Today’s Daily Dose brings you news about the layoff in Allena Pharma; the positive phase III trial results of Aurinia Pharma’s lupus drug; stock offerings of Millendo Therapeutics and Relmada Therapeutics.
ACADIA Pharmaceuticals Inc. (ACAD) is planning to meet with the FDA in the first half of 2020 regarding a supplemental NDA submission for Pimavanserin for the treatment of dementia-related psychosis.
The Company’s phase III study evaluating Pimavanserin for the treatment of dementia-related psychosis, dubbed HARMONY, was stopped early for positive efficacy in September of this year. The trial met its primary endpoint, demonstrating a highly statistically significant longer time to relapse of psychosis with Pimavanserin compared to placebo in a planned interim efficacy analysis.
Pimavanserin is already approved in the U.S., under brand name NUPLAZID, for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. The drug brought home net sales of $94.6 million in the third quarter ended September 30, 2019, up 62% over the year-ago same quarter.
For full-year 2019, the Company expects NUPLAZID net sales to be in the range of $330 to $340 million.
ACAD closed Wednesday’s trading at $44.28, down 1.47%. In after-hours, the stock was up 2.76% to $45.50.
Allena Pharmaceuticals Inc. (ALNA) is trimming its workforce that will lead to a reduction in its salary and related compensation expenses of approximately 30%. The layoff, which is primarily in the area of research and development, is expected to be substantially complete by the end of 2019.
The Company’s lead product candidate is Reloxaliase (formerly ALLN-177), an oral enzyme therapeutic that is initially being developed for the treatment of enteric hyperoxaluria in adults.
Hyperoxaluria is a metabolic disorder characterized by significantly elevated oxalate levels in the urine. This condition can cause kidney stones, damaging the kidney – ultimately leading to kidney failure.
Last month, the Company reported positive topline results from a pivotal phase III trial of Reloxaliase for the treatment of patients with enteric hyperoxaluria, dubbed URIROX-1. A second pivotal phase III trial of Reloxaliase for the treatment of patients with enteric hyperoxaluria, dubbed URIROX-2, is underway.
The Company expects to meet with the FDA in early 2020 and to provide an update on the final design and timing of the URIROX-2 study as it evolves.
ALNA closed Wednesday’s trading at $2.31, up 0.87%.
Aurinia Pharmaceuticals Inc.’s (AUPH) (AUP.TO) pivotal phase III trial of Voclosporin, in combination with mycophenolate and low-dose corticosteroids, in the treatment of lupus nephritis has yielded positive results.
The trial, dubbed AURORA, in which 357 patients with active lupus nephritis were enrolled, met its primary endpoint of Renal Response rates of 40.8% for Voclosporin vs. 22.5% for the control. Additionally, all pre-specified hierarchical secondary endpoints achieved statistical significance in favor of Voclosporin, which included Renal Response at 24 weeks, Partial Renal Response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio (UPCR), and time to 50% reduction in UPCR.
Aurinia plans to submit an NDA for Voclosporin in lupus nephritis to the FDA in the first half of 2020.
AUPH closed Wednesday’s trading at $8.39, up 5.14%. In after-hours, the stock was up 119.90% to $18.45.
Millendo Therapeutics Inc. (MLND) has offered to sell 4.16 million shares of its common stock to the public at a price of $6.00 per share.
The aggregate gross proceeds from the offering are expected to be $25.0 million. The offering is expected to close on December 9, 2019, subject to the satisfaction of customary closing conditions.
In addition, Millendo has granted the underwriters a 30-day option to purchase up to 625,000 additional shares of common stock.
The Company’s pipeline includes two clinical assets – Livoletide (AZP-531) for the treatment of Prader-Willi syndrome, and Nevanimibe (ATR-101) for the treatment of classic congenital adrenal hyperplasia (CAH). Also in the pipeline is MLE-301 in pre-clinical development for the treatment of vasomotor symptoms associated with menopause.
Livoletide is under a pivotal phase IIb/III clinical study in patients with Prader-Willi syndrome, dubbed ZEPHYR, with topline results expected in 1H20.
Nevanimibe is under a phase IIb study in patients with congenital adrenal hyperplasia, and includes two distinct cohorts of patients. Topline results for cohort 1 of the study are anticipated in 2H20.
MLND closed Wednesday’s trading at $7.76, up 1.31%. In after-hours, the stock was down 18.81% to $6.30.
Relmada Therapeutics Inc. (RLMD) has offered to sell 3.33 million shares of its common stock to the public at a price of $30.00 per share in an underwritten offering.
The gross proceeds to Relmada from the offering are expected to be $100 million. The offering is expected to close on December 6, 2019, subject to customary closing conditions.
In addition, Relmada has granted the underwriters a 30-day option to purchase up to an additional 500,000 shares of Relmada’s common stock.
On October 15, 2019, the Company reported promising results from its phase II clinical study evaluating two doses of REL-1017, 25 mg once a day and 50 mg once a day, as an adjunctive treatment in patients with treatment-resistant depression. The news sent the stock soaring 134% to $26 that day.
The Company’s stock underwent a 1-for-4 reverse stock split on September 30, 2019, and the shares were uplisted to the Nasdaq Capital Market on October 10, 2019.
RLMD closed Wednesday’s trading at $47.18, up 36.91%.
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