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CORV Is Back, SENS' Eversense Gets Aetna Coverage, ACRX Nears FDA Decision Day

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The following are some of today's top gainers in the pharma/biotech sector.

1. Correvio Pharma Corp. (CORV)

Gained 25.96% to close Tuesday's (Oct.23) trading at $3.93.

News: Correvio plans to resubmit its New Drug Application for Brinavess, an antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation, during the second quarter of 2019.

The Company has been told by the FDA that no additional studies would be required for the resubmission of the NDA.

Brinavess is approved for marketing in Europe, Canada and several other countries worldwide. The Company has been trying to get approval for BRINAVESS, formerly known as Kynapid, in the U.S. since 2006.

2. Therapix Biosciences Ltd. (TRPX)

Gained 22.17% to close Tuesday's trading at $5.40.

News: The Company is all set to be acquired by Canada-based FSD Pharma Inc. (FSDDF.OB) for US$48 million.

The transaction combines two complementary businesses - the production and distribution of medical and recreational products by FSD Pharma, and the medical and pharmaceutical brands by Therapix Biosciences.

If all goes well as planned, the transaction is anticipated to be completed by Q1 2019.

3. CASI Pharmaceuticals Inc. (CASI)

Gained 20.96% to close Tuesday's trading at $3.52.

News: The Company has acquired a U.S. FDA-approved abbreviated new drug application (ANDA) for Tenofovir disoproxil fumarate, or TDF, from Laurus Labs Limited. The drug, (TDF), is indicated for the treatment of hepatitis B virus.

The upfront and milestone payments involved in the transaction are not disclosed.

4. Senseonics Holdings Inc. (SENS)

Senseonics is a medical technology company commercializing Eversense, a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes.

Gained 17.63% to close Tuesday's trading at $4.07.

News: The Company has announced that Aetna, the third largest commercial health plan provider in the United States, is providing coverage for Eversense, effective immediately.

The coverage decision has the potential to facilitate broad patient and physician access to Eversense in the U.S., according to Senseonics.

5. Regulus Therapeutics Inc. (RGLS)

Gained 15.85% to close Tuesday's trading at $2.12.

News: The Company is scheduled to present preclinical data regarding RGLS4326, a single stranded, chemically modified oligonucleotide in clinical development for Autosomal Dominant Polycystic Kidney Disease (ADPKD), on October 25, at the American Society of Nephrology's Kidney Week.

Recent event:

On October 18, 2018, the Company was notified by the Nasdaq Stock Market LLC "NASDAQ" of having regained compliance with NASDAQ listing requirements.

6. AcelRx Pharmaceuticals Inc. (ACRX)

Gained 10.67% to close Tuesday's trading at $4.15.

News: The Company's investigational drug DSUVIA, for the management of moderate-to-severe acute pain in medically supervised settings for adult patients, is nearing the final FDA decision day, which is expected on November 3.

On October 12, an FDA panel had voted 10-3 in favor of recommending approval of DSUVIA.

DSUVIA is a 30 mcg sufentanil tablet in a pre-filled applicator for sublingual administration by a healthcare professional, and is designed to provide an easy-to-administer dosage form for rapid relief as early as 15 minutes.

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