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Fri, Jan. 8, 6:51 PM
Dec. 23, 2015, 11:34 AM
- Tonix Pharmaceuticals (TNXP +0.8%) has reached its enrollment target of 240+ subjects in its Phase 2 clinical trial, AtEase, assessing lead product candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of post-traumatic stress disorder (PTSD). Top-line data are expected in Q2 2016.
- AtEase is a 25-site, randomized, double-blind, placebo-controlled trial that will evaluate the safety and efficacy of TNX-102 SL in patients with military-related PTSD. Participants will receive either 2.8 mg or 5.6 mg of TNX-102 SL or inactive control once daily at bedtime for 12 weeks. The primary endpoint is the change from baseline at week 12 in a rating scale called CAPS-5 compared to inactive control (placebo). According to clinicaltrials.gov, the estimated study completion date is June 2016.
- According to the company, TNX-102 SL targets mechanisms that are associated with disturbed sleep and nightmares. Cyclobenzaprine, branded as Flexeril, was cleared by the FDA in August, 1977 for the treatment of muscle spasms.
Dec. 8, 2015, 1:54 PM
- Patient enrollment is complete is a Phase 2 proof-of-concept trial assessing Tonix Pharmaceuticals' (TNXP +2.3%) TNX-201 (dexisometheptene mucate) in episodic tension-type headache. The study is a randomized, double-blind, placebo-controlled trial that will evaluate the efficacy of a single 140 mg dose of TNX-201. The co-primary endpoints are the proportion of subjects pain free up to 24 hours and the proportion of subjects pain free at two hours and from two hours to 24 hours post dose. According to clinicaltrials.gov, the estimated study completion date is April 2016.
- The active ingredient in TNX-201 is (R)-isometheptene mucate, a single isomer of isometheptene mucate, a drug that was introduced into the U.S. before 1962. It acts by constricting dilated cranial and cerebral blood vessels thereby reducing the stimuli that causes a headache.
- Episodic tension-type headache affects ~75M Americans. About 21M prescriptions are filled each year in the U.S. for the acute treatment of non-migraine headache.
Nov. 9, 2015, 9:08 AM
- Tonix Pharmaceuticals (NASDAQ:TNXP): Q3 EPS of -$0.72 misses by $0.10.
Aug. 10, 2015, 7:17 AM
- Tonix Pharmaceuticals (NASDAQ:TNXP): Q2 EPS of -$0.73 misses by $0.08.
Jul. 14, 2015, 9:19 AM
Jul. 14, 2015, 8:40 AM
- Tonix Pharmaceuticals (NASDAQ:TNXP) commences a public offering of 2.325M shares of common stock at $7.50 per share. Underwriters over-allotment is an additional 348,750 shares. Closing date is July 17.
- Net proceeds will fund the continued development of Tonmya, TNX-102 SL and other pipeline products, working capital and general corporate purposes.
- Yesterday's close was $8.24.
Jun. 16, 2015, 5:52 PM
- Lab Corp of America (NYSE:LH) initiated with Overweight rating and $143 (19% upside) price target by KeyBanc.
- Quest Diagnostics (NYSE:DGX) initiated with Sector Weight rating by KeyBanc.
- Community Healthcare (Pending:CHCT) initiated with Buy rating and $22 (16% upside) price target by Janney Capital.
- Idera Pharmaceuticals (NASDAQ:IDRA) initiated with Overweight rating and $6 (68% upside) price target by JP Morgan.
- Tonix Pharmaceuticals (NASDAQ:TNXP) initiated with Outperform rating and $18 (82% upside) price target by Oppenheimer.
Jun. 16, 2015, 10:51 AM
- Tonix Pharmaceuticals Holding (TNXP +2.9%) has begun randomizing patients in a Phase 2 clinical trial evaluating TNX-201 (dexisometheptene mucate) in episodic tension-type headache. Top-line results from the 200-subject study are expected in Q4. The primary endpoint, based on a single 140 mg dose of TNX-201, is the proportion of patients pain-free at two hours post dose.
- About 75M Americans experience this type of headache. Currently approved treatments all contain barbiturates. If approved, TNX-201 will be the first non-narcotic medication for episodic tension-type headache and the first such drug approved for the indication in more than 40 years.
Jun. 11, 2015, 12:45 PM
Jun. 11, 2015, 11:25 AM
- Tonix Pharmaceuticals (TNXP -0.8%) presented additional data on its investigational therapy for the treatment of fibromyalgia, TNX-102 SL, in two posters at the European League Against Rheumatism Annual Congress in Rome, Italy. The data are from a Phase 2b study, called BESTFIT, which assessed the efficacy of TNX-102 SL taken at bedtime. The primary endpoint was average perceived pain during week 12 compared to baseline.
- Fibromyalgia is a disorder characterized by widespread musculoskeletal pain, poor sleep patterns and memory/mood problems.
- The first poster, "TNX-102 SL for the Treatment of Fibromyalgia: Role of Nonrestorative Sleep on Pain Centralization, " showed that patients receiving TNX-102 SL experienced statistically significant improvements in sleep quality. The number of 30% responders, those patients who achieved at least a 30% reduction in pain on the daily diary, was also statistically greater than placebo. One the basis of MMRM (mixed model for repeated measures) in the intent-to-treat population the daily pain scores in the TNX-102 SL arm showed a positive bias compared to placebo but fell short of statistical significance (p=0.086).
- The second poster, "TNX-102 SL for Treatment of Fibromyalgia: Approaches to Pain Management," showed, among other measures, the effect of treatment of TNX-102 SL over time (week 2 - week 12). A statistically difference in response rate compared to placebo was achieved during week 12 (p=0.025).
- These data supported the advancement of TNX-102 SL into Phase 3 development, which is ongoing. The primary endpoint the 500-patient trial is the proportion of 30% responders versus baseline.
- TNX-102 SL (cyclobenzaprine HCl) is a sublingual tablet for bedtime use. It aims to provide therapeutic benefit by improving sleep quality.
- Investors appear to like TNX-102 SL's prospects. Shares are up over 40% since early May.
May 11, 2015, 6:54 AM
- Tonix Pharmaceuticals (TNXP -0.5%) Q1 results: Revenues: $0; R&D Expense: $6.8M (+88.9%); SG&A: $2.9M (+81.3%); Net Loss: ($9.7M) (-86.5%); Loss Per Share: ($0.71) (-20.3%); Quick Assets: $58.2M (+52.4%).
- No guidance given.
May 11, 2015, 6:09 AM
- Tonix Pharmaceuticals (NASDAQ:TNXP): Q1 EPS of -$0.71 misses by $0.17.
May 7, 2015, 12:09 PM
- Tonix Pharmaceuticals (TNXP +0.7%) initiated with Buy rating and $10 (63% upside) price target by Janney Capital.
- Infinity Pharmaceuticals (INFI -0.5%) initiated with Buy rating and $20 (67% upside) price target by Deutsche Bank.
- Intra-Cellular Therapies (ITCI -0.8%) initiated with a Buy rating and $50 (138% upside) price target by SunTrust Robinson Humphrey.
- Onconova Therapeutics (ONTX +1.7%) initiated with Buy rating and $6 (153% upside) price target by H.C. Wainwright.
- CONMED (CNMD +0.9%) initiated with Buy rating and $63 (18% upside) price target by Deutsche Bank.
- Carbylan Therapeutics (CBYL +1.8%) initiated with Outperform rating and $16 (183% upside) price target by Leerink Swann.
- NovaBay Pharmaceuticals (NBY -6.5%) initiated with Buy rating and $2 (251% upside) price target by Maxim Group.
- Rosetta Genomics (ROSG -0.6%) initiated with Outperform rating and $8 (229% upside) price target by Barrington Research.
- Lion Biotechnologies (LBIO -0.5%) initiated with Buy rating and $30 (162% upside) price target by Chardan Capital.
- Shire plc (SHPG +0.5%) initiated with Outperform rating by Exane BNP Paribas.
Apr. 21, 2015, 9:22 AM
Apr. 21, 2015, 8:59 AM
- SA author Jeff Eiseman says shares could be worth anywhere from $54 to $225, and thinks other (bullish) analysts aren't bullish enough.
- Source: Tonix Pharmaceuticals: Four Data-Based Valuations Of A Deeply Underappreciated Pharmaceutical Company
- Jason Napodano, who also covers the stock, thinks Eiseman's estimates are "wildly too high." He has a $14 target on TNXP.
- Shares are up 12% premarket on light turnover of 17K.
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