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Trading FDA, Clinical Trial Binary Events: $MNKD $AXN $GERN

By Mike Havrilla on 07/20/2010 – 6:28 am PDTLeave a Comment

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news…

On 7/20/10, MannKind (NASDAQ:MNKD) announced that the FDA accepted its New Drug Application (NDA) resubmission for AFREZZA (orally inhaled device for ultra-rapid onset human insulin, rDNA origin) and issued a Class 2 (six-month) review period. The new PDUFA action goal date is 12/29/10 for an expected FDA decision, following a previously issued Complete Response Letter (CRL) received from the FDA in March 2010. MNKD has submitted additional clinical efficacy and safety data plus data on its next-generation MedTone inhaler device that was requested by the Agency in the CRL.

On 7/19/10, Aoxing Pharma (AMEX:AXN) announced over 120 patients are enrolled in its ongoing pivotal (China SFDA) Phase 3 clinical trial and it expects to complete enrollment of all 440 patients by year-end 2010 in this 12-week randomized, active-controlled study for primary dysmenorrhea (menstrual pain) in adult women treated with oral TJSL capsules

On 7/19/10,Geron (NASDAQ:GERN) announced that the first patient was enrolled in a Phase 2 study to evaluate GRN163L (imetelstat sodium) (telomerase inhibitor anti-cancer stem cell agent) as a maintenance therapy following platinum-based induction therapy for patients with non-small cell lung cancer (NSCLC) and the Company also plans to begin Phase 2 studies for three other indications in 2010 including breast cancer. is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials. The HavRx Regulatory Catalyst Index update report is currently tracking 607 entries and 411 companies (with approximately 200 stocks trading under $5 per share and 67 private companies). Click here for a subscriber overview article that includes an email archive web link for a 50% discount ($150) promo code off the regular one-year, non-recurring subscription price.

Disclosure: No positions

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