ATNX To Face FDA In Feb, ICPT Trims Workforce, JNCE Jumps On GILD Deal, SNY's Kevzara Flops Again

biotech sept02

Today's Daily Dose brings you news about regulatory catalysts of Athenex and Vertex Pharma, layoffs in Intercept, licensing deal between Jounce and Gilead, and Sanofi's repurposed arthritis drug failing to meet goals in the COVID-19 trial.

Read on…

1. Athenex to Face FDA in February

Athenex Inc.'s (ATNX) New Drug Application for oral Paclitaxel in combination with Encequidar, proposed for the treatment of metastatic breast cancer, has been accepted for Priority Review, with a decision date set for February 28, 2021.

Additionally, the company has been informed that the FDA is not currently planning to hold an advisory committee meeting to discuss the NDA.

ATNX closed Tuesday's trading at $12.53, up 9.05%.

2. Evogene Gets $10 Mln Investment

Evogene Ltd. (EVGN) has entered into a definitive agreement with ARK Investment Management, LLC and Alpha Capital Anstalt in connection with a registered direct offering of ordinary shares at a price per share of $1.70, for an aggregate cash consideration of $10 million.

Of the $10 million, ARK Invest, a technology investment firm, specializing in thematic investing in disruptive innovation, will invest $7 million and Alpha Capital Anstalt will invest $3 million.

The offering is expected to close on or before September 3, 2020.

EVGN closed Tuesday's trading at $2.74, up 32.3%.

3. Intercept Pharma Laying Off 25% Workforce

Seeking to streamline its operations and reduce operating expenses, Intercept Pharmaceuticals Inc. (ICPT) has decided to reduce its workforce by approximately 25%, which equates to roughly 170 employees.

As a result of the job cuts, the company will incur aggregate charges of approximately $18.0 million, consisting primarily of severance pay and related termination costs - with the majority of the costs to be incurred during the third quarter of 2020.

The layoff process is expected to be completed by the end of this year.

In June of this year, the FDA refused to approve the company's Obeticholic Acid for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH). The regulatory agency had sought additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval.

ICPT closed Tuesday's trading at $44.53, down 10.73%.

4. Jounce Jumps on Licensing Deal with Gilead

Shares of Jounce Therapeutics Inc. (JNCE) jumped more than 55 percent on Tuesday, following a license agreement with Gilead Sciences Inc. (GILD).

As per the agreement terms, Jounce will exclusively license its investigational monoclonal antibody JTX-1811 to Gilead.

In return, Gilead will make an upfront payment of $85 million and a $35 million equity investment to Jounce. In addition, Jounce is entitled to receive up to an additional $685 million in future clinical, regulatory, and commercial milestone payments as well as royalties ranging from high single-digit to mid-teens based upon worldwide sales, subject to certain adjustments.

JTX-1811 is a monoclonal antibody designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory (TITR) cells. An Investigational New Drug (IND) application for JTX-1811 is scheduled to be filed in the first half of 2021.

Jounce will be responsible for getting IND clearance for JTX-1811, and thereafter, Gilead will have the sole right to develop JTX-1811.

JNCE closed Tuesday's trading at $7.53, up 55.58%.

5. Sanofi's Repurposed Arthritis Drug fails in ex-U.S. COVID-19 Trial Too

Sanofi's (SNY) phase III trial investigating intravenously administered Kevzara at a dose of 200 mg or 400 mg in severely or critically ill patients hospitalized with COVID-19 did not meet its primary endpoint and key secondary endpoints.

The phase III trial, which involved 420 COVID-19 patients, was conducted outside the U.S. in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia, and Spain.

In the Kevzara treatment arms, 26-29% of the patients experienced serious adverse events compared to 24% in the placebo arm.

Kevzara is an approved drug to treat moderate to severe rheumatoid arthritis in adults.

In July, the company had announced that a phase III trial of Kevzara involving hospitalized patients with COVID-19 in the U.S., failed to achieve its primary and key secondary endpoints.

SNY closed Tuesday's trading at $49.94, down 1.27%.

6. Vertex Seeks to expand the label of Cystic Fibrosis Drugs

The FDA has accepted for review Vertex Pharmaceuticals Inc.'s (VRTX) three supplemental New Drug Applications for TRIKAFTA, SYMDEKO, and KALYDECO, and has assigned a decision date of December 30, 2020.

The company is seeking approval to expand the label of the three cystic fibrosis drugs to include additional rare CFTR mutations, allowing people with cystic fibrosis (CF) not previously eligible for these medicines an opportunity to benefit from treatment that targets the underlying cause of their disease.

In addition, these regulatory submissions may also allow certain people with CF who are currently eligible for KALYDECO to become eligible for SYMDEKO or TRIKAFTA and certain people currently eligible for SYMDEKO to become eligible for TRIKAFTA.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2020. The regulatory submissions are based on data from an in vitro cell assay showing that these rare CFTR mutations respond to one or more of these CFTR modulator regimens.

VRTX closed Tuesday's trading at $275.49, down 1.30%.

7. Stocks That Moved On No News

Nano-X Imaging Ltd. (NNOX) closed Tuesday's trading at $35.75, up 29.72%.

TRACON Pharmaceuticals Inc. (TCON) closed Tuesday's trading at $2.41, up 27.51%.

Nurix Therapeutics Inc. (NRIX) closed Tuesday's trading at $27.27, up 16.54%.

Vir Biotechnology Inc. (VIR) closed Tuesday's trading at $33.89, down 16.28%.

UroGen Pharma Ltd. (URGN) closed Tuesday's trading at $21.32, down 15.03%.

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