CNCE Hits A Low, UTHR Throws In The Towel On PAH Drug, ZGNX Plunges On FDA Snub

pharma 030718 09apr19

Today's Daily Dose brings you news about the inter partes review decision on Concert Pharma's patents related to CTP-543; the proposed public offering of Daré Bioscience and Zosano Pharma; United Therapeutics' decision to discontinue the development of a PAH drug and FDA's refusal to review Zogenix' seizure drug candidate FINTEPLA.

Read on...

Concert Pharmaceuticals Inc. (CNCE) touched a new-52-week low on Monday, following an unfavorable decision from the Patent Trial and Appeal Board, or PTAB, in an inter partes review proceeding related to the Company's investigational drug CTP-543.

CTP-543, or deuterated Ruxolitinib, is being developed by Concert for the treatment of moderate-to-severe alopecia areata. Ruxolitinib, a drug which selectively inhibits Janus kinases 1 and 2 (JAK1 and JAK2), is marketed by Incyte in the U.S. as Jakafi and by Novartis as Jakavi outside the U.S for the treatment of patients with myelofibrosis and polycythemia vera.

In April 2017, Incyte Corporation filed an inter parties review, or IPR, petition with the PTAB, of the U.S. PTO, challenging the validity of U.S. Patent No. 9,249,149, which claims deuterium-modified versions of ruxolitinib, including CTP-543.

Now according to the final decision in the inter partes review (IPR), the claims of the '149 patent are not patentable.

Commenting on the outcome, Roger Tung, President and Chief Executive Officer of Concert Pharmaceuticals said, "We remain highly committed to the continued advancement of CTP-543 as a potential treatment for alopecia areata. The outcome of this proceeding does not prohibit us from developing CTP-543 for alopecia areata and our development timelines for CTP-543 remain on track".

CNCE closed Monday's trading at $11.00, down 15.71%.

Shares of Daré Bioscience Inc. (DARE) plunged over 16% in extended trading on Monday, following a proposed public offering of common stock.

The Company expects to grant the underwriters of the offering a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the underwritten public offering on the same terms and conditions.

Roth Capital Partners is acting as the sole book-runner for the offering. Aegis Capital Corp. is acting as co-manager for the offering.

DARE closed Monday's trading at $1.37, up 4.58%. In after-hours, the stock fell 16.88% to $1.14.

The FDA has approved ViiV Healthcare Ltd.'s New Drug Application for a single-tablet, two-drug regimen of Dolutegravir (DTG) and Lamivudine (3TC) for the treatment of HIV-1 infection.

The two-drug HIV regimen, whose brand name is Dovato, is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV.

Usually, three or more drugs are included in standard HIV treatment. Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients.

The first-ever two-drug HIV regimen - Juluca - secured FDA approval in 2017, and it is indicated for the treatment of adults with HIV-1 infections whose virus is currently suppressed on a stable regimen for at least six months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca. Juluca is also from the stable of ViiV Healthcare.

ViiV Healthcare Limited, the global specialist HIV company, is majority-owned by GlaxoSmithKline plc, with Pfizer Inc. and Shionogi Limited.

GSK closed Monday's trading at $41.67, up 0.17%.

SCYNEXIS Inc. (SCYX) will be presenting two case studies of patients with Candida auris infections successfully treated with oral Ibrexafungerp from its CARES study on April 13, 2019.

The CARES study is a phase III, multi-center (U.S. and India), open-label, single-arm study evaluating oral Ibrexafungerp for the treatment of Candida auris infections.

Oral Ibrexafungerp continues to advance across multiple additional indications, including the prevention of recurrent vulvovaginal candidiasis and invasive aspergillosis.

A phase II study of oral Ibrexafungerp in combination with voriconazole for the treatment of invasive aspergillosis, dubbed SCYNERGIA, is ongoing.

In January 2019, SCYNEXIS announced the initiation of the Phase 3 VANISH registration program of Oral ibrexafungerp.

The VANISH program is comprised of two Phase 3 clinical trials (approximately 350 patients each) designed to evaluate the efficacy of a one-day 600mg oral dose of Ibrexafungerp versus placebo for the treatment of vulvovaginal candidiasis. Top-line results from the study are anticipated in the first half of 2020.

SCYX closed Monday's trading at $1.80, up 10.43%.

United Therapeutics Corporation (UTHR) has pulled the plug on the development of Esuberaprost, which was being evaluated for the treatment of pulmonary arterial hypertension.

The decision to discontinue the development of Esuberaprost was taken after a phase III study of Esuberaprost tablets in patients suffering from pulmonary arterial hypertension, dubbed BEAT, did not meet its primary endpoint of delayed time to first clinical worsening event.

UTHR closed Monday's trading at $113.92, down 5.70%.

Shares of Zogenix Inc. (ZGNX) were down more than 31% in extended trading on Monday, following disappointing regulatory news.

The FDA has declined to even accept for review the Company's New Drug Application for FINTEPLA for the treatment of seizures associated with Dravet syndrome.

In its Refusal to File letter, the FDA has stated that certain non-clinical studies were not submitted to allow assessment of the chronic administration of FINTEPLA, and that the application contained an incorrect version of a clinical dataset, which prevented the completion of the review process that is necessary to support the filing of the NDA.

The FDA has not requested or recommended additional clinical efficacy or safety studies, noted the Company.

Zogenix's Marketing Authorization Application for FINTEPLA for the treatment of seizures associated with Dravet syndrome is under review by the European Medicines Agency - with a decision expected in the first quarter of 2020.

ZGNX closed Monday's trading at $51.85, down 0.29%. In after-hours, the stock plunged 31.53% to $35.50.

Zosano Pharma Corporation (ZSAN) dropped nearly 20% in after-hours on Monday, following a proposed public offering of common stock.

In addition, the Company intends to grant to the underwriter a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering, on the same terms and conditions.

The net proceeds from the offering will be used to fund the ongoing development and preparation for potential commercialization of Qtrypta, and for working capital and general corporate purposes noted the Company.

The New Drug Application for Qtrypta in acute migraine is expected to be filed in the fourth quarter of 2019.

Cantor Fitzgerald & Co. is the sole book-running manager for the proposed offering.

ZSAN closed Monday's trading at $5.01, down 1.57%. In after-hours, the stock was down 19.96% to $4.01.

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