Company

Product

Description

Indication

Status

Aldeyra Therapeutics Inc., of Lexington, Mass.

ADX-2191 (methotrexate)

DHFR inhibitor

Retinopathy

FDA granted fast track status for the prevention of proliferative vitreoretinopathy

Bavarian Nordic A/S, of Copenhagen, Denmark

Jynneos (MVA-BN, liquid frozen)

Smallpox and monkeypox vaccine, live, nonreplicating

Prevention of smallpox or monkeypox infection

Approved by FDA for use in adults 18 and older determined to be at high risk of infection

Bristol-Myers Squibb Co., of Princeton, N.J.

Opdivo (nivolumab)

PD-1 inhibitor

Melanoma

EMA's Committee for Medicinal Products for Human Use recommended approval of flat dosing schedule for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection

Capricor Therapeutics Inc., of Los Angeles

CAP-1002

Cardiosphere-derived allogenic stem cell therapy

Duchenne muscular dystrophy

Granted a type B end-of-phase II meeting with the FDA to discuss prespecified interim analysis of Hope 2 trial; exploring potential for accelerated approval under regenerative medicine advanced therapy designation

Cumberland Pharmaceuticals Inc., of Nashville, Tenn.

Ifetroban

Thromboxane-prostanoid receptor antagonist

Cardiomyopathy associated with Duchenne muscular dystrophy

FDA cleared application to study ifetroban in patients, 7 and older

Linnaeus Therapeutics Inc., of Haddonfield, N.J.

LNS-8802

Small-molecule agonist of G protein-coupled estrogen receptor

Solid and hematologic cancers

FDA cleared IND for a phase I/II trial in patients with advanced cancers

MC2 Therapeutics A/S, of Copenhagen, Denmark

Wynzora cream

Calcipotriene 0.005% and betamethasone dipropionate 0.064%

Plaque psoriasis

Submitted NDA to FDA

Springworks Therapeutics Inc., of Stamford, Conn.

Nirogacestat

Oral, small-molecule gamma-secretase inhibitor

Soft tissue sarcoma

European Commission granted orphan designation

Tarsius Pharma Ltd., of Tel Aviv, Israel

TRS-01

Phosphorylcholine-tuftsin

Ocular inflammation

FDA accepted IND for a phase I/II trial in patients following cataract surgery

Theraly Fibrosis Inc., of Germantown, Md.

TLY-012

Recombinant human TRAIL protein

Chronic pancreatitis

FDA granted orphan designation

Notes

For more information about individual companies and/or products, see Cortellis.

 

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