KRTX Makes Giant Leap, The Medicines' Working Well, AGRX On The Move

(RTTNews) - Today's Daily Dose brings you news about Karuna Therapeutics' psychosis trial results, The Medicines Co's detailed results from ORION-9 study, Dicerna's collaboration with Novo Nordisk and the 25th biosimilar approved by the FDA.

Read on…

Perceptive Advisors LLC, a major shareholder in Agile Therapeutics Inc. (AGRX), has increased its stake in the firm to 18.5% from 10.37%, according to an SEC filing.

Agile Therapeutics is a women's healthcare company whose lead product candidate, Twirla, also known as AG200-15, is a once-weekly prescription contraceptive patch.

On October 30, 2019, an FDA panel voted 14 to 1, with 1 abstention, that the benefits of Twirla in the prevention of pregnancy outweigh the risks to support approval. The FDA's final decision on Twirla is now set for February 16, 2020. It was originally slated for November 16, 2019.

AGRX closed Monday's trading at $1.37, down 8.05%. In after-hours, the stock was up 20.44% to $1.65.

Dicerna Pharmaceuticals Inc. (DRNA) and Novo Nordisk A/S (NVO) have inked an agreement to discover and develop novel therapies for the treatment of liver-related cardio-metabolic diseases using Dicerna's proprietary GalXC RNAi platform technology.

As per the agreement, each company has the rights to co-develop and co-commercialize product candidates discovered under the collaboration. Novo Nordisk will lead programs targeting cardio-metabolic disorders and other indications with Dicerna having the option to opt into two programs during clinical development.

Under the terms of the agreement, Dicerna is entitled to receive from Novo Nordisk an upfront payment of $175 million, a $50 million equity investment, $25 million annually during each of the first three years of the collaboration, contingent on Dicerna delivering RNAi molecules for a defined number of targets, up to $357.5 million per target in development, regulatory, and commercialization milestone payments, plus tiered royalties on product sales ranging from the mid-single-digits to mid-teens.

The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.

DRNA closed Monday's trading at $21.39, up 10.83%.

Shares of Karuna Therapeutics Inc. (KRTX) skyrocketed as much as 465% in intraday trading to touch a high of $100, following positive results from its phase II clinical trial of KarXT for the treatment of acute psychosis in patients with schizophrenia.

In the clinical trial, KarXT demonstrated a statistically significant and clinically meaningful 11.6 point mean reduction in total Positive and Negative Syndrome Scale score compared to placebo and also demonstrated good overall tolerability. A statistically significant reduction in the secondary endpoints of PANSS-Positive and PANSS-Negative scores were also observed.

The Company plans to have an end-of-phase II meeting with the FDA in the second quarter of 2020, and a phase III clinical trial of KarXT in patients with schizophrenia is expected to be initiated by the end of 2020.

In other news, the Company announced that it has commenced an underwritten public offering of 2.6 million shares of its common stock. Karuna intends to grant the underwriters a 30-day option to purchase an additional 390,000 shares of its common stock, at the public offering price, less the underwriting discounts and commissions.

KRTX closed Monday's trading at $96, up 442.99%. In after-hours, the stock was down 6.47% to $6.21.

The Medicines Company (MDCO) reported detailed results from ORION-9, the last of three pivotal phase III clinical studies of Inclisiran, an investigational twice-yearly therapy to reduce LDL, the "bad" cholesterol.

In the ORION-9 trial, Inclisiran achieved 50% LDL-C lowering with time-adjusted reductions of 45% sustained over 18 months of treatment in patients with heterozygous familial hypercholesterolemia (HeFH).

In the ORION-10 trial, the results of which were announced on November 16, 2019, Inclisiran achieved 58% LDL-C lowering with time-adjusted reductions of 56% sustained over 18 months of treatment in patients with atherosclerotic cardiovascular disease.

The company expects to file regulatory submissions for Inclisiran in the U.S. in the fourth quarter of 2019 and in Europe in the first quarter of 2020.

MDCO touched an all-time high of $59 in intraday trading on Monday, before closing at $58.65, up 12.83%.

Pfizer Inc.'s (PFE) ABRILADA, a biosimilar to Humira, has received FDA approval for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis.

ABRILADA is the fifth Humira biosimilar to secure the regulatory nod in the U.S. Amgen's Amjevita; Boehringer Ingelheim Pharmaceuticals' Cyltezo; Sandoz' Hyrimoz and Samsung Bioepis Co.'s Hadlima are the other 4 FDA-approved Humira biosimilars.

In the U.S., although the biosimilar versions of Humira have been approved, they are not going to be launched till 2023.

HUMIRA, developed by AbbVie (ABV), had global sales of $19.936 billion in 2018, up 8.2% over the prior year.

In the U.S., the first biosimilar to receive FDA approval was Zarxio, in March 2015, and since then, including Pfizer's ABRILADA, 25 biosimilars have secured the FDA nod.

PFE closed Monday's trading at $37.22, down 0.16%.