|
|
Post by selluwud on Mar 2, 2021 15:46:11 GMT
I think any news will have to be released AH, anything else is speculation or manipulation.
|
|
|
|
Post by JHam on Mar 2, 2021 15:48:16 GMT
I think any news will have to be released AH, anything else is speculation or manipulation. Bear raid or leak. But as others have said, not sure how it would be a leak. Those holding big positions must have just laid a big one. |
|
|
|
Post by JHam on Mar 2, 2021 15:49:41 GMT
That could have been a good time to jump back in, assuming it was just a bear raid. Too scary for me to touch though at this point.
|
|
|
|
Post by magnus123 on Mar 2, 2021 15:52:35 GMT
I think any news will have to be released AH, anything else is speculation or manipulation. Bear raid or leak. But as others have said, not sure how it would be a leak. Those holding big positions must have just laid a big one. The move prior to halt was on low volume within seconds. You don't need a million shares to do this. After the halt, all stop losses have been activated through market sells. More than 1 million shares traded in these 5 minutes after the halt. I think that someone made big profit here... I say it was a bear raid, but definitely pure speculation. |
|
|
|
Post by JHam on Mar 2, 2021 15:58:22 GMT
Bear raid or leak. But as others have said, not sure how it would be a leak. Those holding big positions must have just laid a big one. The move prior to halt was on low volume within seconds. You don't need a million shares to do this. After the halt, all stop losses have been activated through market sells. More than 1 million shares traded in these 5 minutes after the halt. I think that someone made big profit here... I say it was a bear raid, but definitely pure speculation. Craziness. One of the drawbacks with setting stop losses. I’m not even holding shares, but I am caught up in the drama here. |
|
|
|
Post by lcd on Mar 2, 2021 16:14:12 GMT
Stop losses going into a binary event like this just don't seem to work. I got burned by a stop loss back in the 2010 flash crash and have never used one again. That crash drove the volatility based trading halt, but it still likely didn't work for a lot of holders today.
|
|
|
|
Post by magnus123 on Mar 2, 2021 17:58:58 GMT
I used the opportunity and sold half of my calls. It's just a lottery position now.
|
|
|
|
Post by selluwud on Mar 2, 2021 23:26:48 GMT
After hours creeping back up. Maybe they'll PR in the morning?
|
|
|
|
Post by lcd on Mar 3, 2021 0:56:57 GMT
It is pretty entertaining to watch the chatter on twitter. A rumor started that someone saw a large delivery of pizzas go to the KemPharm office so lots of memes followed.
Based on twitter, it appears that many people invested more than they could lose on this one.
|
|
|
|
Post by JHam on Mar 3, 2021 1:38:12 GMT
It is pretty entertaining to watch the chatter on twitter. A rumor started that someone saw a large delivery of pizzas go to the KemPharm office so lots of memes followed. Based on twitter, it appears that many people invested more than they could lose on this one. I was wondering what all the pizza memes were about, lol. And yeah, that’s the sense I get too. There are also a lot of people who know nothing about the company, the drug up for review, or about trading stocks in general (not that I am a professional or anything). They are dumping their life savings in and hoping for a miraculous lottery ticket. It’s never that easy and it makes me nervous when people like that flood into a stock I own. That’s a big reason why I got out when I did. I’m also puzzled that ST has added 11K followers over the last two weeks and the buzz on Twitter/social media is off the charts, yet the pps has not gone up at all. |
|
|
|
Post by JHam on Mar 3, 2021 6:11:05 GMT
It has been approved!! I don't see anything mentioned about 30/13 though so I am a bit curious about that: investors.kempharm.com/news-releases/news-release-details/kempharm-announces-fda-approval-azstarystm-serdexmethylphenidateKemPharm Announces FDA Approval of AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHDMarch 2, 2021 at 11:31 PM EST
Conference Call and Live Audio Webcast Scheduled for Tomorrow, Wednesday, March 3, at 8:30 a.m. ET
CELEBRATION, Fla., March 02, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for (NDA) AZSTARYS™ (formerly referred to as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. AZSTARYS consists of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.
Corium, Inc. (Corium), a portfolio company of Gurnet Point Capital (GPC), will lead the commercialization of AZSTARYS per the definitive collaboration and license agreement (the “License Agreement”) between KemPharm and an affiliate of GPC. Corium expects to make AZSTARYS commercially available in the U.S. as early as the second half of 2021.
“The FDA approval of the AZSTARYS NDA is a transformational event for KemPharm and, we believe, an important advancement in the treatment of ADHD,” said Travis C. Mickle, Ph.D., President and CEO of KemPharm. “Today’s approval highlights both the value potential of SDX, our prodrug of d-MPH, and the ability of our LAT® platform technology to develop new prodrugs of approved medications that improve one or more of the attributes of the parent drug. We look forward to continuing our support of Corium as they forge ahead with the commercial launch of AZSTARYS.”
“Today’s approval by the FDA is met with great excitement for this innovative new ADHD therapy and the potential it holds to meet the unmet needs of children, adolescents and adults,” said Perry Sternberg, CEO of Corium. “Our team is mobilized to put our commercial plans into action as the approval of the AZSTARYS NDA now enables us to finalize our preparations for commercial launch as early as the second half of this year.”
Ann Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine and an investigator in the AZSTARYS clinical trial, commented: “The ADHD industry, and specifically the MPH space, has seen little innovation in recent years, leaving prescribers and patients desiring new treatment options. In my research and practice, three properties are repeatedly cited by patients and their caregivers as being underserved by current ADHD medications: onset of action, duration of effect and consistency of therapy. Having investigated AZSTARYS and directly observed its clinical impact on patients, I believe this product will be an important new tool for physicians to use in providing effective care for patients with ADHD.”
As a result of the FDA’s approval of the AZSTARYS NDA, KemPharm has earned a regulatory milestone payment following FDA approval as provided under the License Agreement, and KemPharm is working with GPC to evaluate the related provisions and amounts. Under the License Agreement, KemPharm may be eligible for up to $468 million in regulatory and sales milestone payments, as well as tiered royalty payments, on a product-by-product basis for net sales, with potential percentages up to the mid-twenties for U.S. net sales, and up to the mid-single digits of net sales in each country outside of the U.S.
The complete label for AZSTARYS, including prescribing information and important safety information, may be found at www.kempharm.com/pipeline-products/#kp415.
The complete label may also be downloaded in PDF format here: ml.globenewswire.com/Resource/Download/4f63af91-9427-40da-b881-82a5e22a0315.
Conference Call Information:
KemPharm will host a conference call and live audio webcast with slide presentation tomorrow, Wednesday, March 3, 2021, at 8:30 a.m. ET, to discuss FDA approval of the AZSTARYS NDA. Interested participants and investors may access the conference call by dialing either:
(866) 395-2480 (U.S.)
(678) 509-7538 (international)
Conference ID: 4272912
An audio webcast with slide presentation will be accessible via the Investor Relations section of the Company’s website, investors.kempharm.com/. An archive of the webcast and presentation will be available for 90 days beginning tomorrow, March 3, 2021, at approximately 9:30 a.m. ET.
About Attention Deficit Hyperactivity Disorder (ADHD):
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common mental disorders affecting children. ADHD also affects many adults. Symptoms of ADHD include inattention (not being able to keep focus), hyperactivity (excess movement that is not fitting to the setting) and impulsivity (hasty acts that occur in the moment without thought).1 An estimated 8.4% of children and 2.5% of adults have ADHD.23
The ADHD market accounted for approximately $17.9 billion of revenue in 2019 with a year-over-year prescription growth rate greater than four percent (4%). Within this, the branded portion of the ADHD market was approximately $7.4 billion in 2019, with extended-release products representing more than 97% of the branded prescriptions. In 2019, the methylphenidate segment of the ADHD market accounted for approximately 20 million prescriptions and $4.9 billion in sales.
About AZSTARYSTM:
AZSTARYSTM is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH.
The complete approved prescribing information for AZSTARYS may be downloaded in PDF format here: ml.globenewswire.com/Resource/Download/4f63af91-9427-40da-b881-82a5e22a0315.
About KemPharm:
KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT® (Ligand Activated Therapy) technology. KemPharm utilizes its proprietary LAT® technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s product portfolio is highlighted by AZSTARYS™, an FDA-approved, once-daily treatment for attention deficit hyperactivity disorder (ADHD) which is based on serdexmethylphenidate, (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH). KemPharm is also advancing several clinical development candidates, including KP484 for the treatment of ADHD and KP879 for the treatment of Stimulant Use Disorder (SUD). AZSTARYS, KP484, and KP879 are all based on SDX. In addition, KemPharm has received FDA approval for APADAZ®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.
Caution Concerning Forward Looking Statements:
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation KemPharm’s proposed development and commercial timelines, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements include statements about the commercial launch of AZSTARYS, including the timing of launch, the regulatory milestone payment, and the potential clinical benefits of AZSTARYS. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning KemPharm’s business are described in detail in the “Risk Factors” sections of KemPharm’s Annual Report on Form 10-K for the year ended December 31, 2019, KemPharm’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and KemPharm’s other filings with the Securities and Exchange Commission. KemPharm is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
KemPharm Contacts:
Jason Rando/Maureen McEnroe, CFA
Tiberend Strategic Advisors, Inc.
(212) 375-2665 / 2664
jrando@tiberend.com
mmcenroe@tiberend.com
________________________
1 American Psychiatric Association (https://www.psychiatry.org/patients-families/adhd/what-is-adhd)
2 Danielson, ML, et al. Prevalence of Parent-Reported ADHD Diagnosis and Associated Treatment Among U.S. Children and Adolescents, 2016. Journal of Clinical Child & Adolescent Psychology, Volume 47, 2018 - Issue 2
3 Simon V , Czobor P, Bálint S , et al: :Prevalence and correlates of adult attention-deficit hyperactivity disorder: a meta-analysis. Br J Psychiatry194(3):204–211, 2009
|
|
|
|
Post by magnus123 on Mar 3, 2021 9:19:30 GMT
Great!!! So happy about that. Overall a classic FDA thriller - I don't need it too often  |
|
|
|
Post by JHam on Mar 3, 2021 9:33:24 GMT
Great!!! So happy about that. Overall a classic FDA thriller - I don't need it too often Haha! Congrats on those $10 calls. Interesting action so far. It spiked at 6am, but so far is stuck between $15-$17. Not sure if it will have one of those parabolic 3-5 bagger runs. |
|
|
|
Post by magnus123 on Mar 3, 2021 10:32:05 GMT
Great!!! So happy about that. Overall a classic FDA thriller - I don't need it too often Haha! Congrats on those $10 calls. Interesting action so far. It spiked at 6am, but so far is stuck between $15-$17. Not sure if it will have one of those parabolic 3-5 bagger runs. Question is, how good shorts are covered with warrants. Volume should be big today. I also believe that the buyout pump is just getting started with approval on hand... |
|
|
|
Post by JHam on Mar 3, 2021 11:16:58 GMT
Haha! Congrats on those $10 calls. Interesting action so far. It spiked at 6am, but so far is stuck between $15-$17. Not sure if it will have one of those parabolic 3-5 bagger runs. Question is, how good shorts are covered with warrants. Volume should be big today. I also believe that the buyout pump is just getting started with approval on hand... So you’re saying I should get in and try to chase...🤔😅 |
|
|
|
Post by jamesjohnson12 on Mar 3, 2021 11:37:36 GMT
Thoughts on how t o trade this today? I’ve got a decent amount of $10 calls. Obviously very happy to see the premature reaction, but worried about a sell the news this morning.
Leaning towards selling half to secure profits and letting half run to see if we get a WSB squeeze today lol. Stocktwits is going bananas, which I’m not confident is a good thing, but there are definitely a lot of eyes on it.
|
|
|
|
Post by JHam on Mar 3, 2021 12:01:22 GMT
Thoughts on how t o trade this today? I’ve got a decent amount of $10 calls. Obviously very happy to see the premature reaction, but worried about a sell the news this morning. Leaning towards selling half to secure profits and letting half run to see if we get a WSB squeeze today lol. Stocktwits is going bananas, which I’m not confident is a good thing, but there are definitely a lot of eyes on it. My goal was to sell at $20 upon FDA approval and never look back. That changed once I got cold feet a few days ago and sold at $11. No regrets there either. However, if I were to still be holding shares at this very moment, I would still be looking to sell a good portion and lock in profits at the very least. |
|
|
|
Post by lcd on Mar 3, 2021 12:23:11 GMT
Does anyone know how high the price got pre-market? I saw it at $16.42 when I first checked this morning, but my Fidelity account doesn't allow pre-market trades until 7AM EST.
If I had a large position, I would definitely cash out at least 50% pre-market. Based on my observations on Twitter, there are a lot of people looking to pay their rent with profits from this one. I have a small position so I am going to hold on and see how regular hours trading goes. I am sure it will be an interesting day.
|
|
|
|
Post by magnus123 on Mar 3, 2021 12:25:18 GMT
Does anyone know how high the price got pre-market? I saw it at $16.42 when I first checked this morning, but my Fidelity account doesn't allow pre-market trades until 7AM EST. If I had a large position, I would definitely cash out at least 50% pre-market. Based on my observations on Twitter, there are a lot of people looking to pay their rent with profits from this one. I have a small position so I am going to hold on and see how regular hours trading goes. I am sure it will be an interesting day. It was about $21 this morning. |
|
|
|
Post by selluwud on Mar 3, 2021 12:31:04 GMT
I was shooting for 20. sell premarket but was limited to a 7:00 am offer and missed the mark. I'll hold through open with a 20. limit left in premarket for the hell of it.
|
|
