Harrow Health Publishes Third Quarter Letter to Stockholders

Harrow Health, Inc. (NASDAQ: HROW) today reported results for the third quarter 2019.  Please click here to review Harrow Health’s complementary Letter to Stockholders for the third quarter 2019.

Mark L. Baum, CEO of Harrow Health, commented, “The third quarter of 2019 brought new records for our core ophthalmology business, as well as record high gross margins and Adjusted EBITDA.  We’ve resolved various legal matters, normalized our cost structure, and completed the restructuring of our pharmaceutical compounding business, which is now sustainably profitable, setting the stage for our march towards our $100 million revenue run rate target in 2021 and 70% gross margins – which should produce about $1 per share of annualized adjusted earnings.  All of these items and more, along with our plans in 2020, are elaborated on in our Letter to Stockholders.”

Conference Call and Webcast

The company’s management team will host a question and answer conference call with analysts and an audio-only webcast Wednesday at 5:00 p.m. Eastern Standard Time / 2:00 p.m. Pacific Standard Time.  To participate, please use the dial in or click on the link below:

• U.S. callers: (844) 602-0380
• International callers: (862) 298-0970
• Audio-only webcast: please click here

Conference Call Replay:

A dial in replay of the call will be available until December 13, 2019.  The webcast replay will be available until February 13, 2020.

• U.S. callers: (877) 481-4010, Replay ID: 55904
• International callers: (919) 882-2331, Replay ID: 55904
• Webcast: please click here

https://www.biospace.com/article/releases/harrow-health-publishes-third-quarter-letter-to-stockholders/

FDA sends warning letter to Dollar Tree stores receiving potentially unsafe drugs

The U.S. Food and Drug Administration has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs produced by foreign manufacturers found to have serious violations of federal law. The warning letter outlines multiple violations of current good manufacturing practices at contract manufacturers used to produce Dollar Tree’s Assured Brand OTC drugs as well as other drug products sold at Dollar Tree and Family Dollar stores.

“Protecting patient health and safety is our highest priority, and the FDA continues to investigate and take action against companies that place U.S. patients at risk. Americans expect and deserve drugs that are safe, effective and that meet our standards for quality. The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “In this case, Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans. We will remain vigilant in our efforts to protect the U.S. public from companies who put the health of Americans at risk – whether through the manufacturing and distribution of products we regulate or other means.”

The warning letter details Dollar Tree’s receipt of adulterated drugs from manufacturers that received FDA warning letters in 2018. The warning letter also details Dollar Tree’s use of contract manufacturers that also received warning letters for similar issues between 2016 and 2019. Manufacturers that received these warning letters were placed on import alert, which are used to prevent potentially violative products from being imported into the U.S. market. The FDA notified Dollar Tree of warning letters sent to these manufacturers at the time the warning letters were sent.

The warning letters sent to the contract manufacturers used by Dollar Tree show a pattern of serious violations of the law, such as not testing raw materials or finished drugs for pathogens and quality. The FDA’s warning letter to Dollar Tree details the corrective actions the agency requested. Among those, the FDA has requested the company implement a system to ensure that they do not import adulterated drugs.

The agency encourages health care professionals and consumers to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letter-dollar-tree-stores-receiving-potentially-unsafe-drugs

BioMarin’s vosoritide shows positive effect in mid-stage achondroplasia study

Preliminary data from an open-label, dose-finding Phase 2 clinical trial evaluating BioMarin Pharmaceutical’s (BMRN -1.2%) vosoritide in children with achondroplasia showed a positive effect on height gain. The data were presented at the company’s R&D Day.

Subjects in Cohort 3 (n=10) receiving 15 µg/kg/day experienced cumulative additional height gain of 9.0 cm at month 54 compared to a natural history dataset. 2.2 cm of the increase was observed in the most recent 12 months.

Achondroplasia is a bone growth disorder characterized by dwarfism.

Topline results from a Phase 3 study should be available by year-end.

Achondroplasia-related tickers: Pfizer (PFE -0.3%), Ascendis Pharma (ASND -0.1%), BridgeBio (BBIO +0.7%)

https://seekingalpha.com/news/3519310-biomarins-vosoritide-shows-positive-effect-mid-stage-achondroplasia-study

Trovagene up on positive onvansertib data

Nano cap Trovagene (NASDAQ:TROV) is up 17% premarket on increased volume in reaction to encouraging data from a Phase 2 clinical trial evaluating onvansertib, combined with J&J’s Zytiga (abiraterone acetate) and prednisone, in patients with metastatic castration-resistant prostate cancer. The results are being presented today at the European Multidisciplinary Congress on Urological Cancers in Vienna.

The response rate was 60% (n=9/15) in patients that completed three months’ treatment. 72% experienced a decline in PSA values after one cycle of treatment (number of patients not provided). Six patients have remained on treatment for at least four months.

On the safety front, the most frequent adverse events were anemia, neutropenia, thrombocytopenia and white blood cell decrease. All were managed by decreasing the dose of onvansertib or adding growth factor support.

The study should wind up in October 2020.

https://seekingalpha.com/news/3519233-trovagene-17-percent-premarket-positive-onvansertib-data

Analyst action, Nov. 14

Arvinas (NASDAQ:ARVN) initiated with Buy rating and $35 (23% upside) price target at Roth Capital.

Bicycle Therapeutics (NASDAQ:BCYC) initiated with Buy rating and $17 (107% upside) at Roth.

Harpoon Therapeutics (NASDAQ:HARP) initiated with Buy rating and $25 (85% upside) price target at Roth.

Turning Point Therapeutics (NASDAQ:TPTX) initiated with Buy rating and $65 (33% upside) price target at Roth.

VBI Vaccines (NASDAQ:VBIV) initiated with Outperform rating and $3 (437% upside) price target at Raymond James. Shares up 10% premarket.

Vir Biotechnology (NASDAQ:VIR) initiated with Neutral rating and $17 (31% upside) price target at Baird.

QIAGEN (NYSE:QGEN) upgraded to Hold with a $36.31 (2% upside) price target at Kepler Cheuvreux. Upgraded to Overweight with a $40 price target at JPMorgan. Shares up 3% premarket.

ElectroCore (NASDAQ:ECOR) downgraded to Market Perform at JMP Securities. Shares down 13% after Q3 miss.

https://seekingalpha.com/news/3519247-jpmorgan-likes-qiagen-premarket-analyst-action

Zealand Pharma reports 9M results

Zealand Pharma (NASDAQ:ZEAL): 9M net loss of $58.7M

Revenue of $4.4M (+12.8% Y/Y)

Press Release

https://seekingalpha.com/news/3519260-zealand-pharma-reports-9m-results

Sarepta teams up with StrideBio to develop up to eight gene therapies

Sarepta Therapeutics (NASDAQ:SRPT) will collaborate with privately held StrideBio to develop up to eight AAV-based gene therapies for central nervous system and neuromuscular disorders.

Under the terms of the agreement, StrideBio will receive $48M upfront in cash and SRPT common stock, milestones and royalties on net sales.

Sarepta will have an exclusive option to in-license up to four programs. It may secure an additional exclusive license for up to four additional targets by paying another upfront fee of $42.5M plus milestones and royalties and has agreed to invest in StrideBio’s next financing round.

SrideBio has the option to co-develop and co-commercialize one target.

The companies will also investigate re-dosing strategies related to AAV-delivered gene therapy (restricted to single administration at present).

Shares down 1% premarket.

https://seekingalpha.com/news/3519264-sarepta-teams-stridebio-develop-eight-gene-therapies