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AXSM Razed By CREATE-1, OMED Continues To Fall, Make Or Break Year For STDY

Jan09-down-010918-lt.jpg

The following are some of the stocks that lost the largest percentage in price today in the pharma/biotech sector.

1. Axsome Therapeutics Inc. (AXSM)

Lost 36.04% to close Tuesday's (Jan.9) trading at $3.55.

News: An independent data monitoring committee (IDMC) has conducted an interim analysis of the Company's trials named COAST-1 and CREATE-1.

COAST-1 is a phase III trial of AXS-02 in knee osteoarthritis associated with bone marrow lesions. CREATE-1 is a phase III trial of AXS-02 in complex regional pain syndrome.

The IDMC has recommended that the COAST-1 trial be continued to full enrollment, and that the CREATE-1 trial be stopped for futility as there is no difference between the placebo and treatment arms.

Want to know which stocks are awaiting clinical trial results this month? Follow the link below.

KDMN And 10 Other Biotech Stocks You Should Watch This Month

2. Selecta Biosciences Inc. (SELB)

Lost 10.5% to close Tuesday's trading at $8.69. This is the second straight day of double-digit loss for the stock.

News: No news:

Near-term Catalysts:

-- Initiate phase I trial of SEL-403 (SVP-Rapamycin in combination with LMB-100) to treat mesothelioma in Q1 2018.
-- The Company plans to meet up with the FDA during the first half of 2018 and initiate its phase III program of SEL-212 to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis, in 2018.

3. OncoMed Pharmaceuticals Inc. (OMED)

Lost 10.49% to close Tuesday's trading at $2.98. This is the second straight day of double-digit loss for the stock.

Recent events:

-- On January 4, 2018, the Company announced that a phase 1a/b clinical program of Rosmantuzumab that included five patients harboring a RSPO3 gene fusion failed to provide compelling evidence of clinical benefit.

The same day, i.e., on January 4th, the Company announced that its Chairman, President and Chief Executive Officer Paul J. Hastings had resigned to pursue new career opportunities, effective January 1st, 2018.

4. SteadyMed Ltd. (STDY)

Lost 6.94% to close Tuesday's trading at $3.35.

News: No news

Recent events:

On August 31, 2017, the FDA refused to even accept the Company's New Drug Application for Trevyent for the treatment of Pulmonary Arterial Hypertension.

Trevyent is a PatchPump wearable injector prefilled with a therapeutic drug, Treprostinil. The active pharmaceutical ingredient used in United Therapeutics' approved PAH drug Remodulin is also Treprostinil.

In its Refusal to File Letter, the FDA had concluded that the application was not sufficiently complete to permit a substantive review.

On November 1, 2017, the Company formally met with the FDA to discuss the issuance of the refuse-to-file letter, and it was informed that no clinical trials are required for NDA resubmission.

The Company has been told by the FDA that a repeat of in vitro Design Verification (DV) testing on Trevyent, supported by pharmacokinetic modeling and Process Validation, are sufficient for the resubmission and acceptance of the NDA.

Near-term Catalysts:

-- Trevyent performance data are expected to be available around mid 2018.
-- Resubmission of Trevyent NDA is expected to occur before the end of 2018.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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