- Spark Newswire

1 minute read

KalVista Shares Climb As Late-Stage Label Extension Study On Skin Disorder Candidate Kicks-off

Today, 4:32 PM

KalVista Pharmaceuticals (NASDAQ: KALV) has initiated the KONFIDENT-S open label extension (OLE) study for its ongoing Phase 3 study of sebetralstat for the on-demand treatment of hereditary angioedema (HAE) attacks.

KALV

1 minute read

Merck Gets FDA Fast Track Status For Chronic Kidney Disease Candidate

By Ragothaman Srinivasan

Today, 4:32 PM

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck's (NYSE: MRK) lead asset MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).

MRK

3 minute read

Recap Of Monday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 4:32 PM

The U.S. Food and Drug Administration (FDA) has announced clearance to Insulet’s (NASDAQ:PODD) Omnipod 5 Automated Insulin Delivery…

BLTE

1 minute read

Geron Commences Initial-Stage Rare Blood Cancer Combination Study

By Ragothaman Srinivasan

Today, 4:32 PM

Geron Corporation (NASDAQ: GERN) has dosed first patient in IMproveMF study evaluating imetelstat in combination with ruxolitinib for patients with frontline myelofibrosis (MF).

GERN

1 minute read

Kronos Bio Shares Fall After Initial-Stage Blood Cancer Study Takes-off

By Ragothaman Srinivasan

Today, 4:32 PM

Kronos Bio (NASDAQ: KRON) has initiated patient dosing in a Phase 1b/2 clinical trial of lanraplenib in combination with gilteritinib in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML).

KRON

1 minute read

Cue Biopharma Shares Decline Following Initial-Stage Metastatic Cancer Study Kicks-off

By Ragothaman Srinivasan

Today, 4:32 PM

Cue Biopharma (NASDAQ: CUE) has dosed the first patient in a Phase 1 dose escalation study evaluating CUE-102 for the treatment of patients with Wilms' Tumor 1 (WT1)-positive recurrent/metastatic cancers.

CUE

1 minute read

Minerva Seeks FDA Approval For Schizophrenia Candidate

By Ragothaman Srinivasan

Today, 4:32 PM

Minerva Neurosciences (NASDAQ: NERV) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roluperidone in the treatment of negative symptoms for patients with schizophrenia.

NERV

1 minute read

Belite Bio Shares Gain On Initiation Of Late-Stage Retinal Disease Study

By Ragothaman Srinivasan

Today, 4:32 PM

Belite Bio (NASDAQ: BLTE) has initiated enrollment for the U.S. Phase 3 clinical trial of its lead asset LBS-008 in patients with Stargardt Disease (STGD1), a progressively blinding disease with no approved treatment.

BLTE

1 minute read

FDA Clears Insulet’s Omnipod 5 Automated Insulin Delivery System For Preschool Children

By Ragothaman Srinivasan

Today, 4:32 PM

The U.S. Food and Drug Administration (FDA) has announced clearance to Insulet’s (NASDAQ: PODD) Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged two years and older with type 1 diabetes (T1D).

PODD

2 minute read

Recap Of Friday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

Today, 4:32 PM

The U.S. Food and Drug Administration (FDA) has approved Axsome Therapeutics’ (NASDAQ:AXSM) lead asset AUVELITY (dextromethorphan HBr -bupropion HCl)…

AXSM