Vericel Corp. (VCEL)

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All Eyes on These Two Biotech Firms Ahead of FDA Decisions (VCEL, SGYP) Partner Content By Tipranks | December 8, 2016 — 11:45 AM EST


Catalysts are swirling for Vericel Corporation (VCEL) and Synergy Pharmaceuticals Inc (SGYP) with FDA decisions looming in the foreground, and all eyes are on the crowning judgements ahead. January will be an imperative time for not only the biotechs, but also the investors who back them. Will the FDA grant SGYP and VCEL the golden ticket of years-long high hopes built on research, time, and high stake finances? Let's take a closer look:

Vericel Corporation: It's Time for a Comeback
Vericel's date with PDUFA destiny is pending on January 3, 2017 for MACI (matrix applied characterized autologous cultured chondrocytes), VCEL's investigational autologous cellular product for the treatment of symptomatic full-thickness cartilage defects of the knee.

As Adage Investments & Research opined yesterday on Seeking Alpha, Vericel shares offer a "unique short-term investment opportunity," contending a resurgence in share dynamism is about to break through once again on back of terrific odds for January MACI approval. Adage approached Vericel from an encouraged standpoint and believes, "the recent green candles are supportive of a move up leading into the catalyst event."

Considering Adage's valid point that "While long-term research goals focus on harnessing stem cell therapies for renewal, in the near term, very few cell therapy based drugs or research exists as a viable treatment option in managing cartilage injuries," MACI's pipeline review could unlock a track to a profit boom considering the unmet need for treating cartilage defects.

As the FDA prepares to cast judgement upon the firm's next-generation pipeline product, the writing on the wall glints with an optimistic sheen. Vericel management has already confirmed that the agency inspected the Cambridge manufacturing facility in the third quarter and the facility has been confirmed to boast zero outstanding 483 deficiency letters, indicating the firm's solid standing with the agency. As such, research analyst Kevin DeGeeter of Ladenburg opines, "We are incrementally more comfortable MACI will be approved by the January 3rd PDUFA date."

"Management is comfortable with the ongoing dialog between FDA and Matricel GmbH, the privately held company that produces the collagen membrane. Based on management's disclosures, in our view, VCEL has the taken the necessary steps to significantly derisk the MACI BLA review," DeGeer asserts, finding all the more reason to be bullish on VCEL stock.

Worthy of note, there will be no FDA advisory panel called upon to evaluate the single Phase III trial administered in Europe. As the VCEL management team alludes to the fact the agency has not skeptically questioned its clinical data for MACI, this leads one to believe that approval will be likely on the horizon.

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