MNKD Takes Giant Leap, REPH On Watch, ALRN To Report Study Data In Q4

pharmauparrow sep5

The following are some of today's top gainers in the pharma/biotech sector.

1. MannKind Corporation (MNKD)

Gained 89.09% to close Tuesday's (Sep.4) trading at $2.08.

News: United Therapeutics Corporation (UTHR) and MannKind Corp. have entered into a worldwide exclusive licensing and collaboration agreement for the development and commercialization of a dry powder formulation of Treprostinil, an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension.

Under the terms of the agreement, MannKind Corporation will receive an upfront payment of $45 million and potential milestone payments of up to $50 million, dependent upon the achievement of specific development targets. MannKind will also be entitled to receive low double-digit royalties on net sales of the product.

2. ESSA Pharma Inc. (EPIX)

ESSA is a pharmaceutical company focused on developing therapies for the treatment of castration-resistant prostate cancer in patients whose disease is progressing despite treatment with current therapies.

Gained 37.54% to close Tuesday's trading at $4.47.

News: No news

Near-term Catalysts:

The Company is currently in the final stages of identifying a lead clinical product candidate and submit an Investigational New Drug application as soon as possible thereafter.

3. Recro Pharma Inc. (REPH)

Gained 26.49% to close Tuesday's trading at $8.07.

News: The Company anticipates resubmitting its New Drug Application for intravenous (IV) Meloxicam, proposed for the management of moderate to severe pain, by the end of September.

The FDA issued a Complete Response Letter for intravenous (IV) Meloxicam on May 24, 2018, stating that the analgesic effect did not meet its expectations.

4. Innovate Biopharmaceuticals Inc. (INNT)

Gained 25.84% to close Tuesday's trading at $8.96.

News: The Company is scheduled to make a presentation at the 20th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC on September 5, 2018 at 12:05pm ET.


-- INN-202 entering Phase 3 for the treatment of celiac disease (CeD) with Fast Track designation
-- INN-217 entering Phase 1/2 for nonalcoholic steatohepatitis (NASH) alone and/or in combination with other agents
-- INN-289 entering Phase 1 for a subset of Crohn's disease (CD)
-- INN-108 entering Phase 2 for inflammatory bowel disorders, mild to moderate ulcerative colitis (UC), and a GI orphan disease in a convenient liquid formulation
-- INN-329 entering Phase 3 for magnetic resonance cholangiopancreatography (MRCP).

5. Therapix Biosciences Ltd. (TRPX)

Gained 19.23% to close Tuesday's trading at $4.65.

News: No news

Clinical Trials & Near-term Catalysts:

-- The first patient in a phase IIb, placebo-controlled 12-week clinical trial for THX-110 in Tourette syndrome, which will be conducted in Germany, is expected to be enrolled by the end of the third quarter. Top line results are expected in the first half of 2020.
-- A phase IIa sponsor-initiated trial with THX-110 in Obstructive Sleep Apnea is underway, with top line results expected in the first half of 2019.

The other ongoing studies are a phase IIa investigator-initiated trial with THX-110 for the treatment of chronic pain, and a pre-clinical study evaluating THX-130 in a rodent model for cognitive impairment related to traumatic brain injury. Results from the pre-clinical study are expected by the second half of this year.

6. MYnd Analytics Inc. (MYND)

MYnd is a predictive analytics company that has developed a decision support tool to help physicians reduce trial and error treatment in mental health and provide more personalized care to patients.

Gained 19.05% to close Tuesday's trading at $2.25.

News: The Company will be presenting at the 20th Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC. on September 6, 2018 at 5:05-5:30 PM (Eastern Time).

Recent event:

On August 13, the Company reported financial results for the fiscal third quarter and nine months ended June 30, 2018.

Revenue for the three months ended June 30, 2018 increased to approximately $392,000, compared to $40,400 for the same period ended June 30, 2017. Looking ahead, the Company is optimistic of achieving a 10-fold increase in revenues for fiscal 2018 as compared to fiscal 2017.

7. Aileron Therapeutics Inc. (ALRN)

Gained 18.49% to close Tuesday's trading at $3.46.

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

8. Tilray Inc. (TLRY)

Gained 18.11% to close Tuesday's trading at $77.01.

News: No news. The stock rallied despite short seller Andrew Left tweeting that TLRY is by far the most expensive in space.

Recent events:

The Company made its debut on the Nasdaq Global Select Market on July 19, 2018 whereby 10.350 million shares of Class 2 Common Stock were sold at an initial price to the public of $17.00 per share.

On August 29, the Company announced financial results for second quarter and six months ended June 30, 2018.

Net loss for the recent second quarter was $12.8 million compared to $2.4 million for the second quarter of 2017. Revenue increased to $9.7 (C$12.7) million, up 95.2% compared to the second quarter of last year. The increase in revenue was driven by increased patient demand in Canada, sales to other Licensed Producers and international sales.

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