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Celldex Therapeutics, Inc. (CLDX)
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Guggenheim Starts Celldex Therapeutics at Buy With $66 Price Target
BY MT Newswires
— 7:56 AM ET 07/22/2021
I have to say I am impressed with recent prices. I really thought the issuances of new shares would hurt us. But, I am happy to be wrong.
'Guggenheim initiates with buy rating and $66'. Good to see.
After Hours Time (ET) After Hours Price After Hours Share Volume
16:53:29 $43.51 2
16:29:37 $44.33 2,245
16:01:29 $44.33 411
16:00:12 $44.33 140
16:00:12 $44.33 1,689
2 shares traded at 43.51 so the rest of the shares that traded at 44.33 tell the true story. Got to like Guggenheim’s Buy rating and $66.00 price target.
Epub advance report: Mast cells are implicated in neurological disorders like Alzhemier's, Parkinson's, autism and several others. Highlights the substantial potential for a robust and safe mast cell inhibitor like CDX-0159 in a variety of disease conditions: Neural Regen Res. 2021 Nov;16(11):2184-2197. doi: 10.4103/1673-5374.310608.Neuroimmune connections between corticotropin-releasing hormone and mast cells: novel strategies for the treatment of neurodegenerative diseasesPiplu Bhuiyan 1, Yi-Wei Wang 2, Huan-Huan Sha 1, Hong-Quan #$%$ 1, Yan-Ning Qian 1Affiliations expandPMID: 33818491 DOI: 10.4103/1673-5374.310608Free articleAbstractCorticotropin-releasing hormone is a critical component of the hypothalamic-pituitary-adrenal axis, which plays a major role in the body's immune response to stress. Mast cells are both sensors and effectors in the interaction between the nervous and immune systems. As first responders to stress, mast cells can initiate, amplify and prolong neuroimmune responses upon activation. Corticotropin-releasing hormone plays a pivotal role in triggering stress responses and related diseases by acting on its receptors in mast cells. Corticotropin-releasing hormone can stimulate mast cell activation, influence the activation of immune cells by peripheral nerves and modulate neuroimmune interactions. The latest evidence shows that the release of corticotropin-releasing hormone induces the degranulation of mast cells under stress conditions, leading to disruption of the blood-brain barrier, which plays an important role in neurological diseases, such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, autism spectrum disorder and amyotrophic lateral sclerosis. Recent studies suggest that stress increases intestinal permeability and disrupts the blood-brain barrier through corticotropin-releasing hormone-mediated activation of mast cells, providing new insight into the complex interplay between the brain and gastrointestinal tract. The neuroimmune target of mast cells is the site at which the corticotropin-releasing hormone directly participates in the inflammatory responses of nerve terminals. In this review, we focus on the neuroimmune connections between corticotropin-releasing hormone and mast cells, with the aim of providing novel potential therapeutic targets for inflammatory, autoimmune and nervous system diseases.
Guess what? Here we go again.
HAMPTON, N.J., July 12, 2021 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced that it is proposing to offer and sell, subject to market conditions, $175 million of shares of its common stock in an underwritten public offering. Celldex expects to grant the underwriters a 30-day option to purchase up to an additional $26.25 million of shares of common stock offered in the public offering.
The Investor Relations website contains information about Celldex Therapeutics's business for stockholders, potential investors, and financial analysts.
The Investor Relations website contains information about Celldex Therapeutics's business for stockholders, potential investors, and financial analysts.
Celldex Therapeutics Presents Positive Data from CDX-0159 Phase 1b Study in Chronic Inducible Urticaria at EAACI 2021
— 6:01 PM ET 07/09/2021
- 95% complete response rate after single dose of CDX-0159 -
- Rapid, profound and durable responses offer patients opportunity for quick, lasting, meaningful relief -
- Median duration of response 77+ days in Cold Urticaria and 57+ days in Symptomatic Dermographism -
- Serum tryptase and skin mast cell depletion mirror clinical activity -
- Favorable safety profile -
- Company to host webcast conference call on Monday, July 12 at 8:15 a.m. ET -
HAMPTON, N.J., July 09, 2021 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. ( CLDX
) today announced updated data from the Company’s ongoing, open label Phase 1b clinical trial of CDX-0159 in patients with antihistamine refractory cold urticaria and symptomatic dermographism, the two most common forms of chronic inducible urticaria. These diseases, which are often severe and debilitating, can significantly impact patients’ lives. CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity.
All 19/19 (100%) patients who received a single full dose of CDX-0159 experienced a clinical response to provocation testing. 18/19 (95%) experienced a complete response and 1/19 (5%) experienced a marked partial response. Responses were rapid, profound, and durable and correlated with a depletion of skin mast cells. CDX-0159 was generally well tolerated. These data were presented by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité – Universitätsmedizin, in Berlin during a late-breaking poster discussion session (#1046) as part of the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2021.
“The achievement of a 95% complete response rate, rapid onset and sustained durability after a single dose is unprecedented in this patient population and clearly demonstrates that CDX-0159 has the potential to become an important new treatment option for patients suffering with chronic inducible urticaria,” commented Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics ( CLDX
). “We believe these impressive early data show that CDX-0159 safely depletes mast cells which indicates its potential to impact other diseases with mast cell involvement. We continue to make excellent progress across the CDX-0159 development program in urticaria and expect to expand into prurigo nodularis later this year, and additional indications with mast cell involvement in the future.”
“These early-stage results are stunning and represent a major breakthrough for patients with inducible urticarias where current treatment options have been unable to provide relief from often severe symptoms,” said Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité - Universitätsmedizin in Berlin, who is conducting the study. “While individuals with inducible urticaria go to great lengths to avoid disease triggers in their daily lives, many find it impossible to do so and are impacted by severe itching and burning hives that impair all parts of their lives—their work, their concentration, their sleep and their social behavior. CDX-0159 clearly provided a real benefit to these patients and has meaningfully improved their lives. This novel mast cell depleting mechanism is especially exciting because it can provide insights into the involvement of mast cells across many diseases where their role is not yet well understood by the scientific community.”
Summary of data from ongoing Phase 1b Trial of CDX-0159:
As of the data cut-off on June 11, 2021, 20 patients had received a single intravenous infusion of CDX-0159 at 3 mg/kg, including 11 patients with cold urticaria and 9 patients with symptomatic dermographism. Patients had high disease activity as assessed by provocation threshold testing. In patients with cold urticaria and symptomatic dermographism baseline critical temperature thresholds were 18.9°C/66°F (range: 5-27°C/41-80.6°F) and FricTest® thresholds were 3.8 (range: 3-4) of 4. Safety results are reported for all 20 patients; activity results are reported for the 19 patients who received a full dose of CDX-0159. 14 of 19 patients completed the 12-week study observation period and five were ongoing (range of 2-8 weeks) as of June 11, 2021.
All 19/19 (100%) patients experienced a clinical response as assessed by provocation threshold testing; 18/19 (95%) experienced a complete response and 1/19 (5%) experienced a partial response.
10/10 (100%) patients with cold urticaria experienced a complete response.
8/9 (89%) patients with symptomatic dermographism experienced a complete response and 1/9 (11%) experienced a partial response.
Compete responses were observed in all 3 patients (1 cold urticaria; 2 symptomatic dermographism) with prior X
7/12: Wainwright analyst Pantginis on CLDX:
"...The shares have extended the gains today with a ~32.0% rise in the pre-market with positive comments from Wall Street. Encouraged by the company’s early clinical updates, H.C. Wainwright analyst Joseph Pantginis has upped the Celldex price target to $50.00 from $36.00 per share, indicating a premium of ~54.3%. Buy rating was maintained.
While the data are from an early-stage trial, they have the potential to build a transformational profile, Pantginis wrote, arguing that there are no approved therapies for chronic inducible urticaria currently...."
7/9/21 CDX-0159 late-breaking abstract at EAACI 2021: robust efficacy/safety, prolonged duration of treatment and molecular mechanism of action defined.
In a nutshell: CDX-0150 is an innovative, revolutionary drug that will transform the treatment landscape for mast cell caused disease.
My take: CDX-0159 is a mega blockbuster in the making. CLDX valuation will at least triple from current levels in the short to mid-term. Long term:....?
HAMPTON, N.J., July 13, 2021 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced the pricing of an underwritten public offering of 5,952,381 shares of its common stock at a public offering price of $42.00 per share. In connection with the offering, Celldex has granted the underwriters a 30-day option to purchase up to an additional 892,857 shares of common stock at the public offering price, less underwriting discounts and commissions.
Jefferies, SVB Leerink, Guggenheim Securities and Cantor are acting as the joint book-running managers for the offering. LifeSci Capital LLC and H.C. Wainwright & Co. are acting as co-lead managers for the offering.
The Company expects to receive gross proceeds from the offering, excluding the exercise of the underwriters’ option, if any, of approximately $250 million, excluding underwriting discounts and commissions and other offering-related expenses.
Celldex intends to use the net proceeds from the offering to continue clinical and preclinical development of its product candidates, including current and future development of CDX-0159, growing its bispecific antibody platform and clinical candidates, funding ongoing efforts to develop additional clinical pipeline products and for general corporate purposes.
The offering is expected to close on July 16, 2021, subject to customary closing conditions.
It goes down only 15 cents. On days it goes up it goes up much more than 15 cents. This stock will be making new highs.
I have been in CLDX from the beginning. I got burned like many here but never lost sight of the science. I bought a ton more shares at the bottom and was lucky enough to catch almost the exact bottom. Then I rode it up into the teens and sold all my shares as I didn't see the reason for the rise. Then when the teens were the new bottom I loaded up again at a higher entry price. Finally I bought more on the "fainting" side effect sell off and here I sit. I bet my pattern is common to many here. But what comes next? The afterhour reaction to the angioedema news out of the German meeting was incredible. I don't know exactly what I will do tomorrow. I fear that some will sell from having weak hands and little scientific knowlege of the massive potential here. Day traders are going to be all over this stock tomorrow and don't be surprised if it trades more shares than the float! I am so afraid of missing out and I really think tomorrow might be the gap up day that never looks back! When it first hit the teens I sold out of lack of conviction, but this time I think I am holding for the long run. You only get one or two of these in a lifetime...
Institution percentage of shares went down 13 %, from 88% to 75%.
Anyone know why?
News: CDX-0159 late-breaking abstract at EAACI 2021: robust efficacy/safety, prolonged duration of treatment and molecular mechanism of action defined.
Report out: Mast cell serotonin release by nerve growth factor is associated with autism. Correlation is not necessarily causation, but it's another data point in the many disease indications for 059:
J Neuroimmunol. 2021 Jun 24;358:577638. doi: 10.1016/j.jneuroim.2021.577638. Online ahead of print.
Plasma levels of nerve growth factor in Egyptian autistic children: Relation to hyperserotonemia and autoimmunity
Gehan Ahmed Mostafa 1, Nagwa Abdel Meguid 2, Abeer Al Sayed Shehab 3, Amal Elsaeid 2, Mahmoud Maher 4
PMID: 34214954 DOI: 10.1016/j.jneuroim.2021.577638
Hyperserotonemia and brain-specific autoantibodies are detected in some autistic children. Nerve growth factor (NGF) stimulates the proliferation of B lymphocytes with production of antibodies and also increases mast cell serotonin release. This work was the first to investigate the relationship between plasma NGF and both hyperserotonemia and the frequency of serum anti-myelin basic protein (anti-MBP) auto-antibodies in 22 autistic children aged between 4 and 12 years and 22 healthy-matched controls. Levels of NGF, serotonin and anti-MBP were significantly higher in autistic children than healthy control children (P < 0.001). There was a significant positive correlation between NGF and serotonin levels in autistic patients (P < 0.01). In contrast, there was a non-significant correlation between NGF and anti-MBP levels (P > 0.05). In conclusions, serum NGF levels were elevated and significantly correlated to hyperserotonemia found in many autistic children.
I cannot believe my own eyes... After 4.5 years I am finally free...
My price is 39 dollars after split... I'm crying :')
What is market size for hives?
Pharma industry is tricky business and according to which direction the political winds are blowing can make the difference between an over the top win or a disappointing loss. I have owned CLDX since the beginning of 2018 and held on through multiple reverse splits. I can only hope that they play this above board and allow the science to speak for it self. Would love to recoup my original investment.
Great news and it has a big demand and good market. Very soon it will cross 100.
Read about mast cells and related diseases. Then read the poster presentation carefully, and ask yourself these questions:
What are the results for the mechanistic endpoints?
What are the results for the clinical endpoints?
Are they consistent?
What are the next steps?
Dupixent at $11 Billion/yr...Humira at $20 Billion/yr...? Nah...!
Both peanuts compared to what 0159 will do!
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