Eleven Biotherapeutics Inc (NASDAQ:EBIO)

Catabasis Pharmaceuticals Inc (NASDAQ:CATB) rebounds to $2.38. Up 68%.

Catabasis Pharmaceuticals Inc (NASDAQ:CATB) rebounded from 2 year lows today. By mid session share hit 2.38 up 68% and for good reason. The company reported positive results from a key clinical trial. This led to excitement among investors, sending the stock up sharply.

CATB Gains On Strong Clinical Results

As mentioned above, Catabasis is having an incredibly strong day in the market today after reporting strong clinical results from a key trial. In a press release, early this morning, the company reported positive efficacy and safety results surrounding a Duchene muscular dystrophy, or DMD, clinical trial. The trial, known as MoveDMD, was an open label extension that followed 48 and 60 weeks of treatment with the company’s drug candidate, edalonexent.

CATB said that improvement in all assessments of muscle function were observed after more than one year of oral 100 mg/kg/day edasalonexent treatment when compared to the rates of change in the pre-specified control period for boys prior to receiving edasalonexent treatment. On top of the data mentioned above, other supportive changes were seen. Supportive changes in non-effort based measures of muscular health and significant longer-term reductions in muscle enzymes and C-reactive protein were seen. This ultimately supports the durability of edasalonexent treatment effects.

In the press release, CATB said that the treatment continued to be well tolerated with no safety signals observed in the trial. The company said that it will be presenting the data on Saturday, February 17, 2018 at the XVI International Conference on Duchenne and Becker Muscular Dystrophy in Rome, Italy.

As a result of the strong data, Catabasis (NASDAQ:CATB) now has plans to initiate a Phase 3 trial. The company said that it plans on initiating a single global Phase 3 trial, assessing edasalonexent in patients with DMD, regardless of mutation type. It is expected that this trial will launch in the first half of 2018 and that top-line results will be available in 2020. In a statement, Jill C. Milne, Ph.D., CEE at CATB, had the following to offer:

We are thrilled to see this preservation of muscle function and substantial slowing of disease progression in boys following more than a year of edasalonexent treatment. This effect has the potential to be extremely impactful for boys affected by Duchenne… Building on the results previously reported for edasalonexent treatment in patients up to 36 weeks, these new data at 48 and 60 weeks show that edasalonexent continued to slow progression of the disease. We look forward to advancing edasalonexent in a single global Phase 3 trial later this year with the goal of improving the quality and length of life for those affected by Duchenne.

Catalyst Biosciences Inc (NASDAQ:CBIO) shares have come off their early morning high of $9.00, bounced off $5.50 level and now trading above $6 handle.

Infinera (NASDAQ: INFN) Up 17%: CEO Predicts Revenue Growth to Continue

Infinera Corp. (NASDAQ:INFN) reported better-than-expected financial results in the fourth quarter of 2017.
At time of writing INFN was up $1.84 to $8.76. That’s just off the morning high of $8.94. Volume is a record 7.02mm.

The company reported net loss on a GAAP basis of $74.0 million or a loss of 50 cents per share against net income of $36.3 million or 25 cents in the year-ago quarter. Infinera’s adjusted loss of 12 cents was narrower than the Zacks Consensus Estimate of a loss of 13 cents.

Total revenues were $195.8 million, up 8.2% year over year and above the Zacks Consensus Estimate of $189.8 million. Segment-wise, product revenues were $160.54 million, up 6.1% year over year. Services revenues increased 18.9% to nearly $35.27 million. Domestic revenues contributed 53% to the total revenues, while the remaining 47% was generated from international markets.

Total operating expenses were $117.79 million, up from $114.90 million in fourth-quarter 2016.

As of Dec 31, 2017, Infinera’s cash from operations was a negative $21.93 million compared with $38.38 million at the end of 2016.

At the end of December 2017, INFN had $116.35 million of cash and cash equivalents compared with $162.64 million at the end of 2016. The company had no debt against debt of $133.59 million at the end of 2016.

The company continues to face stiff competition from peers like Lantronix, Extreme Networks, NETGEAR NTGR and Brocade Communications Systems in the digital optical networking market.

However, Infinera’s strategic business moves which include launches and alliances look impressive. Different network service providers are merging with the company for the deployment of the Infinera Cloud Xpress, regionally and globally, to reach out to customers with higher scalability and reliability. In November 2017, online streaming service provider, Netflix NFLX , deployed the Infinera Cloud Xpress 2 to expand delivery capacity for streaming videos.

Further, Infinera (NASDAQ:INFN)collaborated with CenturyLink CTL to deliver 2.5 terabits per second of capacity to connect research and education community around the world, leveraging the CenturyLink core network.

About Infinera

Infinera Corporation provides optical transport networking equipment, software, and services worldwide. The company’s product portfolio consists of Infinera DTN-X Family of terabit-class transport network platforms, including the XTC Series, XTS Series, and XT Series; and Infinera DTN platform that supports various Ethernet and optical transport network client interfaces for long-haul, subsea, and regional mesh networks. It also provides Infinera XTM Series carrier-grade packet-optical transport platform that enables high-performance metro networks with service-aware, application-specific capabilities; Infinera XTG Series that is a family of passive optical wavelength-division multiplexing products for metro access applications; and Infinera Cloud Xpress Family multiple platforms that are designed to meet the varying needs of cloud service providers, Internet content providers, Internet exchange service providers, enterprises, and other large-scale data center operators

Jaguar Health Inc. (NASDAQ:JAGX)

(NASDAQ: AFMD) up 30% on Positive Hodgkin Lymphoma Drug News

Share price an volume spiked at the open after Affimed N.V. released the following news…..

Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, today reported additional preliminary patient data from two separate clinical studies of its lead NK cell engager candidate AFM13. The data demonstrate that AFM13 was well-tolerated and showed promising therapeutic efficacy both in combination with the anti-PD-1 antibody Keytruda® (pembrolizumab) in Hodgkin lymphoma (HL) and as monotherapy in CD30-positive lymphoma.

“We are extremely encouraged by these new data which indicate that the first-in-class NK cell engager AFM13 has achieved clinically meaningful responses both as single agent and in combination with a checkpoint inhibitor” said Dr. Adi Hoess, CEO of Affimed. “In particular, in our combination trial with Keytruda, we are excited to have increased both overall and complete metabolic response rates.”

AFM13 in combination with Keytruda® in relapsed/refractory HL
Best response preliminary assessment data from 9 patients treated at the highest AFM13 dose level (7 mg/kg) as reported by central read, showed an objective response rate (ORR) of 89% (8/9), including complete metabolic responses (CmR) in 44% (4/9) and partial metabolic responses (PmRs) in 44% (4/9) of patients. One patient experienced stable disease (SD). This ORR of 89% compared favorably to the historical ORR of Keytruda (58-63%) as monotherapy in a similar patient population. Namely, these patients were R/R HL and post autologous stem cell transplantation (ASCT) or ineligible for ASCT and had failed brentuximab vedotin (BV). Importantly, the reported CR rate of 44% represents a doubled CR rate compared to previously reported anti-PD1 studies (9-22%).

The combination was well-tolerated with most of the adverse events observed mild to moderate in nature and manageable with standard of care.

The data shown here comprise six previously reported patients, including one patient evaluated as a PmR at the three-month assessment and who was converted into CmR at the six-month assessment, as well as three additional patients. In total, the extension cohort includes 21 patients and enrollment has recently been completed.

AFM13 as monotherapy in relapsed/refractory CD30-positive cutaneous lymphoma
In an ongoing investigator-sponsored Phase 1b/2a trial of AFM13 in CD30-positive lymphoma with cutaneous manifestation led by Columbia University Medical Center, an analysis of the first dose cohort (3 patients dosed at 1.5 mg/kg) has been completed. The data demonstrated that AFM13 could be safely administered and showed therapeutic activity as a single agent, with an ORR of 66% (2/3). In detail, one complete response (CR), one partial response (PR) and one stable disease (SD) were observed, as determined by global response score (GRS).

“AFM13 is a truly novel immuno-therapeutic that recruits NK cells and targets CD30-expressing lymphomas. Our early clinical experience has been impressive”, said Dr. Ahmed Sawas, Assistant Professor of Medicine at the Columbia University College of Physicians and Surgeons and the New York-Presbyterian Hospital and Principal Investigator of the study. “The treatment was well-tolerated and, importantly, it could provide a new treatment for relapsed/refractory CD30-positive lymphoma patients, who currently have limited to no options.”