AGN's Superbug Antibiotic Gets FDA Nod, AFMD Soars, Boxed Warning For Ocaliva

(RTTNews) - Today's Daily Dose brings you news about Affimed's data from two early-stage trials of AFM13 in Hodgkin and CD30-Positive Lymphomas; Alnylam's upcoming regulatory catalyst; FDA approval for Allergan's expanded label for superbug antibiotic AVYCAZ; Boxed Warning for Intercept's PBC drug Ocaliva, and MediciNova's encouraging data from mid-stage trial of MN-166 in progressive multiple sclerosis.

Read on…

Aethlon Medical Inc. (AEMD), a therapeutic technology company, has announced results for its fiscal third quarter ended December 31, 2017.

The net loss was approximately $1.22 million or $0.08 per share for the December 2017 quarter on revenues of $74,813. This compared with a net loss of about $1.21 million or $0.15 per share and nil revenue in the December 2016 quarter.

The Company, which had a cash balance of roughly $5.6 million at year-end 2017, raised approximately $1.4 million over the month of January 2018 through a combination of cash from warrant exercises and sales under the Company's At-The-Market financing agreement.

AEMD closed Thursday's trading at $1.49, down 0.67%. In after-hours, the stock was up 4.03% at $1.55.

Shares of Affimed N.V. (AFMD) rose as much as 46% on Thursday, following encouraging data from two early-stage trials of AFM13 in Hodgkin and CD30-Positive Lymphomas.

In a phase 1b study of the combination of AFM13 with anti-PD-1 antibody Keytruda in relapsed/refractory Hodgkin lymphoma, the objective response rate (ORR) was 89%. This compares favorably to the historical ORR of Keytruda's 58-63% as monotherapy in a similar patient population.

The Complete Response (CR) Rate was 44% for the combination, and it represents a doubled CR rate compared to previously reported anti-PD1 studies (9-22%).

In a phase 1b/2a trial of AFM13 as monotherapy in relapsed/refractory CD30-positive cutaneous lymphoma, the data demonstrated that AFM13 could be safely administered and showed therapeutic activity as a single agent, with an ORR of 66%.

AFMD closed Thursday's trading at $1.85, up 39.62%.

Alnylam Pharmaceuticals Inc.'s (ALNY) New Drug Application for Patisiran for the treatment of hereditary ATTR (hATTR) amyloidosis has been accepted for priority review by the FDA, with a decision date set for August 11, 2018.

The FDA is not planning to hold an advisory committee meeting to discuss the Patisiran NDA.

Hereditary transthyretin (TTR)-mediated (hATTR) amyloidosis is an inherited, progressively debilitating, and often fatal disease caused by mutations in the TTR gene.

ALNY closed Thursday's trading at $129.43, down 0.42%.

The FDA has approved Allergan plc's (AGN) superbug antibiotic AVYCAZ for yet another indication - this time, for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by certain types of Gram-negative bacteria, in patients 18 years of age or older.

This is the third therapeutic indication for AVYCAZ.

AVYCAZ received its first FDA approval in February 2015 for the treatment of adult patients with complicated intra-abdominal infections (cIAI), in combination with metronidazole. The second indication of the drug to treat patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Gram-negative microorganisms received the FDA blessing in January 2017.

AVYCAZ net revenues in the third quarter of 2017 were $16.9 million compared to $4.8 million in the third quarter of 2016.

AGN closed Thursday's trading at $178.54, down 0.95%.

In order to highlight correct dosing, the FDA has added a Boxed Warning to the label for Intercept Pharmaceuticals Inc.'s (ICPT) Ocaliva, a treatment for primary biliary cholangitis.

Ocaliva was granted accelerated approval by the FDA in May 2016, and was commercially launched in the United States in June 2016.

There have been reports of liver injury, liver decompensation, liver failure, and death in primary biliary cholangitis patients with advanced cirrhosis when Ocaliva was dosed more frequently than the recommended starting dosage.

Intercept is also working with the European Medicines Agency (EMA) to update the Ocaliva European Summary of Product Characteristics (SmPC) to reinforce appropriate dosing in patients with advanced cirrhosis.

Worldwide net Ocaliva sales in Q3, 2017 were $40.9 million compared to $4.73 million in the year-ago quarter.

ICPT closed Thursday's trading at $62.02, down 0.13%. In after-hours, the stock was up 2.14% to $63.35.

Shares of MediciNova Inc. (MNOV) were up more than 8% on Thursday, following additional positive clinical data from its phase 2b trial of MN-166, also known as Ibudilast, in progressive multiple sclerosis.

In the trial, dubbed SPRINT-MS, MN-166 demonstrated a 26% reduction in the risk of confirmed disability progression compared to placebo, reveals the additional data. The study involved subjects with primary progressive or secondary progressive multiple sclerosis.

The top-line results from SPRINT-MS were reported last October. According to the top-line results, the trial achieved both primary endpoints including a significant reduction in whole brain atrophy and safety and tolerability.

Confirmed disability progression was a secondary endpoint in the phase 2b trial but would be considered a primary endpoint in phase III, noted the Company.

Roche's Ocrevus is the first and only FDA-approved drug for primary progressive multiple sclerosis. The U.S. Centers for Disease Control and Prevention estimates that approximately 15 percent of patients with multiple sclerosis have primary progressive multiple sclerosis.

Commenting on the results, Yuichi Iwaki, President and CEO of MediciNova, said, "We are extremely pleased with these results. Ibudilast's magnitude of reduction in disability progression was better than the data reported for the only drug approved for progressive MS and also better than the data reported for the other drugs being developed for progressive MS".

MNOV closed Thursday's trading at $9.62, up 8.82%. In after-hours, the stock was up another 3.95% to $10.00.