Tempest Therpeutics Inc (TPST) News

Tempest Receives Orphan Drug Designation from the U.S. Food and Drug Administration for Amezalpat to Treat Patients with Hepatocellular Carcinoma (HCC)

Source: GlobeNewswire Inc.

Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR? antagonist for the treatment of patients with hepatocellular carcinoma (HCC).
“Receiving orphan drug designation for amezalpat to treat HCC underscores the critical need for new treatment options for patients suffering from this historically hard to treat disease,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D of Tempest. “Tempest is dedicated to developing groundbreaking cancer treatments that will improve patients’ lives, and with broad agreement in hand from both the FDA and EMA, the team continues to prepare for a pivotal phase 3 study for amezalpat in first-line HCC patients.”

This important regulatory designation follows positive data across multiple key study efficacy and safety endpoints in a global randomized Phase 1b/2 clinical study evaluating amezalpat plus standard-of-care atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic HCC. Notable positive outcomes of the randomized comparison include a six-month improvement in median overall survival (OS) with a hazard ratio (HR) of 0.65 for patients receiving the amezalpat combination therapy and an objective response rate (ORR) of 30% vs 13% favoring the amezalpat arm. In addition, survival benefit from the addition of amezalpat was preserved in key sub-populations including PD-L1 negative disease and b-catenin mutated disease, which is consistent with amezalpat’s proposed mechanism of action to target both the tumor cells directly and the patient’s immune system.

It's in the filings...🥳

Do you still think R/S is coming....

TPST...$1.09...🥳...BRISBANE, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the company received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) to evaluate amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab, the current standard of care, versus the standard of care alone in a pivotal randomized Phase 3 trial for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).

“The clinical and regulatory team at Tempest are thrilled to receive this notice from FDA with respect to the planned pivotal Phase 3 trial to evaluate amezalpat as a potential treatment for first-line liver cancer,” said Sam Whiting M.D., Ph.D., chief medical officer and head of R&D of Tempest. “Previously reported positive Phase 2 data underscore amezalpat’s potential to improve the survival of patients facing this life-threatening disease, and our team is dedicated to advancing the program and bringing amezalpat to patients.”

georgie18

Member Level
Re: None

Friday, November 08, 2024 6:22:34 PM

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of 664538
TPST...$1.09...Chart firming up from the .85 Range Bottom...R/S coming here...🥳

I sold my shares, but kept the calls.

TPST...$1.09...Chart firming up from the .85 Range Bottom...R/S coming here...🥳

Not a bad recovery. Will see if an ER or business report is released, then decide to sell or not.

TPST , new 52 week low

Agreed, we will see positive news and a boost in price prior to the split..... the higher the price the lower the split IF its even required. Should they get positive news and more support from ROCHE this can rocket and then cancel split... that's moon time!

We shall see...🥳

1 to 2, or 1 to 15 RS. The split doesn't make sense unless a notable event is coming. Negative sentiment will simply beat it down, and kill existing holders further.

I'm under the impression dilution is coming.

Yes I did...will buy back when the dust settles...🥳...made great profit with TPST and if the reverse should happen it should put this stock in the $40...imo...we shall see...

Did you sell on the 14a news?

You saw the 14a...🥳

aDDed after hours sub $1 range...

RS was unexpected for something without a delisting notice. Perhaps something planned to prevent a takeover. Hmm...

TPST...14A Filing...Approval of a series of alternate amendments to our Restated Certificate of Incorporation to effect, at the option of our Board of Directors, a reverse stock split of our common stock at a ratio in the range of 1-for-2 to 1-for-15, inclusive, with such ratio to be determined by our Board of Directors in its sole discretion (“Reverse Stock Split Proposal” or “Proposal 1”).
What if another matter is properly brought before the Special Meeting?

TPST....85...A/H Dip...🥳

Nice to have you with me on it...🥳

One of your GM favorites been adding myself low $1s for next blastoff to $2s ...newsand trials

TPST...$1.16s in the P/M...🥳

georgie18

Member Level
Re: georgie18 post# 614

Friday, October 25, 2024 12:38:28 PM

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TPST...$1.12s clearing here...🥳Reversing...

georgie18

Member Level
Re: georgie18 post# 662364

Friday, October 25, 2024 9:43:40 AM

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TPST...$1.08...Big Block Buys hitting here...🥳

georgie18

Member Level
Re: None

Wednesday, October 23, 2024 8:55:30 AM

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TPST...Loaded $1.03 to $1.05s...🥳

Long hold. Roche wouldn't supply them with goods if they felt phase 3 would fail. Looking for $2 on positive results.

Have a Great Weekend Y'all...🥳

TPST...$1.12s clearing here...🥳Reversing...

georgie18

Member Level
Re: georgie18 post# 662364

Friday, October 25, 2024 9:43:40 AM

Post#
662715
of 662771
TPST...$1.08...Big Block Buys hitting here...🥳

georgie18

Member Level
Re: None

Wednesday, October 23, 2024 8:55:30 AM

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613
of 613
TPST...Loaded $1.03 to $1.05s...🥳

TPST...$1.08...Big Block Buys hitting here...🥳

georgie18

Member Level
Re: None

Wednesday, October 23, 2024 8:55:30 AM

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613
of 613
TPST...Loaded $1.03 to $1.05s...🥳

TPST...Loaded $1.03 to $1.05s...🥳

May be an AH show after all

Yup TPST! I have RNAZ on list too. Buying both with next check. 🔥

TPST...$1.22...🥳...Dipping it to fill the Open Gap...another great add spot...Ran to $1.60 range in the A/H ...

georgie18

Member Level
Re: georgie18 post# 384329

Tuesday, October 15, 2024 3:37:36 PM

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TPST...$1.14clearing here...🥳

georgie18

Member Level
Re: None

Friday, October 11, 2024 9:46:27 AM

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603
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TPST...99...great add spot....🥳

TPST …yes beauty move in the A/H…🥳

I’m in!

TPST smell green dude!!! RNAZ Next DRUG

Nice Georgie… TPST $1.61 after hours close…

The next DRUG?!

TPST...$1.14clearing here...🥳

georgie18

Member Level
Re: None

Friday, October 11, 2024 9:46:27 AM

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603
of 603
TPST...99...great add spot....🥳

TPST...99...great add spot....🥳

TPST: Nope!! Cancer is NOT trending anymore, CLOWN!!! (Nice call, IDIOT!!!)

TPST...$1.09...Great add opportunity...imo...we shall see...🥳

TPST...$1.59...from the .90 range bottom...🥳BRISBANE, Calif., Oct. 10, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced an agreement with Roche to advance the evaluation of amezalpat (TPST-1120) in combination with atezolizumab (Tecentriq®) and bevacizumab, the current standard of care for unresectable or metastatic hepatocellular carcinoma (HCC), into a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic hepatocellular carcinoma, a form of liver cancer with high unmet need.

georgie18

Member Level
Re: None

Friday, August 09, 2024 2:43:01 PM

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652989
of 660804
TPST...$1.16...Taking a hit on earnings...adding more down here...🥳

july shelf offering allows lender to sell stock at anytime

TPST: Hopefully!! (But is "Cancer" TRENDING anymore??)

TPST 1.82 +’35% resistance at 1.85 looks good again until 2.01- 2.23 resistance then big jump to 2.91

a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic hepatocellular carcinoma, a form of liver cancer with high unmet need.
Under the agreement, Roche will supply atezolizumab globally and Tempest will sponsor and lead the pivotal study. This agreement builds on a clinical collaboration between the companies pursuant to which amezalpat was combined with atezolizumab and bevacizumab in first-line HCC patients and compared to atezolizumab and bevacizumab alone in a randomized Phase 1b/2 study. Tempest retains all development and commercial rights to amezalpat.

TPST: I'm in!! Are you?? (Heck, goin' to Phase-3 with Roche?? I'll jump-on for ride!!)

TPST: Some Roche agreement news.

TPST...$1.44s clearing on the 50MA Break...🥳

TPST...$1.50s clearing into the close...🥳

Have a Great Weekend Y'all...🥳

Nice...will be very pleased with 1/2 that target...🥳

Bought a starter today.
DJ Tempest Therapeutics Price Target Maintained With a $47.00/Share by HC Wainwright & Co.
12:54 PM ET 8/15/24 | Dow Jones

TPST...$1.35...🥳