FDA Approves Regenicin’s PermaDerm, RGIN Stock Jumps

The tweet was out their fast enough before the share price of Regenicin Inc. (OTC: RGIN) penny stock had a chance to shoot up to far. RGIN was trading at just 0.15 when we got the tweet out and is currently trading at 0.20, up 30.72%, on volume of almost 2 million shares. Regenicin, a biotech company specializing in the development and commercialization of regenerative cell therapies to restore the health of damaged tissues and organs, got Orphan Status from the FDA for their PermaDerm® product.

If you got the tweet on RGIN Stock at 0.16, your up 33%. RGIN should be on the watch list as this could easily run to $1.

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RGIN Stock Chart

Market Cap: 18.02M
Price/Book (mrq): 51.00

52-Week High
(Jun 23, 2011): 0.29
52-Week Low
(Apr 10, 2012): 0.05

50-Day Moving Avg: 0.12
200-Day Moving Avg: 0.11

Avg Vol (3 month): 104,542
Avg Vol (10 day): 417,117
Shares Outstanding: 83.81M
Float: 36.71M

Regenicin’s PermaDerm® is the only tissue-engineered skin prepared from autologous (patient’s own) skin cells consisting of both epidermal and dermal layers that is indicated for catastrophic burn patients. The FDA had previously designated PermaDerm® to be a biological/drug (permanent skin replacement) not a medical device (temporary skin replacement).

Note: PermaDerm® is the only skin replacement technology to receive this Biological/drug designation. In the U.S. market alone, the Company estimates the potential markets for severe burns and chronic skin wounds is in excess of $7 billion.

Regenicin applied to the FDA late last year for an Orphan designation as a biologic/drug for PermaDerm®. If received, this would allow the Company to move forward to gain a Biological License Application Approval which would allow Regenicin to sell PermaDerm® in certain defined markets.

Another product Regenicin is banking on is TempaDerm®. TempaDerm® uses cells obtained from human donors to allow the development of banks of cryopreserved (frozen) cells and cultured skin substitute to provide a continuous supply of non-allogenic skin substitutes. This product has applications in the treatment of chronic skin wounds such as diabetic ulcers, decubitus ulcers and venous stasis ulcers.

About FDA Orphan Status

The FDA approval designation of Orphan Status is granted to promote the development of new therapies for rare diseases and disorders. Orphan Status can be applied to products proven safe and effective in treating conditions that affect a relatively small number of patients, and the designation may entitle up to seven years of U.S. marketing exclusivity upon regulatory approval. Companies whose drugs have an orphan designation also receive certain tax credits and are exempted from paying prescription drug user fees normally required of companies submitting products for approval.

About RGIN Stock

Regenicin is a biotechnology company specializing in the development of regenerative cell therapies to restore the health of damaged tissues and organs. Regenicin, which was founded in 2010, has assembled a world-class management team with a proven track record for developing and bringing innovative medical devices and biotechnology products to market. The company is publicly traded with headquarters in New Jersey.

RGIN reported their 10-Q (see here) just a few weeks ago. As expected, revenues were zero, but accumulated deficit was only $6,912,027. That’s is amazing.

Bottom Line: These biotech penny stocks like RGIN, ADXS, GNBT can jump on news from the FDA which s why investors love them so much. This Orphan Status approval for RGIN stock is a major catalyst for both today’s trading and in the futures as Regenicin is now closer to the bullseye of many major pharmaceutical giant’s target. Remember if you trade RGIN: $7 billion market in the U.S. alone.

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