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Fri, Aug. 1, 12:46 PM
Fri, Aug. 1, 10:53 AM
- Shares of thinly- traded Biota Pharaceuticals (BOTA -20.2%) plunge on a 6x surge in volume after the company reported that its flu drug candidate, laninamivir octanoate, failed to achieve its primary endpoint in a Phase 2 clinical trial.
- Neither the 40 mg or 80 mg dosage cohort achieved a statistically significant reduction in the median time to alleviation of influenza symptoms versus placebo. The mean time reduction, as measured by the Flu-iiQ patient-recorded outcome questionnaire, for the 40 mg group was 102.3 hours compared to the 80 mg group's 103.2 hours and placebo's 104.1 hours.
- Patients in both treatment arms demonstrated a statistically significant reduction in viral shedding on Day 3 of the study versus placebo as quantified by qRT-PCR. Also, a statistically significant proportion of patients were culture negative on Day 3 compared to placebo. Neither result translated into reduced time to alleviation of symptoms, however.
Fri, Aug. 1, 9:15 AM
Thu, May. 8, 8:54 AM
- The Biomedical Advanced Research & Development Authority (BARDA) has ended funding for the development of Biota Pharmaceuticals' (BOTA) Laninamivir Octanoate influenza drug.
- The agency didn't provide a reason for the action.
- In 2011, BARDA agreed to provide up to $231M million to develop the therapy, which is in Phase II trials.
- Biota's shares are -7.4%. (PR)
Tue, May. 6, 6:36 PM| Comment!
Thu, May. 1, 10:00 AM
- BARDA director Robin Robinson, Ph.D. says his agency's recent Stop-Work Order regarding the development of Biota Pharmaceuticals' (BOTA +0.8%) flu drug laninamivir octanoate is not a contract termination. The timing has more to do with the post-flu season lull.
- His group has concerns over some aspects of the project pertaining to product manufacturing, clinical study enrollment pace, costs and contractor performance. They want to assess the status of the project and the most appropriate next step before proceeding with clinical studies in the Southern Hemisphere and manufacturing optimization and validation.
- A final decision regarding the outcome of the In Process Review should happen by next week.
Tue, Apr. 29, 12:46 PM
Tue, Apr. 29, 9:16 AM
- The U.S. Department of Health and Human Services (HHS) office of the Assistant Sercretary for Preparedness and Response (ASPR) and the Biomedical Advanced Research and Development Authority (BARDA) issue a Stop-Work Order to Biota Pharmaceuticals (BOTA) to cease work on its contract to develop its influenza A&B drug laninamivir octanoate.
- The action comes after an In Process Review by federal representatives to assess the progression of milestones and deliverables under the contract. The review is standard operating procedure for contracts of this nature. It was the first review conducted since the initiation of the agreement in March 2011.
- As a result, Biota will not enroll patients in a clinical trial in the Southern Hemisphere for the upcoming flu season. Patient recruitment for Its Phase 2 IGLOO trial in the Northern Hemisphere is complete. Top-line results will be available in Q3.
- The company was surprised by the action and awaits the agencies' final decision after they complete their review.
- Shares are down 20% premarket on light volume.
Mon, Feb. 10, 7:11 AM
Dec. 23, 2013, 8:31 AM
- Shares of Biota Pharmaceuticals (BOTA) may see some upside action in Monday's session.
- The company announced Friday that partner Daiichi Sankyo has won Japanese marketing approval for laninamivir octanoate for the prevention of influenza A and B.
- BOTA is developing the treatment outside of Japan. (PR)
Sep. 18, 2013, 7:34 AM
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