Today's Daily Dose brings you news about Avinger's reverse stock split; FDA clinical hold on Bellicum's BPX-501 trials; Elite's progress with SequestOx and Vical's restructuring.
Read on…
Avinger Inc. (AVGR) has implemented a 1-for-40 reverse stock split of its common stock, which came into effect at 5:00 p.m. Eastern time on Tuesday, January 30, 2018.
The reverse split will reduce the number of shares of the Company's common stock outstanding from approximately 35.1 million to about 877,000.
AVGR closed Tuesday's trading at $0.18, down 1.56%.
Shares of Bellicum Pharmaceuticals Inc. (BLCM) plunged more than 37% in extended trading on Tuesday, following announcement of the FDA clinical hold on the Company's U.S. studies of BPX-501 due to three cases of encephalopathy deemed as possibly related to that drug candidate.
BPX-501 is being evaluated in multiple phase 1/2 clinical trials in adults and pediatric patients with leukemias, lymphomas, and genetic blood diseases in the U.S. and Europe.
BLCM closed Tuesday's trading at $8.20, down 5.53%. In after-hours, the stock was down 37.68% to $5.11.
Elite Pharmaceuticals Inc.'s (ELTP.OB) pilot study conducted with SequestOx, with the objective of establishing bioequivalence to the reference drug Roxicodone, has yielded positive results. SequestOx is an immediate release Oxycodone Hydrochloride product that incorporates Elite's proprietary abuse-deterrent technology being developed for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
SequestOx was issued a Complete Response Letter for its SequestOx NDA in July 2016.
Elite intends to get the study results reviewed by the FDA, and discuss the pharmacokinetic study requirements for a re-submission of the NDA.
ELTP.OB closed Tuesday's trading at $0.12, up 15.77%.
Mallinckrodt plc (MNK) has enrolled the first patient in its phase 4 pilot study to further assess the efficacy of H.P. Acthar Gel as a therapy option in patients with pulmonary sarcoidosis.
H.P. Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications. Acthar was reported as effective for the treatment of pulmonary sarcoidosis in the 1950s.
The results of the phase 4 study may potentially provide evidence to further support Acthar as a treatment option in appropriate symptomatic sarcoidosis patients," said Dr. Robert Baughman, M.D., Professor in the Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.
MNK closed Tuesday's trading at $18.37, down 9.51%.
Solid Biosciences Inc. (SLDB) has completed its IPO of 8.98 million shares of its common stock, sold by the Company at a price of $16.00 each, including full exercise of underwriters' overallotment option.
The shares began trading on the Nasdaq Global Select Market on January 26, 2018.
The Company's lead product candidate is SGT-001 for the treatment of Duchenne muscular dystrophy (DMD).
A phase I/II study of SGT-001 in ambulatory and non-ambulatory adolescents and children with DMD, dubbed IGNITE DMD, is underway. A pre-specified interim analysis of preliminary data is expected in the first half of 2019.
SLDB closed Tuesday's trading at $22.50, down 5.06%.
Seeking to extend its cash runway, and focus its efforts on antifungal program, Vical Inc. (VICL) has embarked on a restructuring process.
Accordingly, the Company will reduce its staff from 74 to 34 employees, and terminate all activities related to the ASP0113 program licensed to Astellas Pharma.
The Company's lead antifungal drug product candidate VL-2397 for the treatment of invasive aspergillosis is entering a pivotal Phase 2 clinical trial in the first quarter of 2018.
Also in the pipeline is HSV-2 therapeutic vaccine, VCL-HB01, to treat patients with symptomatic genital herpes infection, which is currently being evaluated in a Phase 2 study The top-line results from the trial are expected during the second quarter of 2018.
VICL closed Tuesday's trading at $1.48, down 3.27%.
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