APOP Pops On Study Data, EYEG Catches Investors' Eyes, CDTX Loses Radiance

(RTTNews) - Shares of Cellect Biotechnology Ltd. (APOP) rose over 15% on Tuesday, following positive final results from its clinical trial of ApoGraft in healthy donors.

Commenting on the results, Cellect CEO said, "In plain words, these positive results bring us one step closer to making stem cell therapies safe, effective and available" The company's ApoGraft process is designed to prevent Graft-versus-Host Disease (GHz), a common complication associated with stem cell transplant.

APOP closed Tuesday's trading at $6.72, up 15.27%.

Shares of Cidara Therapeutics Inc. (CDTX) plunged more than 38% on Tuesday after its phase II trial, dubbed RADIANT, evaluating gel and ointment topical formulations of antifungal CD101 in women with moderate-to-severe acute vulvovaginal candidiasis, failed to show sufficient efficacy to warrant further development.

According to the trial results, the gel and ointment topical formulations of CD101 were similar in efficacy to each other but lower in clinical and mycological cure rates compared to oral fluconazole, the current standard of care.

A phase II trial of CD101 IV in candidemia, dubbed STRIVE, is ongoing. This study is comparing the safety and efficacy of CD101 IV to standard-of-care therapy, Caspofungin with an optional step-down to oral fluconazole. The top line data from the STRIVE study are anticipated in the fourth quarter (Q4, 2017).

CDTX closed Tuesday's trading at $7.20, down 38.46%. In after-hours, the stock was down another 2.08% to $7.05.

Shares of EyeGate Pharmaceuticals Inc. (EYEG) rocketed on Tuesday after it entered into a licensing agreement again with Valeant Pharmaceuticals International Inc. (VRX) for EyeGate II Delivery System and EGP-437 combination product candidate, extending their 2015 partnership.

Under the new agreement, Valeant has been granted worldwide commercial and manufacturing rights to the EyeGate II Delivery System and EGP-437 combination product candidate for the treatment of post-operative pain and inflammation in ocular surgery patients.

EyeGate has received an upfront cash payment and is also entitled to receive milestone payments, as well as royalties on Valeant's net sales of the product.

In December 2016, EyeGate reported positive top-line data from a Phase 1b/2a trial assessing iontophoretic EGP-437 in the treatment of ocular inflammation and pain in post-surgical cataract patients.

In July 2015, EyeGate granted Valeant worldwide commercial and manufacturing rights to its EyeGate II Delivery System and EGP-437 combination product in the field of uveitis.

EyeGate remains on track to submit the NDA for potential FDA approval of EGP-437 in uveitis by the end of this year.

EYEG closed Tuesday's trading at $3.70, up 125.62%.

RedHill Biopharma Ltd. (RDHL) has completed treatment of the last patient enrolled in its Phase III study of BEKINDA 24 mg for the treatment of acute gastroenteritis and gastritis.

The study, dubbed GUARD, has treated 320 adults and children over the age of 12 with gastroenteritis and gastritis. Top-line results are expected in the second quarter of 2017.

If approved, BEKINDA could become the first 5-HT3 antiemetic drug in the U.S. indicated for the treatment of acute gastroenteritis and gastritis, targeting a potential worldwide market estimated to exceed $650 million annually, noted the company.

A phase II study of BEKINDA 12 mg is ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), with top-line results expected in mid-2017.

RDHL closed Tuesday's trading at $9.63, down 2.53%.

Shares of Trevena Inc. (TRVN) plunged more than 40% on Tuesday, despite positive top-line results from its two phase III piivotal efficacy studies of Oliceridine - one in moderate-to-severe acute pain following bunionectomy and the other in abdominoplasty.

In the phase III study of Oliceridine in moderate-to-severe acute pain following bunionectomy, dubbed APOLLO-1, all three Oliceridine regimens of 0.1 mg, 0.35 mg, and 0.5 mg, were found to be statistically superior to placebo at 48 hours. But only two dose regimens of Oliceridine - 0.35 mg and 0.5 mg - demonstrated efficacy comparable to morphine at 48 hours.

Similar were the results in the phase III study of Oliceridine in moderate-to-severe acute pain following abdominoplasty, dubbed APOLLO-2. All three Oliceridine regimens of 0.1 mg, 0.35 mg, and 0.5 mg, were found to be statistically superior to placebo. But only two dose regimens of Oliceridine - 0.35 mg and 0.5 mg - demonstrated efficacy comparable to morphine at 24 hours.

According to the company, Oliceridine has an advantage over conventional opioids like morphine and hydromorphone, given its ease of administration particularly in at-risk patients for whom safe opioid titration can be challenging.

The company has plans to submit the NDA for Oliceridine in the fourth quarter of this year.

TRVN closed Tuesday's trading at $4.27, down 40.11%.

XBiotech Inc. (XBIT) has received the go-ahead from an Independent Data Monitoring Committee to continue its pivotal phase III study of Xilonix as a treatment for advanced colorectal cancer.

The IDMC reported that the FDA Fast-Tracked study, dubbed XCITE, had no safety concerns and that indications of efficacy were sufficient to recommend proceeding with the study without modification.

The primary endpoint of this study is overall survival, with secondary endpoints including objective response rate, progression free survival, change in lean body mass and patient reported quality of life measures.

XBIT closed Tuesday's trading at $12.62, up 2.85%.