Category - Developments

Developments

FibroGen flunks Phase 3 in non-ambulatory DMD

FibroGen’s (NASDAQ: FGEN) Phase 3 LELANTOS-1 placebo-controlled trial of pamrevlumab for the treatment of non-ambulatory patients with Duchenne muscular dystrophy (DMD) on background corticosteroids did not meet the...

June 8, 2023

Developments

Vistagen posts positive Phase 2A study in women with menopausal hot flashes

Vistagen (NASDAQ:VTGN) reported that PH80, one of the company’s five investigational neuroactive nasal sprays, demonstrated statistically significant efficacy versus placebo in an exploratory Phase 2A study for the...

June 7, 2023

Developments

Check-Cap reviewing strategic alternatives

Check-Cap (NASDAQ:CHEK) is exploring strategic alternatives, such as the sale of all or part of the company, licensing, merger or reverse merger, and has retained Ladenburg Thalmann as an advisor to the company. Check...

June 6, 2023

Developments

Synlogic initiates pivotal study for phenylketonuria

Synlogic (NASDAQ:SYBX) initiated Synpheny-3, a global, Phase 3 study evaluating the efficacy and safety of SYNB1934 as a potential treatment for phenylketonuria (PKU), a rare inherited disorder that causes an amino...

June 5, 2023

Developments

Jazz, Zymeworks present positive pivotal data in BTC

Jazz Pharmaceuticals (NASDAQ:JAZZ) and Zymeworks (NASDAQ:ZYME) presented positive pivotal trial data, including new data on progression-free survival (PFS), from the Phase 2b HERIZON-BTC-01 trial of the bispecific...

June 5, 2023

Developments

AMA unveils new CPT Category 1 codes for Profound Medical’s TULSA-PRO

Profound Medical (NASDAQ:PROF; TSX:PRN) announced that, with sponsorship and support from multiple physician specialty societies, it has received from the American Medical Association (AMA) three new Current Procedural...

June 2, 2023

Developments

Vistagen presents Phase 3 data for SAD

Vistagen (NASDAQ:VTGN) presented positive safety and exploratory efficacy data at the American Society for Clinical Psychopharmacology annual meeting in Miami from its large Phase 3 open-label study of fasedienol nasal...

June 1, 2023

Developments

Ionis posts late-stage clinical progress in HAE

Ionis Pharmaceuticals (NASDAQ:IONS) reported positive clinical progress with donidalorsen, its late-stage investigational prophylactic therapy for hereditary angioedema (HAE). Topline two-year open-label extension (OLE)...

June 1, 2023

Developments

Glyscend posts positive topline Phase 2a results for Type 2 diabetes and obesity

Closely-held Glyscend Therapeutics reported that Phase 1 and Phase 2a clinical trials demonstrated that the novel mechanism of its lead candidate, GLY-200, offers significant and clinically relevant reductions in...

May 31, 2023

Developments

IntelGenx unveils short-term commercial objectives

IntelGenx (TSX:IGX; OTCQB:IGXT) unveiled a plan focussed on near-term revenue generation. “There is no question in my mind that IntelGenx has great science, services, assets, and people,”Dwight Gorham, the company’s...

May 31, 2023

Category - Developments

FibroGen flunks Phase 3 in non-ambulatory DMD

Vistagen posts positive Phase 2A study in women with menopausal hot flashes

Check-Cap reviewing strategic alternatives

Synlogic initiates pivotal study for phenylketonuria

Jazz, Zymeworks present positive pivotal data in BTC

AMA unveils new CPT Category 1 codes for Profound Medical’s TULSA-PRO

Vistagen presents Phase 3 data for SAD

Ionis posts late-stage clinical progress in HAE

Glyscend posts positive topline Phase 2a results for Type 2 diabetes and obesity

IntelGenx unveils short-term commercial objectives

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