AGTC Abuzz, AMRN Slumps & CORT Soars As Oral Arguments Commence, FLGT Gears Up, NNVC On Watch

biotech sept03

Today's Daily Dose brings you news about Applied Genetic's upcoming presentation, oral arguments in patent suits of Amarin and Corcept, Fulgent's partnership with New York City Health and Hospitals, NanoViricides' update on COVID-19 drug development, and Sunesis Pharma's reverse stock split, among others.

Read on…

1. Applied Genetic Tech To present New data On Sep.9

Applied Genetic Technologies Corp. (AGTC) is scheduled to present new preliminary visual sensitivity data from Group 5 of a phase I/II trial of its lead product candidate in X-Linked Retinitis Pigmentosa on September 9.

The company will also present an update on its planned Phase 2/3 X-Linked Retinitis Pigmentosa (XLRP) clinical trial design.

A full interim data from Groups 5 and 6 of the phase I/II trial in X-Linked Retinitis Pigmentosa analysis is expected to be provided next quarter.

AGTC closed Wednesday's trading at $5.15, up 0.19%. In after-hours, the stock was up another 13.20% at $5.83.

2. Will Amarin prevail in the Appeal?

Shares of Amarin Corporation plc (AMRN) slumped over 30 percent Wednesday, as oral arguments in the company's appeal in the patent case related to its lead drug Vascepa commenced.

Vascepa is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, and as an adjunct to statin therapy to reduce the risk of cardiovascular events. The drug generated annual sales of $427 million for Amarin in 2019 compared to $228 million in 2018.

In March of this year, the patents covering Vascepa were invalidated by a Nevada district judge, favoring Hikma and Dr. Reddy's Labs, paving the way for generic versions of the drug to be launched in the U.S. The ruling was appealed by Amarin and as mentioned above, the oral hearing commenced on September 2.

AMRN closed Wednesday's trading at $5.04, down 30.58%.

3. Corcept's Patent Fight

Shares of Corcept Therapeutics Inc. (CORT) jumped over 58% Wednesday, following the commencement of oral arguments of an *inter partes review related to the validity of the company's flagship drug Korlym for Cushing's syndrome.

Corcept is locked in a patent battle over Korlym with Teva Pharmaceuticals (TEVA) and Sun Pharmaceuticals, which are seeking to sell a generic version of Korlym.

Teva received tentative approval from the FDA for its generic version of Korlym in October 2018 while Sun Pharma filed for a generic version of the drug last June.

In its lawsuit, originally filed against Teva in 2018 and then amended in 2019, Corcept has alleged that Teva's generic version of Korlym infringes on 6 patents covering the brand drug Korlym, i.e., '348 patent, '495 patent, '526 patent, '214 patent, '242 patent and '243 patent.

Last May, Teva petitioned the Patent Trial and Appeals Board (PTAB), challenging the validity of the '214 patent covering Korlym. The decision of the PTAB is expected on November 19. The trial is slated to begin on February 2, 2021.

Korlym brought in quarterly revenue of $88.6 million in the second quarter of 2020 compared to $72.3 million in the second quarter of 2019.

*An inter partes review (IPR) is a trial proceeding conducted at the Patent Trial and Appeal Board to review the patentability of one or more claims of an issued patent. (Source: Smith & Hopen).

CORT closed Wednesday's trading at $19.87, up 58.45%.

4. Fulgent Genetics In full gear to fight COVID-19

Fulgent Genetics (FLGT) is teaming up with New York City Health and Hospitals to provide COVID-19 testing to hundreds of thousands of students across nearly 1,600 sites when they return to school in September and in the coming months.

Fulgent's at-home testing solution for COVID-19, which was issued Emergency Use Authorization by the FDA in June, utilizes a self-collected nasal swab sample. Fulgent will provide results within 24-48 hours from the time when Fulgent receives and accepts a specimen for the test.

FLGT closed Wednesday's trading at $28.83, down 0.31%.

5. All Eyes On NanoViricides

NanoViricides Inc. (NNVC) is slated to make a presentation related to its COVID-19 drug development at the LD 500 investor conference on Thursday, September 3rd.

The company noted that in lab studies, its COVID-19 drug development candidates have shown efficacy against multiple different coronaviruses and that it is working to finalize its clinical candidate.

NNVC closed Wednesday's trading at $5.58, up 42.35%.

6. Rocket Pharma To Report Danon Disease Trial Data In Q4

Rocket Pharmaceuticals Inc. (RCKT) has treated the first patient in the higher dose cohort in its phase I clinical trial of RP-A501, an adeno-associated viral vector (AAV)-based gene therapy, for the treatment of Danon Disease.

Danon disease is a condition characterized by weakening of the heart muscle (cardiomyopathy); weakening of the muscles used for movement, called skeletal muscles, (myopathy); and intellectual disability. Males with Danon disease usually develop the condition earlier than females and are more severely affected. (Source: NIH).

The phase I study is designed to enroll both pediatric and young adult male patients, with preliminary safety and efficacy data expected in the fourth quarter of this year.

RCKT closed Wednesday's trading at $24.78, down 1.27%.

7. Sunesis Pharma Implements Reverse Stock Split

Sunesis Pharmaceuticals Inc. (SNSS) implemented a 1-for-10 reverse stock split after the bell Wednesday, in order to regain compliance with the $1.00 minimum bid price rule required for continued listing on the Nasdaq.

SNSS closed Wednesday's trading at $0.16, down 37.00%.

8. Sutro Biopharma To Present Updated Data On STRO-002 Trial

Sutro Biopharma Inc. (STRO) announced that data from a phase I dose escalation study of STRO-002 in ovarian and endometrial cancer demonstrate promising efficacy and safety profile in a heavily pretreated patient population.

The company is slated to host a conference call on Sept. 9 to discuss updated data from the trial.

STRO closed Wednesday's trading at $11.27, up 11.53%.

9. Stocks That Moved On No News

Baudax Bio Inc. (BXRX) closed Wednesday's trading at $3.85, up 26.64%.

SmileDirectClub Inc. (SDC) closed Wednesday's trading at $9.80, up 24.52%.

Repare Therapeutics Inc. (RPTX) closed Wednesday's trading at $29.05, up 15.51%.

Rexahn Pharmaceuticals Inc. (REXN) closed Wednesday's trading at $1.78, down 17.97%.

Aptorum Group Limited (APM) closed Wednesday's trading at $1.78, down 13.17%.

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