$TNXP news 08-26-2020 With Key Data Nearing, Tonix Looks to Spotlight Robust Pipeline In Immunology And CNS Therapeutics Benzinga Chris Dier-Scalise ,Benzinga•August 26, 2020
$TNXP news 08-26-2020 #2 With Key Data Nearing, Tonix Looks to Spotlight Robust Pipeline In Immunology And CNS Therapeutics Benzinga Chris Dier-Scalise ,Benzinga•August 26, 2020
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Summary My Holdings Fundamentals Performance Characteristics Risk Analysis Basic DayWatch Performance latest CE Grey to CE PinkCreate New View Add SymbolReorderCurrency in USD Symbol Last Price Change Chg % Currency Market Time Volume Shares Avg Vol (3m) Day Range 52-Wk Range Day Chart Market Cap TRVN 1.5308 -0.0492 -3.1139% USD 1:23PM EDT 2.550M - 8.791M 202.052M ADMA 2.7052 -0.1248 -4.4099% USD 1:23PM EDT 5.517M - 5.801M 232.713M IBIO 2.0250 -0.2750 -11.9565% USD 1:23PM EDT 24.112M - 30.969M 353.278M KMDA 11.07 -0.05 -0.48% USD 1:23PM EDT 414.005k - 439,324 483.525M SONN 3.0100 -0.1500 -4.7468% USD 1:22PM EDT 1.541M - 4.298M 41.183M MAKAF 1.1000 0.0000 0.00% USD 1:05PM EDT 114.281k - - - BRTXQ 0.0105 +0.0017 +19.3182% USD 1:08PM EDT 73.137M - 47.279M 497,098 CZNI 0.0030 0.0000 0.00% USD 1:01PM EDT 23.286M - 13.431M 1.171M GPVRF 2.6299 +0.1799 +7.3429% USD 1:08PM EDT 2.863M - 707,714 272.54M EGYF 0.1140 +0.0326 +40.0491% USD 1:00PM EDT 772.006k - 183,823 10.486M GRST 0.0017 0.0000 0.00% USD 12:59PM EDT 15.804M - 96.931M 3.13M MGON 0.0105 +0.0012 +12.90% USD 12:58PM EDT 8.886M - 3.638M 9,227 DKSC 0.0056 +0.0004 +7.6923% USD 1:07PM EDT 67.223M - 16.296M 93,333 VYST 0.0489 +0.0019 +4.0426% USD 1:08PM EDT 11.721M - 36.959M 53.077M PNNX 0.1438 +0.0218 +17.91% USD 12:11PM EDT 67,620 - 106,258 2.244M SNSS 0.2890 +0.0116 +4.1817% USD 1:23PM EDT 8.603M - 13.621M 52.38M TRNF 0.1450 +0.0105 +7.81% USD 12:57PM EDT 589,650 - 897,218 23.436M PCRFY 9.18 +0.08 +0.88% USD 1:06PM EDT 128.171k - 186,430 21.398B NTEI 0.5110 0.0000 0.00% USD 3:08PM EDT 8,175 - 1,762 7,368 HCAC 10.98 +0.13 +1.20% USD 1:23PM EDT 1.496M - 663,190 411.768M FUJIF 46.80 0.00 0.00% USD 3:55PM EDT 35 - 1,267 18.937B RVVTF 0.2011 +0.0006 +0.2993% USD 1:08PM EDT 2.993M - 4.521M 33.616M CVAC 60.18 -3.07 -4.85% USD 1:23PM EDT 529.760k - 7.464M 10.574B OCLG 0.0014 +0.0005 +55.5556% USD 1:07PM EDT 572.929M - 42.953M 442,162 MRNA 70.41 +4.16 +6.28% USD 1:23PM EDT 22.592M - 22.81M 27.664B ABUS 3.0799 +0.0799 +2.6633% USD 1:23PM EDT 1.903M - 8.568M 211.022M AGNPF 0.2875 +0.0055 +1.9504% USD 1:04PM EDT 323.282k - 860,946 31.335M DNRCQ 0.0239 +0.0004 +1.7021% USD 1:07PM EDT 2.043M - 20.154M 11.916M ANTM 268.85 -7.62 -2.76% USD 1:23PM EDT 582.076k - 1.233M 67.671B ZBRA 284.54 +6.68 +2.40% USD 1:22PM EDT 170.033k - 309,506 15.163B TDOC 213.71 +1.70 +0.80% USD 1:23PM EDT 2.288M - 3.709M 17.378B LOGM 86.01 -0.00 -0.01% USD 1:19PM EDT 647.252k - 468,493 4.217B SQ 155.90 +0.90 +0.58% USD 1:23PM EDT 3.264M - 13.067M 69.16B SNST 1.9000 -0.3000 -13.64% USD 12:12PM EDT 26,159 - 30,983 28.635M INTV 0.0296 +0.0003 +1.0239% USD 1:05PM EDT 350.947k - 2.096M 2.603M SAML 0.0014 +0.0002 +16.6667% USD 1:05PM EDT 40.060M - 26.306M 5.667M BIGC 130.34 +26.25 +25.22% USD 1:23PM EDT 12.046M - 3.78M 8.778B SOLO 3.0770 +0.0670 +2.2259% USD 1:23PM EDT 20.045M - 14.672M 197.372M NKLA 38.71 -0.47 -1.21% USD 1:23PM EDT 4.634M - 20.757M 14.667B KNDI 7.07 +0.40 +6.00% USD 1:23PM EDT 4.510M - 6.074M 382.675M SHLL 39.60 +0.72 +1.85% USD 1:23PM EDT 3.595M - 4.981M 1.138B SPAQ 13.47 -0.45 -3.23% USD 1:23PM EDT 4.819M - 5.937M 930.81M DPHCW 5.91 +1.17 +24.68% USD 1:16PM EDT 724.639k - - - DPHCU 18.25 +1.74 +10.54% USD 12:32PM EDT 48,491 - 47,529 618.392M DPHC 15.99 +1.54 +10.66% USD 1:23PM EDT 4.372M - 1.225M 560.525M WKHS 17.72 -0.48 -2.64% USD 1:23PM EDT 15.252M - 24.934M 1.85B ALYI 0.0092 0.0000 0.00% USD 1:07PM EDT 6.981M - 39.114M 699,698 CSLT 1.2575 +0.0675 +5.6723% USD 1:22PM EDT 155.986k - 1.375M 186.911M GRPS 0.0027 +0.0001 +3.85% USD 12:35PM EDT 1.381M - 1.679M 2.543M SIGA 7.07 -0.08 -1.12% USD 1:10PM EDT 143.324k - 350,432 552.314M VXRT 6.76 -0.19 -2.73% USD 1:23PM EDT 5.768M - 25.978M 735.475M KIN 3.9700 -0.0500 -1.2438% USD 1:13PM EDT 57.867k - 400,580 156.293M KODK 6.38 -0.38 -5.62% USD 1:23PM EDT 6.448M - 18.487M 480.125M TNXP 0.9070 +0.0539 +6.3181% USD 1:23PM EDT 7.845M - 24.868M 119.8M SUTI 0.0001 0.0000 0.00% USD 1:01PM EDT 1M - 17.907M 459,894 PFE 37.84 -0.57 -1.48% USD 1:23PM EDT 12.944M - 30.897M 210.55B OPGN 2.2950 -0.0150 -0.6493% USD 1:20PM EDT 527.989k - 7M 45.244M NVAX 116.60 +3.49 +3.09% USD 1:23PM EDT 5.398M - 8.345M 7.117B MSMY 0.0017 -0.0001 -2.86% USD 12:16PM EDT 1.705M - 13.705M 3,281 MNLO 1.4200 -0.0800 -5.3333% USD 1:23PM EDT 1.850M - 4.452M 243.152M MARK 1.1300 -0.0200 -1.7391% USD 1:22PM EDT 1.880M - 15.981M 111.835M MATN 0.1825 -0.0065 -3.44% USD 12:22PM EDT 39,401 - 222,290 16.352M FLIR 35.50 +0.06 +0.17% USD 1:23PM EDT 932.991k - 1.617M 4.663B CAPR 5.54 -0.17 -2.98% USD 1:21PM EDT 547.691k - 2.634M 109.271M COCP 1.3900 -0.0400 -2.7972% USD 1:22PM EDT 639.059k - 4.775M 72.231M BNTX 68.18 -2.31 -3.28% USD 1:22PM EDT 1.092M - 3.162M 16.266B ACCR 0.0034 -0.0015 -30.61% USD 10:30AM EDT 75,580 - 317,064 1.02M ARCS 0.0004 0.0000 0.00% USD 3:41PM EDT 2.053M - 2.313M 28,566 AEMD 1.5000 -0.0200 -1.3158% USD 1:20PM EDT 61.723k - 2.55M 18.106M AABB 0.0030 0.0000 +1.6949% USD 1:06PM EDT 8.131M - 19.156M 1.214M OEDVQ 0.0017 -0.0002 -12.82% USD 12:36PM EDT 70,500 - 72,469 30,220 DESTQ 0.0160 -0.0030 -15.79% USD 10:33AM EDT 52,505 - 44,312 227,617 RGDXQ 0.0025 -0.0012 -32.43% USD 12:22PM EDT 176,400 - 109,120 22,630 PFWIQ 0.0005 0.0000 0.00% USD 12:05PM EDT 2.017M - 9.03M 50,646 LIQDQ 0.0017 0.0000 0.00% USD 11:44AM EDT 6,300 - 88,594 36,198 CQRLF 0.0528 +0.0017 +3.33% USD 11:48AM EDT 16,107 - 29,395 6.776M RDHL 7.41 +0.16 +2.28% USD 1:23PM EDT 84.445k - 360,118 260.995M IMVT 34.71 +0.05 +0.14% USD 1:22PM EDT 174.678k - 465,224 2.85B AREXQ 0.0185 +0.0010 +5.57% USD 12:28PM EDT 18,201 - 849,318 1.73M GMEV 0.0017 +0.0001 +8.63% USD 12:46PM EDT 8.486M - 18.049M 328,686 MLND 1.8000 -0.0400 -2.1739% USD 1:23PM EDT 64.587k - 1.335M 34.199M GRSO 0.0004 0.0000 0.00% USD 12:16PM EDT 12.318M - 50.088M 580,555 CADMF 0.6550 +0.0250 +3.9683% USD 1:03PM EDT 92.599k - 63,693 19.202M RADR 0.0008 0.0000 0.00% USD 12:35PM EDT 400 - 220 52,240 ALLIF 0.5100 -0.0050 -0.97% USD 12:57PM EDT 349,099 - 1.037M 31.811M OGEN 0.7622 -0.0178 -2.28% USD 1:13PM EDT 712,002 - 8.49M 46.498M AMPG 0.0600 -0.0056 -8.54% USD 12:55PM EDT 48,103 - 196,910 2.972M MDGS 1.3536 -0.0164 -1.20% USD 1:11PM EDT 52,598 - 450,872 10.631M OPK 4.0150 -0.3700 -8.44% USD 1:13PM EDT 15.371M - 17.242M 2.689B AKTX 1.6800 -0.0100 -0.59% USD 1:10PM EDT 71,342 - 371,407 56.21M SRCRF 0.1320 0.0000 0.00% USD 1:36PM EDT 6,622 - 31,992 9.491M CERPQ 0.0374 -0.0016 -4.02% USD 12:40PM EDT 123,875 - 294,241 21,415 NOVN 0.4563 +0.0005 +0.11% USD 1:13PM EDT 2.786M - 28.353M 62.727M STWC 0.0014 -0.0001 -6.67% USD 12:58PM EDT 5.765M - 67.912M 124,063 ITOX 0.0101 +0.0003 +3.06% USD 12:54PM EDT 383,031 - 4.471M 1.432M ATDS 0.0111 +0.0003 +2.96% USD 12:56PM EDT 9.844M - 16.746M 3.374M BIOC 0.7050 -0.0389 -5.23% USD 1:13PM EDT 3.885M - 29.709M 94.423M TGRR 0.0002 +0.0000 +33.33% USD 11:30AM EDT 5.01M - 51.159M 27,352 HEME 0.0025 0.0000 0.00% USD 9:30AM EDT 23,000 - 1.376M 18,209 EQ 6.71 -0.33 -4.66% USD 1:12PM EDT 302,275 - 2.612M 162.856M UDHI 0.0335 +0.0021 +6.69% USD 11:53AM EDT 1.809M - 3.235M 611,174 OPTI 0.0684 -0.0039 -5.39% USD 12:56PM EDT 9.134M - 92.69M 657,921 BMIX 0.0008 -0.0001 -11.11% USD 12:45PM EDT 2.518M - 18.942M 1.127M VSYM 0.0012 +0.0001 +9.09% USD 12:58PM EDT 18.909M - 94.623M 2.292M HOFV 4.8400 -0.0500 -1.02% USD 1:12PM EDT 170,056 - 464,156 154.03M JETR 0.1469 +0.0009 +0.62% USD 12:35PM EDT 84,951 - 184,258 - WOGI 0.0006 0.0000 0.00% USD 11:51AM EDT 35.234M - 34.492M - STHC 0.0187 -0.0018 -8.78% USD 12:39PM EDT 3.888M - 24.864M 89,055 HMNU 0.0118 0.0000 0.00% USD 10:34AM EDT 124,000 - 1.111M 10.235M RSPI 0.0057 0.0000 0.00% USD 12:41PM EDT 4.436M - 22.997M 1.752M TSOI 0.0095 0.0000 0.00% USD 12:53PM EDT 3.231M - 43.853M 18.88M VNTN 0.0007 0.0000 0.00% USD 12:49PM EDT 1.637M - 689,052 691,882 NBIO 0.0848 +0.0092 +12.17% USD 12:29PM EDT 20,644 - 230,875 5.474M INKW 0.0014 -0.0001 -6.67% USD 12:14PM EDT 5.852M - 27.897M 1.096M CGAC 0.0016 0.0000 0.00% USD 3:49PM EDT 10,000 - 60,332 2,152 RCPIQ 0.0021 +0.0002 +10.53% USD 11:42AM EDT 597 - 733,317 97,618 VBIV 3.1950 -0.0800 -2.44% USD 1:13PM EDT 4.103M - 12.435M 738.678M LIACF 1.0272 +0.0072 +0.71% USD 12:56PM EDT 302,888 - 2.013M 89.121M SRNE 8.57 +0.34 +4.15% USD 1:13PM EDT 33.689M - 41.138M 2.073B FONU 0.0010 -0.0004 -28.57% USD 12:37PM EDT 53.083M - 29.871M 86,768 AIM 2.1900 +0.0200 +0.92% USD 1:11PM EDT 886,451 - 5.554M 86.921M SGMO 11.16 -0.13 -1.15% USD 1:13PM EDT 299,969 - 2.109M 1.573B AYTU 1.1900 -0.0200 -1.65% USD 1:13PM EDT 1.352M - 7.021M 143.532M GNMK 14.93 -0.06 -0.40% USD 1:12PM EDT 436,456 - 1.742M 1.061B TRNX 0.0372 +0.0082 +28.28% USD 12:58PM EDT 3.044M - 3.853M 7.015M BTI 33.86 -0.35 -1.03% USD 1:13PM EDT 1.257M - 2.323M 76.611B NSPX 0.0230 +0.0010 +4.55% USD 12:28PM EDT 75,704 - 1.189M 151,504 TBIO 14.98 -0.02 -0.13% USD 1:13PM EDT 399,505 - 1.963M 1.112B PCTL 0.0410 -0.0005 -1.20% USD 12:43PM EDT 600,704 - 4.245M 24.014M OPNT 8.97 -0.01 -0.11% USD 12:36PM EDT 7,388 - 73,035 38.195M DLYT 0.1500 0.0000 0.00% USD 11:51AM EDT 301 - 1,691 41,719 BCRX 4.0350 -0.0950 -2.30% USD 1:13PM EDT 1.418M - 7.261M 712.444M SNPW 0.0019 -0.0003 -13.64% USD 12:54PM EDT 1.361M - 10.511M 1.836M GILD 65.44 -0.61 -0.92% USD 1:13PM EDT 4.053M - 9.493M 82.043B ALT 18.42 -3.15 -14.58% USD 1:13PM EDT 1.964M - 4.695M 606.4M APDN 8.58 -0.27 -3.05% USD 1:12PM EDT 131,029 - 1.279M 44.125M GOVX 0.4575 -0.0350 -7.11% USD 12:58PM EDT 81,450 - 511,307 7.062M IPATF 1.2644 +0.0644 +5.37% USD 12:35PM EDT 8,453 - 102,021 86.371M LLIT 0.4127 -0.0063 -1.50% USD 1:12PM EDT 168,318 - 2.801M 11.884M PULM 1.1250 -0.0550 -4.66% USD 1:12PM EDT 275,981 - 873,390 38.708M VXLLF 0.0673 -0.0029 -4.13% USD 12:27PM EDT 2,035 - 78,107 6.387M CYDY 3.5550 -0.2550 -6.69% USD 12:58PM EDT 2.405M - 7.804M 2.02B CPHI 0.4007 -0.0092 -2.24% USD 12:56PM EDT 138,410 - 1.777M 17.463M ENLV 4.9000 -0.2100 -4.11% USD 1:08PM EDT 26,701 - 109,247 65.973M XAIR 6.14 +0.09 +1.49% USD 1:13PM EDT 43,144 - 269,470 105.284M NFH 8.06 +0.05 +0.62% USD 1:02PM EDT 61,643 - 53,946 1.059B CTSO 8.50 -0.02 -0.23% USD 1:12PM EDT 115,434 - 579,246 366.842M TORC 2.2000 +0.1500 +7.32% USD 1:10PM EDT 116,661 - 1.086M 80.199M MGEN 0.9789 -0.0411 -4.03% USD 1:11PM EDT 514,299 - 3.116M 55.416M ONCY 1.7366 -0.0334 -1.89% USD 1:13PM EDT 294,467 - 635,830 73.745M FATE 34.79 +0.04 +0.12% USD 1:13PM EDT 250,799 - 911,489 3.021B CERS 6.26 -0.05 -0.79% USD 1:13PM EDT 1.309M - 1.926M 1.041B CBLI 1.9500 -0.0200 -1.02% USD 1:09PM EDT 23,018 - 1.491M 25.382M CODX 12.97 -0.07 -0.58% USD 1:12PM EDT 1.346M - 3.376M 364.092M AHPI 7.12 -0.16 -2.13% USD 1:12PM EDT 90,921 - 557,209 28.596M APT 15.27 +0.41 +2.76% USD 1:11PM EDT 562,230 - 3.315M 207.486M CMRX 2.7750 -0.0250 -0.89% USD 1:13PM EDT 149,959 - 466,326 172.606M GBIM 0.3000 -0.1000 -25.00% USD 12:08PM EDT 1,000 - 20,912 1.473M GNBT 0.4215 -0.0150 -3.44% USD 12:58PM EDT 176,428 - 488,529 33.656M HEB - - - - - - - - - LAKE 22.08 +0.29 +1.33% USD 1:13PM EDT 131,604 - 1.102M 176.116M NLNK - - - - - - - - - NSPH - - - - 6:07PM EDT - - - - OBCI 15.05 -0.44 -2.84% USD 1:07PM EDT 12,541 - 130,273 142.405M PSID 0.0001 0.0000 0.00% USD 3:46PM EDT 32.7M - 0 939 PURE 1.4001 -0.0199 -1.40% USD 12:28PM EDT 20,412 - 176,175 121.656M RMCP - - - - - - - - - SIMH - - - - 6:07PM EDT - - - - SRPT 149.03 +4.09 +2.82% USD 1:12PM EDT 270,917 - 835,067 11.7B TKMR 3.0600 +0.0600 +2.00% USD 1:13PM EDT 1.88M - 670,000 165.926M VICL - - - - - - - - - SFOR 0.0165 +0.0007 +4.76% USD 12:45PM EDT 270,415 - 14.472M 262,147 Portfolio News MRNA PFE Investor's Business Daily • 5 minutes ago Dow Jones Turns Positive; Nasdaq And S&P 500 Mark New Record Highs Ad Legacy Research “Buy This,” Says Man Who Picked Bitcoin in 2016 VXRT ACCESSWIRE • 19 minutes ago The Klein Law Firm Reminds Investors of Class Actions on Behalf of Shareholders of GWRE, FE and VXRT MRNA PFE Yahoo Finance Video • 24 minutes ago U.S. authorities charge Teva in generic price-fixing probe NKLA TipRanks • 25 minutes ago Nikola Remains a ‘Show Me’ Story, Says 5-Star Analyst MRNA Yahoo Finance • 59 minutes ago Stock market news live updates: S&P, Nasdaq touch new records as tech shares surge Ad History A2Z 30 Car Cleaning Tricks Local Dealers Keep Hidden VXRT Business Wire • 1 hour ago Glancy Prongay & Murray LLP Announces the Filing of a Securities Class Action on Behalf of Vaxart, Inc. 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With Key Data Nearing, Tonix Looks to Spotlight Robust Pipeline In Immunology And CNS Therapeutics Benzinga Chris Dier-Scalise ,Benzinga•August 26, 2020
The following article is sponsored by the clinical communications unit of Redington, Inc. The information contained in this article in no way represents investment advice or opinion on the part of Benzinga or its writers and is intended for informational purposes only.
Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) has been operating under the radar of major institutional investors, but that may soon change.
After a series of near misses in a handful of clinical trial programs, the company is closing in on data from two important programs. Positive readouts from either one promises to spotlight the company’s diverse portfolio built on unmet needs in billion-dollar medical categories.
Before yearend, Tonix expects to release data from advanced non-human primate studies of its lead Covid-19 T cell eliciting vaccine candidate utilizing live attenuated virus vectors. Vaccines made with attenuated viruses are known to confer long term immunity with a single dose (think vaccines for smallpox, measles, mumps and rubella) – and they are the only ones known to prevent forward transmission or contagion.
Tonix’s decision to develop T cell vs. antibody eliciting vaccines puts it in a race alongside Merck & Co. (NYSE: MRK), the only other US company developing Covid-19 vaccines with a similar approach.
Another expected fourth quarter highlight could position Tonix to tap into a nearly $9 billion fibromyalgia drug market, one that was created by Pfizer, Inc’s (NYSE: PFE) Lyrica and Eli Lilly and Company’s (NYSE: LLY) Cymbalta before both products went generic two years ago.
Tonix’s fibromyalgia candidate, TNX-102 SL, is more than half-way through a Phase 3 registration trial, with topline results due before yearend.
No new branded fibromyalgia drug has entered the market since Cymbalta and Lyrica went generic – a void Tonix hopes to fill with a better, more tolerable product following completion of its Phase 3 programs.
“We are nimble, focused and we work on big medical challenges,” said Tonix CEO Seth Lederman, MD in a recent interview with Benzinga. “Many other companies are focused on a particular proprietary technology, while we are opportunity-focused.”
Driven By Opportunity
In describing the driving philosophy underlying Tonix Pharmaceutical’s trials of its leading and exploratory drug candidates, Dr. Lederman emphasized the company’s focus on discovering impactful approaches to often overlooked clinical diagnoses.
This is particularly reflected in Tonix’s pursuit of a non-addictive treatment for fibromyalgia, a generalized pain disorder that is often misdiagnosed or mistreated due to the multifarious manifestations of the condition.
“We like the opportunity-focused model better because it fits more directly with our passion for tackling medical problems that others avoid because of past failures or other difficulties,” Dr. Lederman elaborated. “We believe we can win some victories for desperate patients that medicine has heretofore overlooked because the hill seemed too steep to climb. The solutions we seek have the potential to be tremendously meaningful and rewarding”
In this interview, Dr. Lederman spoke to the history and progress of both drug candidates as well as the unique markets they aim to serve. He also touches on his personal history in rheumatology, patient pain-management and immunology and what the future looks like for Tonix’s lead drug candidates and for the company.
The company’s strategy often involves looking at markets that have been created by blockbuster products, identifying their shortcomings, and then developing novel approaches to deliver a unique product profile.
“One of the big triumphs of rheumatology was the recognition some 15 years ago that fibromyalgia was a distinct disorder, not a stigmatized set of complaints offered up by folks who doctors thought were malingerers with fabricated symptoms,” Dr. Lederman explained.
That victory has led to other advances, for example, the understanding that fibromyalgia is a chronic pain disorder relating to central pain.
As the formal diagnoses of fibromyalgia were being advanced, Pfizer launched Lyrica and Lilly launched Cymbalta, which had combined peak sales of roughly $9 billion before they went off patent. Now there is only one remaining branded product on the market — Savella from AbbVie Inc. (NYSE: ABBV) — a Cymbalta-like drug selling at the rate of about $400 million a year.
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“At peak sales, Cymbalta was a $5 billion product and Lyrica wasn’t far behind at $3.5 billion,” Dr. Ledrman elaborated. “Now that both are generic, the dollar value of the market is smaller, but the patients haven’t disappeared – in fact, if anything, they’ve grown in number – and there is still widespread dissatisfaction within their ranks. Our research indicates that doctors and patients are constantly on the search for other options. We think we can capitalize on that dissatisfaction with a substantially differentiated product.”
For Dr. Lederman, the pursuit is more than simply one of opportunity. He has a longstanding interest in the diagnosis of fibromyalgia dating back to his medical training with Columbia University’s Division of Rheumatology 35 years ago.
“It is all about knowing the cause and source of the pain,” he said.
Dr. Lederman explained that, as opposed to “nociceptive” and “neuropathic,” which denote pain caused by injury to the body or parts of the central nervous system, central pain originates in an individual’s brain. This distinction, as well as advances in patient care, helped to foster the recognition of fibromyalgia as a distinct medical condition affecting about seven million adults in the United States, with 95% of those being female over the age of 50 who generally begin experiencing symptoms with the onset of menopause.
With the introduction of FDA-approved Cymbalta and Lyrica – and later a drug called Savella – doctors moved many patients away from off-label treatments, but dissatisfaction still runs high with a lot of switching and on-off use, often due to side effects becoming intolerable.
As a result, there is still widespread use of addictive opiates. Although they are not approved for this indication, Dr. Lederman asserts that one-third of fibromyalgia patients end up on long-term opiates. “These patients often end up in a very bad place and become part of the rising death toll attributed to opiate overdose.
We believe TNX-102 SL will provide a meaningful alternative, a better option.”
Seeking Solutions To A Painful Syndrome
The current Phase 3 trial of TNX-102 SL in fibromyalgia was initiated last year following a prior, lower-dose trial that fell short of endpoint results.
TNX-102 SL aims to distinguish itself from existing fibromyalgia treatments by acting on a patient’s central nervous system to inhibit symptoms of pain by improving sleep quality, which Dr. Lederman sees as a key feature in addressing one of the most consistent aspects of the overall condition.
“Fibromyalgia is a syndrome that is defined by a collection of symptoms,” he explained. “By addressing this sleep disturbance symptom with TNX-102 SL, we've shown in two large studies that there was improvement in fibromyalgia that extends beyond sleep and into improvement across the spectrum of other fibromyalgia symptoms. Because TNX-102 SL provides improvement of many different symptoms, beyond the sleep quality improvement, we believe that TNX-102 SL acts at a syndrome-level and not just at the symptom-level.”
Dr. Lederman sees the opportunity in TNX-102 SL as an alternative for patients who might suffer deleterious side effects that impact the quality of the treatment or cause patients to stop taking them altogether.
“TNX-102 SL is a medicine taken every night at bedtime, and it has been well-tolerated in all the studies we've done, although some patients experience side effects like transient numbness in the mouth, sleepiness and dry mouth” explained Dr. Lederman. “Based on the two prior studies and our experience with the 5.6 mg dose in PTSD, we believe TNX-102 SL could have a tolerability edge.”
While the peaks sales numbers for Cymbalta and Lyrica may seem lofty, Dr. Lederman is encouraged by the numbers and the need they demonstrate for an array of fibromyalgia treatment options. Tonix is also exploring other potential indications for TNX-102 SL, including for symptoms associated with alcoholism and Alzheimer’s disease.
“This is an exciting time for our portfolio of 10 CNS indications, and especially for TNX-102 SL in fibromyalgia. We look forward to an interim analysis in the Phase 3 study to be reported next month, and we expect top line data from that study in the fourth quarter of this year.”
Live Vaccines in An Ongoing Pandemic
In addition to progress on the TNX-102 SL trials, Dr. Lederman also touched on the other leading drug candidates that Tonix is currently putting resources toward investigating, several self-attenuated vaccines for the COVID-19 virus strain. The pursuit is especially dire in Dr. Lederman’s estimation, characterizing the ongoing pandemic as “the biggest global public health threat since the Spanish Flu in 1918.”
“We have several vaccine candidates in development, all based on our proprietary live attenuated-virus vector platform,” said Dr. Lederman. “Live attenuated viruses like horsepox or bovine parainfluenza virus can induce infected lung cells to present antigens to T cells directly. TNX-1800, our lead vaccine in development, is designed to express the spike protein from CoV-2, the virus that causes Covid-19.”
The interest in developing a novel and effective vaccine should be self-evident to most given the mounting infection rates. And while many of the potential early vaccine candidates from firms like Moderna, Inc. (NASDAQ: MRNA) or AstraZeneca PLC (NYSE: AZN) have progressed into trial stages, Dr. Lederman highlighted the need for a variety of vaccine platforms. This is in order to both find an ideal vaccine for the virus as well as a greater variety of effective vaccines that can be used in case others are ineffective in certain individuals.
“There are currently over 150 potential Covid-19 vaccines in various stages of development but relatively few utilize live attenuated viral platforms. Live attenuated viruses have the potential to confer long-term immunity and prevent forward transmission,” Dr. Lederman said. “These vaccines are live, attenuated vaccines, like the vaccines that successfully eradicated smallpox, and helped to contain rubella, mumps, measles, and several other lethal viruses.”
In a practical sense, Dr. Lederman explained that the ability to prevent forward-transmission — the spread of the virus from one host to another — is what sets live-attenuated vaccines apart from vaccines derived from inactivated virus strains. The active stimulation of the immune system’s Tcells that result from effective live-attenuated vaccines is what evokes a strong, long-lasting and durable immunity to the virus strain.
The challenge of developing such a vaccine lies in working with similar viral strains as a platform and, even then, no one vaccine is 100% effective in all cases. This is another area of opportunistic research on the part of Tonix, which recently announced a sponsorship with Columbia University that Dr. Lederman explained is meant to “address these potential variables and to develop precision medicine tools that would allow tailoring of vaccines based on a person’s biomarkers.”
At the moment, Tonix is still exploring the potential of the horsepox and BPI virus platforms, with the former producing one of the company’s more viable vaccine candidates, TNX-1800, which is in pre-IND phase of development.
Should the animal studies prove positive, the company expects to start human trials of TNX-1800 next year.
Said Dr. Lederman, “We recently announced a partnership with Fujifilm Diosynth in College Station, Texas, who will be manufacturing the vaccine. We expect it will be manufactured at the level of quality and in a sufficient quantity to conduct clinical trials next year. We are also guiding that we will have the results of both small animal and non-human primate studies in the fourth quarter of this year. Those results will include studies of non-human primates that were challenged with the CoV-2 virus.”
Drawing the interview to a close, Dr. Lederman reflected that, between the phase 3 fibromyalgia treatment and the ongoing exploration of a COVID-19 vaccine, Tonix Pharmaceuticals is focused on exactly the specialized and targeted drug development that has guided its mission thus far.
“We are well-funded at the moment with $67 million pro forma cash on hand at June 30 and all in all, we think this is a very exciting time for Tonix” he said.
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