Geron Corp (GERN)

[big bambino]

Thank You

[Spike5]

It actually would be funny if it was not so sad

[attilathehunt]

UPDATE 2-US FDA staff raises concerns on Geron's blood disorder drug
8

002722.SZ
+1.24%
Christy Santhosh and Pratik Jain
Updated Tue, March 12, 2024 at 9:55 AM CDT
In this article:

002722.SZ
+1.24%

(Adds statement from staff reviewers paragraph 5 onwards, analyst comment in paragraph 9)

By Christy Santhosh and Pratik Jain

March 12 (Reuters) - The U.S. Food and Drug Administration's staff reviewers said on Tuesday they were unclear if Geron's blood disorder drug provided a clear benefit to patients in a late-stage trial and raised multiple safety concerns with the treatment.

Geron is seeking approval of the injectable drug, called imetelstat, for treating transfusion-dependent anemia in patients with a group of blood cancers called myelodysplastic syndromes (MDS).

The drug, if approved, will compete with Bristol Myers Squibb's Reblozyl, which has been approved by the FDA for the same disease indication.

Last year in January, Geron CEO John Scarlett told Reuters that the company anticipates a peak market potential of $1.2 billion for imetelstat in the United States and some key EU countries by 2030.

While Geron's drug met the main goal of increasing independence from transfusion at eight weeks in a late-stage study, the FDA's staff said the "clinical meaningfulness" of the data was unclear.

"The general consensus among MDS experts has been that only a 16-week or longer period of transfusion independence is clinically meaningful," the agency's staff said ahead of a meeting of FDA's independent advisers scheduled for Thursday.

The agency said that while the drug is believed to work by treating the underlying cancer, the study did not show a "disease-modifying effect" in either extending survival or helping drive disease remission.

It also highlighted a high rate of low red blood cell count in the late-stage study.

Wedbush analyst Robert Driscoll said it was expected that the briefing documents would lean negative and added that Geron will be able to provide a strong case against the points made by the FDA. (Reporting by Christy Santhosh and Pratik Jain in Bengaluru; Editing by Shailesh Kuber)

[big bambino]

Where did it mention about the advisory committee?

[Spike5]

I think we are seeing what the outcome is going to be it will nothing after Thursday and the bag holders will go through a terrible RS

[attilathehunt]

Lets see what the advisory committee recommends on Thursday.


Yes, adverse effects were more in treat arm than placebo....means it's working...benefits outweigh risk?


We will learn on Thursday.

[Spike5]

Oh my goodness what an absolutely sickening fucking company . There isn’t any good news coming out this will do a reverse split soon .

[learningcurve2020]

#10

https://www.fiercepharma.com/special-reports/top-10-most-anticipated-drug-launches-2024

[Spike5]

Not surprised this board is so quiet … there really is nothing to say about this company . They have a cure for cancer my ass !

[Spike5]

OMG what and absolutely terrible company

[Spike5]

Oh what a surprise geron is in giveback mode … so predictable!

[Spike5]

Oh my goodness what a disgusting company !

[learningcurve2020]

Giving shareholders GERD.

[Monksdream]

GERN under $2

[learningcurve2020]

Cold fusion?

[Spike5]

The chain reaction is starting !

[attilathehunt]

And approval is imminent within 90 days!

We should see tutes buying in soon.

[big bambino]

Geron to Announce Fourth Quarter and Full-Year 2023 Financial Results on February 28, 2024

[learningcurve2020]

Disappointing follow through but we'll see if 2.10 is the new bottom.

[Spike5]

A 30 cent loss on a slightly over 2 dollar stock is brutal and can very possibly start a bad chain reaction . I hope not but who knows

[Spike5]

Oh please ! I love chicken shit investors and I’m one myself and least I do not pretend to be anything else than that . Acting like I have any idea what I am talking about and thinking this company is going anywhere. Trust me is isn’t . At least this site is not any where as bad as those complete assholes on yahoo . Of course I do get a good laugh out of them.

[learningcurve2020]

That's some volume! Finally looks like it's out of that 1.80-2.10 channel.

[big bambino]

SHE'S FLYINNNNNNNNNN

[big bambino]

3 mil already. Anxious to see if it holds Fridays and today's gains by EOD

[learningcurve2020]

Geron looks like a geriatric.

[Spike5]

What an effing disgrace… cancer cures are not worth $1.84 .. this is why the FDA didn’t immediately approve their NDA . And the FDA is a total joke ! What does that tell you ?

[Spike5]

This stock sucks this company sucks they don’t have a cure for any cancer it’s all bullshit ..

[Spike5]

I have never seen a board that needs to be fired more … pathetic !

[Spike5]

I have never seen a board that needs to be fired more … pathetic !

[learningcurve2020]

Compared to NWBO this is a sure thing.

[Spike5]

I can not believe those fucking morons on yahoo are correct about this company . What an absolute disgrace!

[Spike5]

I can not believe this piece of garbage is going to be below 2 dollars again … it is clear the board only has themselves in mind could not care less about shareholders

[Dapper1]

Look for GERN to climb back to $3+ in Jan!

[Spike5]

Oh my goodness this is absolutely disgusting!

[Spike5]

Wow you talk about a one step forward and two steps back company ….. this company is the epitome of that!

[learningcurve2020]

I'm just talking in general over the years not specific to one event. It's almost like there's a group paid to post on specific stocks.

[big bambino]

True, but there is nothing Gern can do till FDA sends out their response to approval. They gave a time line and we are approaching that now. Hence the high daily volume and upward price. JMHO

[big bambino]

Nice steady accumulation with an Uptick. Can we reach and stay at $2.35 by close?

[learningcurve2020]

It's weird how a company like NWBO can constantly have the "Most read" board while Geron has practically no activity at all.

[big bambino]

I guess there are some who know the meaning? Like maybe 10 mil shares worth.

[big bambino]

Volume picking up! Let,s see if we can hold in the green again.

[learningcurve2020]

"Closer"...Whatever that means. My sense is regulators intend to take their sweet time with this. Hope I'm wrong but this is Geron, after all.

[big bambino]

Picked up a couple K more, lowering avg. I feel anything below $2 is a good price. Getting closer & closer to FDA response.

[learningcurve2020]

Could make a small fortune timing it right between 1.80 and 2.10. LOL.

[Spike5]

What a f****** disgrace

[Spike5]

Oh my goodness!!!!!!

[Spike5]

Yes it will be 2000 and never

[big bambino]

does anyone know by when FDA has to reply to gern's submission? I thought it was by Jan?

[Spike5]

WOW!! What else can you say ?

[learningcurve2020]

Is that air under the wings or the goose flying into the jet engine?