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AKAO On Watch, SCYX To Report Data In July, FDA Panel Nod For SIGA

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Today's Daily Dose brings you news about FDA panel backing for SIGA's smallpox drug; Karyopharm's public offering; Veracyte's rosy outlook; Retrophin's upcoming milestones and expansion of VIVUS' commercial product portfolio.

Read on…

Karyopharm Therapeutics Inc. (KPTI) has commenced a registered underwritten public offering of $125 million in shares of its common stock. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to $18.75 million in shares of its common stock.

On April 30, 2018, the Company reported positive top-line data from Part 2 of its phase IIb trial of Selinexor in patients with Penta-Refractory Multiple Myeloma, dubbed STORM.

Near-term Catalysts:

-- Karyopharm plans to submit a New Drug Application to the FDA during the second half of 2018, with a request for accelerated approval for oral Selinexor as a new treatment for patients with penta-refractory multiple myeloma.
-- The Company also plans to submit a Marketing Authorization Application to the European Medicines Agency in early 2019 with a request for conditional approval.
-- A phase III study evaluating Selinexor in combination with Velcade and dexamethasone (SVd) for the treatment of patients with multiple myeloma who have had one to three prior lines of therapy, dubbed BOSTON, is ongoing - with top-line data anticipated in 2019.

KPTI closed Tuesday's trading at $14.51, up 10.93%. In after-hours, the stock fell 3.03% to $14.07.

Ophthotech Corp. (OPHT) has completed patient enrollment in its phase 2a clinical trial of Zimura in patients with wet age-related macular degeneration. A total of 64 patients have been enrolled in the study.

Zimura is administered in combination with Lucentis in treatment naïve patients with wet AMD.

The Company expects initial top-line data from the study to become available before the end of 2018.

OPHT closed Tuesday's trading at $2.62, down 0.38%.

Retrophin Inc. (RTRX) has a couple of events to watch out for in the coming months.

A phase III trial of Fosmetpantotenate in patients with pantothenate kinase-associated neurodegeneration, aged 6 to 65 years, dubbed FORT, is underway.

Enrollment of pediatric patients is expected to commence in the FORT Study during the second quarter of 2018, and completion of patient enrollment around year-end 2018.
Top-line data are expected in the second half of 2019.

A pivotal phase III clinical trial evaluating the safety and efficacy of Sparsentan in patients with focal segmental glomerulosclerosis, aged 8 to 75 years, known as DUPLEX Study, is ongoing. Top-line data from the 36-week interim endpoint efficacy analysis are expected in the second half of 2020.

A pivotal phase III trial of Sparsentan in IgA nephropathy is expected to be initiated in the fourth quarter of 2018.

A phase II proof-of-concept study of CNSA-001 in patients with phenylketonuria (PKU) remains on track to commence in mid-2018, with results expected to be available in early 2019.

An NDA for the new formulation of Thiola for the treatment of cystinuria is expected to be filed this year.

RTRX closed Tuesday's trading at $25.18, up 0.32%.

SCYNEXIS Inc.'s (SCYX) oral formulation of SCY-078 has been granted both Qualified Infectious Disease Product and Fast Track designations for the treatment of vulvovaginal candidiasis (VVC) and for the prevention of recurrent VVC.

The Company has completed enrollment in its phase 2b, dose-finding study of oral SCY-078 for the treatment of VVC, dubbed DOVE, with release of top-line data expected by July 2018.

SCYX closed Tuesday's trading at $1.29, up 9.32%.

An FDA panel has voted unanimously, 17 to 0, recommending approval of SIGA Technologies Inc.'s (SIGA) oral TPOXX, a small molecule antiviral treatment for smallpox.

TPOXX was developed under the FDA "Animal Rule," in which efficacy endpoints are determined in animal studies, and human clinical studies are conducted to determine safety and confirm dosing.

The FDA's final decision on TPOXX is expected on August 8, 2018.

SIGA closed Tuesday's trading at $5.89, down 1.34%.

Trevena Inc. (TRVN) has granted Jiangsu Nhwa Pharmaceutical Co. Ltd. exclusive license to develop and commercialize its investigational product Oliceridine for the management of moderate to severe acute pain.

Oliceridine (brand name Olinvo) is under FDA review, with a decision expected in the fourth quarter of 2018. Oliceridine is also scheduled to be reviewed by an FDA panel on November 2, 2018.

Under the agreement, Trevena expects to receive near-term payments of $5.5 million, including an upfront payment of $2.5 million and a milestone payment of $3.0 million upon regulatory approval of Oliceridine in the United States, as well as additional approval and commercialization milestones and 10% royalties on all product sales in China.

TRVN closed Tuesday's trading at $1.81, down 2.69%. In after-hours, the stock was up 7.73% to $1.95.

Veracyte Inc. (VCYT) reported solid financial results for the first quarter of 2018, and boosted its 2018 annual revenue guidance.

Net loss and comprehensive loss for the recent first quarter widened to $9.18 million or $0.27 per share from $8.22 million or $0.24 per share in the year-ago quarter. Revenue rose to $20 million in Q1, 2018 from $16.43 million in the comparable year-ago period.

The Company has increased its 2018 annual revenue guidance range to $83 million to $86 million, from its prior guidance of $81 million to $83 million.

VCYT closed Tuesday's trading at $6.13, up 1.16%.

VIVUS Inc. (VVUS) has entered into a definitive agreement to acquire all product rights for PANCREAZE Delayed-Release Capsules in the United States and Canada held by Janssen Pharmaceuticals Inc. for $135 million.

PANCREAZE is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions.

The acquisition of PANCREAZE by VIVUS is the first step towards expanding its commercial product portfolio, and series of product acquisitions are expected to follow suit.

VVUS closed Tuesday's trading at $0.53, up 46.68%.

Today's event to watch:

A panel of outside experts convened by the FDA will vote on Achaogen Inc.'s (AKAO) Plazomicin on May 2, 2018.

Plazomicin IV is proposed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and bloodstream infections (BSI) due to certain Enterobacteriaceae in patients who have limited or no alternative treatment option.

The FDA's final decision on Plazomicin is expected on June 25, 2018.

AKAO closed Tuesday's trading at $14.70, up 2.73%.

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