The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of February 13, 2017.
1. Zosano Pharma Corp. (ZSAN)
Gained 41.67% to close Monday's trading at $1.70.
News: The company's pivotal phase III efficacy study of M207 in migraine met endpoints.
In the pivotal phase III efficacy study, dubbed ZOTRIP, M207 achieved both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours.
M207 is a zolmitriptan-coated microneedle patch that is designed to rapidly deliver anti-migraine agent zolmitriptan during a migraine attack.
2. Protalix BioTherapeutics Inc. (PLX)
Gained 29.70% to close Monday's trading at $1.31.
News: The company will be making oral and poster presentations on alpha-Gal-A enzyme for Fabry disease on Feb.14 & Feb.16 at the 13th Annual WORLD Symposium 2017.
The company's lead product candidate is PRX-102, a recombinant plant cell expressed, chemically modified version of the human alpha-Galactosidase-A enzyme, under phase III testing for Fabry disease. Enrollment in the trial is expected to be completed in 2017 - with interim data analysis anticipated in 2018 to support EMA and other regulatory filings outside of the United States.
3. Pulse Biosciences Inc. (PLSE)
Gained 26.63% to close Monday's trading at $11.84.
News: Healthcare executives and entrepreneurs Robert Duggan and Maky Zanganeh have purchased a combined stake of 17.1% of the company. Zanganeh has also been appointed to Board of Directors.
The transactions of Robert Duggan and Maky Zanganeh include $5 million, or 819,673 shares, purchased from the company and $5 million, or 819,672 shares, purchased from existing shareholders that have been released from a one year lock-up restriction from the date of the company's initial public offering. These shares are in addition to 771,799 shares purchased on the open market prior to these transactions.
Pulse Biosciences went public on the NASDAQ Capital Market on May 18, 2016, offering its shares at a price of $4.00 each.
4. Catalyst Biosciences Inc. (CBIO)
Gained 22.90% to close Monday's trading at $9.50.
News: A 1-for-15 reverse stock split was implemented after the market close on Friday (Feb.10, 2017) and it began trading on a split-adjusted basis at the opening of trading on February 13, 2017.
The reverse stock split was effected in order is to enable Catalyst to regain compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market. Following the reverse split, the number of shares of Catalyst's common stock outstanding has decreased from approximately 13.0 million pre-split shares to approximately 868,000 post-split shares.
5. Electromed Inc. (ELMD)
Gained 21.92% to close Monday's trading at $4.95.
News: No news
Recent event: Fiscal 2017 Q2 financial results were announced on February 8, 2017.
Net revenues in Q2 FY 2017 increased 1.8% to $6.4 million from $6.3 million in Q2 FY 2016. The net income was $444,000 or $0.05 per share in Q2 FY 2017, compared to $1.1 million or $0.13 per share in Q2 FY 2016.
6. XOMA Corp. (XOMA)
Gained 19.60% to close Monday's trading at $4.82.
News: The company has agreed to sell 1.2 million shares of its common stock at a price of $4.03 each and 5,003 shares of convertible preferred stock directly to Biotechnology Value Fund, L.P. and certain of its affiliates ("BVF") in a registered direct offering.
The gross proceeds from the offering are expected to be approximately $25.0 million. The offering is expected to close on or about February 15, 2017.
7. Cerulean Pharma Inc. (CERU)
Gained 18.46% to close Monday's trading at $1.54.
News: No news
On February 1, 2017, Cerulean announced it is evaluating potential alternatives such as the sale of the company, a merger, a business combination, a strategic investment into the company, or a sale, license or disposition of assets of the company to maximize stockholder value.
8. ZELTIQ Aesthetics Inc. (ZLTQ)
Gained 13.22% to close Monday's trading at $55.93.
News: Allergan has agreed to acquire ZELTIQ for $56.50 per share, or $2.475 billion, subject to customary adjustments.
ZELTIQ's commercial product, the CoolSculpting System, is designed to selectively reduce stubborn fat bulges. The transaction is expected to close in the second half of 2017.
9. Aurinia Pharmaceuticals Inc. (AUPH)
Gained 12.42% to close Monday's trading at $3.62.
News: No news
- 48-week secondary endpoint results from a phase IIb study of Voclosporin in the treatment of lupus nephritis, dubbed AURA, are expected to be reported this quarter (Q1 2017).
The primary endpoint results from the AURA trial reported last August were positive - where Voclosporin 23.7mg BID showed a statistically significant improvement in complete remission.
- The company plans to initiate a phase III study of Voclosporin in patients with active lupus nephritis, dubbed AURORA, in Q2 2017.
10. Sage Therapeutics (SAGE)
Gained 11.75% to close Monday's trading at $52.99.
News: The company reported positive results from part A of phase II study of SAGE-217 for the treatment of major depressive disorder.
The phase II trial is a two-part trial evaluating the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in moderate to severe major depressive disorder (MDD) patients.
Part A of the Phase 2 trial evaluated the safety and tolerability of SAGE-217 in 13 patients. According to the trial results, SAGE-217 has been found to be generally well-tolerated with no serious adverse events or discontinuations reported. SAGE-217 has also demonstrated positive signal of activity - with patients experiencing reduced depressive symptoms as assessed by the HAM-D total score.
1. Cara Therapeutics, Inc. (CARA)
Lost 15.17% to close Monday's trading at $12.30.
News: No news
Near-term catalyst: Top-line data from Part A of the company's phase 2/3 trial of I.V. CR845 in pruritus associated with chronic kidney disease are anticipated this quarter (Q1 2017).
2. Biocept Inc. (BIOC)
Lost 8.44% to close Monday's trading at $2.17.
News: No news
Anticipated event: Q4 and Full-year 2016 financial results to be reported on March 7, 2017.
The company's revenue in Q3, 2016 was $1.05 million compared to $165,000 in Q3, 2015.
3. Chiasma Inc. (CHMA)
Lost 8.11% to close Monday's trading at $1.70.
News: No news
Chiasma's lead product candidate is Mycapssa. The NDA for Mycapssa capsules for the maintenance treatment of U.S. adult patients with acromegaly was turned down by the FDA last April. The company needs to conduct another clinical trial before Mycapssa could be approved.
A phase III clinical trial to investigate the non-inferiority of Mycapssa to once-a-month injectable somatostatin analogs, dubbed MPOWERED, is underway. The results of this study are expected to support the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA).
by RTT Staff Writer
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