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ARDM Chokes, ABEO On Track, MASI Gets FDA Nod, ALBO Up 50% YTD

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Today's Daily Dose brings you news about FDA's refusal to approve Aradigm's Linhaliq in its present form; Abeona's progress in its clinical trial with EB-101 for a very rare inherited skin disorder; Albireo's stock offering; enrollment data related to Bellerophon's phase III INOvation-1 study; headway in Cellectar's phase II trial of CLR 131 and Diffusion Pharma's progress in INTACT study.

Read on...

As expected, Aradigm Corp. (ARDM) failed to win FDA approval for its investigational therapy Linhaliq, sending its stock plunging as much as 33% on Monday.

Linhaliq (formerly known as Pulmaquin) was proposed for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.

On January 11, 2018, a panel of outside experts convened by the FDA had voted against recommending approval of Linhaliq.

In its Complete Response Letter issued for Linhaliq, the FDA has requested the Company to conduct an additional Phase 3 clinical trial and a Human Factors Study, and also provide additional product quality information.

ARDM closed Monday's trading at $1.59, down 29.02%.

Abeona Therapeutics Inc.'s (ABEO) investigational gene-corrected autologous cell therapy EB-101 for patients with recessive dystrophic epidermolysis bullosa, a very rare inherited skin disorder, has been granted Regenerative Medicine Advanced Therapy designation by the FDA.

The Company has successfully completed a Phase 1/2 clinical trial of EB-101. The study met the primary endpoints for safety and efficacy, where wound healing after EB-101 administration was compared to control untreated wounds.

A phase III trial with EB-101 is expected to begin later this year.

ABEO closed Monday's trading at $16.30, up 0.31%.

Shares of Albireo Pharma Inc. (ALBO) touched an all-time high of $39.87 in intra-day trading on Monday.

The Company announced the completion of its previously announced underwritten public offering of 1.97 million shares of its common stock at a price to the public of $33.00 per share. In addition, the underwriters have exercised an option to purchase an additional 295,500 shares of common stock.

The net proceeds from the offering were approximately $69.9 million.

To know more about Albireo, please visit our Company Spotlight column. The stock was trading around $21 when we alerted our readers to it last June.

ALBO closed Monday's trading at $38.95, up 5.78%.

Bellerophon Therapeutics Inc.'s (BLPH) phase III INOvation-1 study evaluating INOpulse in patients with pulmonary arterial hypertension has exceeded enrollment of 100 patients.

An interim analysis of this trial will be performed by the Data Monitoring Committee when half of the subjects complete the 16-week blinded treatment phase. The interim analysis will determine if the study should be stopped early for efficacy or futility, continued as planned, or if the trial size should be increased.

The Company anticipates the readout of the interim analysis in mid-2018, and the top-line data from the trial is expected by the end of this year.

BLPH closed Monday's trading at $2.48, up 2.90%.

BioCardia Inc. (BCDA.OB) has received the go-ahead from FDA to conduct a pivotal trial of its CardiAMP investigational cell therapy in patients having chronic myocardial ischemia with refractory angina.

This trial is designed to enroll up to 343 subjects at up to 40 U.S. centers, and has the potential to support functional benefit claims sufficient for product registration without a second confirmatory trial, according to the Company.

Another FDA-approved pivotal clinical trial of CardiAMP cell therapy in ischemic heart failure is already underway.

BCDA.OB closed Monday's trading at $2.74, down 0.36%.

Cellectar Biosciences (CLRB) has enrolled the first patient in the diffuse large B-cell lymphoma cohort of its Phase 2 clinical trial of CLR 131. Up to 10 patients with diffuse large B-cell lymphoma will be enrolled in this cohort.

The diffuse large B-cell lymphoma cohort represents the fourth and final cohort of the company's Phase 2 study of CLR 131 in patients with relapsed or refractory B-cell hematologic cancers.

CLRB closed Monday's trading at $1.32, up 7.32%.

Corbus Pharmaceuticals Holdings Inc. (CRBP) has reached an agreement with the FDA to set pulmonary exacerbation rate as the sole primary end point in its phase 2b study of Lenabasum in the treatment of cystic fibrosis.

The Company expects the first patient to be dosed in the cystic fibrosis trial during this quarter.

Lenabasum, formerly known as Anabasum, is also under a Phase 3 "RESOLVE-1" study in systemic sclerosis. It is also under phase II studies in dermatomyositis and lupus, in addition to cystic fibrosis.

CRBP closed Monday's trading at $9.25, up 3.93%.

Diffusion Pharmaceuticals Inc. (DFFN) has dosed the first patient in its phase III clinical trial with Trans sodium crocetinate in patients with newly-diagnosed inoperable glioblastoma multiforme, a type of brain cancer.

The trial, dubbed INTACT, will compare standard of care radiation therapy and chemotherapy plus Trans sodium crocetinate against standard of care radiation therapy alone.

About 264 patients are expected to be enrolled in the trial, and overall survival at two years will be compared between patients in the treatment and control groups.

DFFN closed Monday's trading at $0.67, down 2.75%. In after-hours, the stock was up 2.80% to $0.69.

Masimo's (MASI) Next Generation SedLine brain function monitoring has received FDA clearance.

SedLine helps clinicians monitor the state of the brain under anesthesia with bilateral acquisition and processing of four leads of electroencephalogram (EEG) signals, and the Next Generation SedLine features an enhanced signal processing engine, driving a variety of performance improvements and helping give clinicians a more complete picture of the brain, says the Company.

The Company is slated to report fourth quarter and full-year 2017 financial results on February 12, 2018.

MASI closed Monday's trading at $94.08, up 2.77%.

Theravance Biopharma Inc. (TBPH) and Mylan N.V.'s (MYL) New Drug Application for Revefenacin for the treatment of chronic obstructive pulmonary disease in adults has been accepted for review by the FDA.

An advisory committee meeting to review Revefenacin is not going to be convened, and the U.S. regulatory agency's decision is expected on November 13, 2018.

TBPH closed Monday's trading at $28.36, down 2.14%.

VistaGen Therapeutics Inc. (VTGN) is all set to initiate its Phase 2 study of AV-101 for Major Depressive Disorder during the current quarter, with topline data expected to be available during the first half of 2019.

In addition, the Company expects one of its principal collaborators, the U.S. National Institute of Mental Health, to complete its Phase 2 monotherapy study of AV-101 in treatment-resistant Major Depressive Disorder patients during 2018.

VTGN closed Monday's trading at $1.53, down 3.77%. In after-hours, the stock was down 4.61% to $1.45.

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