Category - Developments

Developments

Medicus submits study design to FDA for Teverelix in AURr

Medicus Pharma (NASDAQ: MDCX) has submitted an optimized Phase 2 clinical study design to the FDA for Teverelix, its investigational GnRH antagonist, for the prevention of recurrent acute urinary retention (AURr) in men...

April 6, 2026

Developments

FDA clears Stereotaxis’ Synchrony system

Stereotaxis (NYSE: STXS) has received FDA 510(k) clearance for its Synchrony system, designed to digitize and modernize the interventional cath lab. According to Stereotaxis, Synchrony is made available with SynX, a...

April 6, 2026

Developments

PureTech’s Seaport reports positive data from trial of GlyphAgo in GAD

PureTech Health (NASDAQ: PRTC; LSE: PRTC) has announced that its founded entity, closely held Seaport Therapeutics, has reported positive proof of concept topline data from portions of its ongoing Phase 1 proof-of...

April 2, 2026

Developments

Adagene and Incyte collaborate to evaluate combination therapy in MSS CRC patients

Adagene (NASDAQ: ADAG) and Incyte (NASDAQ: INCY) have announced a clinical collaboration to evaluate the combination of muzastotug (ADG126) and INCA33890, a TGFβR2 × PD-1 bispecific antibody, in patients with...

April 2, 2026

Developments

EBMT journal publishes findings from MaaT’s CHRONOS study in 3L aGvHD

MaaT Pharma (EURONEXT: MAAT) announced the publication of CHRONOS, a large, multicenter, retrospective cohort study evaluating real-world outcomes of third-line (3L) systemic therapies, excluding microbiotherapy, in 59...

April 1, 2026

Developments

Cereno reports positive data from CS1 treatment in PAH

Cereno Scientific (NASDAQ First North: CRNO B) has announced initial learnings from its 12-month expanded access program with lead candidate, oral, once-daily CS1, in pulmonary arterial hypertension (PAH), confirming...

March 31, 2026

Developments

BioVersys enters agreement with HMH to develop ansamycin

BioVersys (SIX: BIOV) has entered into an exclusive ansamycin drug discovery collaboration and license agreement with Hackensack Meridian Health (HMH), a U.S.-based private nonprofit health system, to jointly profile...

March 31, 2026

Developments

Idorsia highlights positive results from study of DORA in pediatric patients with insomnia

Idorsia (SIX: IDIA) has announced positive top-line results from its Phase 2 dose-finding study evaluating 10, 25, and 50 mg doses of daridorexant—the company’s dual orexin receptor antagonist (DORA)—in pediatric...

March 30, 2026

Developments

FDA grants accelerated approval of Rocket’s KRESLADI for pediatric LAD-I

Rocket Pharmaceuticals (NASDAQ: RCKT) has announced FDA approval of KRESLADI, an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of pediatric patients with severe leukocyte adhesion...

March 27, 2026

Developments

FDA clears Lantern/Starlight’s IND for trial of STAR-001 in pediatric cancer

Lantern Pharma (NASDAQ: LTRN) and its subsidiary, closely held Starlight Therapeutics, have announced FDA clearance of the investigational new drug (IND) application for STAR-001, in a planned Phase 1 pediatric clinical...

March 27, 2026

Category - Developments

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