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CERS Boosts Revenue Outlook, KOOL Hands Out Pink Slips, EIGR'S UTLRA Study Fails

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Today's Daily Dose brings you news about Celcuity's clinical trial agreement with Puma; Cerus' upbeat revenue outlook; workforce reduction at Cesca; positive results from pilot study of Cannabics capsules; and Eiger's disappointing results from ULTRA study.

Read on...

Celcuity Inc. (CELC) has entered into a clinical trial agreement with Puma Biotechnology Inc. (PBYI) and West Cancer Center to conduct a Phase II clinical trial.

The phase II trial will evaluate the efficacy and safety of Puma's approved breast cancer drug, NERLYNX, and chemotherapy in up to 27 early stage triple-negative breast cancer patients selected with Celcuity's CELx HER2 Signaling Function ("CELx HSF") Test.

Celcuity will provide its CELx HSF Test to select triple-negative breast cancer patients who have hyperactive HER2-driven signaling pathways for the trial and will initially fund the patient-related trial costs.

Enrollment in the trial is expected to begin in early 2019, and interim results are expected in 10 to 12 months after the first patient is enrolled and final results within 18 to 24 months.

CELC closed Tuesday's trading at $26.98, up 0.52%.

Shares of Cerus Corp. (CERS) rose more than 15% on Tuesday after the Company announced its preliminary Q3 product revenue, and boosted its revenue guidance for full year 2018.

The preliminary Q3 product revenue is $15.4 million, which underscores the strong market demand for the INTERCEPT Blood System during the quarter, especially in the U.S., according to the Company.

Based on the preliminary Q3 results, Cerus raised its full year product revenue guidance from a range of $56 million to $58 million to a new range of $58 million to $60 million. The product revenue in 2017 was $43.6 million.

CERS closed Tuesday's trading at $6.88, up 15.44%.

Cesca Therapeutics Inc. (KOOL) has reduced its workforce as part of a series of initiatives designed to lower operating losses and achieve cash flow positive position in 2019.

Vivian Liu, Chief Operating Officer, and Joseph Balagot, Senior Vice President of Corporate Development, and one other member of the managerial team have left the Company.

KOOL closed Tuesday's trading at $0.37, up 6.05%.

Cannabics Pharmaceuticals Inc.'s (CNBX.OB) pilot study that tested the efficacy of Cannabics capsules for the treatment of cancer anorexia-cachexia syndrome (CACS) in advanced cancer patients has yielded positive results.

Preliminary findings showed that all patients who were involved in the study for the first four and a half months reported an increase in appetite, as well as 83 percent of all those that completed the study. Results also demonstrated a weight increase of over 10 percent for 60 percent of the patients who completed the study, and 50 percent of the patients who completed the study reported pain reduction and sleep improvement, according to the Company.

CNBX.OB closed Tuesday's trading at $0.69, up 1.29%.

Eiger BioPharmaceuticals Inc.'s (EIGR) phase II study of Ubenimex in lower leg lymphedema, dubbed ULTRA, demonstrated no improvement over placebo in the primary endpoint of skin thickness and secondary endpoints of limb volume and bioimpedance.

In other news, the Company announced that its phase II study of subcutaneous Avexitide in post-bariatric surgical patients who experience dangerously low, postprandial blood glucose levels (hypoglycemia), dubbed PREVENT, achieved primary and secondary endpoints with statistical significance.

EIGR closed Tuesday's trading at $10.87, up 7.09%. In after-hours, the stock was down 8% to $10.00.

FibroGen Inc. (FGEN) will be presenting results of four phase III clinical trials of Roxadustat in anemia of chronic kidney disease (CKD) at the American Society of Nephrology (ASN) Kidney Week 2018 annual meeting on October 25 and October 27.

The 4 phase III trials are:

-- A phase III active-comparator (Darbepoetin Alfa) conversion study of Oral Roxadustat in CKD Patients with Anemia on Hemodialysis in Japan.
-- A phase III active-controlled study of efficacy and safety of Roxadustat for treatment of Anemia in subjects with CKD on dialysis.
-- A phase III placebo-controlled study of efficacy and safety of Roxadustat for treatment of anemia in subjects with CKD not on dialysis.
-- A phase III study of intermittent Oral Roxadustat in Peritoneal Dialysis CKD patients with anemia.

FGEN closed Tuesday's trading at $53.52, up 7.75%.

Medical device company SI-BONE Inc. has priced its IPO of 7.2 million shares of common stock at $15.00 each. The underwriters have a 30-day option to purchase up to an additional 1.08 million shares of common stock.

The shares are expected to begin trading on The Nasdaq Global Market under the ticker symbol "SIBN" on October 17, 2018.

VBI Vaccines Inc. (VBIV) has completed vaccination in 1,537 subjects in PROTECT, a phase III study of Sci-B-Vac, its third-generation prophylactic hepatitis B vaccine.

The PROTECT study is one of two ongoing global pivotal studies that form the Phase 3 program for Sci-B-Vac. Top-line data from this study are expected mid-2019.

Additionally, the independent Data and Safety Monitoring Board has reviewed all safety data from the global Phase 3 program available to-date and has not identified any safety signals or vaccine-related adverse events.

VBIV closed Tuesday's trading at $2.17, up 3.33%.

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