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TRVN Nearing D-Day, ABUS Skids On Study Delay, SNGX On Watch

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The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.

1. Trevena Inc. (TRVN)

Lost 64.09% to close Tuesday's (Oct.9) trading at $1.07.

News: The briefing documents, posted ahead of the FDA panel review of the Company's OLINVO (oliceridine) Injection for the management of moderate to severe acute pain, have raised issues regarding the safety and abuse potential of the drug candidate.

The FDA panel is slated to review OLINVO on October 11, 2018. The regulatory agency's final decision on OLINVO is anticipated on November 2, 2018.

2. Arbutus Biopharma Corporation (ABUS)

Lost 33.99% to close Tuesday's trading at $6.00.

News: The Company has decided to delay the initiation of its phase I clinical trial for AB-452, its novel HBV RNA de-stabilizer that was planned in Q4.

The Company also announced the appointment of Dr. Picchio, formerly Janssen's Infectious Diseases & Vaccines VP Hepatitis Disease Area Leader, as its new Chief Development Officer.

3. Affimed N.V. (AFMD)

Lost 24.41% to close Tuesday's trading at $3.50.

News: the Company has placed AFM11 phase I program on clinical hold.

AFM11 is being evaluated in two phase I clinical studies for the treatment of patients with relapsed or refractory CD19 positive B-cell non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL).

The clinical hold was initiated after the occurrence of Serious Adverse Events (SAEs) in three patients, which included a death in the ALL study and two life-threatening events in the NHL study.

The other clinical programs of the Company namely AFM13 and AMV564 are not affected by the clinical hold.

Near-term Catalysts:

-- A phase Ib combination study of AFM13 with Merck's Keytruda in patients with relapsed/refractory Hodgkin lymphoma is underway.

The interim study data reported in June of this year showed that the combination of AFM13 and Keytruda was well tolerated and had encouraging response rates versus Keytruda monotherapy.

Updated 3- and 6-month results from the study are expected this quarter.

-- An investigator-sponsored translational phase Ib/IIa study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation is ongoing. Results from this study are also expected this quarter.

4. Vaxart Inc. (VXRT)

Lost 16.33% to close Tuesday's trading at $4.10.

News: No news

Recent event:

On October 4, the Company announced that its oral tablet vaccine provided 39% reduction in flu illness compared to 27% for Sanofi's Fluzone in a phase II challenge study.

5. Soligenix Inc. (SNGX)

Lost 14.81% to close Tuesday's trading at $1.61.

News: No news

Clinical Trials & Near-term Catalysts:

-- A phase III trial of SGX301 for the treatment of cutaneous T-cell lymphoma is underway, with interim analysis expected in the October 2018 timeframe, and final topline results in the first half of 2019.
-- A phase III trial of SGX942 for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy is ongoing, with final results anticipated in the second half of 2019.

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