EYES Turns Vision Into Reality, QDEL Gets FDA Nod, Watch Out For ADHD

(RTTNews) - Alcobra Ltd.(ADHD) is scheduled to present results from its phase II clinical trial of MDX in adolescents and adults with Fragile X Syndrome on Wednesday, June 24, 2015 at 8:00am Eastern Time.

METADOXINE EXTENDED RELEASE, or MDX, is the company's proprietary drug, which is being tested to treat cognitive disorders including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome.

The company successfully completed a phase II safety and tolerability study of a single administration of MDX in adolescent patients with ADHD in March of this year - achieving the primary endpoint.

ADHD closed Tuesday's trading 2.82% higher at $8.39. In after hours, the stock was down 9.42% to $7.60.

Cara Therapeutics Inc. (CARA) has completed enrollment in its phase 2 proof-of-concept trial of its lead kappa opioid agonist, I.V. CR845, for the treatment of uremic pruritus, and expects to announce top-line data early next quarter.

The study enrolled 65 dialysis patients at multiple sites in the U.S. A previously completed phase I study of CR845 in 24 dialysis patients indicated that I.V. CR845 was safe and well-tolerated, and exhibited dose-linear pharmacokinetics across a five-fold dose range.

CARA closed Tuesday's trading at $11.32, up 0.09%.

GlycoMimetics Inc. (GLYC) is all set to receive a $20 million payment from Pfizer Inc. (PFE) following the initiation of a phase III trial assessing the efficacy and safety of Rivipansel for the treatment of vaso-occlusive crisis in patients hospitalized with sickle cell disease who are six years of age or older.

This is the second of two milestone payments from Pfizer to GlycoMimetics totaling $35 million for phase III initiation. GlycoMimetics received a $15 million milestone payment from Pfizer in May 2014.

Rivipansel has previously received both Orphan Drug and Fast Track status for the treatment of VOC from the FDA, and Orphan Product status in the European Union.

GLYC closed Tuesday's trading 12.12% higher at $8.79.

Quidel Corp. (QDEL) has received 510(k) clearance from the FDA to market a new instrumented molecular system - Solana - and for the Solana Group A Strep Assay for the rapid, qualitative detection of ß-hemolytic, Group A Streptococcus nucleic acids isolated from throat swab specimens from patients with signs and symptoms of pharyngitis, such as sore throat.

With the 510(k) clearance of Solana, Quidel now offers three molecular platforms namely AmpliVue, Lyra, and Solana that are designed to meet the unique needs of customers in different market settings.

Combined, the three molecular platforms provide for the enhanced diagnosis of fourteen different infectious diseases, including those caused by Influenza A, Influenza B, hMPV, RSV, Group A Strep, Groups C/G Strep, Group B Strep, C. difficile, Bordetella pertussis (whooping cough), adenovirus, parainfluenza virus, HSV 1, HSV2, and Trichomonas.

QDEL closed Tuesday's trading at $23.32, up 0.82%. In after-hours, the stock was up 5.02% at $24.49.

Second Sight Medical Products Inc.'s (EYES) multi-center clinical trial evaluating the long-term results of its Argus II Retinal Prosthesis System has demonstrated long-term reliability of the device, long-term benefit to the users, and an acceptable safety profile.

Argus II retinal prosthesis system, intended to restore some useful vision to patients who are blind and have lost most or all of their vision due to retinitis pigmentosa, is approved by the FDA, and is also marketed in Europe, Saudi Arabia, Spain and Canada.

Revenue from the sale of Argus II System was $1.7 million in the first quarter ended March 31, 2015, up from $0.7 million in the prior year period.

EYES closed Tuesday's trading 3.10% higher at $16.28.

Vanda Pharmaceuticals Inc.'s (VNDA) study dubbed REPRIEVE, evaluating the long-term maintenance effects of Fanapt, an antipsychotic for the treatment of schizophrenia, has demonstrated the ability of the drug to prevent relapse or impending relapse in adult patients with schizophrenia as compared to placebo.

According to the REPRIEVE study results, 79.6% of patients treated with Fanapt remained relapse free compared to 36.6% for placebo-treated patients.

Fanapt was approved by the FDA in May 2009 to treat adults with schizophrenia. The drug is also approved and marketed in Israel and Mexico. Vanda regained US and Canadian rights to Fanapt from Novartis last December. For the full year 2014, the U.S. net product sales of Fanapt were $65.0 million, as reported by Novartis.

Vanda intends to file a supplemental New Drug Application for Fanapt with the FDA in the second half of 2015 to include the results from the REPRIEVE study in the Fanapt package insert.

VNDA closed Tuesday's trading at $12.91, down 0.58%. In after-hours, the stock was up 4.61% at $13.50.

Zosano Pharma Corp. (ZSAN) has completed enrollment in its phase 2 clinical trial of ZP-Glucagon, a novel investigational patch treatment for severe hypoglycemia in diabetics.

The company anticipates announcing top-line data from the trial around September of this year.

ZSAN closed Tuesday's trading at $7.48, up 2.33%.