Atara Biotherapeutics Inc.’s eagerly awaited update on the phase II Embold study testing ATA-188 in progressive multiple sclerosis (MS) left investors scratching their heads, and shares (NASDAQ:ATRA) closed at $3.89, down $4.77, or 55%.
The U.S. FDA has put five phase III studies of Sanofi SA’s potential multiple sclerosis and myasthenia gravis blockbuster tolebrutinib on partial clinical hold after several cases of liver injury were identified after exposure to the drug. Sanofi said new recruitment in the U.S. is paused and participants who have been part of the trial for fewer than 60 days should stop taking tolebrutinib, although those taking the drug for longer can continue.
Novartis AG is not going quietly into the night after the U.S. Court of Appeals for the Federal Circuit reversed itself, invalidating a method patent covering a dosing regimen for the company’s blockbuster multiple sclerosis drug, Gilenya (fingolimod). After the split opinion came down June 21 from the three-judge panel, Novartis said it planned to file a petition seeking further review of the decision by the full court.
Ekso Bionics Holdings Inc. added a new indication for its robotic Eksonr exoskeleton with a U.S. FDA 510(k) clearance for use of the mobility device in patients with multiple sclerosis (MS). The green light for MS follows clearances for stroke and spinal cord rehabilitation in 2016 and acquired brain injury (ABI) in 2020.
Poor phase II top-line data for Immunic Inc.’s lead candidate, vidofludimus calcium (IMU-838) hammered the stock June 2 as the study of the selective oral DHODH inhibitor missed its primary endpoint of clinical remission in treating moderate to severe ulcerative colitis. The failure means Immunic won’t pursue a phase III study on its own in the indication, but it won’t affect the company’s planned phase III studies of IMU-838 in treating relapsing multiple sclerosis (MS) and a phase II in treating progressive MS.
As the six-month interim analysis of phase II data for ATA-199 in progressive forms of multiple sclerosis (MS) nears, investors in Atara Biotherapeutics Inc. – not to mention patients – are growing more intrigued by the prospect, an off-the-shelf T-cell candidate that targets Epstein Barr virus-infected B cells and plasma cells in the central nervous system.
Screening a panel of potential autoantigens, investigators at the Karolinska Institute have identified four autoantigens that are targeted by the T cells of multiple sclerosis patients.
Quanterix Corp.’s Simoa technology helped drive a large, international study to establish reference ranges of serum neurofilament light chain (sNfL) to assess individual disease activity and drug response in multiple sclerosis (MS) patients. The study, published in The Lancet Neurology, utilized Simoa’s ability to precisely detect sNfL protein at ultra-low levels, enabling it to be reliably measured across a broad range of healthy individuals.
Neuron23 Inc. came out of stealth mode in late 2020 with a $113.5 million combined series A and B round to support its AI-enabled drug discovery effort aimed at bringing a precision medicine approach to neuroimmunology. Now it has added another $100 million in a series C financing as it gears up to move into clinical testing with lead programs targeting LRRK2 and TYK2.
Tiziana Life Sciences Inc.’s intranasal, fully human anti-CD3 monoclonal antibody will need testing in 10 or 20 more patients to confirm the signal in secondary progressive multiple sclerosis (SPMS), but key opinion leaders on a conference call March 14 sounded optimistic as they checked out the prospect’s early efficacy.
