WASHINGTON (dpa-AFX) - The following are some of today's top gainers in the pharma/biotech sector.
1. Delcath Systems Inc. (DCTH.OB)
Gained 56.19% to close Monday's (Sep.10) trading at $3.28.
News: No news
The Company's investigational product - Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) - is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects.
A global phase III trial of Melphalan/HDS for patients with Hepatic Dominant Ocular Melanoma, dubbed FOCUS, and a registration trial, called ALIGN, for intrahepatic cholangiocarcinoma are underway.
Melphalan/HDS is yet to be approved by the FDA. However, in Europe, it has been commercially available since 2012 under the trade name Delcath Hepatic CHEMOSAT Delivery System, where it has been used at major medical centers to treat a wide range of cancers of the liver.
On August 28, the Company announced that it completed the initial rights offering period and will be extending for an additional 30-day period, until 5:00 PM Eastern time on September 26, 2018.
2. ProQR Therapeutics N.V. (PRQR)
Gained 18.04% to close Monday's trading at $18.65.
News: No news
-- On September 5, the Company announced positive interim results from its phase I/II trial of QR-110 in patients with Leber's congenital amaurosis 10 (LCA10), the most common cause of blindness due to genetic disease in children. The news sent the stock as much as 120% to $17.55 that day. -- On September 7, the Company offered to sell 5.75 million ordinary shares to the public at a price of $15.75 each. The offering is expected to close on September 11, 2018, subject to customary closing conditions. Gross proceeds from the offering are expected to be approximately $90.6 million.
-- A phase I/II clinical trial of QR-313 in patients that have recessive dystrophic epidermolysis bullosa (RDEB) due to mutations in exon 73 of the COL7A1 gene, dubbed WINGS, is underway. Interim results from this trial are expected in late 2018, with full data expected in 2019. -- A phase II/III pivotal trial of QR-110 in patients with Leber's congenital amaurosis 10 (LCA10) is expected to start in the first half of 2019.
3. Aptinyx Inc. (APTX)
Gained 13.75% to close Monday's trading at $31.85.
News: No news
The Company has 3 clinical drug candidates.
-- NYX-2925 in two Phase 2 studies - the first is in subjects with painful diabetic peripheral neuropathy (DPN), and the second is in subjects with fibromyalgia. -- NYX-783 as a therapy for post-traumatic stress disorder (PTSD), currently in a Phase 1 study to establish safety and tolerability. -- NYX-458 as a treatment for cognitive impairment associated with Parkinson's disease, under phase I study.
-- On June 21, 2018, the Company made its debut on the Nasdaq Global Select Market, offering its shares at a price of $16 each. -- On June 25, 2018, the Company closed its IPO and full exercise of underwriters' option.
-- Reporting of data from NYX-2925 pharmacodynamic/biomarker studies in healthy volunteers in the second half of 2018. -- Reporting of top-line data from Phase 2 study of NYX-2925 in subjects with painful diabetic peripheral neuropathy in the first half of 2019. -- Reporting of top-line data from Phase 2 exploratory study of NYX-2925 in subjects with fibromyalgia in the first half of 2019. -- Completion of NYX-458 Phase 1 clinical study in the first half of 2019. -- Reporting of data from NYX-783 planned Phase 2 study in subjects with post-traumatic stress disorder (PTSD) in the second half of 2019.
4. BIOLASE Inc. (BIOL)
Gained 12.57% to close Monday's trading at $2.06.
News: No news
-- On August 8, the Company reported its financial results for its second quarter and six months ended June 30, 2018.
Net loss for the second quarter of 2018 was $4.9 million or a $0.24 loss per share, compared to a net loss of $4.3 million, or a $0.32 loss per share, for the second quarter of 2017. Worldwide revenue in the recent second quarter was $12.2 million compared to $12.6 million in the second quarter of 2017.
-- On May 30, 2018, the Company regained compliance with Nasdaq minimum bid price requirement of $1.00 per share for continued listing on the Nasdaq Capital Market.
-- On May 10, 2018, the Company effected a 1-for-5 reverse stock split to raise the per share trading price of its common stock to continue its listing on the Nasdaq Capital Market.
5. Endocyte Inc. (ECYT)
Gained 11.38% to close Monday's trading at $18.89.
News: The Company announced that the FDA supports the use of radiographic progression free survival (rPFS) as an appropriate efficacy endpoint in the ongoing phase 3 VISION trial to support the submission of a New Drug Application for full FDA approval of 177Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
Initially, the primary endpoint of the study was only overall survival. Now, with the FDA accepting radiographic progression free survival (rPFS) as an alternative primary endpoint in addition to overall survival, the Company expects to obtain a full approval for 177Lu-PSMA-617 sooner than previously anticipated.
The analysis of rPFS for potential full approval is expected to occur before the end of 2019, and the final, fully powered overall survival analysis is expected to occur near the end of 2020.
In after-hours, the Company announced that it intends to offer and sell $175.0 million of its common stock in an underwritten registered public offering. The stock was down 3.97% in after-hours.
6. Sorrento Therapeutics Inc. (SRNE)
Gained 11.11% to close Monday's trading at $5.50.
News: The Company's majority-owned subsidiary, Scilex Pharmaceuticals Inc. raised $140 million in non-dilutive royalty-based financing to support the commercialization of non-opioid ZTlido pain medication.
ZTlido, a transdermal anesthetic formulation for the treatment of pain associated with postherpetic neuralgia, received FDA approval in February 2018. ZTLIDO will be commercially available in October.
On September 7, the Company announced data showing ZTlido demonstrated a statistically significant improved adhesion profile compared to Lidoderm patch and Versatis (Medicated Plaster 5%). In a separate study, ZTlido was found to be bioequivalent to Lidoderm.
7. Tocagen Inc. (TOCA)
Gained 10.86% to close Monday's trading at $12.25.
News: No news
-- On August 23, the Company announced that its phase III trial evaluating the safety and efficacy of Toca 511 & Toca FC compared to standard of care in patients undergoing resection for recurrent high grade glioma, dubbed Toca 5, will continue without modification following a planned first interim analysis of data conducted by an Independent Data Monitoring Committee (IDMC).
The second interim analysis of the Toca 5 study is expected to be conducted in the first half of 2019.
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