The U.S. Food and Drug Administration (FDA) has given Xellsmart Biopharmaceutical the go-ahead to start a Phase 1 clinical trial testing its stem cell-based therapy XS-228 in people with amyotrophic lateral sclerosis (ALS). This milestone, reflecting the approval of Xellsmart’s investigational new drug (IND) application, follows promising results…
The first patient has been dosed in a Phase 1 clinical study testing AMX0114, an experimental therapy being developed by Almylyx Pharmaceuticals for amyotrophic lateral sclerosis (ALS). The treatment targets calpain-2, a protein believed to contribute to nerve cell damage in ALS. Called LUMINA (NCT06665165), the study was cleared…
The first patient has been enrolled in an expanded access program (EAP) trial evaluating MN-166 (ibudilast), Medicinova’s oral anti-inflammatory drug, in people with amyotrophic lateral sclerosis (ALS). EAPs, also known as compassionate use programs, allow patients with serious or life-threatening conditions to access investigational therapies outside of clinical…
Denali Therapeutics‘ oral candidate DNL343 has failed to reduce levels of an established biomarker of nerve cell damage in adults with amyotrophic lateral sclerosis (ALS). That’s according to new data from the DNL343 arm of the HEALEY ALS platform trial (NCT04297683), where patients who received the experimental…
Pathmaker Neurosystems has received three new patents — two in the U.S. and one in Japan — that cover the use of its noninvasive neuromodulation technology in people with amyotrophic lateral sclerosis (ALS). The patents, which specifically cover the systems and methods used for treating ALS and related diseases,…
Tiziana Life Sciences is seeking regulatory clearance in the U.S. to launch a Phase 2 clinical trial evaluating foralumab nasal spray, its lead therapeutic candidate, as a treatment for amyotrophic lateral sclerosis (ALS). The filing of the company’s investigational new drug application with the U.S. Food and Drug…
Woolsey Pharmaceuticals has extended its Series B preferred financing round, securing additional funds to continue advancing its ROCK inhibitor Bravyl (oral fasudil) for amyotrophic lateral sclerosis (ALS). The extension was completed with participation from existing investors. Series B financing is an early round of funding that usually takes…
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