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

(RTTNews) - 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 planned for the fourth quarter of 2017.

4. Marinus Pharmaceuticals Inc. (MRNS)

Gained 12.70% to close Monday's trading at $5.50.

News: No news

Upcoming event:

The Company's CFO, Edward F. Smith, will make a presentation at the Cantor Fitzgerald Global Healthcare Conference on Wednesday, September 27, 2017 at 9:45 a.m. EDT.

Near-term catalysts:

-- Initiate a phase II study of Ganaxolone capsules in women with moderate Postpartum Depression, dubbed Amaryllis, later this year. -- Initiate a phase II study of Ganaxolone in patients with status epilepticus later this year.

5. Dicerna Pharmaceuticals Inc. (DRNA)

Gained 10.26% to close Monday's trading at $5.05.

News: No news

Near-term catalysts:

-- The Company plans to file a clinical trial application (CTA) in Europe for DCR-PHXC for primary hyperoxaluria in late 2017 and commence human clinical trials in the first quarter of 2018. -- File an IND application in the U.S. and/or CTA in Europe for a second candidate for an undisclosed rare disease involving the liver in the second quarter of 2018. -- File an IND application in the U.S. or CTA in Europe for DCR-HBVS program, which targets HBV directly, at approximately the end of 2018.

6. Immunomedics Inc. (IMMU)

Gained 9.85% to close Monday's trading at $12.60.

News: No news

Near-term catalysts:

-- Enroll first patient into phase III confirmatory trial of IMMU-132 in metastatic triple-negative breast cancer in Q4, 2017. -- Submit / present full set of phase II data of IMMU-132 in mTNBC in late 2017/early 2018. -- Submit BLA for accelerated approval of IMMU-132 in mTNBC to FDA in late2017/early 2018.

7. Regenxbio Inc. (RGNX)

Gained 9.56% to close Monday's trading at $30.95.

News: No news

Near-term catalyst:

-- Interim trial update from phase I study evaluating RGX-314 for patients with wet age-related macular degeneration is expected by year-end 2017.

LOSERS

1. Akari Therapeutics Plc (AKTX)

Lost 11.37% to close Monday's trading at $7.25.

News: No news

Near-term catalyst:

-- The Company plans to advance its lead investigational drug, Coversin, towards Phase III clinical studies in Paroxysmal Nocturnal Hemoglobinuria in Q1 2018.

2. Versartis Inc. (VSAR)

Lost 9.34% to close Monday's trading at $2.42.

News: No news

Recent event:

Last Thursday (Sep.21, 2017) after the bell, the Company announced that its phase III study of Somavaratan in pre-pubertal children with Growth Hormone Deficiency, dubbed VELOCITY, did not meet the trial goals. The news sent the stock tumbling nearly 88% on Sep.22, 2017.

3. Dova Pharmaceuticals Inc. (DOVA)

Lost 8.52% to close Monday's trading at $22.45.

News: No news

Pipeline:

The Company's lead product candidate is Avatrombopag for the treatment for thrombocytopenia in patients with chronic liver disease (CLD). The compound was tested in two pivotal clinical trials, ADAPT 1 and ADAPT 2, in which all primary and secondary endpoints were met with high statistical significance.

Recent event:

On September 22, 2017, the Company announced the submission of NDA for Avatrombopag for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.

4. Altimmune Inc. (ALT)

Lost 7.29% to close Monday's trading at $2.29.

News: No news

Recent event:

On September 20, 2017, the Company announced that it has received FDA clearance to initiate a phase II study of NasoVAX, an intranasally administered recombinant flu vaccine. The study is expected enroll 60 healthy adults, between the ages of 18 and 49. Data from this trial are expected in the first quarter of 2018.