DBVT Disappoints, GSK Gets Greenlight, AIMT Catches Eyes, FDA Snubs ATRS

(RTTNews) - Today's Daily Dose brings you news about promising results from Albireo's phase II study of A4250 in children with cholestatic liver disease; Complete Response Letter for Antares' Xyosted, designed for treating hypogonadism in adult men; disappointing results from DBV Technologies' phase III trial of Viaskin Peanut and FDA approval of GlaxoSmithKline's Shingrix for the prevention of shingles.

Read on...

Shares of Aimmune Therapeutics Inc. (AIMT) were up 45% in after-hours on Friday as the Company gets ready to discuss global screening data from its phase III PALISADE trial on October 27, 2017.

The PALISADE trial is designed to investigate the efficacy and safety of AR101 in peanut-allergic children, adolescents, and adults. The top line data from this trial are expected to be available in the first quarter of 2018.

On October 16, 2017, Aimmune entered into a clinical collaboration with Regeneron (REGN) and its strategic alliance collaborator Sanofi (SNY) to study AR101 treatment with adjunctive *dupilumab in peanut-allergic patients in a Phase 2 clinical trial.

Regeneron's Dupilumab, approved on March 28, 2017, is indicated for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis. It is sold under the brand name Dupixent.

AIMT closed Friday's trading at $25.66, down 0.23%. In after-hours, the stock was up 45.36% to $37.30.

Albireo Pharma Inc.'s (ALBO) final results from its Phase 2 study of lead product candidate A4250 in children with cholestatic liver disease have been found to be promising.

In the study, A4250 reduced serum bile acids (sBA) and improved pruritus in most patients, particularly patients with progressive familial intrahepatic cholestasis (PFIC). A4250 exhibited a favorable overall tolerability profile in the study, with all patients completing the four-week treatment period and no reports of diarrhea associated with multiple dose therapy, noted the Company.

Progressive familial intrahepatic cholestasis is a devastating rare liver disease for which there is currently no approved drug treatment.

Based on the promising results, the Company looks forward to advancing its planned Phase 3 clinical trial of A4250 in patients with progressive familial intrahepatic cholestasis.

ALBO closed Friday's trading at $28.14, up 2.36%.

The FDA has declined to approve Antares Pharma Inc.'s (ATRS) Xyosted, a drug-device combination product, for the treatment of adult men with low testosterone associated with a diagnosed condition known as hypogonadism.

In its Complete Response Letter, the FDA has raised two concerns regarding XYOSTED - a clinically meaningful increase in blood pressure and the occurrence of depression and suicidality.

Robert F. Apple, President and CEO of Antares said, "We are disappointed with the outcome of the review and are assessing the content of the Complete Response Letter, including the information that may be needed to resolve the deficiencies. The Company remains committed to bringing XYOSTED to market and will work closely with the FDA to determine the appropriate responses to the deficiencies noted in the letter."

ATRS closed Friday's trading at $2.18, up 2.83%.

DBV Technologies SA (DBVT) slumped nearly 53% in after-hours on Friday as its phase III trial of Viaskin Peanut in children four to 11 years of age failed to meet its primary endpoint.

In the trial, dubbed PEPITES, Viaskin Peanut 250 µg after 12 months of treatment did not reach the 15% lower bound confidence interval (CI) in the difference in response rates between the active and placebo arms.

However, there was a statistically significant response with a favorable tolerability profile, with 35.3% of patients responding to Viaskin Peanut 250 µg after 12 months of treatment as compared to 13.6% of patients in the placebo arm.

Another phase III trial of Viaskin Peanut, dubbed REALISE, is underway. Results from this trial are expected in November 2017.

DBVT closed Friday's trading at $48.07, up 1.95%. In after-hours, the stock was down 52.6% to $22.75.

The FDA has approved GlaxoSmithKline plc's (GSK) Shingrix for the prevention of shingles (herpes zoster) in adults aged 50 years and older.

In clinical studies, the vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a painful and potentially serious disease that affects 1 in 3 people in the United States.

Shingrix contains Agenus Inc.'s (AGEN) proprietary immune adjuvant, QS-21 Stimulon.

Merck & Co. Inc.'s (MRK) Zostavax is the other shingles vaccine available for use in the United States. The effectiveness of Zostavax at preventing shingles is 70% in adults aged 50-59 years and just around 18% in adults aged 80 years or older.

The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) is expected to vote on a recommendation for the use of Shingrix at its meeting on 25 October 2017.

Shingrix is expected to be available in the U.S. shortly. It was approved in Canada on October 13, 2017. Regulatory filings in the European Union, Australia and Japan are underway.

GSK closed Friday's trading at $40.84, down 0.61%.

Organovo Holdings Inc. (ONVO) on Friday presented new preclinical data showing extended survival and sustained functionality of its 3D bioprinted human liver tissue when implanted into diseased animal models.

The pathologic evaluation of diseased animals receiving implanted bioprinted liver tissues suggests an approximately 75 percent reduction in the pathologic hallmarks of the disease in treated animals versus non-treated control animals in the region of implant, according to the Company.

Organovo intends to submit an Investigational New Drug application to the FDA for its therapeutic liver tissue in calendar-year 2020.

ONVO closed Friday's trading at $1.61, up 15%.

Xencor Inc. (XNCR) will be presenting final results from its open-label, Phase 2 study of XmAb5871 in patients with IgG4-Related Disease in a late-breaking, oral presentation on Tuesday, November 7, 2017 at the American College of Rheumatology (ACR) 2017 Annual Meeting.

In June of this year, the Company reported encouraging data from an ongoing, open-label, pilot phase II study of XmAb5871 in patients with active IgG4-Related Disease. According to the trial results, 93% of patients achieved a response to therapy, 12 of them within two weeks of their first dose.

XNCR closed Friday's trading at $21.29, down 2.34%.

Zosano Pharma Corp. (ZSAN) has entered into a common stock purchase agreement with Lincoln Park Capital Fund, LLC for up to $35 million.

As part of the agreement, Zosano will have the right and the sole discretion to sell to LPC up to $35.0 million worth of shares over a 30-month period subject to certain limitations.

Proceeds from the purchase agreement will be used to fund the long term safety study for the Company's lead product candidate, M207, and for general corporate purposes. M207 is under a pivotal Phase 2/3 study, dubbed ZOTRIP, for the treatment of migraine.

ZSAN closed Friday's trading at $0.84, up 0.50%.