circuit told a lower court April 1 when it returned Janssen Pharmaceuticals Inc. and Teva Pharmaceuticals USA Inc.’s patent squabble for a do-over.
Updated results from Stoke Therapeutics Inc.’s studies of antisense oligonucleotide STK-001 showed a reduced convulsion seizure frequency in those ages 2 to 18 with Dravet syndrome. The new data, which also showed improved cognition and behavior in participants, substantially boosted the company’s stock value and caused analysts to applaud.
Despite numerous marketed anti-seizure medications in the U.S., patients with epilepsy continue to experience breakthrough seizures and tolerability issues compounded with drug interactions and side effects, leaving room for companies like Praxis Precision Medicines Inc. to fill treatment gaps. The Boston-based company presented phase IIa proof-of-concept data March 26 showing that in an evaluation of photo paroxysmal response, its once-daily oral small-molecule treatment, PRAX-628, resulted in a complete response in three epilepsy patients receiving 45 mg of the drug and four patients receiving 15 mg for a combined complete response rate of 88%.
Europe may still await its first disease-modifying Alzheimer’s drug after the EMA postponed its decision on Leqembi (lecanemab, Biogen Inc./Eisai Co. Ltd) on March 22, but leading members of the World Dementia Council were in an optimistic mood when they convened in London four days later.
An asset that some investors may have overlooked came through for Axsome Therapeutics Inc., which rolled out phase III data from the trial called Symphony with AXS-12 (reboxetine), which hit the primary endpoint by significantly reducing cataplexy attacks in narcolepsy patients vs. placebo.
South Korean biopharma Aribio Co. Ltd. signed a $770 million deal to sign off exclusive rights to its early Alzheimer’s disease drug, AR-1001 (mirodenafil), in China. The exclusive deal for marketing rights will total about ¥5.59 billion (US$770 million), which includes a non-refundable up-front payment of ₩120 billion (US$90 million) and potential milestone payments, along with royalties.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Pfizer Inc.’s Emblaveo (aztreonam-avibactam), an antibiotic combination that would offer a new option to patients with serious bacterial infections caused by multidrug-resistant gram-negative bacteria. If approved, Emblaveo would be among the first beta-lactam/beta-lactamase inhibitor combos cleared for use in Europe.
Kazia Therapeutics Ltd. has out-licensed paxalisib as a potential treatment for intractable epilepsy in focal cortical dysplasia type 2 and tuberous sclerosis complex disease in a carve-out deal with Sovargen Co. Ltd. for $20.5 million plus sales royalties.
After many years of testing different monoclonal antibodies against amyloid-β protein, the results obtained are far from being outstanding, and the control of the progression and symptoms of Alzheimer’s disease (AD) remains elusive. At the recent AD/PD 2024 conference held in Lisbon, new non-anti-amyloidogenic strategies in the starting line against AD were discussed. Professor Einar Sigurdsson from New York University gave a presentation entitled, “Single domain antibodies for therapy and diagnosis of synucleinopathies and tauopathies.”