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TXMD Giving A 2nd Try, PLX On Watch, NAOV's Shield Against Suicide Disease

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Today's Daily Dose brings you news about Adamis' prior approval supplement of allergy shot drug Symjepi; Aeglea's progress in Phase 1/2 clinical trial with Pegzilarginase; near-term catalyst of Protalix; NanoVibronix's trial results of its PainShield device in treating patients with Trigeminal Neuralgia (suicide disease); Regeneron's unique deal with privately-held Decibel and TherapeuticsMD's second attempt to get FDA approval for TX-004HR.

Read on...

Adamis Pharmaceuticals Corp. (ADMP) has submitted a prior approval supplement to the FDA for a pediatric version of allergy shot drug Symjepi of strength 0.15mg.

Symjepi of 0.3mg strength received FDA approval in June of this year for the emergency treatment of allergic reactions (Type I) including anaphylaxis, designed for patients weighing 66 pounds or greater.

The pediatric version (0.15mg) is intended to potentially treat patients weighing 33-65 pounds.

A prior approval supplement is filed with the FDA to gain approval of a major change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product as these factors may relate to the safety or effectiveness of the drug product. (Source: Contract Pharma).

ADMP closed Wednesday's trading at $3.50, down 7.89%.

Aeglea BioTherapeutics Inc. (AGLE) has dosed the first pediatric patient in its ongoing Phase 1/2 clinical trial of Pegzilarginase (AEB1102) in patients with Arginase 1 Deficiency.

The trial will enroll approximately 10 patients, adult and pediatric, with Arginase 1 Deficiency in the United States, Canada, and Europe.

The Company expects top line results from the study to be available in the third quarter of 2018.

AGLE closed Wednesday's trading at $4.00, down 2.32%.

Protalix BioTherapeutics Inc. (PLX) has completed enrollment in its phase II clinical trial of OPRX-106 in patients with ulcerative colitis. The trial has enrolled 19 patients.

Patients have been randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily, for 8 weeks. The Company expects to report top-line results from this study in the first quarter of 2018.

PLX closed Wednesday's trading at $0.69, down 1.43%.

Medical device company NanoVibronix Inc. (NAOV) has reported successful interim trial results for its PainShield device in treating patients with Trigeminal Neuralgia.

Trigeminal Neuralgia, often called the "suicide disease", is pain that spreads over the face and down the neck. As many as 280,000 individuals in the U.S. and 7 million worldwide are estimated to suffer from the condition. Opioids and surgical interventions are the current treatment options for Trigeminal Neuralgia.

The trial evaluating PainShield device in patients with Trigeminal Neuralgia is expected to be completed in the first quarter of 2018.

PainShield has received 510(k) clearance from the FDA and CE Mark approval in Europe, to treat pain.

Can PainShield emerge as a potential alternative to Opioid and surgical interventions? We'll have to wait and watch.

NAOV closed Wednesday's trading at $4.55, unchanged from the previous day's close.

Regeneron Pharmaceuticals Inc. (REGN) has inked a collaboration with privately held Decibel Therapeutics Inc., to discover and develop new potential therapeutics for hearing loss.

The collaboration is said to be unique because Decibel, besides gaining access to Regeneron's proprietary suite of technologies, will also retain worldwide development and commercialization rights to any products discovered in the collaboration. In return, Regeneron will be paid tiered royalties based on net sales.

Commenting on the deal, Kevin Starr, Co-Founder and Partner at Third Rock Ventures and Chairman of Decibel said, "This stands out as one of the most unique collaborations that I have seen in my 30-plus years in biotech. The scope of the collaboration in research and discovery, as well as the retention by the younger biotechnology company to all commercial rights worldwide are unprecedented in my experience. It positions Decibel to lead the way in developing meaningful therapeutics for hearing."

REGN closed Wednesday's trading at $358.63, down 2.01%.

Revance Therapeutics Inc. (RVNC) is planning to commence phase III program of DaxibotulinumtoxinA Injection for the treatment of cervical dystonia, a movement disorder of the neck, in adults in the second quarter of 2018.

The phase III program will be conducted at multiple sites in the U.S., Canada and Europe, and will be designed to fulfill regulatory submission requirements in both the U.S. and Europe, the Company noted.

DaxibotulinumtoxinA (RT002) is designated an Orphan Drug by the FDA.

RVNC closed Wednesday's trading at $27.10, up 6.48%.

TherapeuticsMD Inc. (TXMD) has resubmitted the New Drug Application for TX-004HR for the treatment of moderate-to-severe vaginal pain during sexual intercourse with the FDA.

TX-004HR is an applicator-free vaginal estradiol softgel. The FDA had turned down the Company's request to approve TX-004HR in May of this year, citing lack of long-term endometrial safety data for the product candidate beyond the 12-weeks studied in the pivotal phase III study.

Whether or not the FDA accepts the NDA resubmission will be known within 30 calendar days. Upon acceptance, the NDA resubmission will be classified as Class 1 or Class 2. A Class 1 review constitutes a two-month review from the date of resubmission and a Class 2 review constitutes a six-month review from the date of resubmission.

TXMD closed Wednesday's trading at $6.07, up 0.83%. In after-hours, the stock was up another 1.32% to $6.15.

Zogenix Inc. (ZGNX) has initiated a phase III trial of its lead investigational therapy, ZX008, as an adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

This phase III trial of ZX008, which will involve children and adults, is designed to enroll a total of 225 patients.

ZX008 is also being evaluated in patients with Dravet syndrome, and a phase III trial in this indication is ongoing. Top-line data from this study is expected in the second quarter 2018.

ZGNX closed Wednesday's trading at $37.90, down 0.13%.

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