TLPH

Talphera Inc.

NASDAQ

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TLPH

Talphera Inc.

NASDAQ

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Whalatane

04/25/24 7:34 PM

Post #1,404

Re: #1,403: @rosemountbomber - I see that. Here is hoping for

The benefits of diversification
I have positions in UNCY , RZLT ( sold half recently up 100% ) and TLPH ...plus a little AMRN cos I'm an idiot and take their drug Vascepa
So the gain in TLPH today outweighs the loss in RZLT and UNCY .
Now if I could just get all 3 heading higher ...:--)
Kiwi

rosemountbomber Free

04/25/24 3:24 PM

Post #1,403

Re: #1,402: @Whalatane - Well they may have finally got their pivotal

I see that. Here is hoping for good news down the road

Whalatane

04/25/24 1:09 PM

Post #1,402

Well they may have finally got their pivotal trial underway ( was delayed due to hospital site admin delays ) ...stock up on heavy vol
Kiwi

Whalatane

04/11/24 11:42 AM

Post #1,401

Re: #1,400: @rosemountbomber - Don’t see any news —- anyone know the

RMB. very low vol so wouldn't take much to drop the PPS if someone unloaded 20,000 shares at once , .simply because of general risk off ....nothing TLPH specific.
There is a lot to be on edge for right now . Inflation coming in hotter than expected , interest rate cuts delayed ( or eliminated ) for 24. How is Iran going to retaliate against Israel and will this cause a spike over $100 in oil. .
Market over all has run a lot the past 6 mths so some are simply reducing their exposure .
Market was broadening out, but after the CPI reading , small caps in particular sold off .

Note. as example I reduced my position in RZLT before the CPI report

Up close to 80% since my initial purchase. Reduced my position somewhat going into the CPI report tomorrow as a bad report will mean a sell off in spec biotechs as well as small caps .
Simple risk mgt.

Kiwi

rosemountbomber Free

04/11/24 10:06 AM

Post #1,400

Don’t see any news —- anyone know the reason for this morning’s drop?

glenn1919

04/06/24 4:35 PM

Post #1,399

Re: #1,390: @glenn1919 - TLPH...............................https://stockcharts.com/h-sc/ui?s=TLPH&p=W&b=

TLPH.......................................https://stockcharts.com/h-sc/ui?s=TLPH&p=W&b=5&g=0&id=p86431144783

Whalatane

04/04/24 8:20 PM

Post #1,398

Re: #1,397: @rosemountbomber - Thanks Kiwi for pointing me here. I

RMB. sorry been doing some minor retrofitting in the house ...remind me to never do that again ..always costs more and takes longer then I planned for ..---)
Re TLPH .....This Co is very unlikely to sell this product . They will sell to a large Pharma in the Renal space.
This is a specialty drug / treatment simply trying to get FDA approval on a drug used for decades in Japan and Korea .
It's a niche drug that ICU MD's needing to dialyze patients ...especially those with trauma or bleeding risk.

Keep an eye on UNCY
Their pivotal trial is fully enrolled . Most have probably already completed .
Its Open Label ...so they know how the patients are doing re tolerability

Brief Summary: The goal of this clinical study is to test the tolerability of oxylanthanum carbonate (OLC) in patients with chronic kidney disease on hemodialysis and have hyperphosphatemia (too much phosphorus in their blood). The main question it aims to answer is whether patients taking OLC for hyperphosphatemia are able to tolerate the drug.
Participants will continue with their scheduled dialysis treatments and replace their current phosphate binder drug with OLC.

Detailed Description: This is a 17-week study consisting of 4 parts. In Part 1, patients are screened for eligibility. In Part 2 patients undergo approximately 3-weeks of washout from previous phosphate binder therapy. Part 3 of the study is up to 6-week titration period where patients are treated with OLC starting at a dose level of 1500 mg/day. At the end of 2 weeks, the dose will be adjusted based on serum phosphate level, up to a maximum dose of 3000 mg/day. Part 4 of the study is a 4-week Maintenance Period with patients treated for 4 weeks on the clinically effective dose of oxylanthanum carbonate (OLC) identified in the Titration Period. Patients will return to the clinic for the End-of-Study Visit on the last day of the 4-week Maintenance Period before restarting their prescribed phosphate binder therapy. The primary endpoint will be to evaluate the tolerability of OLC (as assessed by rate of discontinuations due to treatment-related adverse events) and the secondary endpoints are the evaluation of the safety of clinically effective doses of OLC and evaluate the pharmacokinetics of OLC. Once weekly, at one of the patient's scheduled dialysis appointments and at the End-of-Study Visit, the tolerability will be assessed. After the End-of-Study Visit, patients will reinitiate standard therapy. Toxicity will be assessed during the study based on the severity grade (mild, moderate, or severe) as assessed by the Investigator.
Open or close this module Conditions
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: CKD, ESRD
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 90 [Anticipated]

Kiwi

rosemountbomber Free

04/04/24 8:46 AM

Post #1,397

Re: #1,396: @Whalatane - Its random risk off in a down market

Thanks Kiwi for pointing me here. I didn't recognize the symbol but then found out there was a name change from AcelRx, which I had looked at in the distant past. Will check this out here.

Notice right off the bat that there has been some net insider buying, not a whole lot, but still some. And, of course you mentioned Nantahala. Also I noticed they streamlined their board, reducing from 10 to 7 members. And, they mention keeping their M&A expertise with the company so they may be looking for some bigger group to swoop them up eventually.

Whalatane

04/02/24 10:13 PM

Post #1,396

Re: #1,395: @molee - $TLPH under a buck . Looks like "distribution"

Its random risk off in a down market . This Co will live or die on a successful trial before their money runs out.
JMO
Kiwi

molee

04/02/24 2:45 PM

Post #1,395

$TLPH under a buck . Looks like "distribution" to me .

Monksdream PremiumMember

03/30/24 11:26 AM

Post #1,394

Re: #1,393: @Whalatane - Conclusion: Treatment of patients showing end-stage renal failure

TLPH under $2

Whalatane

03/29/24 3:39 PM

Post #1,393

Conclusion: Treatment of patients showing end-stage renal failure with Nafamostat mesylate can significantly improve therapeutic efficacy and has high safety and clinical value.

Kiwi

Whalatane

03/29/24 3:39 PM

Post #1,392

https://pubmed.ncbi.nlm.nih.gov/38292627/

Kiwi

Whalatane

03/29/24 2:43 PM

Post #1,391

Listened to their 3/4 CC . The drug they are trialling has been used for decades in Japan and Korea ( so good safety profile ) but FDA requires a short trial in US before approving here .
Renal KOL's are very interested in getting this drug / treatment approved because of the problems they face using heparin and citrate in ICU dialysis .
Sites have been slow to be approved due to administrative back log at the academic hospitals that will run this short trial ....but some should be up and running 4/1 onwards .
Short trial ...patients are only on drug for max 72 hrs , DMS safety signal at 32 patients , results expected Q3
Nantahala has provided recent financing and now has a seat on the BOD.
COH to early 2025
Interesting spec
Small position
Kiwi

glenn1919

02/24/24 10:01 AM

Post #1,390

TLPH...............................https://stockcharts.com/h-sc/ui?s=TLPH&p=W&b=5&g=0&id=p86431144783

molee

02/12/24 1:51 PM

Post #1,389

$TLPH >> But , hold on ... Squeezer again perhaps ? Looks like it ... LOL .

molee

02/02/24 11:25 AM

Post #1,388

And down we go with renewed shorting ...

glenn1919

01/27/24 8:35 AM

Post #1,387

TLPH...............................https://stockcharts.com/h-sc/ui?s=TLPH&p=W&b=5&g=0&id=p86431144783

molee

01/23/24 2:56 PM

Post #1,386

Re: #1,385: @molee - $ACRX is now $TLPH and on the move

$TLPH $ 1.17 now ...>> Upgrade >>

HC Wainwright Adjusts Talphera's Price Target to $6 From $5, Keeps Buy Rating

molee

01/10/24 12:11 PM

Post #1,385

$ACRX is now $TLPH and on the move ... wink

( Get with the program iHub ) .

molee

01/09/24 9:16 AM

Post #1,384

AcelRx Announces Rebranding With Name Change to Talphera, Inc.

Name change to "Talphera" reflects a new era of the Company in partnership with the medical community developing novel solutions for medically supervised settings

Talphera will begin trading on Nasdaq under the trading symbol "TLPH" effective January 10

SAN MATEO, Calif., Jan. 9, 2024 /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 the rebranding of the Company, with a name change to Talphera, Inc. ("Talphera"). The rebrand decision was made to reflect the Company's strategy of developing and commercializing products to support advancing care to optimize outcomes in medically supervised settings, moving beyond the original focus on acute pain. The Company's lead nafamostat product candidate, Niyad, is expected to have a Premarket Approval (PMA) submission to the FDA in the second half of 2024.

The name Talphera was derived from "Talisman", meaning a strong leader, and reflects the new "pharmaceutical era" for the Company. The company's new mission at Talphera is to support healthcare providers by developing and commercializing products in medically supervised settings that deliver advances in care to patients. Talphera will commence trading on the Nasdaq Global Market under the ticker symbol "TLPH" effective January 10, 2024.

"We were a company founded on acute pain treatments with the understanding that patient outcomes depend on the quality of the tools available to a patient's medical team. This understanding remains the focal point of our product candidates in development. Rebranding to Talphera represents a new era of the company where we have a broader mission to develop and commercialize innovative therapies for use in medically supervised settings beyond acute pain," said Vince Angotti, Chief Executive Officer of Talphera.

Talphera's lead product candidate, Niyad, has been granted FDA Breakthrough Designation and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit. If approved, Niyad would be the first-ever regional anticoagulant approved by the FDA for use in the dialysis circuit.

Talphera expects to initiate the registrational study of Niyad™, the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) Study, shortly. The study has already received central Institutional Review Board (IRB) approval. The study is designed as a prospective, double-blinded trial to be conducted at up to 10 U.S. hospital intensive care units. The study will enroll and evaluate 166 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk for bleeding. The primary endpoint of the study is mean post-filter activated clotting time using Niyad versus placebo over the first 24 hours. Key secondary endpoints include filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours.

The first patient is expected to be enrolled for the NEPHRO study in the first quarter of 2024. Since the end of last year, the company has completed all sponsor actions and is awaiting activation from registered sites. A PMA submission for Niyad is expected to be filed with the FDA in the second half of 2024.

About Talphera, Inc.

Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation status from the FDA. Talphera is also developing two pre-filled syringes in-licensed from its partner Aguettant: Fedsyra™, a pre-filled ephedrine syringe, and PFS-02, a pre-filled phenylephrine syringe. This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com.

About Nafamostat

Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption, or IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that will be investigated and developed as a potential anti-viral for the treatment of COVID, acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC) and acute pancreatitis.

mick

01/01/24 2:33 PM

Post #1,383

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

molee

11/27/23 10:50 AM

Post #1,382

$ACRX .76 ... Trying to put on a show ...

molee

11/10/23 2:50 PM

Post #1,381

$ACRX >>> 42 cents each ... frown

mick

11/05/23 2:44 PM

Post #1,380

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

molee

10/21/23 11:59 AM

Post #1,379

$ACRX Need to maintain a minimum bid price of $1.00 per share , or else < U no watt >

molee

10/10/23 9:37 AM

Post #1,378

$ACRX .71 today . Will it hold ?

molee

10/02/23 1:49 PM

Post #1,377

Re: #1,374: @molee - $ACRX Oh boy ... .71 a copy ...

$ACRX How about 56 cents ? Bottom ? Stay tuned ...

mick

09/24/23 7:38 PM

Post #1,376

Re: #1,375: @molee - So , I'm guessing there were those that

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

molee

09/23/23 12:34 AM

Post #1,375

So , I'm guessing there were those that had advanced notice of this and piled on the shorts ...

On September 22, 2023, the FDA notified the Company that due to the volume of EUA requests the FDA has received, the FDA has determined that review of the Niyad EUA is not a priority and has therefore declined to issue an EUA for Niyad at this time pursuant to the FDA’s current prioritization of EUA requests.

molee

09/21/23 9:53 AM

Post #1,374

Re: #1,373: @molee - $ACRX back up to .87 for a "short"

$ACRX Oh boy ... .71 a copy ... Load the boat ... wink

molee

09/12/23 2:02 PM

Post #1,373

Re: #1,372: @molee - $ACRX .82 a copy now . Shorts back

$ACRX back up to .87 for a "short" respite , we hope . C'mon man .

molee

09/11/23 11:32 AM

Post #1,372

Re: #1,371: @molee - $ACRX .88 a copy available now ...

$ACRX .82 a copy now . Shorts back on bigly it seems ... frown

molee

09/07/23 2:51 PM

Post #1,371

$ACRX .88 a copy available now ...

cervelo

08/31/23 11:57 AM

Post #1,370

I have not looked in for a long time, in a short sentence could someone please tell me if thinks are looking good for shareholders here or do we have years to go. thank you. Forgot about this until I got a email for a proxy vote

81vette

08/31/23 11:19 AM

Post #1,369

Short 1M / 1.2M settlement dates 7-31 / 8-15 if they actually cover,we moonshot,trend is still good in any case chart not sour yet

Bullish

81vette

08/30/23 4:20 PM

Post #1,368

Closed strong hod,thru 1.05 resistance will be awesome

Bullish

81vette

08/30/23 12:46 PM

Post #1,367

Broke thru resistance,continuation upward time,volume increase as confidence builds

Bullish

81vette

08/29/23 3:01 PM

Post #1,366

Loaded .91 today,beautiful pullback today

molee

08/29/23 12:43 AM

Post #1,365

So , about that "buy and hold" strategy .... Shorts have control here .

Triple nickle Free

08/22/23 9:42 AM

Post #1,364

Buy and hold

molee

08/22/23 9:37 AM

Post #1,363

Re: #1,354: @molee - I liked this better when she was a

$ACRX $1.26 ... Now that's more like it ... wink

Triple nickle Free

08/18/23 9:18 AM

Post #1,362

At .90 smfh a three dollar stock huge discount here

molee

08/18/23 9:15 AM

Post #1,361

$ACRX on the move ... wink

molee

08/17/23 1:58 AM

Post #1,360

Re: #1,359: @81vette - There is no outstanding debt for $ACRX. This

I am with ya . ( Although fingers crossed ) . Market is CRAZY ...

81vette

08/16/23 3:28 PM

Post #1,359

There is no outstanding debt for $ACRX. This means it has a Debt/Equity and Debt/FCF ratio of 0 and it is amongst the best of the industry.

Bullish

81vette

08/16/23 1:51 PM

Post #1,358

Buying vol up 72%,income 47m,book pps 1.31,cash 1.2,debt/eq .23 positive,eps up 200% this year,pps dropped from offering at market price,appears factored in now (we shall see)

Bullish

81vette

08/16/23 1:41 PM

Post #1,357

Watch for thru .80 resistance,1m short has 8 days to cover but they might take profits here and just cover with max,with many news events coming,covering would be smart/safe here

Bullish

81vette

08/16/23 1:28 PM

Post #1,356

Just hit #1 on my screener,time to load up for me,bids wouldn’t fill,I kept getting jumped,mm/someone wants lots of shares,my slap ave in is .7701

81vette

08/16/23 11:01 AM

Post #1,355

All green and blue candle today,over 1m short,demand growing,could see a squeeze soon

Older

Talphera Inc. (TLPH)

Followers	93	Posters	232
Posts (Today)	0	Posts (Total)	1404
Created	02/13/11	Type	Free
Moderators

Market Cap: $108 Million
Cash: $72 Million
Price: $2.40

Shares Out: 45.3 Million

Upcoming Major Milestones

Zalviso Phase 3 Results in July 2017

DSUVIA PDUFA Date October 12, 2017

Zalsviso NDA Resubmission in Q4 2017

DSUVIA CHMP Opinion in 1H 2018 (EU Approval )

Presentation June 2017
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NjczNjExfENoaWxkSUQ9MzgxNTY1fFR5cGU9MQ==&t=1

Jefferies Sees Strong Upside in AcelRx Pharmaceuticals’ Shares and Set a $7 Price Target
https://finance.yahoo.com/news/jefferies-sees-strong-upside-acelrx-145225845.html

Biotech Catalyst Play: AcelRx Pharmaceuticals Inc (NASDAQ:ACRX)...
https://insiderfinancial.com/biotech-catalyst-play-acelrx-pharmaceuticals-inc-nasdaqacrx

While Zalviso is our near-term catalyst, the DSUVIA decision probably holds more weight from a valuation perspective. Why? Because peak sales for this one are estimated at a little over $1.1 billion in the US alone. If FDA gives a green light for commercialization to the asset, therefore, the company could have a blockbuster drug on its hands. Combine that with the close to $400 million in revenues potential from Zalviso, and AcelRx could very justifiably become a multibillion-dollar biotech company before the end of the decade.

https://finviz.com/quote.ashx?t=acrx&ty=c&ta=1&p=d

Shs Outstand

119.10M

Shs Float

116.83M

Short Float

13.47%

Insider Own

2.00%

Inst Own

34.80%

Inst Trans

43.60%

Inst Trans

43.60%

ROE

66.50%

ROI

120.80%

Employees

Forward P/E

16.13

Recom

1.70

52W Range

1.01 - 2.94

minor resistance $1.70 [-chart]finviz.com/chart.ashx?t=acrx&ty=c&ta=1&p=d&s=l[/chart]

02-07-2021
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