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FDA Blesses 2nd CAR-T Cell Therapy, NVO One Step Away From Approval, AKTX Slumps

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Today's Daily Dose brings you news about Akari and Ignyta's public offering; Conatus' drug candidate securing orphan designation from the European Medicines Agency; FDA approval of Gilead's CAR-T therapy for refractory large B-cell lymphoma; FDA panel review of Lipocine's oral testosterone product candidate and FDA panel nod for Novo Nordisk's once-weekly Semaglutide.

Read on...

Shares of Akari Therapeutics Plc (AKTX) slumped over 29% on Wednesday, following the pricing of its previously announced underwritten public offering of 3.48 million American Depositary Shares at a public offering price of $5.00 per ADS.

In addition, Akari granted the underwriters a 30-day option to purchase up to an additional 522,000 ADSs at the public offering price, less the underwriting discounts and commissions. The gross proceeds from the offering are expected to be about $17.4 million

Near-term catalyst:

-- The Company plans to advance its lead investigational drug, Coversin, towards Phase III clinical studies in Paroxysmal Nocturnal Hemoglobinuria in Q1 2018.

AKTX closed Wednesday's trading at $4.50, down 29.69%.

Conatus Pharmaceuticals Inc.'s (CNAT) preclinical drug candidate IDN-7314 has been granted orphan designation by the European Medicines Agency for the treatment of primary sclerosing cholangitis.

IDN-7314 was granted Orphan Drug Designation for the treatment of PSC by the FDA in June 2017.

CNAT closed Wednesday's trading at $5.15, up 0.98%.

Gilead's (GILD) subsidiary Kite has secured FDA approval for Yescarta for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

Yescarta, formerly known as KTE-C19, is the first chimeric antigen receptor T cell (CAR T) therapy for patients with relapsed or refractory large B-cell lymphoma who have run out of treatment options and face a dire prognosis.

The drug, which has a list price of $373,000, sports a Boxed Warning in its product label regarding the risks of cytokine release syndrome (CRS) and neurologic toxicities.

Yescarta is also under review with the European Medicines Agency and potential approval is expected in the first half of 2018.

In August of this year, the FDA approved the first CAR-T cell therapy, Kymriah, for children and young adults with B-cell acute lymphoblastic leukemia that is refractory or has relapsed at least twice.

GILD closed Wednesday's trading at $80.0, down 0.29%. In after-hours, the stock was up 3.42% to $82.75.

Shares of Ignyta Inc. (RXDX) were down over 3% in extended trading on Wednesday, following its proposed public offering of common stock.

The Company's lead compound is Entrectinib, which is under development for solid tumors.

A phase II clinical trial of Entrectinib in cancer patients with "fusions" of NTRK1, NTRK2, NTRK3, ROS1, and ALK genes, dubbed STARTRK-2, is ongoing.

The Company announced updated results from its clinical trials, including the STARTRK-2 trial, yesterday.

Based on interim analysis, Entrectinib demonstrated a 78% confirmed objective response rate ORR (by Investigator; 95%) and a 69% confirmed ORR (by Blinded Independent Central Review) in 32 patients with locally advanced or metastatic non-small cell lung cancer that harbored ROS1 fusions.

Entrectinib showed a median duration of response of 28.6 months and median progression free survival of 29.6 months, with 53 percent of patients remaining on study, added the Company.

RXDX closed Wednesday's trading at $16.25, up 13.24%. In after-hours, the stock was down 3.38% to $15.70.

Lipocine Inc.'s (LPCN) New Drug Application for TLANDO, the Company's oral testosterone product candidate, is slated to be reviewed by the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee on January 10, 2018.

The Company is seeking approval of TLANDO as testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

The FDA's decision is expected on February 8, 2018.

LPCN closed Wednesday's trading at $3.99, up 7.55%.

An FDA panel has voted 16-0 recommending the approval of Novo Nordisk's (NVO) once-weekly Semaglutide to improve glycemic control in adults with type 2 diabetes. One member of the committee abstained.

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, belonging to the same class of drugs as that of Lilly's approved drug Trulicity. This class of drugs stimulates insulin and suppress glucagon, the two hormones that work together to regulate blood sugar.

In a head-to-head study comparing Semaglutide and Trulicity, people with type 2 diabetes treated with once-weekly Semaglutide experienced superior reduction in HbA1c and body weight compared to treatment with once-weekly Trulicity.

The FDA's final decision on Semaglutide is expected by December 5, 2017.

NVO touched a new 52-week intra-day high of $50.47 on Wednesday, before closing the day's trading at $50.13, up 1.66%.

XBiotech Inc. (XBIT) has enrolled the first patient in its phase I single arm study evaluating the maximum tolerated dose of Onivyde and 5-fluorouracil/folinic acid in combination with MABp1 in a cohort of patients with advanced pancreatic adenocarcinoma and cachexia.

The study is designed to enrol a total of 16 patients.

XBIT closed Wednesday's trading at $4.30, down 2.49%.

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