FDA Nod For ALKS, TRXC Sees 4-fold Increase In Q2 Revenue, BCLI On Watch

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Today's Daily Dose brings you news about artificial ovary; FDA approval of Alkermes' INITIO; MabVax' decision regarding Delinquent Filing; Titan Pharma's decision to postpone enrollment in the second cohort of patients in its Phase 1/2 trial of Ropinirole and Merck's upcoming regulatory catalyst.

Read on...

The FDA has approved Alkermes plc's (ALKS) ARISTADA INITIO (aripiprazole lauroxil) for the initiation of ARISTADA, a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults.

ARISTADA INITIO, in combination with a single 30 mg dose of oral aripiprazole, provides physicians for the first time an alternative regimen to initiate patients onto any dose of ARISTADA on day one.

Previously, the standard initiation regimen for ARISTADA included 21 consecutive days of oral aripiprazole starting with the first ARISTADA dose.

ARISTADA INITIO is expected to be available in mid-July.

ALKS closed Monday's trading at $41.91, up 1.82%.

BrainStorm Cell Therapeutics Inc. (BCLI) has entered into a second partnership with Dana-Farber for the manufacturing of NurOwn for its ongoing phase III clinical trial in patients with amyotrophic lateral sclerosis as well as other potential indications.

The phase III trial is designed to enroll 200 patients with amyotrophic lateral sclerosis, and is being conducted at six leading ALS clinical sites in the U.S.
The first meeting of the phase III Data and Safety Monitoring Board (DSMB) is expected by the end of August 2018 and an update will be provided thereafter.

BCLI closed Monday's trading at $4.00, up 2.56%.

Fibrocell Science Inc. (FCSC) is offering for sale 1.47 million shares of its common stock at a purchase price per share of $2.69, for gross proceeds of approximately $3.9 million to several institutional investors.

Additionally, Fibrocell has also agreed to issue to the investors unregistered warrants to purchase up to 958,152 shares of common stock, at a purchase price per warrant of $0.125, for gross proceeds of approximately $0.1 million.

The closing of the offering is expected to take place on or about July 5, 2018.

The Company intends to use the net proceeds from the offering for the continued clinical and pre-clinical development of its product candidates, FCX-007 and FCX-013.

Clinical Trials & Near-term catalysts:

-- Complete enrollment of patients in the Phase 2 portion of the Phase 1/2 clinical trial of FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa in the third quarter of 2018.
-- Initiate enrollment for a Phase 1/2 clinical trial of FCX-013 for the treatment of moderate to severe localized scleroderma in the third quarter of 2018.

FCSC closed Monday's trading at $2.51, down 7.21%.

Cyprium Therapeutics, a Fortress Biotech, Inc. (FBIO) company has secured Fast Track Designation from the FDA for its Copper Histidinate, also referred to as CUTX-101, for patients diagnosed with classic Menkes disease who have not demonstrated significant clinical progression.

CUTX-101 is currently under phase III testing.

FBIO closed Monday's trading at $3.06, up 2.68%.

Shares of MabVax Therapeutics Holdings Inc. (MBVX) plunged more than 36% after the Company decided not to submit a plan to regain compliance with Nasdaq Listing Standards related to Delinquent Filing for the period ended March 31, 2018.

MBVX closed Monday's trading at $0.53, down 36.59%.

Merck (MRK) has sought FDA approval for another indication of its blockbuster drug Keytruda.

This time, it is for the use of Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression.

The company has requested accelerated approval for the new indication, and the FDA decision date is set for Oct. 30, 2018.

Keytruda recorded annual sales of $3.81 billion in 2017, and quarterly sales of $1.46 billion in the first quarter of 2018.

MRK closed Monday's trading at $60.46, down 0.40%.

Neuronetics Inc. (STIM), on July 2, closed its initial public offering of 6.32 million shares of its common stock, including the exercise in full of the underwriters' option to purchase additional shares, at a price of $17.00 per share.

The aggregate gross proceeds to Neuronetics from the offering were $107.5 million.

The Company markets NeuroStar Advanced Therapy System, a non-drug, office-based therapy cleared by the FDA in 2008 to treat adult patients with Major Depressive Disorder who have not seen success with at least one antidepressant medication in the current episode.

STIM closed Monday's trading at $26.41, down 0.75%.

NewLink Genetics Corp. (NLNK) has announced positive updated Phase 1 data evaluating Indoximod plus front-line radiation and maintenance chemotherapy for the treatment of pediatric patients with newly diagnosed diffuse intrinsic pontine glioma.

According to the updated results, all ten newly diagnosed diffuse intrinsic pontine glioma patients who had initiated therapy demonstrated initial symptomatic improvement.

Eight of ten had completed radiation, with the remaining 2 of 10 patients continuing radiotherapy. The updated data include more mature follow-up on the 6 patients previously presented at AACR 2018.

NLNK closed Monday's trading at $4.94, up 3.78%.

Shares of Titan Pharmaceuticals Inc. (TTNP) were down nearly 8% in after-hours trading on Monday, following the Company's decision to temporarily postpone enrollment of the second cohort of patients in its Phase 1/2 trial of Ropinirole implant intended for the treatment of the signs and symptoms of idiopathic Parkinson's disease.

The independent Data Safety Monitoring Board ("DSMB") has completed a review of the data from the first cohort of patients in the Phase 1/2 trial and recommended that the trial continue with enrollment of the second cohort of patients.

The Company noted that its overriding priority over the next few months is to focus its resources on driving the commercial success of Probuphine implant, which was approved by the FDA in May 2016 for the maintenance treatment of opioid dependence.

TTNP closed Monday's trading at $1.07, down 1.83%. In after-hours, the stock fell another 7.48% to $0.99.

TransEnterix Inc. (TRXC) expects second quarter revenue to be in the range of $6.0 million to $6.3 million, up from $1.5 million in the second quarter of 2017.

The Company's flagship product is Senhance Surgical Robotic System. The device received FDA clearance for colorectal and gynecological laparoscopic surgery in October 2017, becoming the first new entrant to abdominal robotics in the U.S. since 2000. It was in the year 2000 that the FDA cleared Intuitive Surgical Inc.'s (ISRG) Da Vinci Surgical System, the first of its kind, for general laparoscopic surgery.

In May of this year, TransEnterix received FDA clearance for expanded indications of its Senhance Surgical System - i.e., for laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery.

In the second quarter, the Company sold 4 Senhance Systems.

Preliminary unaudited cash as of June 30, 2018 was roughly $98 million.

TRXC closed Monday's trading at $4.01, down 8.03%. In after-hours, the stock was up 2% to $4.09.

Artificial Ovary:

Researchers from Rigshospitalet in Copenhagen, a highly specialized hospital in Denmark, have created an artificial ovary, and its viability has been demonstrated in animal trials.

"The artificial ovary will consist of a scaffold (originating from the woman's own tissue or from donated tissue) combined with her own follicles," Susanne Pors, a co-author of the study told CNN.

It is expected to take another 5 to 10 years before the artificial ovary advances into into human testing.

The artificial ovary offers hope to young women affected by cancer who want to conceive because in some cases, cancer treatments have the potential to irreversible damage ovaries.

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