APRI Makes 2nd Try, PRQR To Reveal Data On Sep.25, PFE Awaits FDA Decision

(RTTNews) - Today's Daily Dose brings you news about Apricus' resolve to get its investigational erectile dysfunction product approved by the FDA; special status granted to Abeona's investigational Epidermolysis Bullosa treatment; upcoming regulatory catalyst of BioMarin and Pfizer; Nasdaq notification for Immune Pharma; ProQR Therapeutics' near-term clinical trial catalyst and Sorrento's second try at getting FDA approval for its medicated plaster.

Read on...

Abeona Therapeutics Inc.'s (ABEO) EB-101 gene therapy program for patients with Recessive Dystrophic Epidermolysis Bullosa has been granted Breakthrough Therapy designation by the FDA.

Epidermolysis Bullosa (EB) is a rare genetic disorder that causes the skin to be fragile. Because the skin is so fragile, it can be easily injured, causing painful blisters to form. These blisters can cause serious problems if they become infected. (Source: National Institutes of Health).

In a Phase 1/2 study, EB-101 has demonstrated significant wound healing (greater than 50% healed) in treated wounds for over two years.

The Company looks forward to initiating a pivotal Phase 3 trial of EB-101 for patients with Epidermolysis Bullosa.

ABEO closed Tuesday's trading at $11.25, up 18.42%.

Apricus Biosciences Inc. (APRI) has resubmitted its New Drug Application for Vitaros, a topical vasodilator cream in development for the treatment of erectile dysfunction, to the FDA.

Vitaros was turned down by the FDA in July 2008, with the regulatory agency questioning the results of a transgenic mouse carcinogenicity study, which were completed in 2002.

APRI closed Tuesday's trading at $1.50, up 1.35%.

BioMarin Pharmaceutical Inc.'s (BMRN) Biologics License Application for Pegvaliase has been accepted for priority review by the FDA - with a decision date set for February 28, 2018.

Pegvaliase is proposed as a treatment to reduce blood phenylalanine levels in adult patients with phenylketonuria who have uncontrolled blood phenylalanine levels on existing management.

BMRN closed Tuesday's trading at $82.98, up 0.48%.

Immune Pharmaceuticals Inc. (IMNP) has been notified that it is not in compliance with the minimum stockholders' equity requirement under NASDAQ Listing Rule.

The Company's stockholders' equity for the period ended June 30, 2017 is below the required minimum of $2.5 million. The Company also does not meet the alternative compliance standards relating to the market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years.

The Company has 45 calendar days, or until about October 6, 2017, to submit a plan to regain compliance.

IMNP closed Tuesday's trading at $1.20, down 3.21%.

Moleculin Biotech Inc. (MBRX) has filed with the FDA a revised Investigational New Drug application to study Annamycin in the treatment of relapsed or refractory acute myeloid leukemia.

The Company had withdrawn its original Investigational New Drug application after the FDA requested certain revisions to the protocol, additional information, and additional data related to Chemistry, Manufacturing and Controls (CMC).

MBRX closed Tuesday's trading at $2.57, up 9.83%.

ProQR Therapeutics N.V. (PRQR) is expected to release top-line data from its Phase 1b clinical trial of QR-010 cystic fibrosis patients post-market close on Monday, September 25, 2017.

The Phase 1b trial is a 28-day, safety and tolerability study conducted in patients that have cystic fibrosis due to two copies of the F508del mutation (homozygotes). A total of 4 dose levels were studied: 6.25, 12.5, 25 and 50mg of QR-010 in solution per dose administered via inhalation.

PRQR closed Tuesday's trading at $4.95, up 7.61%.

Pfizer Inc. (PFE) and Avillion LLP's supplemental New Drug Application for BOSULIF has been accepted for priority review by the FDA - with a decision due in December 2017.

The companies are seeking to expand the approved use of BOSULIF to include patients with newly diagnosed chronic phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia, or CML.

BOSULIF is currently indicated in the U.S. for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy.

PFE closed Tuesday's trading at $33.50, up 0.09%.

Sorrento Therapeutics Inc.'s (SRNE) subsidiary SCILEX Pharmaceuticals Inc. has resubmitted the NDA for its investigational medicated plaster, ZTlido, to the FDA.

ZTlido was issued a Complete Response Letter by the U.S. regulatory agency last May.

SRNE closed Tuesday's trading at $1.62, down 7.143%.