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NVS Gets Thumbs Up, Two Biosimilar Candidates To Face FDA Panel, VKTX On Track


Today's Daily Dose brings you news about Amicus' stock offering; the regulatory events related to two biosimilar candidates; Asterias' progress with SCiStar trial; Novartis' leukemia drug wining FDA panel endorsement and the near-term clinical trial catalyst of Viking.

Read on...

Alder Biopharmaceuticals Inc. (ALDR) has offered to sell 15 million shares of its common stock to the public at a price of $10.00 each.

The underwriters have a 30-day option to purchase up to 2.25 million additional shares of common stock at the public offering price. The offering is expected to close on July 18, 2017.

On June 27, 2017, the Company reported positive results from its phase III pivotal clinical trial of Eptinezumab for migraine prevention, dubbed PROMISE I.

The primary endpoint, demonstrating statistically significant reductions in monthly migraine days from baseline over weeks 1 through 12 was 4.3 monthly migraine days for 300mg and 3.9 days for 100mg compared to an average 3.2 days for placebo.

The second pivotal phase III study that focuses on chronic migraine, dubbed PROMISE 2, is enrolling participants, and the Company expects to submit the BLA for Eptinezumab in the second half of 2018.

ALDR closed Wednesday's trading at $10.12, down 17%.

An FDA panel is scheduled to review ABP 215, a biosimilar candidate to Avastin, on July 13, 2017.

Amgen (AMGN) and Allergan PLC (AGN) are collaborating on the development of ABP 215.

Roche's Avastin, the first angiogenesis inhibitor to be approved by the FDA in 2004, is indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer, HER2-negative breast cancer, glioblastoma, renal cell carcinoma and cervical cancer. Avastin generated sales of $6.71 billion for Roche in 2016.

The FDA's final decision on ABP 215 is expected to be announced on September 14, 2017.

AMGN closed Wednesday's trading at $173.27, down 0.03%.

Amicus Therapeutics (FOLD) has offered to sell 18.36 million shares of its common stock to the public at a price of $12.25 per share.

The underwriters have a 30-day option to purchase up to an additional 2.75 million shares of its common stock. The gross proceeds from the offering to Amicus are expected to be $225 million.

The offering is expected to close on July 18, 2017, subject to customary closing conditions.

FOLD closed Wednesday's trading at $13.17, up 1.93%.

Asterias Biotherapeutics Inc. (AST) has completed enrollment and dosing of the AIS-B 10 million cell cohort in the company's ongoing Phase 1/2a clinical study of AST-OPC1 in complete cervical spinal cord injury, dubbed SCiStar.

In this cohort, five patients with AIS-B grade spinal cord injury were administered 10 million AST-OPC1 cells. The company expects to report top-line six-month results from this cohort in January 2018.

The SCiStar study has now completed enrollment and dosing in three of the five planned cohorts.

AST closed Wednesday's trading at $3.45, up 1.47%.

The FDA has granted Mallinckrodt plc's (MNK) investigational drug MNK-1411 orphan drug designation for the treatment of Duchenne muscular dystrophy.

MNK-1411 is a long-acting formulation containing cosyntropin acetate, which has completed a Phase 1 study in healthy volunteers. The compound is expected to move into phase II testing later this year.

MNK closed Wednesday's trading at $44.10, up 2.44%.

Mylan N.V.'s (MYL) biologics license application for MYL-1401O, a proposed biosimilar to Roche's breast cancer med Herceptin, is slated to be reviewed by an outside panel of FDA experts on July 13, 2017.

MYL-1401O is co-developed by Mylan and Biocon.

In March of this year, Roche provided a global license for Mylan to commercialize biosimilar Herceptin in various markets around the world. In return, Mylan agreed to withdraw its pending Inter Partes Review (IPR) challenges against two U.S. Genentech patents.

Roche's Herceptin recorded sales of about $6.7 billion last year.

The FDA's final decision date on MYL-1401O is set for September 3, 2017.

If approved, MYL-1401O will be the first Herceptin biosimilar to secure the FDA nod.

MYL closed Wednesday's trading at $38.58, up 2.47%.

An FDA panel has voted 10-0, unanimously recommending the approval of Novartis AG's (NVS) Tisagenlecleucel-T suspension for the treatment of relapsed or refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia.

Tisagenlecleucel-T suspension is Novartis' first chimeric antigen receptor T cell (CAR-T) therapy to have reached the FDA altar.

On March 29, 2017, the Company announced that the BLA for Tisagenlecleucel-T suspension was granted priority review by the FDA. Although the decision date has not been disclosed, we estimate that the decision is likely to be announced by September 29, 2017 based on the review timeline of 6 months for priority review.

NVS closed Wednesday's trading at $83.21, up 1.49%.

Trovagene Inc. (TROV) has partnered with Novogene Co. Ltd., a global provider of genomic services and solutions.

As part of the deal, Novogene will purchase NextCollect, Trovagene's proprietary urine collection and nucleic acid preservation device for validation in the Chinese market.

The first shipments of NextCollect are planned for July 2017 to support the Novogene partnership and Trovagene's biomarker testing services with pharmaceutical companies, including AstraZeneca.

TROV closed Wednesday's trading at $1.45, up 10.69%.

Viking Therapeutics Inc. (VKTX) has completed enrollment in its ongoing phase II clinical trial of VK5211 in patients recovering from hip fracture.

A total of 108 patients have been randomized to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks. The study's primary endpoint will evaluate the effects of VK5211 on lean body mass after 12 weeks of treatment. Secondary and exploratory objectives include assessments of functional performance, quality-of-life, and activities of daily living, as well as safety, tolerability and pharmacokinetics.

The results from the phase II study of VK5211 are anticipated in the fourth quarter of this year.

VKTX closed Wednesday's trading at $1.10, down 1.79%.

by RTTNews Staff Writer

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