SLXP Gets FDA Nod, Catalyst Makes Right Moves, TKAI On Watch, AMAG Opens Wallet

(RTTNews) - Shares of Acasti Pharma Inc. (ACST) (APO.V) lost more than 20 percent of their value on Monday despite the company reporting successful top-line phase II trial data for its hypertriglyceridemia drug candidate - CaPre - as investors were not impressed with the results.

In the trial, dubbed TRIFECTA, CaPre successfully met the primary endpoint achieving a statistically significant mean placebo-adjusted decrease in triglycerides from baseline to week-12, with reductions of 36.4% for 1 gram and 38.6% for 2 grams.

The company continues to expect full TRIFECTA results by the end of calendar 2014.

ACST closed Monday's trading at $0.78, down 20.20%.

AMAG Pharmaceuticals Inc. (AMAG) rose more than 28% to close at a 4-year high of $29.72 on Monday after the company announced that it is acquiring privately held Lumara Health Inc. in a deal valued at about $1.025 billion.

The transaction brings Lumara's flagship product, Makena, which is approved for the prevention of preterm birth in pregnant women with a history of at least one spontaneous preterm birth, into AMAGG Pharma's fold.

In a separate asset purchase transaction, a subsidiary of Perrigo Company plc (PRGO) will acquire the assets of Lumara Health's Women's Healthcare business including Clindesse Vaginal Cream, 2%, Gynazole-1 and Evamist for $82 million.

The transactions are expected to be completed by the end of 2014.

Shares of Catalyst Pharmaceutical Partners Inc. (CPRX) were up more than 16% at $3.48 in extended trading on Monday after the company reported positive top-line phase III data from a pivotal Firdapse clinical trial in patients with Lambert-Eaton Myasthenic Syndrome.

The company expects to initiate rolling NDA submission for Firdapse in early-2015.

Firdapse is approved in the EU, and is the first and only approved drug for the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome in adults, a rare autoimmune disease with the primary symptoms of muscle weakness.

CymaBay Therapeutics Inc. (CBAY) has completed enrollment in its ongoing phase 2b clinical trial of Arhalofenate in patients with gout. The company expects to announce top-line results from the study in the second quarter of 2015.

The company's stock was up-listed to the NASDAQ Capital Market from the OTC Bulletin Board on June 18, 2014.

CBAY closed Monday's trading 1.05% higher at $6.76.

CytRx Corp.'s (CYTR) drug candidate Aldoxorubicin has received Orphan Drug Designations from the FDA for three indications - glioblastoma multiforme, small cell lung cancer and ovarian cancer. Aldoxorubicin is CytRx's modified version of the widely-used chemotherapeutic agent, doxorubicin.

The company looks forward to reporting top-line results from its phase II trial of Aldoxorubicin in glioblastoma multiforme and phase II trial of Aldoxorubicin in Kaposi's sarcoma in the first half of 2015.

CYTR closed Monday's trading at $2.73, down 1.80%.

Intuitive Surgical Inc. (ISRG) has received FDA clearance for its Single-Site Wristed Needle Driver for use in single-incision surgery, which is the latest addition to the Single-Site suite of instruments.

The company's Single-Site Wristed Needle Driver will be used with the da Vinci Si Surgical System for minimally invasive removal of the uterus (hysterectomy), the ovaries and fallopian tubes for benign conditions, as well as removal of the gallbladder.

ISRG closed Monday's trading at $464.72, up 0.96%.

Luminex Corp. (LMNX) has received FDA clearance to add three new targets to its xTAG Gastrointestinal Pathogen Panel namely, Adenovirus 40/41, Entamoeba histolytica and Vibrio cholerae.

The xTAG Gastrointestinal Pathogens Panel kit is a multiplex molecular assay allowing the identification of several gastrointestinal pathogens: virus, bacteria and parasites.

In addition, the diagnostic device has now been cleared by the regulatory agency for use with specimens in Cary-Blair medium, a common transport medium for collection and preservation of microbiological specimens.

LMNX closed Monday's trading at $19.42, up 0.94%.

Salix Pharmaceuticals Ltd. (SLXP) and Progenics Pharmaceuticals Inc. (PGNX) on Monday announced that the FDA has approved RELISTOR for the additional indication of opioid-induced constipation in patients taking opioids for chronic non-cancer pain.

RELISTOR is under license to Salix Pharma from Progenics under an agreement signed in 2011.

RELISTOR is already approved for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.

SLXP closed Monday's trading at $155.78, down 3.70%.

Tokai Pharmaceuticals Inc. (TKAI) said that the updated interim results from its ongoing phase II clinical trial of its experimental drug Galeterone in patients with castration-resistant prostate cancer has demonstrated clinically meaningful reductions in prostate-specific androgen levels, a marker of prostate cancer growth.

The data also provide additional support for Galeterone's potential activity in castration-resistant prostate cancer, or CRPC, patients whose tumors express androgen receptor (AR) splice variants, which are believed to be associated with resistance to hormonal agents commonly used to treat CRPC, noted the company.

The company expects to initiate its pivotal phase III trial, ARMOR3-SV, in CRPC patients with splice variants in the first half of next year.

Tokai Pharma went public on the NASDAQ Global Market as recently as September 17, 2014, offering its shares at a price of $15 each.

TKAI closed Monday's trading at $15.71, down 0.51%.

Tonix Pharmaceuticals Holding Corp. (TNXP) plunged more than 50% to $6.95 on Monday after the company announced that its phase IIb study of TNX-102 SL in patients with fibromyalgia failed to meet the primary efficacy endpoint.

The trial, dubbed BESTFIT, failed to achieve statistical significance in the primary efficacy endpoint of change in average daily pain score at week 12, according to the company.