PERTH, Australia – After hitting a few setbacks in recent months, regenerative medicine company Mesoblast Ltd. believes it finally has a path to market with its allogeneic mesenchymal precursor cell therapy, rexlemestrocel-L, in chronic low back pain.
Nearly five months after its tau-directed antibody, semorinemab, failed to demonstrate efficacy in a phase II trial in Alzheimer’s disease, AC Immune SA is back with positive data on a different approach with its anti-phospho-tau vaccine candidate, ACI-35.030.
Questions about the price tag, the extent of diligence done on intellectual property, and the staying power of Epidiolex (cannabidiol) as well as the potential of other prospects in the acquiree’s pipeline bubbled up during the conference call related to Jazz Pharmaceuticals plc’s whopping takeover of GW Pharmaceuticals plc.
When Cassava Sciences Inc.’s president and CEO, Remi Barbier, opened up the interim analysis of the company’s open-label study for Alzheimer’s disease candidate simufilam, he was more than pleased with the results but found himself an audience of one. His researchers had been confident about the results before the data were tallied. “I was ecstatic,” he told Bioworld. “No one’s seen this type of improvement in Alzheimer’s. But our scientists said, ‘See, I told you so.’ It was not my expectation.” The new data showed six months’ treatment with the oral, small molecule not just stabilized but improved cognition and behavior scores in AD patients.
Concert Pharmaceuticals Inc. is scratching further work on CTP-692 after the deuterated form of D-serine missed the primary endpoint in a phase II study in schizophrenia. The news sent shares of Concert (NASDAQ:CNCE) falling 28% Feb. 1 and shifts focus to the firm’s sole remaining clinical-stage program in the competitive alopecia areata space.
Triggering a wave of commentary over its import, Biogen Inc. on Jan. 29 said the FDA has extended to June 7 its review of a BLA for the experimental Alzheimer's disease therapy aducanumab after the company submitted additional analyses and clinical data, making for a major amendment to the application. The three-month delay, from an earlier assigned PDUFA date of March 7, followed a thumbs-down vote by agency advisors in November. It sparked both sunny optimism and a bit of pessimism about the program's prospects on Friday.
Tonix Pharmaceuticals Holding Corp.’s failure last December in the phase III study called Recovery with TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg dented hopes for patients with civilian and military-related post-traumatic stress disorder (PTSD), but other developers remain in the game.
Phase II data with San Diego-based Heron Therapeutics Inc.’s pain drug HTX-011 (Zynrelef) graced the online pages of the Journal of the American Podiatric Medical Association in early January, whetting investor thirst for an FDA decision regarding approval, slated by May 12. And the agency’s go-ahead, if it comes, could have special meaning for Pacira Biosciences Inc. with competing analgesic Exparel (bupivacaine).
LONDON – Remynd NV has extended its series B, raising a further €12 million and bringing the total for the round to €24 million (US$29 million). The new money will fund clinical proof-of-concept trials in the diverse indications of Alzheimer’s disease and diabetes.
Aging is not just wear and tear. It is an active process that is driven, at least in part, by chronic inflammation that is the result of immune cell dysfunction. Now, investigators at Stanford University have identified the metabolic switch underlying immune cell switch from function to dysfunction.
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