Shares of A.P. Pharma Inc. (APPA) is continuing its upward trend even during after market hours in anticipation of the FDA decision today on its lead product candidate APF530 for chemotherapy-induced nausea and vomiting. No news has come out yet, as of 5.45 pm ET, but a halt is in place on the stock now.
After hours, the stock has gained $0.13 or 6.31%, compared to the $0.50 or 32.05% surge it witnessed before closing. The volume of 6.32 million is close to 10-time normal volume whereas the $2.06 high reached today is the most the stock has advanced in almost a year. The stock had moved in a range of $0.38 to $2.16 in the past 52 weeks.
The company's product candidate APF530, which enables control of chemotherapy-induced nausea and vomiting, is of important to cancer treatment as a majority of patients receiving chemotherapy experience nausea and vomiting, leading to patients discontinuing chemotherapy.
The current treatment options include 5-HT3 antagonists such as palonosetron, which is marketed as Aloxi by Eisai Co.; ondansetron, marketed as Zofran by GlaxoSmithKline plc; dolasetron, marketed as Anzemet by Sanofi-Aventis (SNY); granisetron, marketed as Kytril by Roche; and aprepitant, which is sold as Emend by Merck & Co. Inc. (MRK). Among these, Zofran and Kytril have exited patent protection.
APF530 that is delivered by a single subcutaneous injection contains 5-HT3 antagonist, granisetron and is designed to provide five days of continuous relief from chemotherapy-induced nausea and vomiting, or CINV.
Injections and oral tablets containing granisetron are currently approved for the prevention of acute onset CINV, but not for delayed onset CINV. The unmet need is the greatest with patients receiving highly emetogenic chemotherapy, particularly delayed onset CINV.
During late-stage study, APF530 was shown to be equally as effective as Aloxi in the prevention of both acute onset and delayed onset CINV. APF530 also demonstrated that it can prevent acute onset CINV for both moderately and highly emetogenic chemotherapy, and to prevent delayed onset CINV in moderately emetogenic chemotherapy. However, no drug has been approved by the FDA for the prevention of delayed onset CINV in patients receiving highly emetogenic chemotherapy.
APPA is currently gaining $0.13 or 6.31%, and is currently trading at $2.19 on Nasdaq. The stock closed regular trading at $2.06, up $0.50 or 32.05%, on a volume of 6.32 million shares.
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