Oragenics Inc.’s (OGEN - Free Report) shares skyrocketed 81.4% after the company announced that the FDA has granted Fast Track status to its lead candidate – AG013 – for the treatment of oral mucositis. Shares further gained 2.6% in the subsequent trading session. Overall, the company’s shares are up a whopping 86%.
We note that the FDA grants Fast Track status to facilitate the development and expedite the review process of candidates being developed for the treatment of serious conditions with unmet medical needs.
Fast Track status will allow the company to communicate with the FDA more frequently throughout the development and review process. It makes the candidate eligible for priority review or accelerated approval. Additionally, the company is eligible to make a rolling submission of its new drug application for the candidate. This implies that the company can submit the marketing application in parts, as and when data is available.
Oragenics expects to file an investigational new drug update and start a phase II study on the candidate in early 2017. Data from a phase Ib study, evaluating AG013 in head and neck cancer patients at high risk of oral mucositis, has demonstrated that patients, when treated with AG013, witnessed a 35% reduction in the duration of ulcerative oral mucositis in comparison to placebo treated patients.
ORAGENICS INC Price
AG013 is being formulated as a convenient oral rinsing solution, utilizing Intrexon Corporation’s (XON - Free Report) ActoBiotics platform. Oragenics has an exclusive worldwide license to develop and commercialize AG013 for the treatment of oral mucositis in cancer patients, under an exclusive channel collaboration with Intrexon.
We are encouraged by the FDA granting Fast Track status to AG013. The candidate also enjoys Orphan Drug status in the EU.
According to the press release issued by Oragenics, oral mucositis is one of the most commonly reported adverse events associated with cancer chemotherapy, affecting up to 500,000 patients annually.
Currently, there is no approved drug to prevent this condition broadly and the existing therapies are primarily palliative in nature, only addressing symptom relief. These drugs do not treat the underlying causes of the condition. An approval would, thus, provide an alternative to patients who currently have limited treatment options.
Zacks Rank & Key Picks
Oragenics currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Sucampo Pharmaceuticals, Inc. (SCMP - Free Report) and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vanda’s loss per share estimates narrowed from 68 cents to 56 cents for 2016, while earnings per share estimates increased from 16 cents to 17 cents for 2017, over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged 80% year to date.
Sucampo’s earnings per share estimates increased from $1.03 to $1.22 for 2016 and from $1.30 to $1.58 for 2017, over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 35.55%.
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