ACRX Nearing ‘Big Day’, No Respite For VSAR, ARDM To Face FDA

The following are some of the biotech stocks that made their way onto the Day’s Gainers & Losers’ list of September 25, 2017.

GAINERS

1. Aradigm Corp.(ARDM)

Gained 32.41% to close Monday’s (Sep.25) trading at $3.35.

News: The FDA has accepted for filing with Priority Review the Company’s New Drug Application for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis patients with chronic infections with Pseudomonas aeruginosa.

The FDA’s decision on the Linhaliq NDA is set for January 26, 2018.

2. AcelRx Pharmaceuticals Inc. (ACRX)

Gained 16.42% to close Monday’s trading at $3.90.

News: No news

Near-term catalyst:

— The FDA decision on the Company’s investigational product Dsuvia for the treatment of moderate-to-severe acute pain in a medically supervised setting is expected to be announced on October 12, 2017.

Dsuvia, formerly known as ARX-04, consists of 30 mcg sufentanil in very small sublingually absorbed tablets that are delivered via a disposable, pre-filled, single-dose applicator.

AcelRx estimates that the market potential of Dsuvia in the U.S. will be roughly $1.1 billion.

3. Celldex Therapeutics Inc. (CLDX)

Gained 12.78% to close Monday’s trading at $3.00.

News: No news

Upcoming event:

The Company will present a corporate overview at the Cantor Fitzgerald Global Healthcare Conference on September 26, 2017 at 11:30 a.m. EDT in New York.

Near-term catalysts:

— Enrollment in the Company’s phase IIb study of Glembatumumab vedotin in patients with metastatic triple negative breast cancers, dubbed METRIC, is expected to be completed by the end of September 2017.
— Top-line results from phase IIb study of Glembatumumab vedotin in patients with metastatic triple negative breast cancers, dubbed METRIC, likely in the second quarter of 2018.
— Data from Glembatumumab vedotin and Varlilumab combination arm in phase II study in checkpoint-refractory metastatic melanoma are expected in the fall of 2017.
— Enrollment in phase II portion of Varlilumab/Opdivo combination in cohorts of colorectal cancer, ovarian cancer, head and neck squamous cell carcinoma, renal cell carcinoma and glioblastoma are expected in the first quarter of 2018.
— Data from phase 1 study of CDX-0158 in patients with advanced refractory gastrointestinal stromal tumors (GIST) and other KIT-positive tumors are expected by year-end 2017.
— Initiation of a phase II study of CDX-3379 in patients with recurrent/metastatic head and neck squamous cell cancer who are refractory to Erbitux is…

Read the full article from the Source…

Leave a Reply

Your email address will not be published. Required fields are marked *