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AMRX Soars On Contract Win, TRPX Looks Ahead With Hope, ALXN To Face FDA In Feb

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Today's Daily Dose brings you news about Amneal Pharma's contract with Jerome Stevens; Alexion Pharma's regulatory catalyst in February 2019; FDA's expanded approval for Merck's Keytruda; ProPhase Labs' improving financials and Therapix Biosciences' anticipated milestones.

Read on...

Shares of Amneal Pharmaceuticals Inc. (AMRX) rose more than 12% on Monday, following a 10-year license and supply agreement with Jerome Stevens Pharmaceuticals for Levothyroxine sodium tablets. The agreement is effective March 22, 2019.

Full details of the agreement were not disclosed.

Jerome Stevens' Levothyroxine sodium tablets are used in the therapeutic areas of hypothyroidism and pituitary TSH suppression. The U.S. brand and generic market for Levothyroxine sodium tablets is estimated to be approximately $2.6 billion in annual sales and 122 million annual prescriptions, according to IQVIA for the 12 months ending June 30, 2018.

AMRX touched a new high of $24.43 on Monday before closing the day's trading at $24.27, up 12.78%.

Alexion Pharmaceuticals Inc.'s (ALXN) Biologics License Application for ALXN1210 for the treatment of patients with paroxysmal nocturnal hemoglobinuria has been accepted for priority review by the FDA, with a decision date set for February 18, 2019.

ALXN1210 is also under review in the European Union. The Company is preparing a submission for a New Drug Application for ALXN1210 as a treatment for patients with paroxysmal nocturnal hemoglobinuria in Japan in the second half of the year.

ALXN closed Monday's trading at $116.17, up 0.15%.

The National Institute on Alcohol Abuse and Alcoholism, which is part of the National Institutes of Health, will fund a phase IIb clinical trial to evaluate MediciNova Inc.'s (MNOV) MN-166 (ibudilast) as a potential treatment to decrease alcohol consumption in treatment-seeking patients with alcohol use disorder.

The study will enroll up to 132 patients. MediciNova will provide drug supply and regulatory support for the clinical trial.

Meanwhile, the Company is also planning a separate clinical trial evaluating MN-166 in alcohol dependence and withdrawal in approximately 50 non-treatment seeking individuals with moderate-to-severe AUD. This study is funded by the NIH's National Institute on Drug Abuse (NIDA).

MNOV closed Monday's trading at $8.98, down 1.32%.

The FDA has expanded approval for Merck's (MRK) KEYTRUDA in combination with ALIMTA and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations, nearly a month ahead of the decision date.

KEYTRUDA in combination with ALIMTA and carboplatin was first approved in 2017 under the FDA's accelerated approval process for the first-line treatment of patients with metastatic nonsquamous NSCLC.

The drug is also approved for the treatment of melanoma, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, and primary mediastinal large B-cell lymphoma.

Keytruda generated sales of $3.81 billion for full year 2017, and $3.13 billion in the first half of 2018.

MRK touched a new high of $70.22 in intraday trading on Monday, before closing the day's trading at $70.17, up 1.61%.

ProPhase Labs Inc. (PRPH) has reported a narrower loss and higher sales for the second quarter ended June 30, 2018.

Net loss for the recent second quarter was $260,000 or $0.02 per share on net sales of $3.2 million. This compared with a net loss of $2.3 million or $0.14 per share and net sales of $1.9 million in the year-ago quarter.

PRPH closed Monday's trading at $2.97, up 1.02%.

Therapix Biosciences Ltd. (TRPX) has a couple of events to watch out for in the coming months and years.

The first patient in a phase IIb, placebo-controlled 12-week clinical trial for THX-110 in Tourette syndrome, that 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.

TRPX closed Monday's trading at $3.60, up 0.84%.

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