Shareholder Ups Stake In AFMD, Sweet Tidings From DXCM, PFE Snubbed, LLY Beams

(RTTNews) - An existing shareholder in Affimed N.V. (AFMD) has increased his position in the company by purchasing 3.3 million shares last week, which translates to an investment of $21.8 million (€19.2 million).

The company had cash of €66.3 million on June 30, 2015.

The company's lead candidate, AFM13, is under a phase 2a clinical trial in Hodgkin lymphoma - with interim data expected in the first half of 2016 and full data on schedule to be completed in 2016.

Another clinical candidate of the company is AFM11, currently under a phase 1 clinical trial in patients with nonHodgkin lymphoma (NHL) and acute lymphocytic leukemia (ALL). Data from this trial are expected in the second half of 2016.

AFMD closed Wednesday's trading at $6.14, up 0.82%. In after hours, the stock was up 5.86% at $6.50.

Avinger Inc. (AVGR) has received FDA clearance for its Pantheris image-guided atherectomy system for the treatment of patients with peripheral arterial disease.

Pantheris combines directional atherectomy with real-time, intravascular visualization and is designed to empower physicians to precisely remove plaque from blocked arteries, while avoiding disruption of normal arterial wall structures, according to the company.

Avinger went public on January 30, 2015, offering its shares at a price of $13 each. The stock closed Wednesday's trading at $15.48, down 2.58%.

Shares of CASI Pharmaceuticals Inc. (CASI) surged over 40% on Wednesday, following the receipt of Orphan Drug designation from the European Medicines Agency for the company's oncology drug candidate, ENMD-2076, for the treatment of hepatocellular carcinoma, including fibrolamellar carcinoma, a rare type of HCC.

ENMD-2076 is currently in phase II clinical trials in multiple indications, including triple-negative breast cancer, soft tissue sarcoma, ovarian clear cell carcinomas and fibrolamellar carcinoma. The drug candidate has also received orphan drug designation from the FDA for the treatment of ovarian cancer, multiple myeloma, acute myeloid leukemia, and hepatocellular carcinoma.

CASI closed Wednesday's trading at $1.43, up 40.20%.

Shares of DexCom Inc. (DXCM) were up more than 13% in extended trading on Wednesday, following the company's rosy revenue outlook for the third quarter 2015.

For the third quarter ended September 30, 2015, the company expects revenue of approximately $105 million well above Wall Street analysts' estimate of $97.47 million. The company reported revenue of $69.0 million in Q3-2014 and $93.2 million in Q2-2015.

The company is scheduled to report Q-3 results on November 4, 2015.

DXCM closed Wednesday's trading at $70.65, down 6.35. In after hours, the stock was up 13.94% at $80.50.

Digirad Corp. (DRAD) has entered into a definitive agreement to acquire DMS Health Technologies Inc. for $36 million in cash from Los Angeles-based Platinum Equity.

DMS Health provides mobile diagnostic imaging and related sales and services to small and regional hospitals throughout the country, with a large concentration in the upper Midwest region.

The transaction, which is expected to increase Digirad's pro forma revenue and adjusted EBITDA to over $125 million and $17 million annually, is scheduled to close before the end of the year and is subject to the satisfaction of customary closing conditions.

DRAD closed Wednesday's trading at $4.81, up 18.77%.

The fourth phase III study of Baricitinib, an investigational medicine for patients with moderately-to-severely active rheumatoid arthritis, licensed by Eli Lilly and Co. (LLY) from Incyte Corp. (INCY), has also met its primary objective of demonstrating superiority compared to placebo after 12 weeks of treatment.

The study, dubbed RA-BEAM, has also demonstrated that Baricitinib was superior to AbbVie's (ABBV) HUMIRA in improving signs and symptoms of rheumatoid arthritis after 12 weeks of treatment.

The results from the first phase III trial of Baricitinib, known as RA-BEACON, were announced in December 2014, the second phase III trial data (RA-BUILD) in February 2015, and the third phase III data (RA-BEGIN) were reported in September 2015.

LLY closed Wednesday's trading at $79.25, down 0.46%.

IGI Laboratories Inc. (IG), which is trading on the NYSE MKT, is all set to commence trading on the NASDAQ Global Select Market when the market opens on October 26, 2015.

The move to NASDAQ will improve the visibility of the stock, enhance trading liquidity in shares, and provide greater exposure to a broader base of institutional investors, said the company.

IG closed Wednesday's trading at $7.84, up 0.26%.

Ocular Therapeutix Inc. (OCUL) has begun enrollment in its third phase 3 clinical trial for DEXTENZATM (sustained release dexamethasone) 0.4mg Intracanalicular Depot, for the treatment of post-surgical ocular inflammation and pain.

Based on the results of the two previously completed phase 3 clinical trials and following a Pre-NDA Clinical meeting with the FDA in April 2015, a New Drug Application for DEXTENZAT for the treatment of ocular pain following ophthalmic surgery was submitted to the FDA on September 28, 2015.

The top-line efficacy results from the third phase III trial are expected in late 2016. Ocular intends to submit a supplement to the NDA for the treatment of post-surgical inflammation as part of its label expansion strategy for DEXTENZA if favorable results are obtained from the third trial and subject to receiving approval of the pain indication pursuant to the initial NDA.

OCUL closed Wednesday's trading at $15.30, up 0.39%.

Pfizer Inc.'s (PFE) supplemental New Drug Application seeking approval of Xeljanz 5mg and 10mg tablets in the indication of moderate-to-severe plaque psoriasis in adults has been turned down by the FDA.

Xeljanz is already approved in the U.S. to treat adults with moderately to severely active rheumatoid arthritis who do not respond well to methotrexate.

Approved in 37 countries around the world for rheumatoid arthritis, Xeljanz had global sales of $308 million in 2014 compared to $114 million in 2013.

PFE closed Wednesday's trading at $33.04, up 0.18%.

Sarepta Therapeutics Inc.'s (SRPT) New Drug Application for Eteplirsen for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping is all set to be reviewed by an FDA panel on January 22, 2016 before the regulatory agency makes its final decision.

The FDA decision on Eteplirsen is scheduled for February 26, 2016.

Duchenne Muscular Dystrophy, or DMD, is one of the most common fatal genetic disorders, caused by a mutation in a gene that encodes for a structural protein in muscle called dystrophin. It is estimated that DMD affects approximately one in every 3,500 boys born worldwide, with 13% of people with the disease having mutations addressable by eteplirsen/exon 51 skipping.

Sarept's Eteplirsen is designed to work by skipping exon 51 in the dystrophin gene to correct for specific genetic mutations and restore the gene's ability to make a functional, though shorter, form of the dystrophin protein.

SRPT closed Wednesday's trading at $29.06, down 11.78%.