AzurRx Bio up ahead of MS1819-SD data

Thinly traded nano cap AzurRx BioPharma (AZRX +32.7%) is up on more than an 8x surge in volume in early trade ahead of its presentation of new data on lead candidate MS1819-SD on Monday, January 13, at 2020 Biotech Showcase in San Francisco.

Chief Medical Officer Dr. James Pennington will present results from five cystic fibrosis patients who continue to experience clinical symptoms of fat malabsorption despite treatment with commercially available pancreatic enzyme replacement therapies.

MS1819-SD is an orally available recombinant lipase derived from the yeast Yarrowia Lipolytica.

https://seekingalpha.com/news/3530998-azurrx-bio-up-33-ahead-of-ms1819-sd-data

Pavmed adds to EsoGuard-stoked rally

Nano cap PAVmed (PAVM +17.8%) is up on triple normal volume. Shares have jumped 60% in less than a month after it announced the availability of its EsoGuard Esophageal DNA Test (offered as a service at an Irvine, CA lab). The test is designed to aid in the diagnosis of Barrett’s esophagus (complication of gastroesophageal reflux disease) and related precursors to esophageal adenocarcinoma.

https://seekingalpha.com/news/3531001-pavmed-adds-to-esoguard-stoked-rally-up-18

Akari Therapeutics up on positive nomacopan data in PNH

Thinly traded nano cap Akari Therapeutics (AKTX +10.4%) is up on more than a 6x surge in volume on the heels of interim data from a Phase 3 clinical trial, CAPSTONE, evaluating Coversin (nomacopan) in complement inhibitor naïve, transfusion-dependent paroxysmal nocturnal hemoglobinuria (PNH) patients, an Orphan Drug indication in the U.S. and Europe.

All four participants who were transfusion-dependent at study entry who received nomacopan were transfusion independent for the first six months of therapy.

All four participants who were transfusion-dependent at study entry who received standard-of-care treatment remained transfusion-dependent.

No new safety signals were observed.

Additional data will be presented in June at the European Hematology Association Annual Congress in Frankfurt.

https://seekingalpha.com/news/3531003-akari-therapeutics-up-10-on-positive-nomacopan-data-in-pnh

Trillium Therapeutics upbeat in update on cancer-treatment programs

Shares of Trillium Therapeutics Inc. TRIL, +15.22% nearly doubled in very active trading Thursday, after the developer of cancer treatments provided an upbeat update on its TTI-621 and TTI-622 programs. The stock shot up 93% in afternoon trading, toward the highest close since Nov. 30. Trading volume spiked to 46.4 million shares, well above the full-day average of about 2.3 million shares. The company said it has completed the initial-dose-finding and signal-seeking parts of a phase 1 study of intravenous TTI-621, and the program continues to demonstrate “clear single agent activity across a range of hematologic malignancies, as well as a strong tolerability profile, Chief Executive Jan Skvarka stated. “We are equally excited about the dose escalation progress with our IgG4-based agent, TTI-622,” Chief Medical Officer Yaping Shou said. The stock has run up nearly 10-fold (up 880%) over the past three months, while the S&P 500 SPX, +0.16% has climbed 12.1%.

https://www.marketwatch.com/story/trillium-therapeutics-stock-rockets-on-heavy-volume-after-an-upbeat-update-on-cancer-treatment-programs-2020-01-09

Chiasma refiles Mycapssa application in U.S

Thinly traded micro cap Chiasma (NASDAQ:CHMA) perks up 4% premarket on light volume on the heels of its corporate update and 2020 expected milestones.

It resubmitted its Mycapssa (octreotide) application to the FDA on December 26 for the maintenance treatment of adults with acromegaly. It received a CRL in April 2016 citing the new for another clinical trial. If all goes well, commercial launch should commence in Q4.

2020 key expected events:

FDA decision on Mycapssa application expected mid-year (assuming acceptance of the filing for review).

Topline data from open-label Phase 3 MPOWERED study comparing oral Mycapssa to injectable somatostatin analogs expected in Q4.

https://seekingalpha.com/news/3530962-chiasma-refiles-mycapssa-application-in-u-s-shares-up-4-premarket

Seelos up on favorable safety data on SLS-002

Nano cap Seelos Therapeutics (NASDAQ:SEEL) is up 10% premarket on light volume on the heels of preliminary data from a Phase 1 study of intranasal racemic ketamine (SLS-002) that showed a favorable safety profile.

SLS-002 alone or combined with an oral antidepressant was generally safe and well-tolerated. All adverse events, except one, were mild or moderate, transient and resolved without medical intervention. There was one discontinuation (the last day of the study).

SLS-002 has Fast Track status in the U.S. for acute suicidal ideation and behavior in patients with major depressive disorder.

https://seekingalpha.com/news/3530969-seelos-up-10-premarket-on-favorable-safety-data-on-slsminus-002

PhaseBio up on PB2452 collaboration with SFJ Pharma

PhaseBio Pharmaceuticals (NASDAQ:PHAS) is up 12% premarket on announcing financing and co-development collaboration with SFJ Pharmaceuticals for the development of PB2452, a reversal agent for the antiplatelet therapy ticagrelor.

Under the terms of the agreement, SFJ has agreed to fund up to $120M to support the development of PB2452 and regulatory activities outside the U.S. SFJ will fund up to $90M of development expenses through the end of 2021 and up to an additional $30M based on PhaseBio meeting specific, pre-defined clinical milestones for PB2452.

PhaseBio will pay SFJ a series of annual payments over seven to eight years following receipt of regulatory approvals in the U.S., the European Union and either China or Japan.

PhaseBio will retain exclusive worldwide commercial rights to PB2452.

https://seekingalpha.com/news/3530974-phasebioplus-12-premarket-on-pb2452-collaboration-sfj-pharma