logo
Plus   Neg
Share
Email

MACK Halts MM-310 Study, VKTX On Watch, NAII Hits New High

pharma-030617_05apr19-lt.jpg

Today's Daily Dose brings you news about the upcoming key milestones of Stealth BioTherapeutics; the extended partnership between Natural Alternatives and The Juice Plus+ Company; Merrimack's discontinuation of phase I study of MM-310 for the treatment of solid tumors; and Sangamo's pricing of its public offering.

Read on...

Shares of Merrimack Pharmaceuticals Inc. (MACK) plunged over 13% in extended trading on Thursday, following the Company's decision to discontinue the development of MM-310, its antibody-directed nanotherapeutic for the treatment of solid tumors.

The decision to pull the plug on MM-310 was based on the available safety data from its phase I study, which was unable to reach optimal therapeutic index for the compound due to the continued observation of cumulative peripheral neuropathy.

With a narrowed preclinical pipeline, the Company expects to initiate a workforce reduction as it closes out clinical activities.

Last October, the Company had terminated its phase II trial of MM-121 in patients with heregulin positive in patients with non-small cell lung cancer, dubbed SHERLOC, due to futility.

MACK closed Thursday's trading at $7.18, up 0.84%. In after-hours, the stock was down 13.77% to $6.20.

Natural Alternatives International, Inc. (NAII) has further extended its partnership with The Juice Plus+ Company covering Juice Plus+ capsule and powder products sold in over 24 markets around the world.

The effective date of the Amended and Restated Exclusive Manufacturing Agreement is March 31, 2019. As part of the extension, Juice Plus+ will receive a cash-based discount during the remaining term of the original agreement, and subject to minimum annual purchases by Juice Plus+ an additional cash based discount during the extended period of the agreement.

Last month, the U.S. Court of Appeals for the Federal Circuit ruled in Natural Alternatives International's favor, holding that its CarnoSyn beta-alanine patents are "patent eligible" under existing law. The Court's decision reverses a 2017 ruling by a California district court and revives important patent rights in the Company's existing patent portfolio.

NAII touched a new high of $12.88 in intraday trading on Thursday before closing at $12.79.

Sangamo Therapeutics Inc. (SGMO) has offered to sell 11 million shares of its common stock to the public at a price of $11.50 per share.

The gross proceeds to Sangamo from the offering are expected to be approximately $126.5 million. The offering is expected to close on or about April 8, 2019, subject to customary closing conditions.

The underwriters have been granted a 30-day option to purchase up to an additional 1.65 million shares of the Company's common stock.

On April 2, the Company announced positive interim data from its phase 1/2 study evaluating investigational SB-525 gene therapy for severe hemophilia A, dubbed Alta, sending its stock price up as much as nearly 46% to $13.91 that day.

SGMO closed Thursday's trading at $12.14, down 6.83%. In after-hours, the stock was up 0.66% to $12.22.

Stealth BioTherapeutics Corp (MITO) has a couple of key milestones coming up this year.

Stealth's ADSs began trading on The Nasdaq Global Market on February 15, 2019, at a public offering price of $12 per ADS.

A phase II study of Elamipretide in patients with dry age-related macular degeneration with geographic atrophy, dubbed ReCLAIM-2, is underway. Enrollment in the study is expected to be completed by early 2020.

A phase II/III clinical trial of Elamipretide for the treatment of Barth is ongoing, with an end-of-Phase 2 meeting with the FDA regarding this program is planned during the first half of 2019 to discuss a potential NDA submission.

A phase III clinical trial of Elamipretide for the treatment of primary mitochondrial myopathy is underway, with top-line data expected by the end of 2019.

The Company expects to initiate a phase I clinical trial of a new pipeline candidate, SBT-272, by the end of 2019.

MITO closed Thursday's trading at $14.46, up 1.76%.

Viking Therapeutics Inc. (VKTX) is slated to present data from its 12-week phase II study of VK2809 in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C), including new data from the study's 5 mg treatment arm, on April 11.

As previously reported, the phase II study successfully achieved both its primary and secondary endpoints, and demonstrated an encouraging safety and tolerability profile for VK2089.

The trial's low-dose 5 mg cohort treatment arm has also demonstrated statistically significant reductions in liver fat content relative to placebo, as well as statistically significant response rates, defined by the proportion of patients experiencing at least a 30% or 50% relative reduction in liver fat, compared with placebo.

Consistent with prior data from the 10 mg cohorts, VK2809 was well tolerated when dosed at 5 mg daily, and no serious adverse events were reported among patients receiving either VK2809 or placebo, added the Company.

VKTX closed Thursday's trading at $10.32, up 0.88%. In after-hours, the stock was up 1.66% to $10.49.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT