First Drug For 2 Forms Of MS Gets FDA Nod, RTTR Abuzz, VRTX Gains On Trial Data

(RTTNews) - AstraZeneca plc's (AZN) New Drug Application for LYNPARZA tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting has been accepted for priority review by the FDA - with a decision expected in the third quarter 2017.

In clinical trials, LYNPARZA demonstrated a median Progression Free Survival of 30.2 months compared with 5.5 months for placebo, representing an improvement of 24.7 months.

LYNPARZA capsules (400mg twice daily) are currently approved in the U.S. as a monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.

AZN closed Tuesday's trading at $31.33, down 1.48%.

Shares of Catalyst Biosciences Inc. (CBIO) soared more than 190% on Tuesday, following the go-ahead from the Korean Ministry of Food and Drug Safety to conduct a clinical trial with CB 2679d/ISU30, a next-generation Factor IX drug for the treatment of patients with hemophilia B.

Accordingly, Catalyst's collaborator, ISU Abxis, plans to initiate a phase 1/2 proof-of-concept study in individuals with severe hemophilia B in the second quarter of 2017.

After phase 1/2 study, ISU Abxis has an option for exclusive commercial rights in South Korea and a profit share on ex-South Korean commercialization. Catalyst retains full development and commercial rights for CB 2679d/ISU304 outside of South Korea.

CBIO touched a new high of $18.88 on Tuesday, before closing the day's trading at $15.01, up 191.46%.

InVivo Therapeutics Holdings Corp. (NVIV) on Tuesday announced that yet another patient in the INSPIRE study of the Neuro-Spinal Scaffold has been converted from complete to incomplete spinal cord injury with sensory and motor improvements.

This is the seventh out of the 11 patients (63.6% conversion rate) with at least one month of follow-up to have had an AIS grade improvement, noted the company. Two additional patients are early in follow-up and have not yet had their one-month visit.

NVIV closed Tuesday's trading at $4.15, up 2.47%.

The FDA has approved Roche's (RHHBY.OB) OCREVUS for relapsing and primary progressive forms of multiple sclerosis.

OCREVUS becomes the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis (MS). The majority of people with MS have a relapsing form or primary progressive MS at diagnosis.

OCREVUS will be available to people in the U.S. within two weeks. The drug could have peak sales in the range of $2.6 billion to $3.8 billion, say some analysts.

RHHBY.OB closed Tuesday's trading at $32.03, down 0.65%.

Ritter Pharmaceuticals Inc.'s (RTTR) topline findings from its phase 2b/3 study of RP-G28 in subjects with lactose intolerance have demonstrated efficacy and clinically meaningful benefit.

In some people, consuming milk and dairy products can result in diarrhea, gas and bloating. The reason is that they lack lactase, an enzyme which is necessary to break down lactose in the small intestine. This condition is known as lactose intolerance, one of the most common food intolerances.

The primary endpoint of the trial, i.e., a clinically meaningful benefit to patients suffering from lactose intolerance, met statistical significance, and no significant adverse events (SAEs) were reported from treatment, says the company.

Based on the trial results, the company believes that the successful completion of a confirmatory phase III program could be adequate to support a New Drug Application submission and therefore has requested an end-of-Phase II meeting with the FDA.

RTTR closed Tuesday's trading at $1.95, down 0.51%. In after=hours, the stock was up 15.38% to $2.25.

The FDA has approved Regeneron Pharmaceuticals Inc.'s (REGN) and Sanofi's (SNY) Dupixent for the treatment of adults with moderate-to-severe atopic dermatitis.

DUPIXENT (dupilumab) Injection becomes the first and only biologic medicine approved for this indication.

Atopic dermatitis, also known as atopic eczema, is a skin disorder that involves scaly and itchy rashes. This chronic disorder is more common in infants, but can also develop in children and adults.

In order to provide support and services to patients throughout every step of the treatment process, Regeneron and Sanofi have launched a comprehensive and specialized program known as DUPIXENT MyWay. This program will help eligible patients who are uninsured, lack coverage, or need assistance with their out-of-pocket costs, added the companies.

Dupixent is also being explored in multiple indications, including asthma and pediatric atopic dermatitis.

According to analysts, Dupixent could reach peak annual sales of up to $3 billion if approved for atopic dermatitis and asthma.

Last December, the FDA approved a topical treatment for atopic dermatitis by the name Eucrisa, developed by Anacor Pharmaceuticals, which Pfizer Inc. (PFE) acquired last May.

But Eucrisa targets a milder form of atopic dermatitis and it addresses a different patient population - i.e., patients two years of age and older.

REGN closed Tuesday's trading at $382.55, down 0.29%.

Shares of Vertex Pharmaceuticals Inc. (VRTX) were up more than 18% in extended trading on Tuesday as two phase III studies of Tezacaftor/Ivacaftor combination treatment, dubbed EVOLVE and EXPAND, met the primary endpoints with statistically significant improvements in Lung Function (FEV1) in people with Cystic Fibrosis.

The EVOLVE study evaluated the combination of Tezacaftor/Ivacaftor in people who have two copies of the F508del mutation. The second study, EXPAND, evaluated the combination treatment in people who have one mutation that results in residual CFTR function and one F508del mutation.

Commenting on the results, Jeffrey Chodakewitz, Executive Vice President and Chief Medical Officer at Vertex said, "The tezacaftor/ivacaftor combination treatment demonstrated clinically meaningful benefits, with a favorable safety profile, across multiple patient groups. This combination treatment may provide a promising new option for treating the underlying cause of CF in the future and brings us increasingly closer to our goal of developing new medicines for all people with the disease".

VRTX closed Tuesday's trading at $89.67, down 1.24%. In after-hours, the stock was up 18.21% to $106.00.