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MRNS Catches Eye, SAVA Soars On Alzheimer's Study, ETNB Abuzz Over NASH Trial, GILD Snaps Up IMMU

pharma 010919 15sep20 lt

Today's Daily Dose brings you news about Gilead's acquisition of Immunomedics, Marinus' CDKL5 deficiency disorder trial results, Seattle Genetics' oncology collaborations with Merck, 89bio's NASH trial data, and Cassava Sciences' Alzheimer's trial results.

Read on…

1. Cassava Sciences' Alzheimer's Trial Data Catches Eye

Shares of Cassava Sciences Inc. (SAVA) were up 133% at $7.75 on Monday, following final results of a phase IIb study with its lead drug candidate, Sumifilam, in Alzheimer's disease.

In the clinical trial, Alzheimer's patients treated with Sumifilam showed statistically significant improvements in biomarkers of the disease and improved cognition compared to the placebo group.

Sumifilam is the first of a new class of drug compounds that bind to a protein called Filamin A.

Commenting on the findings, Jeffrey Cummings, Founding Director of the Cleveland Clinic Lou Ruvo Center for Brain Health, and Chambers Professor of Brain Science at the University of Nevada, Las Vegas, said, "Filamin-binding molecules are new to Alzheimer's research and may represent an important advance if these data can be replicated in larger studies."

SAVA closed Monday's trading at $7.75, up 133.43%.

2. 89bio is Abuzz and the reason is NASH

89bio Inc.'s (ETNB) phase 1b/2a trial with BIO89-100 in patients with nonalcoholic steatohepatitis has yielded positive topline results.

Non-alcoholic steatohepatitis, or NASH, refers to liver inflammation due to fat buildup in the liver.

According to the results, BIO89-100 in all doses namely 3mg, 9mg, 18mg, and 27mg, demonstrated significant reductions in liver fat at week 13, with relative reductions up to 60% versus baseline and up to 70% versus placebo, as measured by magnetic resonance imaging - proton density fat factor (MRI-PDFF).

A significant proportion of subjects responded to therapy with up to 88% and 71% of subjects achieving "equal to more than 30%" or "equal to more than 50%" reduction in liver fat versus baseline, respectively, noted the company.

ETNB closed Monday's trading at $36.75, up 6.34%.

3. Gilead Loosens Purse Strings Yet Again

Immunomedics Inc. (IMMU) is all set to be acquired by Gilead Sciences Inc. (GILD) for $88.00 per share in cash or approximately $21 billion and the deal is expected to close next quarter.

The acquisition adds Immunomedics' Trodelvy, which was granted accelerated approval by the FDA in April this year, to Gilead's portfolio.

Trodelvy is indicated for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Submission of a supplemental Biologics License Application to support full approval of Trodelvy in the United States is expected in the fourth quarter of 2020 and filing for regulatory approval in Europe is on track in the first half of 2021.

The acquisition of Immunomedics marks the fourth deal for Gilead this year - the acquisition of a 49.9 percent equity interest in privately-held Tizona Therapeutics, Inc., for $300 million in July, 49.9 percent equity interest in privately-held Pionyr Immunotherapeutics Inc. for $275 million in June, and the acquisition of Forty Seven Inc for $95.50 per share in cash or approximately $4.9 billion in March are the other three purchases of Gilead this year.

IMMU was trading around $7 when we alerted readers to this stock on May 12, 2017. (https://www.rttnews.com/2774925/company-spotlight-immunomedics.aspx?Arch=1)

IMMU closed Monday's trading at $83.65, up 97.99%.

4. Marinus Blooms on Marigold Data

Marinus Pharmaceuticals Inc.'s (MRNS) phase III clinical trial of oral Ganaxolone in children and young adults with CDKL5 deficiency disorder (CDD), a rare, genetic epilepsy with refractory seizures, has achieved the primary endpoint.

In the trial, dubbed Marigold, patients given oral Ganaxolone showed a significant 32.2 percent median reduction in 28-day major motor seizure frequency, compared to a 4.0 percent reduction in the placebo arm.

The company plans to submit an NDA for oral Ganaxolone in the treatment of CDKL5 deficiency disorder (CDD) to the FDA in mid-2021 and a Marketing Authorization Application to the European Medicines Agency by the end of the third quarter of 2021.

An estimated 12,500 children in the United States and European Union are affected by CDD, with the majority of them being females. Currently, there are no approved therapies for CDD.

In other news, the company announced that it has been awarded a BARDA contract to develop IV Ganaxolone for the treatment of refractory status epilepticus caused by nerve agent exposure. Under the 5 year contract, BARDA will fund up to $51 million for the company's phase III clinical trial of IV Ganaxolone for the treatment of refractory status epilepticus and Marinus will be responsible for cost-sharing in the amount of $33 million.

MRNS closed Monday's trading at $2.11, up 5.50%. In after-hours, the stock was up 63% at $3.44.

5. Seattle and Merck Ink Oncology Deals

Seattle Genetics Inc. (SGEN) has entered into new strategic oncology collaborations with Merck (MRK) - one related to investigational drug Ladiratuzumab Vedotin and the other involves an approved drug Tukysa.

Ladiratuzumab vedotin is an antibody-drug conjugate (ADC) that is under phase II study in advanced solid tumors. Tukysa in combination with trastuzumab and capecitabine is approved by the FDA for the treatment of people with advanced metastatic HER2-positive breast cancer, including cancer that has spread to the brain. The drug is also being evaluated in several ongoing clinical trials.

According to the deal related to Ladiratuzumab Vedotin, Seattle Genetics and Merck will collaborate and equally share costs on the global development of this compound and other LIV-1-targeting ADCs.

Seattle Genetics will receive $600 million upfront and $1.0 billion equity investment - with Merck acquiring 5.0 million shares of Seattle Genetics common stock at a price of $200 per share. In addition, Seattle Genetics will be eligible to receive up to $2.6 billion in milestone payments, including $850 million in development milestones and $1.75 billion in sales milestones. The Ladiratuzumab vedotin collaboration deal fetches Seattle Genetics about $4.2 billion.

As per the Tukysa collaboration deal, Merck has been granted exclusive rights to commercialize this drug in Asia, the Middle East, and Latin America and other regions outside of the U.S., Canada and Europe. Merck will also co-fund a portion of the Tukysa global development plan.

In return, Seattle Genetics will receive from Merck $125 million as an upfront payment and is eligible to receive progress-dependent milestones of up to $65 million. Seattle Genetics will also receive $85 million in prepaid research and development payments to be applied to Merck's global development funding obligations and tiered royalties on sales of Tukysa in Merck's territory.

Seattle Genetics retains commercial rights and will record sales in the U.S., Canada, and Europe.

SGEN closed Monday's trading at $171.79, up 14.55%.

6. Stocks That Moved On No News

Mersana Therapeutics Inc. (MRSN) closed Monday's trading at $24.17, up 29.60%.

NantKwest Inc. (NK) closed Monday's trading at $8.09, up 22.58%.

Genocea Biosciences, Inc. (GNCA) closed Monday's trading at $2.59, up 19.35%.

Nano-X Imaging Ltd. (NNOX) closed Monday's trading at $49.21, down 23.34%.

Teligent Inc. (TLGT) closed Monday's trading at $1.22, down 12.23%.

For comments and feedback contact: editorial@rttnews.com

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