Talphera Inc. (TLPH)

[subslover]

AcelRx Pharmaceuticals Announces European Peer-Reviewed Publication Supporting the Benefits of Sublingual Sufentanil Tablets For Post-Operative Pain Management in the Journal of Clinical Medicine

https://ih.advfn.com/stock-market/NASDAQ/acelrx-pharmaceuticals-ACRX/stock-news/89737073/acelrx-pharmaceuticals-announces-european-peer-rev

[molee]

OOOOPS ! Twisted ankle ...

[Disquisition]

RUNNING

[molee]

I know , let's have a stock split .....

When should we tell the shareholders ?

How does 15 minutes sound ? ( After the market has closed ) .

Is that reasonable ?

Who cares ? They were suckers for staying with us this long anyway .

[mick]

ACRX
AcelRX Pharmaceuticals Inc
0.201
-0.001 (-0.50%)
Volume: 706,429
Day Range: 0.1951 - 0.218699
Bid: 0.1667
Ask: 0.2552
Last Trade Time: 6:17:52 PM EDT
Total Trades: 1,514
ACRX Detailed Quote

[mick]

ACRX
AcelRX Pharmaceuticals Inc
0.2802
-0.0068 (-2.37%)
Volume: 793,318
Day Range: 0.2711 - 0.30
Bid: 0.29
Ask: 0.3039
Last Trade Time: 5:44:31 PM EDT
Total Trades: 814
ACRX Detailed Quote

[Anite]

results.
"Our commercial emphasis on procedural suites has resulted in a successful quarter of growth for DSUVIA, while also reducing our costs, allowing us to focus on our robust pipeline," stated Vince Angotti, Chief Executive Officer of AcelRx. "DSUVIA continues to demonstrate solid sales growth in the procedural suite setting, with adoption beginning across national accounts. Our European partner, Aguettant, also is gearing up for the launch of DZUVEO. This said, we remain mindful of our operating costs and plan to continue reducing our cash burn. Importantly, we remain in discussions with potential partners with the commercial resources to amplify the expected growth for DSUVIA."
Mr. Angotti continued, "We're focused on a potential Emergency Use Authorization for our lead nafamostat candidate, Niyad™, in 2023 as we are making solid progress across the supply chain. Additionally, our pre-filled syringes remain on track for NDA submissions this year. We believe each of these product candidates will provide multiple value-creating catalysts in the near-term."

[Invest-in-America]

ACRX: Watch-out, NASA fans!!! MOON shot today??? Who the fluck knows???!!! Nevertheless, E-Turd has this puppy FIRED-UP by 68% in the "Extended Hours"!! WHAT????

[mick]

ACRX
AcelRX Pharmaceuticals Inc
0.23
-0.0124 (-5.12%)
Volume: 1,132,603
Day Range: 0.222 - 0.2424
Bid: 0.2294
Ask: 0.23
Last Trade Time: 7:45:31 PM EDT
Total Trades: 1,999
ACRX Detailed Quote

[mick]

AcelRX Pharmaceutica (ACRX)
0.24 ? -0.0029 (-1.19%)
Volume: 2,287,790 @06/03/22 7:58:49 PM EDT
Bid Ask Day's Range
0.2 0.2405 0.2245 - 0.267
ACRX Detailed Quote

[Box Money]

Watch this one. Conference today, about to be selling in Europe. This is going to be a money making pig. Pay attention

[mick]

AcelRX Pharmaceutica (ACRX)
0.236 ? 0.0006 (0.25%)
Volume: 691,776 @04/29/22 6:04:43 PM EDT
Bid Ask Day's Range
0.2361 0.25 0.235 - 0.25
ACRX Detailed Quote

[mick]

AcelRX Pharmaceutica (ACRX)
0.351 ? -0.0808 (-18.71%)
Volume: 2,962,319 @03/11/22 7:47:14 PM EST
Bid Ask Day's Range
0.35 0.351 0.32 - 0.3999
ACRX Detailed Quote

[Williambilla]

hey mick . SEC is watching

[mick]

AcelRX Pharmaceutica (ACRX)
0.45 ? 0.0251 (5.91%)
Volume: 1,048,494 @02/04/22 6:14:45 PM EST
Bid Ask Day's Range
0.43 0.45 0.4171 - 0.4698
ACRX Detailed Quote

[cervelo]

maybe it was a type error and they meant to say .40.

this has turned out to be a real loser.

[mick]

https://www.otcmarkets.com/stock/ACRX

[SmallCapStockGuy]

ACRX analyst rating

Most recently, Cantor Fitzgerald adjusted its rating to $4 but maintained an Overweight rating.

Top Penny Stocks To Buy According To Analysts & Targets Up To 615%

[mick]

https://www.otcmarkets.com/stock/ACRX

[mick]

AcelRX Pharmaceutica (ACRX)
0.8697 ? 0.0066 (0.76%)
Volume: 656,426 @11/05/21 5:59:20 PM EDT
Bid Ask Day's Range
0.8612 0.8697 0.86 - 0.896
ACRX Detailed Quote

[mick]

AcelRX Pharmaceutica (ACRX)
1.0199 ? 0.0199 (1.99%)
Volume: 1,039,168 @10/08/21 7:34:07 PM EDT
Bid Ask Day's Range
0.9705 1.02 0.91 - 1.02
ACRX Detailed Quote

[mick]

AcelRX Pharmaceutica (ACRX)
1.03 ? 0.02 (1.98%)
Volume: 441,764 @09/22/21 7:18:31 PM EDT
Bid Ask Day's Range
1.01 1.03 1.0 - 1.04
ACRX Detailed Quote

[cervelo]

I guess I am the only one dumb enough to still be holding this pig since no post are happening

[cervelo]

where is everyone we ran up today a whole penny

[cervelo]

dang i look back in and we are almost a penny stock

[molee]

Did ya buy the "dip" yesterday ?? I did ... $$$ coming to those that took the risk ...

Stay safe >> M

[mick]

AcelRX Pharmaceutica (ACRX)
1.17 ? -0.02 (-1.68%)
Volume: 743,852 @08/13/21 6:38:34 PM EDT
Bid Ask Day's Range
1.16 1.18 1.16 - 1.195
ACRX Detailed Quote

[mick]

DID NOT HELP $ACRX

[cervelo]

[color=red]and yet the stock continues to drop. then again any and all info from the company in the PR's could be outright lies

[molee]

AcelRx Enters into Licensing Agreement for DZUVEO® in Europe and In-licensing Agreement for Two Products in the U.S.

AcelRx to receive up to approximately $55 million in combined up-front and sales-based milestone payments for DZUVEO licensing agreement

AcelRx obtains the rights to file NDAs and commercialize two innovative pre-filled syringe product candidates for the U.S.

HAYWARD, Calif., July 14, 2021 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced agreements with Laboratoire Aguettant (Aguettant) providing Aguettant with a license to commercialize DZUVEO in Europe, and providing AcelRx with two innovative pre-filled syringe product candidates for the U.S.

Under the DZUVEO licensing agreement, Aguettant will have the right to commercialize DZUVEO in Europe. AcelRx is entitled to receive up to approximately $55 million in a combination of up-front and sales-based milestone payments at various annual sales levels from Aguettant, along with revenue share payments ranging from 35% to 45% of net sales. AcelRx will manufacture and supply DZUVEO to Aguettant at an agreed supply price.

Under the terms of a separate licensing agreement, AcelRx obtained the rights to file NDAs, and subject to U.S. Food and Drug Administration approval, commercialize in the United States two of Aguettant's innovative, EU-approved, pre-filled syringe products – ready-to-use ephedrine and phenylephrine. Aguettant has the right to receive up to $24 million in sales-based milestone payments, at various annual sales levels up to $60 million, along with revenue share payments of 40 to 45% of the net sales of the two pre-filled syringe products, if approved in the U.S. by the Food and Drug Administration.

[mick]

AcelRX Pharmaceutica (ACRX)
1.255 ? -0.015 (-1.18%)
Volume: 781,266 @07/09/21 5:20:08 PM EDT
Bid Ask Day's Range
1.27 1.3 1.25 - 1.29
ACRX Detailed Quote

[dsscam]

If there weren't 1000+ lawsuits against this crap company- they'd have NO news for the last month

[cervelo]

keep pumping, the stock just keeps falling. so if you want to know what is going on? management is on vacation with our money

[mick]

$ACRX Bullish ONE OF DA BEST AcelRx Pharmaceuticals, Inc. (ACRX)'

"This is one of the best values in the stock market now

Commercial Pain Monopoly on the
US Military,
Dental,
Spinal,
Plastic Surgery verticals really heating up
Sickle Cell Pain study
Oncology Pain study,
Pre/Post Operative Pain Study,
Cleveland Clinical Cardiovascular Surgery Pain study
VERY GOOD April 2021 sales (numbers ?????),
Partnership with Zimmer Biomet
worth $10 OR MORE

[mick]

$ACRX AcelRx Pharmaceuticals, Inc.,
a specialty pharmaceutical company, focuses on the development and commercialization of therapies for the treatment of acute pain.

The company's lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.

It also develops ZALVISO, a pre-programmed and patient-controlled
analgesia system that allows hospital patients with moderate-to-severe acute pain to self-dose with sufentanil sublingual tablets to manage their pain.

The company was formerly known as SuRx, Inc. and changed its name to
AcelRx Pharmaceuticals, Inc. in August 2006.

AcelRx Pharmaceuticals, Inc. was founded in 2005 and is headquartered in Redwood City, California.

[mick]

$ACRX $ACRX appears to be something going, mgmt is quiet on many microcap stocks, with approved asset, a buy out or M&A happens a lot

over $100mil cash

[mick]

$ACRX LISTEN and BE INFORMED!
- Fast forward 41 minute mark " DSUVIA no active metabolites... No does staking (you get in Morphine), keeping elderly patients out of care facilities...
- Fast forward 44 minute mark "DSVUVIA is TOO GOOD TO BE TRUE" 1 tiny tablet used on either 100 pound patient or 400 hundred pound patient... **SAME DOSE EFFECT on all weights....**
event.webcasts.com/starther...
- Fast forward 52 minute mark "DSUVIA (sufentanil) "CARDIAC STABLE" not fentanyl.
- Fast forward 59 minute mark "Orthopedic Surgeons are over the moon for DSUVIA"

[mick]

$ACRX cash cow !!!!!
used to pay for 2nd Phase 3 trial, SUCCESSFUL outcome:
NOTE: AcelRx Pharmaceuticals Receives $65 Million from the
Partial Sale of Zalviso™ European Royalties
and Commercial Milestones to PDL BioPharma
REDWOOD CITY, Calif., Sept. 21, 2015

"This transaction provides AcelRx with significant capital in a non-dilutive manner.

It will increase our estimated cash at year end to over $100 million
and should provide sufficient capital to complete regulatory submissions for ARX-04 in the U.S. and Europe,

and to conduct limited additional work on Zalviso, if needed,
in preparation for re-submitting a New Drug Application to the
U.S. Food and Drug Administration."

[mick]

i see pipeline all approved but one. 'AcelRx Pharmaceuticals, Inc. (ACRX)'

gemstone here;

[mick]

i placed some stats in ibox for all, 'AcelRx Pharmaceuticals, Inc. (ACRX)'

[mick]

$ACRX 1y Target Est 6.67

[mick]

$ACRX AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. For more information, please select a product below.
DSUVIA® (in US)
PRE-CLINICALPHASE 1PHASE 2PHASE 3NDA FILEDAPPROVED
DZUVEO™ (in EU)
PRE-CLINICALPHASE 1PHASE 2PHASE 3MAA FILEDAPPROVED
Zalviso® (in US)
PRE-CLINICALPHASE 1PHASE 2PHASE 3NDA FILEDAPPROVED
Zalviso® (in EU)
PRE-CLINICALPHASE 1PHASE 2PHASE 3MAA FILEDAPPROVED
ARX-02
PRE-CLINICALPHASE 1PHASE 2PHASE 3NDA FILEDAPPROVED
ARX-03
PRE-CLINICALPHASE 1PHASE 2PHASE 3NDA FILEDAPPROVED


DSUVIA (sufentanil) sublingual tablet 30 mcg

In November of 2018, DSUVIA was approved by the U.S. Food and Drug Administration.

To learn more about DSUVIA, please visit DSUVIA.com.

In June of 2018, AcelRx received approval for DZUVEO from the European Commission for use in medically monitored settings.

Zalviso (sufentanil sublingual tablet system)

Zalviso has completed three Phase 3 clinical trials: two placebo-controlled efficacy and safety trials and one open-label active comparator trial, in which Zalviso was compared to IV PCA morphine. Each of the three Phase 3 trials successfully achieved its primary endpoint. Based on FDA feedback, AcelRx has completed a fourth study (IAP312) in a diverse post-surgical population to further evaluate the overall performance of the Zalviso System.

ARX-02 (higher strength sufentanil sublingual tablets)

A Phase 2 trial evaluating the efficacy and safety of ARX-02 (higher strength sufentanil sublingual tablets) for the treatment of cancer breakthrough pain in opioid-tolerant patients has been completed.

ARX-03 (combination sufentanil/triazolam sublingual tablet)

The combination sufentanil/triazolam sublingual tablet has been studied in a Phase 2 trial, which evaluated the efficacy and safety of this product for procedural anxiety and acute pain.

[mick]

Sufentanil
Sufentanil is an opioid analgesic currently marketed for IV and epidural anesthesia and analgesia; however, its postoperative use has been limited due to its short duration of action when delivered intravenously.1
The pharmaceutical attributes of sufentanil, including lipid solubility and degree of non-ionization, result in rapid cell membrane penetration allowing entry into the central nervous system (CNS).2 In addition, its pharmacokinetic profile when delivered sublingually could potentially avoid the high peak plasma levels and short duration of action observed with IV administration.3 Sufentanil has been shown to be 5- to 10-fold more potent than fentanyl4. The following additional differences to other opioids have been observed:

No Active Metabolites: Active metabolites can increase the risk of delayed opioid side effects. Morphine, for example, has the active metabolite morphine-6-glucuronide (M6G) and M3G and hydromorphone has the active metabolite hydromorphone-6-glucuronide (H6G) and H3G, which can accumulate in renally impaired or elderly patients.5-7
Rapid Transmucosal Uptake: Sufentanil is highly lipophilic and is readily absorbed through mucosal tissues8 and distributed throughout the body. The short 6-minute brain:plasma equilibration half-life (t1/2ke0) of sufentanil demonstrates its ease of penetrating into the CNS.9
High Therapeutic Index: In animal studies, sufentanil has one of the highest therapeutic indexes (~27,000) of any commercially available opioid.10 The therapeutic index is the ratio of the lethal dose to the effective dose of a drug. These differences may potentially result in clinically relevant improvements for patients.
AcelRx's proprietary, noninvasive sublingual formulation technology efficiently delivers highly lipophilic drugs with consistent pharmacokinetic profiles. These sublingual dosage forms are designed to minimize the natural saliva response, thereby potentially reducing the amount of swallowed drug that results from typical oral transmucosal products. Drug absorbed from the gastrointestinal (GI) tract can potentially lead to more erratic and delayed timing to peak plasma levels compared to transmucosal absorbtion.10,11



Sufentanil Sublingual Mechanism of Action

[mick]

DSUVIA (in US) approved
PRE-CLINICALPHASE 1PHASE 2PHASE 3NDA FILEDAPPROVED

[mick]

EU Regulatory Status at a Glance: approved
PRE-CLINICALPHASE 1PHASE 2PHASE 3MAA FILEDAPPROVED

[mick]

Zalviso® US in phase 3
Zalviso (in US)
PRE-CLINICALPHASE 1PHASE 2PHASE 3NDA FILED APPROVED

[mick]

Zalviso® EU APPROVED
Zalviso (in EU)
PRE-CLINICALPHASE 1PHASE 2PHASE 3SUBMITTED MA APPROVED

[PRED2020]

And now it's 1.14. Same thing happened with NNDM they sold 500,ooo million shares at $12.80 and now it's below 7! I think they bought them then shorted them.

[cervelo]

it is already below 1.76 and has been for some time. thank you management for your concern for shareholder value. just warms your heart don't it

[wannabemillionaire]

these guys must all be dummies!

Several large investors have recently modified their holdings of ACRX. BlackRock Inc. boosted its stake in AcelRx Pharmaceuticals by 3.4% during the 4th quarter. BlackRock Inc. now owns 5,640,946 shares of the specialty pharmaceutical company’s stock worth $6,995,000 after purchasing an additional 185,924 shares during the last quarter. Morgan Stanley lifted its stake in AcelRx Pharmaceuticals by 30.4% in the 3rd quarter. Morgan Stanley now owns 801,424 shares of the specialty pharmaceutical company’s stock worth $1,138,000 after purchasing an additional 186,993 shares in the last quarter. Wells Fargo & Company MN grew its position in shares of AcelRx Pharmaceuticals by 54.3% in the fourth quarter. Wells Fargo & Company MN now owns 316,632 shares of the specialty pharmaceutical company’s stock valued at $393,000 after purchasing an additional 111,399 shares in the last quarter. GSA Capital Partners LLP increased its holdings in shares of AcelRx Pharmaceuticals by 28.9% in the fourth quarter. GSA Capital Partners LLP now owns 203,830 shares of the specialty pharmaceutical company’s stock valued at $253,000 after purchasing an additional 45,656 shares during the last quarter. Finally, Charles Schwab Investment Management Inc. boosted its stake in AcelRx Pharmaceuticals by 8.0% during the fourth quarter. Charles Schwab Investment Management Inc. now owns 202,469 shares of the specialty pharmaceutical company’s stock worth $252,000 after buying an additional 15,060 shares during the last quarter. 24.45% of the stock is currently owned by hedge funds and other institutional investors.