Durect Corp (DRRX) ニュース

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

Up 26.67% today! Looks like FDA Breakthrough Therapy Designation (BTD) has created some investor interest. What may come next?

In my opinion the Breakthrough Therapy Designation (BTD) for larsucosterol could indeed increase the chances of a potential buyout or partnership with a larger pharmaceutical company for a few reasons:

Promising drug candidate: The BTD designation in my opinion highlights the potential of larsucosterol as a treatment for a serious condition with no approved options. This can make it an attractive acquisition target for larger companies with the resources to complete late-stage trials and commercialization.

Reduced development risk: The possible FDA's involvement and guidance through the BTD process my lessen the risk of failure for larsucosterol in later trials. This de-risking can make DURECT more appealing to potential acquirers or partner.

Access to funding and expertise: A larger pharma company either through an acquisition or a partnership would have the financial resources to fund the expensive phase 3 trials and navigate the complex regulatory approval process. They would also I believe bring with them their expertise in drug development and commercialization.

Overall, I believe the BTD designation is very positive and may significantly improve DURECT's attractiveness as an acquisition target or lead to a partnership with a major pharmaceutical companies.

DRRX receives Breakthrough Therapy Designation (BTD) from FDA. In my opinion this can result in the following:

Expedited development: The FDA will provide more intensive support to DURECT during the development process of larsucosterol for AH. This can help expedite clinical trials, data analysis, and regulatory filings.

Increased chances of approval: Drugs with BTD designation tend to have a higher success rate in obtaining final FDA approval. This can give investors more confidence in the drug's potential for market.

Potential for earlier commercialization: If larsucosterol receives FDA approval, BTD status may allow for an earlier launch date compared to drugs without this designation. This could mean faster revenue generation for DURECT.

Overall, BTD status can significantly improve DURECT's chances of successfully developing and commercializing larsucosterol, potentially leading to increased stock value.

FDA Update & Key Points:

“We are pleased that the feedback from the U.S. Food and Drug Administration (FDA) supports the advancement of larsucosterol into a single pivotal Phase 3 clinical trial"

"if successful, may serve as the basis for a New Drug Application (NDA) in alcohol-associated hepatitis (AH),” stated James E. Brown, D.V.M., President and CEO of DURECT.

“We are in the process of designing the registrational Phase 3 trial incorporating the FDA’s comments and insights gained from our Phase 2b AHFIRM trial."

"We expect to provide additional details on our planned Phase 3 protocol and present new analyses from AHFIRM later in the year.”

"During a Type C meeting with the FDA, DURECT received feedback on the recommendations for a Phase 3 clinical trial for larsucosterol in AH that could support a potential NDA filing. DURECT is in the process of designing its planned Phase 3 clinical trial based on the FDA feedback and the results from its completed Phase 2b AHFIRM clinical trial."

DUR-928, also known as larsucosterol, is an investigational drug being developed by DURECT Corporation (DRRX) for the treatment of Alcoholic Hepatitis (AH) and it has received Fast Track designation from the FDA.

How Epigenetics Plays a Role:
DUR-928 is believed to work through epigenetics. Epigenetics refers to changes in gene expression that don't involve alterations in the DNA sequence itself. These changes can influence how cells function.

Here's a simplified explanation of how DUR-928 might work:
In AH, the liver becomes inflamed and damaged due to excessive alcohol consumption. This damage disrupts epigenetic processes, leading to abnormal gene expression and contributing to liver dysfunction. DUR-928 may help restore normal epigenetic patterns in liver cells, promoting healthy gene expression and potentially facilitating liver repair.

Importance of FDA Fast Track Designation:
The FDA Fast Track designation is designed to expedite the development and review of drugs that address serious or life-threatening conditions and have the potential to fill an unmet medical need. DUR-928, has received Fast Track designation from the FDA.

U.S. Market Size: Approx. 150,000 patients are hospitalized annually with AH. Currently there is a very high mortality rate associated with AH (30% at 90 days approx.). It is estimated that DUR-928 if approved may have the potential to generate $1B in annual sales.

Is conditional approval possible?
Mortality Benefit: The substantial reduction in mortality observed in the US-specific data aligns with the FDA's mission and strongly supports granting conditional approval.
Positive Safety Profile: DUR-928 was well-tolerated in the trial, further strengthening its case for conditional approval, as safety is a major consideration.

Path to Approval:
US-Focused Strategy: In my opinion DRRX could strategically pursue an initial conditional approval specifically targeting the US market based on the strength of their US data.
Phase 3 Confirmation: A U.S.-focused Phase 3 trial with 90-day mortality as the primary endpoint could further solidify the findings and pave the way for full approval in the US market.

By focusing specifically on the significantly improved survival outcomes observed within the U.S. patient group in the 2b Trial should substantially strengthen DUR-928's potential for FDA approval for the following reasons.

Enhanced Statistical Significance:
I believe the 57% and 58% reductions in 90-day mortality observed in U.S. patients for the 30mg and 90mg doses respectively, are both clinically significant and statistically compelling (p-values of 0.014 and 0.008). This data solidifies the initial signal seen in the overall trial, surpassing the conventional p-value threshold indicating a strong treatment benefit.

Implications for FDA Approval:
Clear Benefit: The U.S. specific results demonstrate a compelling survival benefit for American patients with severe AH.

Supports Further Trials: I believe the positive U.S. findings strongly justify a U.S. focused Phase 3 trial with 90-day mortality as the primary endpoint.

Overall Impact:
In my opinion focusing on the U.S. patient data dramatically transforms the 2b Trial results. It moves DUR-928 from the realm of a promising potential therapy to a drug with demonstrable, statistically significant survival benefit. This finding leads me to be highly bullish about the prospects of FDA approval and the potential for DUR-928.

Expected Impact of Mortality on P-Value:
I believe factoring in transplants as live patients would likely lower the overall mortality rate within the U.S. larsucosterol groups even further.
Stronger Significance: In my opinion this decrease in mortality for this group would likely push the p-value to a highly statistically significant level (potentially well below 0.001).

Deeper Dive into DUR-928 Hypothetical Scenario and Implications:
Transplant Counts: Let's assume that approximately half the transplants in the study were in patients who would have died without one. Recategorizing these patients as alive would change the results significantly.
Revised Mortality: Factoring those transplants into the 'alive' category would likely lower the observed mortality rates in both the larsucosterol groups and the SOC group, likely resulting in a statistically significant difference between them.
Stronger Endpoint: By recognizing the lifesaving power of transplants, the analysis becomes a better reflection of the overall effectiveness of larsucosterol in improving patient outcomes beyond simply postponing death.
Conclusion: In my opinion even though the results for 90-day mortality didn't quite reach statistical significance, they strongly suggest that larsucosterol has the potential to be a transformative therapy for alcohol-associated hepatitis. Recategorizing transplant patients as alive would likely solidify the statistical significance of the findings. This, coupled with the strong trends observed across other outcomes and the drug's favorable safety profile, presents a compelling case for further investigation and potential approval.

Lets assume that liver transplant recipients in the study were categorized as alive instead of deceased. In my opinion it's very likely that the DUR-928 2b trial would have achieved a statistically significant difference in the 90-day mortality endpoint. Here's why:
Mortality Reduction: The initial results show a clinically meaningful reduction in 90-day mortality for both dosages:
41% reduction for the 30mg dose (p-value = 0.070)
35% reduction for the 90mg dose (p-value = 0.126)
Transplants as a Lifesaving Intervention: Liver transplants are performed in severe AH cases to prevent imminent death. Again in my opinion by including successful transplants in the "alive" category, we are essentially factoring in the positive impact larsucosterol could have on disease progression and the need for this critical intervention.

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

I want news!! I want $30, lol

Can we move this today

That’s what these A Hoes want you to believe so you can sell at A loss MM tricks

Owell

This pos is done……..forget about it. I lost a lot on this one.

Yeah something fishy going on here looks illegal to me

ANALYST RATING
Buy
3.00 Rating Score
UPSIDE/?DOWNSIDE
1,227.5% Upside
$34.25 Price Target

Why not ?

Why ?

Good opportunity here $$$$

Cheapies

"The topline results from AHFIRM provide compelling evidence that administration of larsucosterol can reduce mortality at 90 days in this devastating disease," said James E. Brown, D.V.M., President and CEO of DURECT. "We have strong rationale to advance larsucosterol into a Phase 3 registration trial designed with adequate power to detect a statistically significant result using 90-day mortality as the primary endpoint. We look forward to meeting with the FDA to discuss next steps. Based on the strength of the clinical data generated to date, if approved, larsucosterol could save many patient lives. We extend our thanks to all the patients, families, clinical trial investigators, and staff across the multiple sites globally who have worked with the DURECT team to bring larsucosterol to this advanced stage."

Cat bounce here got some

Bullish price target.
Looking at the drug they are developing it’s either home run or nothing.

$44 price target. Lol

https://www.benzinga.com/quote/DRRX/analyst-ratings

100% agree. This will be a total loss for investors.

There is really nothing positive about a R/S in a penny stock. It always seems to get back to the pre split price and 90% of your investment is toast. $3.60 looks better but in reality only 36 cents compared to last week

1/10 RS. 100% loss incoming. Smfh!

Been not liking this company since I was told about it. They are just trying to buy time. Stick a fork in this POS.

The vote is mostly just symbolic since corporate has enough votes to pass what they want.

I have NEVER seen a stock selling for under a buck do well after a R/S....it just seems to eventually get back to the pre split price and you are minus 90% of your shares.

I also voted against it

I voted against the R/S. F them!!! Hope everyone does the same. Garbage…..

Yup....I just dumped my shares at a loss to salvage something

R/S incoming! F’in BS!!!!

.how do you let your share price get this low.

When you don't have much in the pipeline and you have novice investors falling for every stupid PR you put out there. SO glad I stayed away form DRRX. Total garbage.

What a garbage company…….how do you let your share price get this low.

How low are they gonna let this POS go?! My god……Smfh.

Pretty much puts everything in a nutshell. DRRX POS~!

Will be lucky to see $2 again.....

If in this play.... get out ...... or take the ride down.

Just my opinion.

What a POS this stock is!! Smh

The two big catalyst for me is: (1). The authorized share count was not increased to 600,000,000 shares, even though DRRX had the votes; that is very, very, interesting. (2) The quarterly filing was was moved up to 7/29/2021. Theses two catalyst, could pertain to a partnership or a buyout news pending. The ship is getting ready to sail, and the rocket is going to the moon. My Opinion!

I see why the stock price is down; all the Insiders are Filing Form 4 today and receiving stock at a very low price.

I’ll take $3.49

WILL NOT MOVE OVER $3.5O

DRRX is going nowhere real fast. Bail and grab some $AMC.

Durect Price Target Announced at $6.00/Share by HC Wainwright & Co.

DRRX: This CEO doesn't PR much.

The hogs are now fed; now we move up!

Three Conference's coming this March, start your engines!

Um... maybe?

https://towardsdatascience.com/effect-of-financial-statement-release-on-stock-prices-97932b2cb05

Will the 3/4/2021 10Q move the stock?