AFMD Soars On Genentech Deal, AKCA Slumps On Rejection, FDA Nod For TTPH

(RTTNews) - Today's Daily Dose brings you news about the Complete Response Letter issued for Akcea; FDA approval of Tetrphase Pharma's XERAVA; Affimed's collaboration agreement with Genentech and Esperion's positive results from its phase 3 bempedoic acid/ ezetimibe combination pill study.

Read on...

Shares of Affimed NV (AFMD) vaulted over 140% in extended trading on Monday after the Company announced a collaboration agreement with Genentech, a member of the Roche Group, to develop and commercialize novel NK cell engager-based immunotherapeutics to treat multiple cancers.

The collaboration entitles Affimed to receive $96 million upfront and committed funding and is eligible for up to an additional $5.0 billion over time, including milestone payments, and royalties on sales.

The agreement is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and closing is expected to occur in the third quarter of 2018.

AFMD closed Monday's trading at $1.60, down 1.54%. In after-hours, the stock was up 140.63% to $3.85.

Shares of Akcea Therapeutics Inc. (AKCA) were down more than 24% in extended trading on Monday, after the FDA rejected the Company's drug candidate WAYLIVRA for the treatment of familial chylomicronemia syndrome, a rare lipid disorder.

Waylivra is co-developed by Akcea and Ionis Pharmaceuticals Inc. (IONS).

In May of this year, an FDA panel had voted 12-8 to recommend the approval of Waylivra. Currently, there are no approved therapies for the treatment of familial chylomicronemia syndrome.

AKCA closed Monday's trading at $33.12, up 1.50%. In after-hours, the stock was down 24.49% to $25.01.

Aeglea BioTherapeutics Inc. (AGLE) is slated to present an enrollment status update and new interim Phase 1/2 clinical trial data of Pegzilarginase demonstrating clinically relevant treatment effects in patients with Arginase 1 Deficiency on September 5.

AGLE closed Monday's trading at $10.54, up 2.53%.

Esperion (ESPR) on Monday announced positive top-line results from its pivotal Phase 3 bempedoic acid / ezetimibe combination pill study, sending its shares up more than 4%.

In the 12-week study, Bempedoic Acid/Ezetimibe combo pill achieved an additional 35% LDL-C lowering in patients on maximally tolerated statins. It also provided an additional 34% reduction in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease.

Another pivotal study evaluating Bempedoic acid in 3,000 patients with ASCVD on maximally-tolerated statin therapy is ongoing, with top-line results expected in October 2018.

ESPR closed Monday's trading at $51.41, up 4.75%.

Shares of Tetraphase Pharmaceuticals Inc. (TTPH) rose nearly 7% in after-hours on Monday, following FDA approval of XERAVA (eravacycline) for the treatment of complicated intra-abdominal infections.

XERAVA is expected to be made available to patients in the United States in the fourth quarter of this year.

Complicated intra-abdominal infections are the second-most prevalent infection site in intensive care units (ICUs), as well as the second leading cause of infection-related mortality in ICUs," said Philip Barie, Professor of Surgery and Professor of Public Health in Medicine at Weill Cornell Medicine, and an attending surgeon at New York-Presbyterian/Weill Cornell Medical Center in New York City.

TTPH closed Monday's trading at $3.41, up 10.09%. In after-hours, the stock was up another 6.95% to $3.65.

The European Commission has approved Ultragenyx Pharmaceutical Inc.'s (RARE) Mepsevii for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome).

Mepsevii is now approved for use in all 28 EU countries and in Iceland, Liechtenstein and Norway. The drug was approved by the FDA for the treatment of pediatric and adult patients with MPS VII in November 2017.

RARE closed Monday's trading at $78.66, up 3.54%.

Wright Medical Group N.V. (WMGI) has offered to sell 18.25 million ordinary shares at an initial price to the public of $24.60 per share. The net proceeds to Wright from the offering are expected to be $423 million.

The offering is expected to close on or about August 30, 2018, subject to customary closing conditions.

The Company announced financial results for its second quarter ended July 1, 2018 on August 8.

Net sales totaled $205.4 million during the second quarter ended July 1, 2018 compared to $179.7 million in the year-earlier quarter. Net loss from continuing operations for the recent second quarter widened to $90.6 million or $0.85 per share from $20.96 million or $0.20 per share in the year-ago quarter.

Looking ahead to 2018, on a non-GAAP adjusted basis, the Company expects to incur a loss of $0.14 to $0.21 per share.

WMGI closed Monday's trading at $26.79, down 4.22%.