FDA Greelinghts PGNX' Azedra, MYND Delighted, CORV Looks Ahead With Hope

(RTTNews) - The following are some of today's top gainers in the pharma/biotech sector.

1. MYnd Analytics Inc. (MYND)

MYnd is a predictive analytics company that has developed a decision support tool to help physicians reduce trial and error treatment in mental health and provide more personalized care to patients.

Gained 33.81% to close Monday's (Jul 30) trading at $1.86.

News: The Company has launched a new program offering behavioral health solutions for skilled nursing and assisted living facilities, which will be deployed at the Bayside Health and Rehabilitation skilled nursing facility in Florida.

The Company has partnered with Gulf Coast Health Care in deploying the program at Bayside Health and Rehabilitation, and will be rolling out the program across Gulf Coast's entire network.

2. Correvio Pharma Corp. (CORV)

Gained 10.29% to close Monday's trading at $4.61.

News: No news

The lead product is BRINAVESS (vernakalant hydrochloride, IV), to restore normal heart rhythm in adult patients (aged 18 years or over) who have recently started having atrial fibrillation. The Company has been trying to get approval for BRINAVESS, formerly known as Kynapid, in the U.S. since 2006.

Brinavess is approved for marketing in Europe, Canada and several other countries worldwide.

Near-term Catalyst:

The Company is expected to schedule a Pre-NDA meeting with the FDA to discuss the content and format of a potential resubmission of the NDA for BRINAVESS in the fourth quarter of this year.

3. PAVmed Inc. (PAVM)

PAVmed is a medical device company.

Gained 10% to close Monday's trading at $1.54.

News: No news

Pipeline:

The Company's lead product candidates are PortIO, an implantable vascular access device, CarpX, a percutaneous carpal tunnel device, and EsoCheck, a revolutionary office-based alternative to endoscopy, among others.

Near-term Catalysts:

-- The resubmitted 510(k) application for CarpX is under FDA review, with a response to the resubmission expected by the end of the summer. -- The Company is targeting European CE Mark submission for CarpX late this year and a first-in-human clinical series in New Zealand this fall. -- Initiate a GLP animal study and prepare an IDE application for a small clinical study with PortIO this summer. -- Submission of 510(k) application for EsoCheck by the end of this year.

4. DURECT Corporation (DRRX)

Gained 9.93% to close Monday's trading at $1.55.

News: The Company is all set to receive a $5 million milestone payment and future earn-out payments based on U.S. net sales, following the FDA approval of Indivior's PERSERIS.

PERSERIS, which was formerly known as RBP-7000, is the first once-monthly subcutaneous risperidone-containing, long-acting injectable for the treatment of schizophrenia in adults, and it was approved on July 27, 2018.

In September 2017, DURECT Corp. (DRRX) assigned certain of its U.S. patent rights on RBP-7000 to Indivior under a patent purchase agreement. Under the terms of the agreement, Indivior made an upfront non-refundable payment to DURECT of $12.5 million, with the potential for an additional $5 million based upon approval of RBP-7000, as well as quarterly earn-out payments.

5. Soleno Therapeutics Inc. (SLNO)

Gained 9.84% to close Monday's trading at $2.79.

News: The Company's investigational drug Diazoxide Choline Controlled-Release (DCCR) has been granted Fast Track designation by the FDA for the treatment of Prader-Willi Syndrome.

Diazoxide Choline Controlled-Release is under phase III testing for the treatment of Prader-Willi Syndrome.

6. Progenics Pharmaceuticals Inc. (PGNX)

Gained 8.49% to close Monday's trading at $8.31.

News: The Company's Azedra, a radio-therapeutic proposed for the treatment of patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors, has received FDA approval.

Analysts expect Azedra to rake in peak sales of between $200 million and $300 million.