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Keep An Eye On ATNM Today, PETQ Upbeat, MTFB To Face FDA In Feb


Today's Daily Dose brings you news about Actinium's immediate catalyst; CEL-SCI Corp' progress in phase III Multikine study; PetIQ's upbeat outlook; Motif Bio's regulatory catalyst and ViewRay's stock offering.

Read on...

It's a big day for investors of Actinium Pharmaceuticals Inc. (ATNM) as the Company will be providing an update on its pivotal trial, dubbed SIERRA, on Wednesday, August 15, 2018 at 9:00 AM ET.

SIERRA is a multicenter pivotal phase III clinical trial evaluating Iomab-B in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above.
Actinium recently announced that the SIERRA trial had reached twenty-five percent patient enrollment and that the independent Data Monitoring Committee would conduct a formal analysis, which has now occurred.

ATNM closed Tuesday's trading at $0.62, up 1.66%.

Busy days are ahead for Biohaven Pharmaceutical Holding Company Ltd. (BHVN) with a number of clinical trial catalysts lined up like the ones mentioned below.

-- Report the preliminary readout of the long-term safety study of Rimegepant for the acute treatment of migraine in the fourth quarter of 2018.
-- Report topline results from a Phase 3 Rimegepant Zydis ODT trial for the acute treatment of migraine in the fourth quarter of 2018.
-- Initiate a Phase 3 trial evaluating Rimegepant as a preventive therapy for migraine in fourth quarter of 2018.
-- Submit an IND for BHV-3500, its third generation CGRP receptor antagonist for the acute treatment and prevention of migraine, and initiate a Phase 1 clinical trial in the second half of 2018.
-- Submit an NDA for Rimegepant for the acute treatment of migraine to the FDA in 2019.
-- Continue enrollment of the Phase 2/3 Alzheimer's disease trial with troriluzole.
Commence a second randomized controlled trial to assess the efficacy of troriluzole in SCA in the second half of 2018.
-- Continue enrollment in the Phase 2/3 Obsessive-Compulsive Disorder trial with Troriluzole.
-- Submit an NDA to the FDA via the 505(b)(2) pathway for BHV-0223 in patients with amyotrophic lateral sclerosis (ALS) in the second half of 2018.
-- Complete a Phase 1 trial for BHV-5000 for the treatment of symptoms associated with Rett syndrome in the second half of 2018.
-- Report top line data from a Phase 2 investigator-initiated, double-blind, investigator-sponsored, proof of concept study on public speaking in social anxiety disorder with BHV-0223 in the second half of 2018.

BHVN closed Tuesday's trading at $32.79, down 2.15%.

CEL-SCI Corp. (CVM) expects top line results from its phase III study evaluating Multikine for the treatment of head and neck cancer to be available in early 2019.

In the study, newly diagnosed patients with advanced primary squamous cell carcinoma are treated with the Multikine treatment regimen for 3 weeks prior to the Standard of Care (SOC) which involves surgery, chemotherapy and/or radiation. This is the largest Phase 3 study in the world for the treatment of head and neck cancer.

CVM closed Tuesday's trading at $1.03, up 0.98%.

Cytori Therapeutics (CYTX) has a couple of catalysts coming its way this year and early 2019.

-- Complete ATI-0918 development and manufacturing required to prepare and file a MAA with the EMA.
-- Receive Orphan Drug Designation and 505(b)(2) pathway feedback from the U.S. FDA for ATI-1123.
-- Enroll burn patients in BARDA-funded U.S. RELIEF clinical trial.
-- Report 3 and 6 month French SCLERADEC II clinical trial data for scleroderma hand dysfunction.
-- Report 1 year Japanese ADRESU clinical trial data for post-surgical male stress urinary incontinence.

CYTX closed Tuesday's trading at $0.39, up 5.46%.

Motif Bio plc's (MTFB) New Drug Application for Iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections, has been accepted for review by the FDA - with a decision date set for February 13, 2019.

Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA. If iclaprim is approved as a new chemical entity with QIDP designation, it will be eligible for 10 years of market exclusivity in the U.S. starting from the date of approval, under the Generating Antibiotic Incentives Now Act (the GAIN Act).

MTFB closed Tuesday's trading at $9.00, up 13.92%.

Shares of PetIQ Inc. (PETQ) were up more than 14% in after-hours on Tuesday, following encouraging second-quarter financial results and upbeat outlook.

Net income was $5.4 million and adjusted net income was $10.6 million for the second quarter of 2018. Net sales increased 96% to $171.1 million for the second quarter of 2018, compared to $87.2 million for the same period in the prior year.

For full year 2018, the Company now expects net sales of approximately $500 million. Net sales were $266.7 million in 2017.

PETQ closed Tuesday's trading at $28.28, up 3.82%. In after-hours, the stock was up 14.92% to $32.50.

ViewRay Inc. (VRAY) has offered to sell 16.2 million shares of common stock to the public at a price to of $9.25 per share, for gross proceeds of $150 million. The offering is expected to close on or about August 17, 2018.

The underwriters have a 30-day option to purchase up to an additional 2.43 million shares of common stock.

For the second quarter of 2018, the results of which were reported on August 3, the net loss was $22.0 million, or $0.30 per share on total revenue of $16.4 million. This compared with a net loss of $8.4 million or $0.15 per share and total revenue of $0.7 million for the same period last year.

Looking ahead, the Company anticipates 2018 annual total revenue to be in the range of $80 million to $90 million. The total revenue in 2017 was $34.0 million.

VRAY closed Tuesday's trading at $9.88, down 0.20%.

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