5 Top Losers In Healthcare Sector (EVOK, IGXT.OB, APYX...)
(RTTNews) - The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.
1. Evoke Pharma Inc. (EVOK)
Lost 47.06% to close Tuesday's (Apr.2) trading at $0.90.
News: The Company's investigational drug Gimoti, proposed for the relief of symptoms associated with acute and recurrent diabetic gastroparesis, has been turned down by the FDA.
The writing was already written on the wall as the regulatory agency had issued a not-so-favorable preliminary communication related to the Gimoti NDA in March. In the preliminary communication, the FDA had raised concerns in three sections of the Gimoti NDA - Chemistry, Clinical, and Clinical Pharmacology.
In the Complete Response Letter, issued on April 1, the FDA has raised issues related to clinical pharmacology and product quality/device quality. The Agency did not request any new clinical data and did not raise any safety concerns.
2. Apyx Medical Corporation (APYX)
Apyx Medical, formerly known as Bovie Medical Corp., is a medical device company.
Lost 35.83% to close Tuesday's trading at $4.46.
News: The Company has voluntarily withdrawn its application for premarket notification 510(k) regulatory clearance of J-Plasma/Renuvion for use in dermal resurfacing procedures.
The premarket notification 510(k) was filed last December, and in course of the review, the FDA has raised a number of questions and concerns related to superior clinical results from one investigational center as compared to the other two investigational centers in the study, among others.
The Company will continue to work with the FDA relative to the development of a new 510(k) submission. However, a timeline for resubmission has not been provided.
3. IntelGenx Technologies Corp. (IGXT.OB)
Lost 22.23% to close Tuesday's trading at $0.52.
News: The FDA has refused to approve RIZAPORT, proposed for the treatment of acute migraines, yet again.
This is the third time that the regulatory agency is turning down RIZAPORT. The FDA had refused to approve RIZAPORT in 2014, and again in 2017.
4. Meridian Bioscience Inc. (VIVO)
Lost 19.32% to close Tuesday's trading at $14.20.
News: The Company expects a decline in second fiscal quarter revenue, and also revised down its financial guidance for fiscal 2019.
The second fiscal quarter of 2019 revenues are expected to be approximately $50.0 million compared to $56.5 million in the second fiscal quarter of 2018. For the fiscal year ending September 30, 2019, the Company now expects net revenues to be down 3%. Earlier, the Company was expecting revenue to be flat or record a growth of 2%.
5. NovaBay Pharmaceuticals Inc. (NBY)
NovaBay is a biopharmaceutical company focusing on commercializing prescription Avenova for the domestic eye care market.
Lost 15.65% to close Tuesday's trading at $0.97.
News: No news
On March 28, the Company reported financial results for the fourth quarter and full year ended December 31, 2018.
The net loss for the fourth quarter of 2018 was $1.3 million, or $0.07 per share, compared with net income for the fourth quarter of 2017 of $0.8 million, or $0.02 per share.
Net sales for the fourth quarter of 2018 dropped to $3.6 million from $6.3 million for the fourth quarter of 2017, with the decrease primarily due to lower insurance reimbursement resulting in a lower average selling price of Avenova, along with a $1.3 million reduction in non-Avenova sales.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.