It's Raining FDA Approvals, MSON Muscling Up, RDHL To Report Data In Aug.

(RTTNews) - Today's Daily Dose brings you news about FDA approval of Astellas Pharma's Myrbetriq/VESIcare combo for overactive bladder; MediciNova's progress in MN-166 in alcohol dependence and withdrawal; regulatory nod for expanded use of DARZALEX; Ultragenyx Pharma's near-term catalysts; solid financial results of Misonix and Xencor's upcoming clinical trial plans.

Read on…

The FDA has approved Astellas Pharma Inc.'s (ALPMY.OB) supplemental New Drug Application for the use of Myrbetriq in combination with VESIcare for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.

Myrbetriq and VESIcare are each approved as a monotherapy for overactive bladder.

Carol Schermer, senior medical director, urology, Astellas said, "OAB patients may have symptoms that are not fully managed with their current treatment. With the FDA approval of Myrbetriq in combination with VESIcare, Astellas is able to offer an additional treatment option to individuals living with symptoms of OAB."

ALPMY.OB closed Monday's trading at $14.86, up 1.92%.

InspireMD Inc. (NSPR) has reported solid revenue growth for the first quarter ending March 31, 2018, thanks to 132% increase in CGuard EPS sales.

Net loss for the recent first quarter narrowed to $2.4 million or $1.08 per share from $2.56 million or $28.31 per share in the same period in 2017. Revenue for the first quarter ended March 31, 2018 was $1 million, up from $0.56 million during the same period in 2017.

NSPR closed Monday's trading at $1.27, up 2.42%. In after-hours, the stock was up 8.66% to $1.38.

The FDA has approved the supplemental Biologics License Application for the use of DARZALEX in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

DARZALEX is being developed by Johnson & Johnson (JNJ) subsidiary Janssen Biotech under an exclusive worldwide license from Genmab.

The drug is already approved in the United States in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy.

DARZALEX is also approved in Europe and Japan.

The global sales of DARZALEX in 2017 were $1.24 billion compared to $572 million in 2016.

JNJ closed Monday's trading at $123.59, down 0.48%.

MacroGenics Inc. (MGNX) has a couple of events to watch out for in the coming months.

Enrollment in the company's pivotal phase III study evaluating the efficacy of Margetuximab plus chemotherapy compared to Trastuzumab plus chemotherapy in relapsed/refractory HER2-positive metastatic breast cancer patients, dubbed SOPHIA, is expected to be completed in the fourth quarter of 2018, with top line progression-free survival data to be reported in the first half of 2019.

Updated data from a phase II study of Margetuximab plus an anti-PD-1 agent in patients with gastric and gastroesophageal junction (GEJ) cancer is anticipated to be presented at the 2018 ASCO Annual Meeting in June.

Updated data from a phase I study of Flotetuzumab in acute myeloid leukemia dose expansion cohort is expected during the second half of 2018.

A combination study of Flotetuzumab with INCMGA0012 is expected to be initiated during the third quarter of 2018.

Submission of IND application for MGD019 in the second half of 2018.

MGNX closed Monday's trading at $22.50, up 1.21%.

MediciNova Inc. (MNOV) is planning to initiate a clinical trial of MN-166 (ibudilast) in alcohol dependence and withdrawal in collaboration with researchers at the University of California, Los Angeles (UCLA).

The proposed clinical trial will evaluate MN-166 (ibudilast) as a potential treatment for individuals diagnosed with alcohol use disorder (AUD), and test whether MN-166 is more effective for those patients who experience withdrawal-related dysphoria than those who do not experience withdrawal.

Previous findings showed that MN-166 was effective in blunting alcohol reward among participants with greater depressive symptoms, a hallmark symptom of prolonged alcohol withdrawal, according to the Company.

MNOV closed Monday's trading at $11.05, up 0.09%.

Misonix Inc. (MSON), a provider of minimally invasive therapeutic ultrasonic medical devices, has delivered solid financial results in the 2018 fiscal third quarter.

Net income for the recent third quarter was $2.24 million or $0.23 per share compared to a net loss of $0.15 million or $0.04 per share in the year-ago quarter. Revenue for 2018 fiscal third quarter surged to $12.44 million from $7.18 million in the year-ago period.

Looking ahead for the year ending June 30, 2018, the Company expects revenue to be between $35 million and $36 million. Total revenue for fiscal year ended June 30, 2017, was $27.3 million.

MSON closed Monday's trading at $10.10, down 2.42%.

Provectus Biopharmaceuticals Inc. (PVCT.OB) has completed enrollment of 24 patients with metastatic melanoma in the phase 1b portion of its phase 1b/2 study of intralesional PV-10 in combination with KEYTRUDA in patients with metastatic melanoma.

The Company also plans to present comprehensive Phase 1b data in the first half of 2019.

PVCT.OB closed Monday's trading at $0.078, down 2.00%.

RedHill Biopharma Ltd. (RDHL) announced that the last patient enrolled in the first Phase III study with RHB-104 for Crohn's disease, dubbed MAP US study, has completed 26 weeks of treatment for primary endpoint evaluation. Top-line results are expected to be announced in approximately three months - i.e., by August 2018.

RDHL closed Monday's trading at $5.13, up 2.60%.

Ultragenyx Pharmaceutical Inc. (RARE) has a couple of catalysts coming its way this year.

-- Data from a phase III study of Crysvita in pediatric patients with XLH is expected in the second half of 2018. -- Data from all patients in a phase II study of Crysvita in tumor-induced osteomalacia (TIO) is expected in mid-2018. -- In Europe, an opinion from the Committee for Medicinal Products for Human Use on Mepsevii in mucopolysaccharidosis VII (MPS VII) is expected in mid-2018. -- Decision on a potential filing for approval of UX007 in long-chain fatty acid oxidation disorders will be made in mid-2018. -- Data from a phase III movement disorder study of UX007 in patients with glucose transporter type-1 deficiency syndrome are expected in the second half of 2018.

RARE closed Monday's trading at $57.96, up 6.35%. In after-hours, the stock was up $59.50, up 2.66%.

Xencor Inc. (XNCR) has charted out its clinical trial plans and has provided an overview of its near-term catalysts.

The Company expects to initiate a phase III trial of XmAb5871 in IgG4-RD in 2H18. A phase II trial of XmAb5871 in Systemic Lupus Erythematosus (SLE) is underway, with top line data anticipated in 4Q, 2018.

Initial data from Phase 1 study of XmAb14045 for the treatment of AML and other CD123-expressing hematologic malignancies expected in 2018, pending alignment on timing with Novartis.

Initial data from Phase 1 study of XmAb13676 for the treatment of B-cell malignancies expected in 2019, pending alignment on timing with Novartis.

Initial data from Phase 1 study of XmAb18087 for the treatment of neuroendocrine tumors (NET) and gastrointestinal stromal tumors (GIST) expected in 2019.

Initiation of Phase 1 trial evaluating XmAb20717 for the treatment of multiple oncology indications is expected in 2018.

Filing of Investigational New Drug (IND) application for XmAb23104 for the treatment of multiple oncology indications is expected in 2018 and initiation of Phase 1 trial expected in 2019.

IND filing for XmAb22841 for the treatment of multiple oncology indications is expected in 2018 and initiation of Phase 1 trial expected in 2019.

IND filing for XmAb24306 for the treatment of multiple oncology indications is expected in 2019.

XNCR closed Monday's trading at $30.84, up 2.15%.