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FDA Approves First Neulasta Biosimilar, HQY Hits New High, TGTX Turns Heads


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(RTTNews.com) - Today's Daily Dose brings you news about Cellectis' progress related to its CAR T-cell product candidate; HealthEquity's first-quarter results; FDA approval of the first biosimilar to Neulasta; TG Therapeutics' encouraging updated clinical data from its ongoing Phase 2 study of Umbralisib in patients with relapsed or refractory Chronic Lymphocytic Leukemia; and TESARO's TOPACIO and QUADRA trial results.

Read on…

Cellectis (CLLS) is all set to initiate a Phase 1 clinical trial for UCART22 for the treatment of B-cell acute lymphoblastic leukemia (B-ALL) in adult patients in the second half of 2018.

UCART22 is the 3rd allogeneic, off-the-shelf, gene-edited CAR T-cell product candidate to enter into clinical trials - the other two being UCART19, exclusively licensed to Servier, and UCART123.

In the study, Dose level 1 of 1x105 UCART22 cells per kilogram, Dose level 2 of 1x106 UCART22 cells per kilogram, and Dose level 3 of 5x106 UCART22 cells per kilogram will be administered.

CLLS closed Monday's trading at $30.18, down 0.63%.

Shares of HealthEquity Inc. (HQY) rose more than 4% in extended trading on Monday, following the Company's solid first-quarter results and rosy outlook for the year.

For the first quarter ended April 30, 2018, net income was $22.6 million or $0.36 per share on revenue of $69.9 million. This compared with a net income of $14.0 million or $0.23 per share and revenue of $55.4 million.

For the year ending January 31, 2019, the Company now expects revenue to be between $278 million and $284 million; net income to be in a range of $55 million to $59 million, resulting in a net income per share range of $0.86 to $0.92.

Previously for the year, the Company had forecast revenue of $276.0 million and $282.0 million; net income in the range of $47.0 million to $51.0 million, resulting in a net income per share range of $0.74 to $0.80.

HQY closed Monday's trading at $76.36, up 0.35%. In after-hours, the stock was up 4.77% to $80.00.

The FDA has approved Mylan N.V. (MYL) and Biocon Ltd.'s Fulphila, a biosimilar of Amgen's blockbuster Neulasta for treating side effects from chemotherapy.

Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer.

Mylan anticipates launching Fulphila in the coming weeks.

Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon's joint portfolio approved in the U.S.

Fulphila, also known as MYL-1401H, was turned down by the FDA last October, pending update of the Biologics License Application with certain CMC data from facility requalification activities post recent plant modifications.

Coherus Biosciences, Sandoz and Apotex are the other companies developing Neulasta biosimilars.

Coherus resubmitted its BLA for CHS-1701, a biosimilar version of Neulasta, last month, and a decision is awaited. Novartis' subsidiary Sandoz expects to resubmit the BLA for LA-EP2006, a proposed biosimilar of Neulasta, this year.

Neulasta raked in had U.S. sales of $4.2 billion for the 12 months ending March 31, 2018, according to IQVIA.

MYL closed Monday's trading at $38.50, down 0.88%.

TG Therapeutics Inc. (TGTX) presented encouraging updated clinical data from its ongoing Phase 2 study of Umbralisib in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) who are intolerant to prior BTK or PI3K delta inhibitor therapy.

According to the updated results, "Umbralisib demonstrated a favorable safety profile in patients intolerant to prior BTK or PI3K therapy. Only 13% discontinued due to an adverse event, of which only one patient discontinued due to a recurrent adverse event (AE) also experienced with prior KI therapy. Nodal reductions were seen in nearly all patients evaluable for response with 3 patients achieving complete resolution of nodal disease".

TGTX closed Monday's trading at $14.90, up 10.78%.

TESARO Inc.'s (TSRO) TOPACIO and QUADRA trial results presented on Monday demonstrate the potential of ZEJULA not only as a monotherapy treatment for women with advanced ovarian cancer, but also in combination with an anti-PD-1 antibody, to provide a meaningful clinical benefit to patients beyond those with BRCA mutations.

TOPACIO is a Phase 1/2 clinical trial designed to evaluate the safety and efficacy of ZEJULA plus KEYTRUDA in patients with recurrent, platinum-resistant/refractory ovarian cancer or triple-negative breast cancer (TNBC).

QUADRA is a phase II study of ZEJULA in patients with ovarian cancer who have received three or four previous chemotherapy regimens. ZEJULA (niraparib) is approved for the maintenance treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

TESARO intends to submit a sNDA to FDA, seeking label expansion for ZEJULA in the fourth quarter of 2018.

TSRO closed Monday's trading at $42.28, down 9.83%.

VAYA Pharma Inc., a division of Frutarom Industries Ltd. (FRUTF.PK) has launched Vayarin Plus, a medical food for the dietary management of attention-deficit/hyperactivity disorder (ADHD) in adults and adolescents.

Vayarin Plus is a line extension of the Company's flagship product Vayarin, a medical food for the dietary management of ADHD in children 6-13 years of age that has been available in the U.S. since 2011.

Vayarin Plus is available in 1-month supply bottles through local pharmacy, and in 1-month and 3-month bottles through VAYA at www.vayadirect.com, the Company added.


Read the original article on RTTNews (http://www.rttnews.com/2901615/fda-approves-first-neulasta-biosimilar-hqy-hits-new-high-tgtx-turns-heads.aspx)


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