Verastem Inc (VSTM) オプション

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

Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of Recurrent KRAS Mutant Low-Grade Serous Ovarian CancerDecember 30 2024 - 4:30PM
Business Wire
PDUFA target action date is June 30, 2025If approved, avutometinib in combination with defactinib would be the first-ever FDA-approved treatment specifically for adults with recurrent KRAS mutant LGSOCVerastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib, an oral RAF/MEK clamp, in combination with defactinib, an oral FAK inhibitor, for the treatment of adult patients with recurrent low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy and have a KRAS mutation. The NDA, which was completed in October 2024, has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of June 30, 2025. In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application.“The FDA filing acceptance and Priority Review for the combination of avutometinib and defactinib underscores the critical unmet need among patients diagnosed with this rare and insidious disease. We are excited by today’s news and to potentially bring the first ever FDA-approved treatment specifically for recurrent KRAS mutant LGSOC to patients in the U.S.,” said Dan Paterson, president and chief executive officer of Verastem Oncology. “With the acceptance of this NDA, we’re taking an important step forward in addressing a condition that has long been overlooked, and we look forward to working with the FDA during its review process and preparing for a commercial launch in mid-2025.”There are currently no FDA-approved treatments specifically for LGSOC, a rare and distinct ovarian cancer that differs from high-grade serous ovarian cancer in both its biology and how it responds to treatment. Priority Review is granted by the FDA for treatments that offer, if approved, significant improvements over available options or that provide a treatment option where no adequate or approved therapy currently exists.The filing was based on a primary analysis of the Phase 2 RAMP 201 clinical trial that evaluated the combination of avutometinib and defactinib in patients with recurrent LGSOC. The results were presented in an oral presentation at the International Gynecologic Cancer Society (IGCS) Annual Global Meeting in October 2024 and demonstrated that the combination of avutometinib plus defactinib resulted in a substantial overall response rate confirmed by blinded independent central review, with responses that were typically durable, and that the combination was generally well-tolerated in patients with recurrent KRAS mutant LGSOC. The NDA also includes supportive data from the FRAME Phase 1 trial, the first study conducted with the combination therapy in recurrent LGSOC.The Company is currently enrolling patients with recurrent LGSOC regardless of KRAS mutation status for RAMP 301, an international Phase 3 trial, which will serve as a confirmatory study for the initial indication and has the potential to support an expanded indication regardless of KRAS mutation status.About RAMP 201RAMP 201 (ENGOTov60/GOG3052) (NCT04625270) is an adaptive, two-part multicenter, parallel cohort, randomized, open-label Phase 2 registration-directed trial evaluating the efficacy and safety of avutometinib alone and in combination with defactinib in patients with recurrent low-grade serous ovarian cancer (LGSOC). The first part of the study (Part A) determined the selection of the go-forward regimen, which was the combination of avutometinib and defactinib versus avutometinib alone, based on overall response rates. The expansion phases of the trial (Parts B and C) are evaluating the safety and efficacy of the go-forward regimen of avutometinib 3.2 mg twice weekly and defactinib 200 mg twice daily. The Part D portion of the trial is evaluating a low dose of avutometinib in combination with defactinib to inform individualized dose reduction.

4.75

VSTM..............................................a/h

stay tuned-----The oral presentation will include updated safety and efficacy data from the RAMP 201 trial evaluating the combination of avutometinib, an oral RAF/MEK clamp, and defactinib, an oral, selective FAK inhibitor, in patients with recurrent low-grade serous ovarian cancer (LGSOC), including overall response rate, progression free survival, and duration of response.

Company to host investor conference call and webcast on October 17, 2024, at 4:30 pm EDT

VSTM under $3

VSTM new 52 week low

https://www.verastem.com/research/pipeline/ Good pipeline!!!

For those who are curious why $VSTM is down 60% on premarket, being 50% yesterday afterhours, despite positive RAMP 205 data (High ORR)

$VSTM 12 patients experienced treatment emergent serious adverse events, 11 patients with grade ≥3 pic.twitter.com/pY34tS6maD— Swat (@SwatOptions) May 24, 2024
For those who are curious why $VSTM is down 60% on premarket, being 50% yesterday afterhours, despite positive RAMP 205 data (High ORR)❓

Today Company announce that they will submit BLA for combo treatment only for a mutant subgroup, which significantly reduces the TAM

👀 $XBI https://t.co/Au1lEsh0qU pic.twitter.com/LzSvNS1T7n— Dogtor (@Dogtor01416800) May 24, 2024

4.75 NOW VSTM over $18

Brutal morning sell off after what appeared to be good news.

VSTM over $18

VSTM over $10

Read about it at 3.00 it looks like.

Worth reading
https://www.onclive.com/view/avutometinib-defactinib-combo-generates-early-efficacy-signals-in-low-grade-serous-ovarian-cancer

It’s death after a RS. Wait for 4.00 or way under. Then Good risk reward

So, what is next for VSTM in terms of catalysts and results? Any upcoming data points? Is it now free from funding worries and free to focus on producing results? Tartia, your input would be appreciated.

Happy I hit and run. I would consider this at under 4.00

They definite are diluting. They need money. But in long run great for shareholder

highest volume in history -insert dd-

Yep

nice

oh my

Looks like dilution

Looks like real support at a dollar. Could be ready for next leg.

Added the dip

I post so others can ride with me to the victory circle so to speak.
I really like it when peeps get a good run.

VSTM: Well, Capt. T-N, you certainly scored MONSTER TIME on this one today, Dude!!! (EASY money for you, or WHAT, Bro!!! CONGRATS!!!)

Halted?

Nice call

Okay nice run folks

.75 comin up

1.00 soon

LV2 still looks real thin
.75 ?

Really Good Friday here

WHAT NEWS ??????

I’d be nice waking up to thirty bucks a share from this level

This kind of news you can skip PHASEIII and go straight to approval

Next week it should run strong.

This news is very positive

Peeps see double tops and think sell
Just bust through it

You would think.

Break past .52 come on

Insiders are buying options. Time to load imo. Could see 2.00-3.00 like nothing

I'm with you on this one and so are the Baker Bros

Never seen a board that nobody post wtf. Lol. We got things coming imo

2 million volume yesterday. That’s a fund imo. I told you this was coming. Price of a stock does not reflect market value. This combo of drugs is a monster. I see 5-15.00 by Jan 2025

In addition to the progress with avutometinib + defactinib in LGSOC ONCT is moving two KRAS-G12C projects forward: avutometinib + sotorasib and avutometinib + adagrasib in KRAS-(G12C) NSCLC. Preclinical data suggests that we should see synergy with these combinations. I believe that the avuto + soto initial readout should happen at any time and this will be a big deal if the data is encouraging. In the preclinical data VSTM demonstrated that the synergistic effect of avutometinib + a G12C inhibitor was further enhanced with the addition of defactinib. I hope that they advance this G12C program with both the doublet and the triplet approach.

Clinical progress with the LGSOC program and the KRAS-G12C programs justify a much higher market cap than we have now. Any success with pancreatic cancer would be a total game-changer. The LGSOC and KRAS-G12C programs and low market cap provide a low risk opportunity to be in on the big prize which is Pancreatic cancer.

The RAMP201 and FRAME data for LGSOC is excellent so far. We should have final data readout in about 18 months (IMO). This data is expected to support an AA filing with the FDA for LGSOC. The current PPS does not reflect the significance of this. In addition, we have near term pending data on RAMP203 for RAS(G12C) NSCLC. Positive results with RAMP203 will further enhance value and help establish Avutometinib as a valid approach to RAS pathway cancers.

As an aside, I have my eyes on Akena's RAF:MEK clamp which may be even better than Avutometinib. The only problem is that Akena's molecule is several years behind Avuto in development.

I think that anyone interested needs to follow-up reading this PR by listening to the webcast presentation. It provides a more granular and encouraging overview than the PR alone does. I felt much more encouraged after hearing the overview and seeing the slides.

For instance the 28% ORR is interim data, not fully matured data. If one includes the 3 unconfirmed PRs the ORR is 38%. That's very good. If approved there will be TWO drugs approved.

Regulatory Update Following Type B FDA Meeting on LGSOC Program

A recent FDA meeting was held to discuss the encouraging results to date of the ongoing RAMP 201 trial evaluating avutometinib ± defactinib among patients with recurrent LGSOC, confirm the go forward treatment regimen selection and discuss the regulatory path forward. The combination of avutometinib with defactinib has been selected vs monotherapy as the go forward treatment in all recurrent LGSOC regardless of KRAS status, acknowledging the demonstrated contribution of defactinib.

The Company intends to include mature data from RAMP 201, the Verastem sponsored clinical trial, and the FRAME study, led by The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust to potentially support filing for accelerated approval. Both studies are evaluating avutometinib and defactinib in patients with recurrent LGSOC. The Company is in ongoing discussions with the FDA on the confirmatory study and plans to provide an update after agreement with the FDA. Continued enrollment in the combination arm of RAMP 201 is planned to expand the clinical experience in anticipation of initiation of a confirmatory study.

“We appreciate the productive and ongoing discussions with the FDA regarding the progress of our LGSOC program, including the alignment around key next steps as part of our breakthrough therapy designation,” said Brian Stuglik, CEO of Verastem Oncology. “With the encouraging results of the RAMP 201 Part A interim analysis and the FRAME study, we will work expeditiously to prepare to file for an accelerated approval that encompasses the totality of the data from both trials as well as progress on the confirmatory study.”

https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-announces-positive-data-and-regulatory-update