Talphera Inc. (TLPH)

[Whalatane]

Oh keep the faith

Detailed Description:
Patients in intensive care units with acute kidney injury are often too frail to undergo the rapid fluid shifts that accompany intermittent hemodialysis. Continuous renal replacement therapy (CRRT) allows a more gentle continual dialysis, more similar to regular kidney function. Anticoagulation of the CRRT circuit can reduce clotting of the filter, which can lead to less filter changes and possibly less transfusions. Niyad (nafamostat mesylate), an anticoagulant with an ultra-short half-life of 8 minutes, is approved for use in South Korea and Japan for anticoagulation of the CRRT circuit. For patients who cannot tolerate heparin or who are at a high risk of bleeding, nafamostat may be an optimal anticoagulant to infuse into the CRRT circuit as the short half-life should minimize patient exposure. The primary objective of this study is to measure the anticoagulation efficacy of Niyad in the CRRT circuit versus placebo. Evaluation of the safety of Niyad in patients undergoing CRRT versus placebo will also be performed.
Study Design
Go to sections
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double-blind, Multi-center Study of the Safety and Efficacy of Niyad in Patients Undergoing Continuous Renal Replacement Therapy (CRRT) Who Cannot Tolerate Heparin or Are at a Higher Risk for Bleeding
Estimated Study Start Date : March 2024
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

ER MD's needing to dialyze patients ...especially those patients with trauma and bleeding issues ..want FDA approval to use Niyad ...just as the ER MD's are doing in Japan and Korea
Results not to August at earliest
Kiwi

[rosemountbomber]

From a comical point of view, sometimes I feel that my diversification only seems to provide a different disaster du jour every day LOL.

[Whalatane]

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]

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

[Whalatane]

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]

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]

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

[glenn1919]

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

[Whalatane]

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]

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]

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]

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

[Monksdream]

TLPH under $2

[Whalatane]

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]

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

Kiwi

[Whalatane]

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]

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

[molee]

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

[molee]

And down we go with renewed shorting ...

[glenn1919]

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

[molee]

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

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

[molee]

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

( Get with the program iHub ) .

[molee]

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]

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

[molee]

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

[molee]

$ACRX >>> 42 cents each ...

[mick]

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

[molee]

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

[molee]

$ACRX .71 today . Will it hold ?

[molee]

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

[mick]

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

[molee]

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]

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

[molee]

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

[molee]

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

[molee]

$ACRX .88 a copy available now ...

[cervelo]

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]

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

[81vette]

Closed strong hod,thru 1.05 resistance will be awesome

[81vette]

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

[81vette]

Loaded .91 today,beautiful pullback today

[molee]

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

[Triple nickle]

Buy and hold

[molee]

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

[Triple nickle]

At .90 smfh a three dollar stock huge discount here

[molee]

$ACRX on the move ...

[molee]

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

[81vette]

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.

[81vette]

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)

[81vette]

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