Plus   Neg

ACOR Loses Ampyra Patent Appeal, XBIT Awaits Data, AYTU Touches New Low


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

1. Acorda Therapeutics Inc. (ACOR)

Lost 24.50% to close Monday's (Sep.10) trading at $20.80.

News: The United States Court of Appeals for the Federal Circuit has upheld the United States District Court for the District of Delaware's decision to invalidate four patents covering Ampyra, the Company's drug indicated to help improve walking in adults with multiple sclerosis.

Near-term Catalyst:

A new Drug Application for INBRIJA is under FDA review, with a decision expected on October 5, 2018. INBRIJA, a self-administered, orally inhaled levodopa (L-dopa) therapy, is proposed for the treatment of symptoms of OFF periods in people with Parkinson's disease taking a carbidopa/levodopa regimen.

2. XBiotech Inc. (XBIT)

Lost 22.35% to close Monday's trading at $2.78.

News: No news

Clinical Trials & Near-term Catalysts:

-- A phase II clinical trial evaluating MABp1 (Bermekimab) in patients with moderate to severe Atopic Dermatitis is underway.
-- A phase II clinical study evaluating Bermekimab in patients with moderate to severe Hidradenitis Suppurativa is underway.
-- A physician-sponsored clinical research study being conducted to examine the safety of Bermekimab in combination with Onivyde and 5- fluorouracil (5FU)/folinic acid (leucovorin) for pancreatic cancer patients suffering from cachexia is ongoing. Clinical results from this study are expected to be reported later in 2018.

3. Tonix Pharmaceuticals Holding Corp. (TNXP)

Lost 21.14% to close Monday's trading at $0.82.

News: No news

Pipeline & Near-term Catalysts:

-- The lead product candidate is Tonmya, or TNX-102 SL, for military-related post-traumatic stress disorder (PTSD).

In July of this year, the Company announced that it will stop the Phase 3 study of Tonmya in military-related posttraumatic stress disorder, dubbed HONOR, due to inadequate separation from placebo on the primary endpoint at week 12. The Company will be meeting with the FDA in October to discuss a new Phase 3 study of Tonmya for the treatment of PTSD. The new phase III study may be initiated as early as 2019.

-- Tonmya is also being developed as a bedtime treatment for agitation in Alzheimer's disease under a separate IND to support a Phase 2, potential pivotal, efficacy study.

-- TNX-601, which is in the pre-IND application stage, also for the treatment of posttraumatic stress disorder but by a unique mechanism and designed for daytime dosing.

-- TNX-801, a potential smallpox-preventing vaccine based on a live synthetic version of horsepox virus, currently in the pre-IND application stage.

4. Aytu BioScience Inc. (AYTU)

Lost 18.93% to close Monday's trading at $3.04. The stock touched a new low of $2.90 in intraday trading.

Aytu BioScience is a commercial-stage specialty pharmaceutical company, which currently markets Natesto, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"). The Company recently acquired exclusive U.S. and Canadian rights to ZolpiMist, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

News: No news

Recent event:

-- On September 6, the Company announced financial results for its fiscal fourth quarter and year ended June 30, 2018.

Net revenue for the fourth quarter of 2018 was $925,000, an increase of 52% sequentially, compared to $607,000 in Q3 FY18. At June 30, 2018, the Company had cash of $7.1 million.

5. Aileron Therapeutics Inc. (ALRN)

Lost 13.03% to close Monday's trading at $3.07.

News: No news


The Company's lead product candidate is ALRN-6924.

Multiple clinical studies of ALRN-6924 are underway, including a Phase 1 All-comers trial in advanced solid tumors or lymphomas, a Phase 2a trial in peripheral T-cell lymphoma (PTCL), a Phase 1 trial in acute myeloid leukemia (AML) and advanced myelodysplastic syndrome (MDS) as a monotherapy, and a Phase 1b trial in AML/MDS in combination with cytosine arabinoside (Ara-C).

Near-term Catalysts:

-- Additional interim data from the Phase 2a trial of ALRN-6924 for the treatment of patients with peripheral T-cell lymphoma are expected to be reported in the fourth quarter of 2018.
-- Interim data from Phase 1 and 1b open-label, multi-center clinical trials of ALRN-6924 as a monotherapy and in combination with cytosine arabinoside (Ara-C) for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) are expected in the fourth quarter of this year.

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