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FDA Makes 1st Approval Under Project Orbis, KDMN On Watch, TBIO Down After-hrs

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Today's Daily Dose brings you news about Bankruptcy filing of Sienna Biopharma; the first approval under FDA's Project Orbis, and public offering of Translate Bio.

Read on…

Sienna Biopharmaceuticals Inc. (SNNA) has elected to file a voluntary petition to allow restructuring under Chapter 11 of the Bankruptcy Code.

Commenting on the development, Frederick Beddingfield, President and Chief Executive, said, "The protections afforded by Chapter 11 provide for an orderly restructuring process as well as additional time to pursue financial and strategic alternatives. Through this process, we expect to be able to maintain ongoing business activities while we continue to focus our resources on locating a purchaser or strategic partner to maximize the value of the Company."

SNNA closed Tuesday's trading at $0.17, down 73.56%.

Merck's (MRK) Biologics License Application for investigational Ebola vaccine V920 is under FDA review, with a decision anticipated by March 14, 2020. V920 is also under review by the European Medicines Agency.

In other news, the Company's blockbuster drug KEYTRUDA plus Eisai's LENVIMA combination has received FDA approval for treatment of patients with certain types of endometrial carcinoma. The approval marks the first under Project Orbis, an initiative of the FDA Oncology Center of Excellence, to receive simultaneous review decisions in the U.S., Australia and Canada.

Under Project Orbis, the FDA, the Australian Therapeutic Goods Administration (TGA) and Health Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.

MRK closed Tuesday's trading at $82.51, up 0.59%.

Capricor Therapeutics (CAPR) is slated to present expanded interim results from the randomized, double-blind, Phase II clinical trial of CAP-1002 in boys and young men with Duchenne muscular dystrophy, dubbed HOPE-2, on October 5, 2019, at the 24th International Congress of the World Muscle Society.

In July of this year, the Company announced that a pre-specified interim analysis performed on 6-month data from the HOPE-2 trial showed statistically significant results across several independent clinical measures.

CAPR closed Tuesday's trading at $3.10, up 13.97%.

The FDA has approved Kadmon Holdings Inc.'s (KDMN) generic version of Trientine Hydrochloride Capsules USP, 250 mg for the treatment of Wilson's disease in patients who are intolerant of penicillamine.

The Company's generic version of Trientine Hydrochloride has proven to be bioequivalent and therapeutically equivalent to the reference listed drug, Syprine Capsules, 250 mg, developed by Valeant Pharmaceuticals.

Syprine has been marketed since the 1960s, and the first generic version of Syprine was that of Teva Pharma, approved in February 2018.

According to Drugs.com, the cost for Syprine oral capsule 250 mg is around $22,212 for a supply of 100 capsules. The launch of a generic version of Syprine didn't bring cheer to patients because according to reports, the price tag of Teva's generic version of Syprine is $18,275 for 100 pills.

Wilson's disease is a condition characterized by accumulation of copper in the body, leading to organ and neurological damage if left untreated.

KDMN closed Tuesday's trading at $2.62, down 3.32%.

Translate Bio Inc. (TBIO) has offered to sell 9 million shares of its common stock at a public offering price of $10.00 per share.

The gross proceeds from the offering are expected to be $90 million. In addition, Translate Bio has granted the underwriters a 30-day option to purchase up to 1.35 million additional shares of common stock at the public offering price, less the underwriting discounts and commissions.

The offering is expected to close on September 20, 2019, subject to the satisfaction of customary closing conditions.

TBIO closed Tuesday's trading at $10.99, up 3.88%.

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