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FDA Panel Snubs ENDP, Watch Out For TCON, MRK's Keytruda Scores Another Win

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Allergan plc (AGN) has entered into a strategic R&D alliance with Editas Medicine Inc. (EDIT) to discover and develop CRISPR genome editing medicines for eye diseases.

CRISPR, which stands for "clustered regularly interspaced short palindromic repeats," is an advanced genetic engineering technique. Editas has licensed its CRISPR technology from Broad Institute.

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The R&D alliance entitles Allergan to receive exclusive access and the option to license up to five of Editas Medicine's genome-editing ocular programs, including its lead program for Leber Congenital Amaurosis (LCA10), which is currently in pre-clinical development, for an upfront payment of $90 million.

Editas Medicine has the potential to earn additional payments for achieving important near-term milestones specifically related to LCA10 and receive development and commercial milestones, as well as royalty payments on a per-program basis.

EDIT closed Tuesday's trading at $26.04, up 4.54%.

An FDA panel, which reviewed Endo International plc's (ENDP) new formulation of Opana ER designed to be crush-resistant, has voted 18 to eight, with one abstention, that the benefits of the drug no longer outweigh its risks.

Opana ER was approved by the FDA in 2006 for patients requiring continuous, around-the-clock opioid treatment for an extended period of time. The new formulation of Opana ER received FDA approval in December 2011.

In June 2015, the Centers for Disease Control and Prevention blamed the reformulated Opana ER for an outbreak of HIV in southern Indiana.

While the FDA will consider the Committees' vote, any decision regarding whether to take regulatory action rests solely with the Agency.

Net sales of Opana ER in the nine months ended September 30, 2016 declined to $120.05 million from $132.16 million in the comparable year-ago period.

ENDP closed Tuesday's trading at $10.22, down 4.22%.

The FDA has granted accelerated approval to Merck's (MRK) immuno-oncology blockbuster drug Keytruda for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or who have relapsed after three or more prior lines of therapy.

The accelerated approval is based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials, the company noted.

Keytruda has already received FDA approval for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, and recurrent or metastatic head and neck squamous cell carcinoma.

The drug brought home sales of $1.40 billion in 2016, up 148% compared to 2015.

The FDA decision on the supplemental Biologics License Application for KEYTRUDA for previously treated patients with advanced microsatellite instability-high (MSI-H) cancer is now set for June 9, 2017. The decision was supposed to have been announced on March 8, 2017.

MRK closed Tuesday's trading at $64.20, up 0.08%.

Pulse Biosciences Inc. (PLSE) has submitted a 510(k) to the FDA for its PulseTx System for a general indication for soft tissue ablation.

The PulseTx System is based on the Company's proprietary technology called Nano-Pulse Stimulation.

PLSE closed Tuesday's trading at $21.00, up 1.79%.

TRACON Pharmaceuticals (TCON) has received financial support from Aspire Capital Fund LLC., thanks to the $21 million common stock purchase agreement.

Under the terms of the Agreement, Aspire Capital has made an initial purchase of $1.0 million of TRACON common stock at $4.50 per share, and has committed to purchase up to $20.0 million of additional shares of the Company's common stock over a 30 month period.

Commenting on the new development, Charles Theuer, President and CEO of TRACON said, "We welcome the additional flexibility this agreement brings us as we progress our pivotal study of TRC105 in patients with angiosarcoma, approach the initiation of the first-in-human clinical trial of TRC253 in patients with prostate cancer, and provide updates on our Phase 2 TRAXAR trial of TRC105 in combination with Inlyta in patients with renal cell carcinoma as well as the Phase 2 AVANTE study of DE-122 and Lucentis in patients with wet AMD".

TCON closed Tuesday's trading at $4.05, down 2.41%.

by RTT Staff Writer

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