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FDA Approves New HIV Drug, Mark Your Calendar For BHVN, Watch Out For ZFGN

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Today's Daily Dose brings you news about Cumberland Pharma's financial results, FDA approval of the first antiretroviral treatment (ART) with a new mechanism of action in nearly 10 years, Mesoblast's non-dilutive, four-year credit facility, FDA approval of the first and only pediatric mechanical heart valve, and interim analysis results of Zafgen's type 2 diabetes study.

Read on…

The FDA has approved Masters HP, the world's smallest mechanical heart valve for pediatric patients with heart defects.

Developed by Abbott Laboratories (ABT), the dime-sized Masters HP is the first and only pediatric mechanical heart valve to include newborns and infants.

All these years, surgeons had to use only a range of larger-sized valves to replace a pediatric heart valve that could not be repaired, and larger valves are often not suitable given the smaller size of children's hearts. Now, Masters HP offers hope for pediatric patients in urgent need of treatment who have no other approved options.

ABT closed Tuesday's trading at $60.88, up 0.84%.

Biohaven Pharmaceutical Holding Company Ltd. (BHVN) has an important event to watch out for this month.

Two pivotal phase III trials of orally-dosed Rimegepant for the acute treatment of migraine are underway. Topline results from both trials are expected in the first quarter of 2018.

A third phase III efficacy study with Rimegepant commenced in February 2018, and the study is expected to complete in the fourth quarter of 2018.

The Company remains on track to submit an investigational new drug application (IND) in first half of 2018 for BHV-3500, a third-generation CGRP receptor antagonist, for the acute treatment and prevention of migraine, and expects to conduct a Phase 1 clinical trial in the second half of 2018.

BHVN closed Tuesday's trading at $30.69, down 7.59%.

Cumberland Pharmaceuticals Inc. (CPIX) has turned around to profit in the fourth quarter of 2017 on 28% revenue growth.

For the three months ended December 31, 2017, on an adjusted basis, the Company reported a profit of $0.4 million or $0.03 per share, compared to a net loss of $0.1 million or $0.01 per share in the year-ago quarter.

Net revenues were $11.6 million in the recent fourth quarter, up 28% from $9.1 million for the prior year period.

At December 31, 2017, Cumberland had $50.1 million in cash and marketable securities.

CPIX closed Tuesday's trading at $6.97, up 0.87%.

Mesoblast Limited (MESO) has entered into a US$75 million non-dilutive, four-year credit facility with Hercules Capital Inc. (HTGC). Proceeds will be primarily used towards funding the commercialization of MSC-100-IV.

On February 22, 2018, the Company announced that its phase III trial of allogeneic mesenchymal stem cell product candidate MSC-100-IV in children with steroid refractory acute Graft versus Host Disease successfully met the primary endpoint.

There are currently no products approved in the United States for treatment of steroid-refractory aGVHD. Full results from the ongoing trial are scheduled to be reported in the second quarter of this year.

MESO closed Tuesday's trading at $7.25, down 6.09%.

Shares of Theratechnologies Inc. (THERF.OB) (TH.TO) soared more than 30% on Tuesday, following FDA approval of its partner TaiMed Biologics Inc.'s antiretroviral Trogarzo.

Trogarzo (ibalizumab), in combination with other ARTs, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.

Trogarzo is the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing, according to the Company.

THERF.OB closed Tuesday's trading at $7.12, up 30.11%.

Zafgen Inc. (ZFGN) has announced encouraging results from an interim analysis of the ongoing 12 week Phase 2 proof-of-concept ZAF-1061-201 clinical trial of ZGN-1061 in type 2 diabetes. The results represent 8-week data from 57 patients.

The interim data suggest that ZGN-1061 is safe and well-tolerated in the trial, with no safety signals observed or reported, and side effects generally comparable to placebo. According to the Company, the 0.9 mg dose produced a statistically significant A1C lowering compared to placebo at 8 weeks.

The full 12 week topline data from the core part of this clinical trial is expected to be reported mid-year.

Seeking to explore the higher end of the therapeutic range of ZGN-1061, the Company has added a 1.8 mg dose arm to the trial.

ZFGN closed Tuesday's trading at $8.26, up 3.51%.

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