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FONR Upbeat, CCXI Awaits Data In June, DERM Abuzz, KMPH Gears Up For Act 2


Cerulean Pharma Inc. (CERU) has dosed the first patient in its phase 1/2 trial of its lead NDC candidate, CRLX101, in combination with AstraZeneca's (AZN) approved LYNPARZA in patients with advanced solid tumors.

The top-line data from this trial are anticipated in the first half of 2017.

CERU closed Tuesday's trading at $2.44, up 0.83%.

Celator Pharmaceuticals Inc. (CPXX) expects to submit a New Drug Application for VYXEOS in acute myeloid leukemia by the end of the third quarter of this year.

The company reported positive results from its phase III trial of VYXEOS, demonstrating a statistically significant improvement in overall survival, among other benefits, in patients with high-risk acute myeloid leukemia, last month.

CPXX closed Tuesday's trading at $13.11, down 3.03%.

In just a month, ChemoCentryx Inc. (CCXI) is expected to report top-line results from a phase II study of CCX168 in patients with ANCA-associated vasculitis in North America.

A phase Ib clinical trial with CCX872 plus FOLFIRINOX in patients with non-resectable pancreatic cancer is underway - with initial overall response data expected in mid-2016 and initial progression free survival data in the second half of 2016.

CCXI closed Tuesday's trading at $2.99, up 42.38%.

Dermira Inc. (DERM) is all set to report topline results from its phase III trials of DRM04 in hyperhidrosis, dubbed ATMOS-1 and ATMOS-2, in the second quarter of 2016. The two trials have collectively enrolled 697 patients with primary axillary hyperhidrosis.

Another major catalyst is coming up in the first quarter of 2017 when the company reports data from all three phase III trials evaluating CIMZIA in adult patients with moderate-to-severe chronic plaque psoriasis, dubbed CIMPASI-1, CIMPASI-2 and CIMPACT.

Additionally, the company reported positive topline results from its phase 2b dose-ranging study for DRM01 in patients with facial acne vulgaris. DRM01 demonstrated statistically significant improvements in all primary endpoints compared to vehicle at the highest dose and in most primary endpoints at the two lower doses. DRM01 was well-tolerated with adverse events primarily mild or moderate in severity.

DERM closed Tuesday's trading at $28.69, up 17.29%.

Shares of FONAR Corp. (FONR), the company that introduced the world's first Upright Multi-Positional MRI, surged over 15% on Tuesday as investors were happy with the company's third quarter fiscal 2016 results.

For the third quarter ended March 31, 2016, net Revenues increased 9% to $18.6 million and net income per common share available to common stockholders increased 45% to $0.45 per share compared to the same period a year earlier.

In October 2013, when we alerted our premium subscribers to FONR, the stock was trading around $7.40. In the years that followed, it went on to hit new highs, touching a maximum price of $27.95 on January 13, 2014.

FONR closed Tuesday's trading at $16.21, up 15.87%.

Galectin Therapeutics Inc. (GALT) now expects to report top-line data from its 30-patient phase II trial with GR-MD-02 in non-alcoholic steatohepatitis, or NASH, with advanced fibrosis by the end of September.

Another phase II study with GR-MD-02 in NASH with cirrhosis is also underway, and the company is on track to report top-line data in the end of 2017.

GALT closed Tuesday's trading at $1.38, up 9.52%.

KemPharm Inc.'s (KMPH) KP511, an investigational prodrug of hydromorphone, and an abuse-deterrent pain pill candidate, has been granted "Fast Track" designation by the FDA.

The company is all set to initiate human clinical trials of KP511 in the second quarter of 2016.

KemPharm plans to seek approval of KP511/ER under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act with an anticipated New Drug Application submission as early as 2018.

As you may know, the company's investigational abuse-deterrent pain product Apadaz won the panel vote for the proposed indication of the management of acute pain that requires an opioid early this month, but failed to win the backing for inclusion of abuse deterrent labeling for the product. The FDA's final decision on Apadaz is slated for June 9, 2016.

KMPH closed Tuesday's trading at $7.75, up 2.65%.

Synergy Pharmaceuticals Inc. (SGYP) now expects results from two of its pivotal phase 3 trials of Plecanatide in patients with irritable bowel syndrome with constipation, or IBS-C in short, in the third quarter of this year. The company intends to file an NDA for Plecanatide in IBS-C by the end of this year.

An NDA for Plecanatide in the indication of chronic idiopathic constipation, or CIC, is under review, with a decision date set for January 29, 2017.

SGYP closed Tuesday's trading at $2.91, down 2.35%.

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