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Friday, January 10, 2020

Kadmon, BeyondSpring gain a bull as Nomura picks up coverage

BeyondSpring (NASDAQ:BYSI) rises 2.7% and Kadmon Holdings (NYSE:KDMN) also gains 2.7% after Nomura Instinet initiates coverage of the two companies at Buy.
BeyondSpring is testing plinabulin in multiple Phase 2 and 3 studies; “we view the first of these in CIN (chemotherapy-induced neutropenia) to be the most near-term derisking event for BYSI,” Nomura analyst Christopher Marai writes.
Studies may also show benefits beyond CIN, including as an anticancer agent and in immune oncology, he adds.
Sets BYSI price target at $34, implying a 111% rise in the next 12 months.
As for Kadmon, “we believe that KDMN’s success in indications beyond cGVHD (chronic graft-vs-host disease) expected in 2020 will pave the way for a broader, and multi-blockbuster, opportunity for ROCK (Rho-associated coiled-coil kinase) inhibition across autoimmune and fibrotic diseases, analogous to JAK inhibitors and anti-TNF therapeutics,” Marai writes.
Kadmon price target at $10, implying a 117% increase in the next 12 months.
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Profound Medical up on preliminary Q4 results, RadNet deal

Ultra-thinly traded micro cap Profound Medical (OTCPK:PROF +11.8%) is up on double volume, albeit on turnover of only 29K shares, on the heels of preliminary results for Q4 and 2019.
Revenue for the quarter and year should be ~$2.7M (+59%) and ~$5.4M (+108%), respectively, driven by the continued rollout of Sonalleve in China and additional uptake of TULSA-PRO.
In November 2019, the company submitted its U.S. application for a specific Medicare reimbursement code for TULSA-PRO.
This morning, it announced its first multi-state imaging center agreement for TULSA-PRO with RadNet (RDNT -0.4%). The first stage of the deal will be the placement of three rental systems at imaging centers in the Los Angeles area. If successful, more will follow.
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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.
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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.
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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.
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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%.
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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.
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