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ALRN Down 32% This Month, HBIO Hunts For New CFO, TNXP On Watch


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(RTTNews.com) - The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.

1. Aileron Therapeutics Inc. ( ALRN )

Lost 11.02% to close Wednesday's (Aug.22) trading at $2.10.

News: No news

Pipeline:

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.
-- John Longenecker was named interim Chief Executive Officer on May 15, 2018. Aileron is actively engaged in a process to appoint a new CEO.

2. Xtant Medical Holdings Inc. (XTNT)

Lost 10.43% to close Wednesday's trading at $5.15.

News: No news

Recent events:

-- On August 7, the Company reported financial results for the second quarter ended June 30, 2018.

Net loss incurred in the second quarter 2018 narrowed to $5.0 million or $0.38 per share from $9.7 million or $6.43 per share in the same period of the prior year. Revenue for the second quarter of 2018 was $18.7 million, down from $21.4 million compared to the same period of the prior year.

-- A 1-for-12 reverse stock split occurred at the close of business on February 13, 2018.

3. Tonix Pharmaceuticals Holding Corp. (TNXP)

Lost 8.46% to close Wednesday's trading at $1.19.

News: Samuel Saks has stepped down from the Company's board of directors, effective August 21, 2018.

Pipeline & Near-term Catalyst:

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 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. Harvard Bioscience Inc. (HBIO)

Lost 8.06% to close Wednesday's trading at $5.70.

News: The Company announced the resignation of Robert Gagnon, Chief Financial Officer, effective August 31, 2018. A search for a new CFO has been initiated.

5. Entera Bio Ltd. (ENTX)

Lost 8.02% to close Wednesday's trading at $4.59.

News: No news

Clinical Trials & Near-term Catalysts:


-- Oral PTH 1-34 for hypoparathyroidism, which has completed a multi-center Phase II clinical trial in Israel.
-- A phase II study of oral parathyroid hormone drug, EB612, in hypoparathyroidism patients is underway.
-- The Company expects to meet with the FDA in the fourth quarter of 2018 to discuss the development of oral PTH/ EB613 for the treatment of osteoporosis.

6. Evelo Biosciences Inc. (EVLO)

Lost 6.29% to close Wednesday's trading at $12.37.

News: No news

Upcoming Anticipated Milestones:


-- Initiation of the University of Chicago's investigator-sponsored, open-label Phase 2 clinical trial of EDP1503 in combination with a PD-1 inhibitor in patients with metastatic melanoma expected in the second half of 2018.
-- Initiation of a Phase 1 clinical trial of EDP1815, an anti-inflammatory monoclonal microbial product candidate, in patients with psoriasis and atopic dermatitis in the fourth quarter of 2018.
-- Initiation of a Phase 2 clinical trial of EDP1503 in combination with a checkpoint inhibitor in patients with multiple cancer types in the first half of 2019.
-- Initial clinical data from ongoing Phase 1 clinical trial of EDP1066 in patients with psoriasis and atopic dermatitis in the first half of 2019.

Read the original article on RTTNews (http://www.rttnews.com/2928869/alrn-down-32-this-month-hbio-hunts-for-new-cfo-tnxp-on-watch.aspx)


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This article appears in: Stocks , Politics
Referenced Symbols: ALRN ,



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