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GNMX Plunges On ASCEND Data, FLZN On Track, ALNA To Report Phase 3 Data In 2H

pharma 021518 03jan19 lt

Today's Daily Dose brings you news about disappointing trial results of Aevi Genomic; progress in Allena's phase III program of Reloxaliase; FDA approval of Bristol-Myers' blockbuster Sprycel for another indication; and update on Flexion's phase III trial of ZILRETTA in patients with hip osteoarthritis.

Read on...

Shares of Aevi Genomic Medicine Inc. (GNMX) plunged 64.94% in extended trading on Wednesday, following disappointing results from a study, dubbed ASCEND.

ASCEND is a phase II study evaluating AEVI-001 as a potential treatment for a sub-population of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 17 with genetic mutations that disrupt the mGluR network. The trial consisted of 2 parts - A and B.

Part A included subjects determined to have one of eight specific gene mutation(s) implicated in glutamatergic signaling and neuronal connectivity. Part B assessed subjects who did not have copy number variants in any of the specific gene mutation(s) implicated in glutamatergic signaling and neuronal connectivity.

The Company noted that the ASCEND trial did not achieve statistical significance on the primary endpoint of reduction of ADHD rating scale in either Part A or Part B after 6 weeks of treatment with AEVI-001.

GNMX closed Wednesday's trading at $0.77, up 10%. In after-hours, the stock fell 64.94% to $0.27.

Allena Pharmaceuticals Inc.'s (ALNA) phase III program of Reloxaliase in patients with enteric hyperoxaluria, dubbed URIROX, is underway.

The URIROX program consists of two pivotal Phase 3 clinical trials, URIROX-1 and URIROX-2.

The URIROX-1 study is designed to enroll 124 patients for a four-week treatment period. Allena expects to report topline data from URIROX-1 in the second half of 2019.

The URIROX-2 study is designed to enroll 400 patients over a minimum treatment period of two years. This study was initiated in the fourth quarter of 2018.

ALNA closed Wednesday's trading at $6.43, up 17.98%.

The FDA has expanded the indication of Bristol-Myers Squibb Co.'s (BMY) blockbuster drug Sprycel to include the treatment of pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.

Sprycel was first approved (accelerated approval) in June 2006 for the treatment of adults with chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy, including Gleevec. It was converted to regular approval in May 2009. The following year, i.e., in October 2010, the drug received FDA approval for treating adults with Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML).

The approved indication of Sprycel was further expanded in November 2017 to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).

The global sales of Sprycel in the nine months ended September 30, 2018, were $1.46 billion, down 1% from the year-ago same period.

BMY closed Wednesday's trading at $52.43, up 0.87%.

Flexion Therapeutics Inc. (FLXN) announced that, on December 26, 2018, the first patient was enrolled in its phase III clinical trial of ZILRETTA in patients with hip osteoarthritis (OA).

Zilretta, the Company's lead product, received FDA approval for Osteoarthritis (OA) Knee Pain in October 2017.

Similar to knee OA, hip OA is a degenerative disease which has no cure, and it is estimated that roughly 25% of the U.S. population may develop symptomatic hip OA in their lifetime.

The data readout from the phase III hip osteoarthritis is expected in 2020.

Additional phase II studies with ZILRETTA for shoulder OA and adhesive capsulitis (frozen shoulder) are planned for second half of 2019.

The Company is scheduled to announce preliminary unaudited revenue for the fourth quarter and full-year 2018 and provide revenue guidance for 2019 on January 3, 2019, after market close.

FLXN closed Wednesday's trading at $12.46, up 10.07%.

Veracyte Inc.'s (VCYT) chairman and CEO, Bonnie Anderson, is scheduled to present at the 37th Annual J.P. Morgan Healthcare Conference on Thursday, January 10, 2019 at 11:30 a.m. PST (2:30 p.m. EST) followed by a question and answer (Q&A) session at 12:00 p.m. PST (3:00 p.m. EST).

VCYT closed Wednesday's trading at $12.00, down 4.61%.

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