Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
* * $ABEO Video Chart 05-11-2020 * *
Link to Video - click here to watch the technical chart video
* * $ABEO Video Chart 03-17-2020 * *
Link to Video - click here to watch the technical chart video
* * $ABEO Video Chart 02-19-2020 * *
Link to Video - click here to watch the technical chart video
* * $ABEO Video Chart 02-12-2020 * *
Link to Video - click here to watch the technical chart video
* * $ABEO Video Chart 02-11-2020 * *
Link to Video - click here to watch the technical chart video
* * $ABEO Video Chart 02-10-2020 * *
Link to Video - click here to watch the technical chart video
Abeona Therapeutics (NASDAQ:ABEO)‘s stock had its “buy” rating restated by research analysts at HC Wainwright in a note issued to investors on Monday, December 30th, MarketBeat.com reports. They presently have a $11.00 price objective on the biopharmaceutical company’s stock, down from their prior price objective of $15.00. HC Wainwright’s price objective would suggest a potential upside of 366.10% from the company’s current price.
Other research analysts have also recently issued research reports about the company. ValuEngine raised Abeona Therapeutics from a “hold” rating to a “buy” rating in a research note on Tuesday, December 3rd. Cantor Fitzgerald started coverage on shares of Abeona Therapeutics in a research note on Tuesday, December 10th. They set a “hold” rating and a $4.00 price objective on the stock. Zacks Investment Research lowered shares of Abeona Therapeutics from a “buy” rating to a “hold” rating in a research report on Tuesday, October 15th. Finally, Mizuho reaffirmed a “hold” rating and issued a $4.00 price target on shares of Abeona Therapeutics in a research note on Tuesday, December 10th. Five equities research analysts have rated the stock with a hold rating and three have issued a buy rating to the stock. Abeona Therapeutics presently has a consensus rating of “Hold” and an average target price of $7.50.
Shares of NASDAQ ABEO opened at $2.36 on Monday. Abeona Therapeutics has a 12-month low of $1.46 and a 12-month high of $8.41. The company has a current ratio of 2.45, a quick ratio of 2.45 and a debt-to-equity ratio of 0.07. The company has a market cap of $129.15 million, a price-to-earnings ratio of -1.98 and a beta of 2.13. The stock’s 50 day simple moving average is $3.26 and its 200 day simple moving average is $2.93.
Abeona Therapeutics (NASDAQ:ABEO) last released its quarterly earnings results on Tuesday, November 12th. The biopharmaceutical company reported ($0.35) earnings per share for the quarter, beating the Zacks’ consensus estimate of ($0.44) by $0.09. As a group, equities analysts forecast that Abeona Therapeutics will post -1.52 earnings per share for the current fiscal year.
In other Abeona Therapeutics news, Director Stefano Buono bought 200,000 shares of the company’s stock in a transaction dated Tuesday, December 24th. The shares were bought at an average price of $2.50 per share, for a total transaction of $500,000.00. Following the acquisition, the director now directly owns 270,000 shares of the company’s stock, valued at $675,000. The acquisition was disclosed in a filing with the Securities & Exchange Commission, which is available at the SEC website. Insiders own 33.60% of the company’s stock.
Several large investors have recently made changes to their positions in the stock. Tower Research Capital LLC TRC raised its position in Abeona Therapeutics by 434.6% during the second quarter. Tower Research Capital LLC TRC now owns 8,719 shares of the biopharmaceutical company’s stock valued at $42,000 after acquiring an additional 7,088 shares in the last quarter. Ellington Management Group LLC acquired a new position in shares of Abeona Therapeutics during the second quarter worth approximately $50,000. Trexquant Investment LP bought a new stake in shares of Abeona Therapeutics in the second quarter valued at approximately $53,000. D. E. Shaw & Co. Inc. acquired a new stake in shares of Abeona Therapeutics in the second quarter worth $59,000. Finally, Marshall Wace LLP increased its position in Abeona Therapeutics by 45.9% during the second quarter. Marshall Wace LLP now owns 13,254 shares of the biopharmaceutical company’s stock worth $63,000 after acquiring an additional 4,168 shares during the period. Institutional investors and hedge funds own 55.85% of the company’s stock.
About Abeona Therapeutics
Abeona Therapeutics Inc, a clinical-stage biopharmaceutical company, focuses on developing and delivering gene therapy products for severe and life-threatening rare diseases. The company's lead programs are EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB); ABO-102, which are AAV based gene therapies for Sanfilippo syndrome type A; and ABO-101, an adeno-associated virus (AAV) based gene therapies for Sanfilippo syndrome type B.
https://rivertonroll.com/news/2020/01/14/abeona-therapeutics-nasdaqabeo-price-target-increased-to-15-00-by-analysts-at-hc-wainwright-updated-updated.html
Abeona Therapeutics (ABEO) Begins Phase 3 Clinical Trial Evaluating EB-101 Gene Therapy for Recessive Dystrophic Epidermolysis Bullosa
Abeona Therapeutics Inc. (NASDAQ: ABEO) today announced that it has received Institutional Review Board (IRB) approval from Stanford University to commence the VIITAL™ study, the Company’s pivotal Phase 3 clinical trial evaluating EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The majority of patients targeted for enrollment have completed the pre-screening process at Stanford, and the Company expects the first patient in the VIITAL™ study to be treated in the first quarter of 2020.
“We expect 2020 to be a transformational year at Abeona, and we are proud to start it with the initiation of our pivotal Phase 3 study evaluating EB-101 in RDEB,” said João Siffert, M.D., Chief Executive Officer. “We look forward to the first patient receiving EB-101 this quarter, setting in motion the final stages of this important program. We have devoted significant effort to establish and validate our independent, fully-functional GMP facility that will produce EB-101 for the VIITAL™ study and has capacity to support commercial launch. EB-101 has the potential to be the first approved therapy for RDEB and the only durable treatment to address large chronic wounds, which are the most painful and debilitating.”
The VIITAL™ Phase 3 study is a multi-center, randomized clinical trial assessing EB-101 in up to 15 RDEB patients, with approximately 30 large, chronic wound sites treated in total. The primary study endpoint is the proportion of wounds with greater than 50% healing at three months, comparing treated with untreated wound sites on the same patient. Secondary endpoints include the patient’s global impression of change from baseline in pain as well as other patient reported outcomes assessing pain during dressing changes, pain impact and physical function. Investigators at Stanford University Medical Center are currently enrolling eligible patients into the VIITAL™ study, with additional study sites expected to be added in the coming months. Additional information about the trial is available at abeonatherapeutics.com/clinical-trials/rdeb.
Abeona will produce EB-101 for the pivotal VIITAL™ study at the Elisa Linton Center for Rare Disease Therapies, its fully-functional gene and cell therapy manufacturing facility, centrally-located in Cleveland, OH. The center is a 26,000 ft2 facility housing large-scale cGMP capacity and state-of-the-art laboratories to support CMC development for process and analytics, all of which is validated and governed by comprehensive quality systems and overseen by experienced staff. The facility is also capable of clinical production of the Company’s AAV gene therapies.
About EB-101
EB-101 is an autologous, gene-corrected cell therapy in late-stage clinical development for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy. Treatment with EB-101 involves gene transfer to deliver COL7A1 genes into a patient’s own skin cells (keratinocytes) and transplanting them back to the patient to enable normal Type VII collagen expression and facilitate wound healing. Data from a Phase I/IIa clinical trial conducted by Stanford University evaluating EB-101 showed that the gene-corrected cell therapy provided durable wound healing for RDEB patients lasting several 2+ to 5+ years, including for the largest, most challenging wounds that affect the majority of the RDEB population. In the U.S., Abeona holds Regenerative Medicine Advanced Therapy, Breakthrough Therapy, and Rare Pediatric designations for EB-101 and Orphan Drug designation in both the U.S. and EU.
About Recessive Dystrophic Epidermolysis Bullosa
Recessive dystrophic epidermolysis bullosa (RDEB) is a rare connective tissue disorder characterized by severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life. People with RDEB have a defect in the COL7A1 gene, leaving them unable to produce functioning Type VII collagen which is necessary to anchor the dermal and epidermal layers of the skin. There is currently no approved treatment for RDEB.
https://www.streetinsider.com/Corporate+News/Abeona+Therapeutics+%28ABEO%29+Begins+Phase+3+Clinical+Trial+Evaluating+EB-101+Gene+Therapy+for+Recessive+Dystrophic+Epidermolysis+Bullosa/16327388.html
Abeona Therapeutics: Speculative Buy After Financing
Summary
Shares have lost half their value since our first look at this gene therapy story in 2016.
A crisis of confidence in management and lack of timely execution in the clinic brought the valuation down to lows recently seen in Q4.
A highly dilutive offering occurred at a low price point, but there is a silver lining given participation of Great Point Partners and shakeup of the board of directors.
Lead program EB-101 in RDEB was given the green light to proceed into phase 3, and a look at prior data plus the low bar set suggests a high probability of success.
Data for MPS III programs is also promising, and there is long-term value in the AIM platform. Abeona Therapeutics is a Speculative Buy.
Shares of Abeona Therapeutics (ABEO) have lost half of their value since we uncovered this intriguing gene therapy story back in 2016, highlighting promising early data for ABO-102 in Sanfilippo B syndrome and also for EB-101 in RDEB (recessive dystrophic epidermolysis bullosa). My last update was in early 2018, as shortly after we turned negative on this name, it became apparent that management was failing to execute in the clinic in a timely manner.
Recently, the name popped up on my radar after the company finally got a long-awaited green light from the FDA for its phase 3 VIITAL trial evaluating EB-101 in RDEB (clinical hold removed submission of transport stability data). The primary endpoint is going to be the proportion of wounds showing at least 50% healing at month 3 compared to untreated wounds on the same patient, a very low and achieveable bar to my eyes (long-time readers know I am a fan of assets with a clear path to market).
On the other hand, shares took a dive after a highly dilutive $90 million offering was announced, consisting of a mix of common shares at $2.50 per share and pre-funded warrants at $2.4999 per warrant. While this kind of dilution was absolutely atrocious at first glance, I did find it interesting that well-known institutional investor Great Point Partners acquired $31 million of the offering along with the right to nominate and replace two directors (including new chairman of the board).
Perhaps this was the change the company finally needed to turn the page on its troubled past and start moving forward at a more efficient pace. Thus, I decided to revisit.
Figure 1: ABEO daily advanced chart
(Source: Finviz)
When looking at charts, clarity often comes from taking a look at distinct time frames in order to determine important technical levels to get a feel for what's going on. In the above chart (daily advanced), we can see a sickening decline during Q2 and Q3, with the stock bottoming at $2 level in September. September's spike was due primarily to the company's announcement of "exploring strategic alternatives," which in hindsight appears quite sketchy considering it instead chose to access funding via dilutive offering a few months later. In December, the stock began to run up after a series of positive news developments, but gapped down after the secondary was announced. The recent bounce in share price is encouraging, but the burden of proof is on management to actually deliver on key initiatives going forward.
Q3 Update
For the third quarter, the company reported cash and equivalents of $47.9 million (does not include proceeds from $90 million secondary offering). Net cash used in operating activities was $18.3 million, while research & development expenses fell to $10.9 million from $13.2 million in the same period in 2018. General and administrative expenses fell slightly to $4.7 million.
Figure 2: Pipeline
(Source: Corporate presentation)
Regarding program updates, we are reminded for lead asset EB-101 that the phase 3 VIITAL clinical trial protocol with updated PRO assessments was submitted to the FDA (along with retrovirus comparability protocol and the requested transport stability data related to September's clinical hold letter). Clinical results continued to be impressive, with phase 1/2 data showing that three years after treatment with EB-101, most RDEB patients experienced sustained wound healing (80% or 16 of 20 wounds achieving ≥50% healing, and 70% achieving ≥75%). As you can imagine, this data contrasted sharply with prospectively selected control wounds, with 1 of 6 having over 50% healing). 50% or greater wound healing was associated with no pain and no itch, compared with presence of pain in 53% (20/38) and itch in 61% (23/38) of wound sites at baseline. Safety profile was solid as well, with no serious treatment-related adverse events observed during the 3-year observation period.
Figure 3: Impressive data from early-stage study bodes well for odds of success in pivotal study, low hurdle to overcome
(Source: Corporate presentation)
On the conference call, management stated again touched on the above data for EB-101 and then moved onto ABO-102 (AAV-SGSH) in MPSIIIA. The goal here with a one-time infusion is to correct the underlying deficiency of the SGSH enzyme to prevent the toxic accumulation of heparin sulfate (which often lead to such symptoms as loss of speech & vision, cognitive decline, seizures, behavioral abnormalities, etc.). Consider that 70% of MPS III kids do not reach age 18. We are reminded that interim data of 3 young children treated at the highest dose cohort suggested that preservation of neurocognitive development can be achieved when these patients are treated at an early enough stage. More patients are being screened for the study, and we can expect an update when they are treated. An update will also be provided on regulatory pathway after meeting with FDA and EMA agencies (expect the news in Q1).
Figure 4: Change in Mullen Developmental Age post treatment as compared to natural history
(Source: Corporate presentation)
As for ABT-002 for MPSIIIB, a 2-year, open-label study continues to make progress with 6 patients treated across 2 dose cohorts (showed it's well tolerated with up to 23 months of follow-up for first patient enrolled). Early data is showing improvement in biomarkers and reduction of liver volume of similar magnitude to the MPSIIIA program.
As for preclinical assets that haven't received much attention yet, data presented at European Society of Gene and Cell Therapy highlighted the company's library of novel AIM AAV capsids, including presentations showing increased evasion to neutralizing antibodies, improved AAV capsids for intramuscular delivery, delivery to the retina via intravitreal administration and improved PNS tropism for treating Pompe disease via IV administration.
An Eventful December
On December 9th, Abeona Therapeutics announced that it received the go-ahead from the FDA to move forward with the pivotal phase 3 VIITAL study evaluating EB-101 in RDEB patients. The company is guiding for initiation of the study in Q1 2020.
On December 20th, the company's ABO-102 program for MPS IIIA was granted the coveted PRIME designation by the EMA (equivalent to Breakthrough Therapy designation in US). With more support for the program in the form of interaction and early dialogue, prospects of getting this one across the finish line continue to appear brighter.
As for the disastrous pricing of the secondary offering (over 26.9 million shares at a price point of $2.50 per share plus pre-funded warrants to purchase over 9 million shares of common stock, doesn't include underwriter option), the bright side is the $90 million received plus participation from Great Point Partners along with a shakeup of the board of directors as mentioned above.
Final Thoughts
To conclude, with the highly dilutive financing out of the way and gene therapy stocks currently receiving a well-deserved boost in the past quarter due to impressive buyout premiums (think Audentes Therapeutics (BOLD)) and license deals (Sarepta Therapeutics' (SRPT) ex-US DMD deal just recently), I wouldn't be surprised to see the share price recover in 2020 as clinical progress is made across multiple lead assets. To be fair, there are a number of companies going after the DEB space, including Krystal Biotech (KRYS), which has risen by 475% since my initial recommendation and for good reason given advantages in cost and convenience of administration for products based on its STAR-D platform. Likewise, other approaches to treat MPSIII are being employed, including Orchard Therapeutics' (ORTX) ex-vivo gene therapy candidates OTL-201 and OTL-202, as well as Sarepta Therapeutics' and Lysogene's LYS-SAF302.
With a caveat for competition in lead indications targeted and noting significant long-term potential for Abeona's next-generation AAV AIM platform, Abeona Therapeutics is a Speculative Buy. Readers who are interested in the story and have done their due diligence should take advantage of any near-term dips to initiate a pilot position or add to one's stake.
Risks include further setbacks in the clinic or postponed timelines, additional clinical hold or otherwise negative FDA action, disappointing clinical data and competition for certain indications (backed by companies with much more by way of resources). Another financing is not expected until 2H 2020 or later. When the RDEB program reaches commercialization stage, this will be quite the hurdle as well given complicated manufacturing and logistics (the company claims to currently have capacity to treat 120 patients, with plans to expand and support up to 500 patients annually one year after launch).
As for downside cushion and elements of derisking, to my eyes, data for lead programs looks quite promising in indications that are very well-characterized, and the bar is set low, as these patients have no approved therapeutic options.
For our purposes in ROTY, I will continue monitoring progress of the company's clinical assets to determine if it's worthy of entry for us at some point in 2020. I still consider it to be on the speculative side given previous lack of value creation and execution on the part of management, but I'm optimistic that the recent financing (and especially board shakeup) might be the start of a turnaround.
Author's Note: I greatly appreciate you taking the time to read my work and hope you found it useful. Consider clicking "Follow" next to my name to receive future updates and look forward to your thoughts in the Comments section below.
Disclosure: I am/we are long KRYS. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Additional disclosure: Disclaimer: Commentary presented is NOT individualized investment advice. Opinions offered here are NOT personalized recommendations. Readers are expected to do their own due diligence or consult an investment professional if needed prior to making trades. Strategies discussed should not be mistaken for recommendations, and past performance may not be indicative of future results. Although I do my best to present factual research, I do not in any way guarantee the accuracy of the information I post. I reserve the right to make investment decisions on behalf of myself and affiliates regarding any security without notification except where it is required by law. Keep in mind that any opinion or position disclosed on this platform is subject to change at any moment as the thesis evolves. Investing in common stock can result in partial or total loss of capital. In other words, readers are expected to form their own trading plan, do their own research and take responsibility for their own actions. If they are not able or willing to do so, better to buy index funds or find a thoroughly vetted fee-only financial advisor to handle your account.
https://seekingalpha.com/article/4314055-abeona-therapeutics-speculative-buy-after-financing
After an overall market correction garb some shares.
New activist and cell gene Therapies will be hot plays going foreword.
NEW YORK and CLEVELAND, Dec. 09, 2019 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (ABEO), a fully-integrated leader in gene and cell therapy, today announced that the U.S. Food and Drug Administration (FDA) has removed its clinical hold and provided clearance to proceed with the VIITAL™ study, the Company’s pivotal Phase 3 clinical trial evaluating EB-101 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). The FDA removed the clinical hold following the Company’s submission of additional data points on transport stability of EB-101 to clinical sites. Abeona expects to initiate the VIITAL™ study in first quarter of 2020.
“The Abeona team has worked diligently to provide a prompt and thorough response to the FDA, enabling us to proceed with our pivotal Phase 3 trial for EB-101,” said João Siffert, M.D., Chief Executive Officer of Abeona. “Recently published long-term follow up data from our Phase 1/2 trial leaves us increasingly confident that EB-101 can provide durable healing for large, chronic wounds that afflict many RDEB patients. We are now focused on initiating the VIITAL™ study in the first quarter of 2020. The success in building and qualifying a state-of-the-art GMP manufacturing facility also represents a critical step toward bringing this novel product to patients in dire need of effective treatment.”
With two to five years of follow-up, data from a Phase 1/2 clinical trial conducted by Stanford University evaluating EB-101 showed that the gene-corrected cell therapy provided durable wound healing for RDEB patients, including for the largest, most challenging wounds that constitute the majority of wounds in this population.
About The VIITAL™ Study
The VIITAL™ Phase 3 study will be a multi-center, randomized clinical trial assessing EB-101 in 10 to 15 RDEB patients, with approximately 30 chronic wound sites treated in total. The primary study endpoint will be the proportion of wounds with greater than 50% healing at three months, comparing treated with untreated wound sites on the same patient. Secondary endpoints include the patient’s global impression of change in pain from baseline as well as other patient reported outcomes assessing pain during dressing changes, pain impact and physical function.
About EB-101
EB-101 is an autologous, gene-corrected cell therapy in late-stage clinical development for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy. Treatment with EB-101 involves using gene transfer to deliver COL7A1 genes into a patient’s own skin cells (keratinocytes) and transplanting them back to the patient to enable normal Type VII collagen expression and facilitate wound healing. In the U.S., Abeona holds Regenerative Medicine Advanced Therapy, Breakthrough Therapy, and Rare Pediatric designations for EB-101 and Orphan Drug designation in both the U.S.and EU.
What's Ahead For Abeona Therapeutics
https://seekingalpha.com/article/4315072-ahead-for-abeona-therapeutics
On December 30, 2019, H.C. Wainwright analyst Raghuram Selvaraju lowered his price target for Abeona Therapeutics to $11 from $15 to account for the company’s recent sale of common stock and pre-funded warrants, telling investors that he believes the funds raised should extend the company’s operational runway into mid-2021. The analyst, who believes the company’s pivotal EB-101 program for recessive dystrophic epidermolysis bullosa is “likely to be rapid,” keeps a Buy rating on Abeona shares.
The company’s recent sale of common stock that Raghuram is referring to is that on December 24, 2019, Abeona Therapeutics announced the closing of its underwritten public offering, with a gross offering size of approximately $103.5 million, which includes the full exercise of the underwriters’ option to purchase 5,400,000 additional shares of common stock, at a public offering price of $2.50 per share. In addition, as part of the offering, Abeona sold to Great Point Partners (“GPP”), an existing investor, pre-funded warrants to purchase up to an aggregate of 9,017,055 shares of common stock at a purchase price of $2.4999 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.0001 per share exercise price of each pre-funded warrant.
The Company has granted to affiliates of GPP the right to nominate two Board members to Abeona’s Board of Directors, including a new Executive Chairman, due to GPP’s considerable investment in the transaction. As a result, Steven H. Rouhandeh will step down as Executive Chairman and will retain a seat on the Board, while Mark J. Alvino and Richard Van Duyne will exit the Board. These changes will be effective upon the Board’s qualification and election of GPP’s nominees. Such replacement members will be independent of GPP.
“Today’s event strengthens our financial position, providing cash runway into 2021 and resources that will allow us to fund continued clinical development of pipeline products, including the initiation and enrollment of the EB-101 pivotal Phase 3 VIITALTM study, and achieve critical near-term milestones,” said João Siffert, M.D., Chief Executive Officer of Abeona. “On behalf of the Board and all Abeona employees, I am grateful to our outgoing members for their service and dedication to the company, and particularly to Steven, who has served as Chairman of our Board of Directors for a number of years. Finally, I would like to thank our shareholders and new investors for their ongoing support and confidence in our pipeline and the Abeona team.”
“We are excited to lead this recapitalization of Abeona,” said David Kroin, Managing Director of Great Point Partners. “The Company is one of the world leaders in gene therapy technology, developing products using retrovirus, adeno-associated viruses and next generation capsids with potentially improved tropism profiles for a variety of devastating diseases. This funding greatly enhances Abeona’s financial position, and we believe it can now reach its full potential, as other gene therapy companies in which Great Point Partners has invested have been able to do. We intend to recruit the highest caliber people to guide the Company at the Board level in order to unlock the potential of a fully functioning manufacturing facility in Cleveland, Ohio, a late stage pivotal program in Recessive Dystrophic Epidermolysis Bullosa that has BreakThrough and RMAT Designations from the FDA, a pipeline of exciting neurology programs, and a wonderful team of professionals.”
Concurrently, the Company announced that its review of strategic options announced on September 3, 2019 has been completed. The Board of Directors concluded that it is in the best interest of the Company and its shareholders to develop its pipeline products independently, and with the additional funding and planned leadership nominations announced today. While the Board determined that this pathway was the best course of action to advance the Company’s mission and maximize stakeholder value, it was not due to a lack of interested partners, and Abeona continues to entertain strategic alternatives consistent with standard industry practices.
On December 20, 2019, Abeona Therapeutics Inc. (Nasdaq: ABEO) announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to the Company’s ABO-102 program studying its adeno-associated virus 9 (AAV9) gene therapy for Sanfilippo syndrome type A (MPS IIIA). The PRIME designation is based on nonclinical data and clinical data from the Transpher A Study, a global Phase 1/2 clinical trial evaluating a single-dose of ABO-102 for the treatment of children with MPS IIIA.
“EMA’s PRIME designation for the ABO-102 program recognizes the urgent need for a treatment option for children suffering from MPS IIIA, and underscores the potential of ABO-102 to modify the course of this devastating lysosomal storage disease,” said João Siffert, M.D., Chief Executive Officer.
The Transpher A Study is enrolling patients at sites in the U.S., Spain, and Australia.
The PRIME initiative provides access to enhanced support for the development of medicines targeting an unmet medical need. The designation affords sponsors with enhanced interaction and early dialogue regarding promising medicines, as well as the possibility of accelerated assessment of medicines applications. PRIME is intended to optimize development plans and speed up evaluation so these medicines can help patients to benefit as early as possible from therapies that may significantly improve their quality of life.
ABO-102 is a novel gene therapy in Phase 1/2 development for Sanfilippo syndrome type A (MPS IIIA), a rare lysosomal storage disease with no approved treatment that primarily affects the central nervous system (CNS). ABO-102 is dosed in a one-time intravenous infusion using an AAV9 vector to deliver a functional copy of the SGSH gene to cells of the CNS and peripheral organs. The therapy is designed to address the underlying SGSH enzyme deficiency responsible for abnormal accumulation of glycosaminoglycans in the brain and throughout the body that results in progressive cell damage and neurodevelopmental and physical decline. In the U.S., Abeona holds Regenerative Medicine Advanced Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug designations for the ABO-102 clinical program. In the EU, the Company holds PRIME and Orphan medicinal product designations.
* * $ABEO Video Chart 12-23-2019 * *
Link to Video - click here to watch the technical chart video
* * $ABEO Video Chart 12-20-2019 * *
Link to Video - click here to watch the technical chart video
Abeona said Great Point Partners, which already holds Abeona stock, indicated it plans to buy up to $33 million in the offering, including pre-funded warrants, subject to certain conditions, which include the ability to nominate two directors, including a new executive chairman. "As a result, Steven H. Rouhandeh would step down as executive chairman and would retain a seat on the board, while Mark J. Alvino and Richard Van Duyne would exit the board," Abeona said, adding "These changes would be effective upon the board's qualification and election of GPP's nominees."
* * $ABEO Video Chart 12-19-2019 * *
Link to Video - click here to watch the technical chart video
* * $ABEO Video Chart 12-11-19 * *
Link to Video - click here to watch the technical chart video
* * $ABEO Video Chart 11-27-2019 * *
Link to Video - click here to watch the technical chart video
* * $ABEO Video Chart 10-15-2019 * *
Link to Video - click here to watch the technical chart video
Great close today. Broke the 3.00 resistance.
ABEO trading activity yielded significant weekly gains.
3 Penny Stocks Making New Highs In September
$MRNS $DVAX $ABEO
https://www.transparenttraders.me/2019/09/3-penny-stocks-making-new-highs-in.html
Consolidation at new levels. Another good day
* * $ABEO Video Chart 09-03-2019 * *
Link to Video - click here to watch the technical chart video
Wow good accumulation at these levels. Looking very strong
News: $ABEO Abeona Therapeutics Announces Strategic Review
Company engages Jefferies LLC in response to strategic inbound interest NEW YORK and CLEVELAND, Sept. 03, 2019 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that it has retained Jefferies LLC as its financial...
Read the whole news ABEO - Abeona Therapeutics Announces Strategic Review
They missed their target big time, but I am thinking about getting back in.
Median price target is $28.
YAA me TOO. Moved on to a good one now that has gone up 400% in just the past 3 weeks and fully expect it to do even better than that in the next few months.
Nice to hear your doing well in ABEO
This company is getting a lot of media exposure both web and tv news here in Ohio! I've added it to my watchlist.
5 million shares @ $16 plus grants plus warrant conversion plus analysts upgrades plus pipeline = good long term picture IMO
It was trading like a secondary and only question now is at what price? Still long term hold
Canter Fitzgerald raises target price up to $34.00. Came out today at Seeking Alpha.
CitiGroup gives ABEO a buy rating and a $32.00 target price.
Viking Global adds 2,238,720 shares in SC13g filing 10/2/17
Analyst upgrades today. Read PR on your brokerage account.
Nice $24 price target from RBC Capital
another big pop over $17. Can't find any news. Decent volume. Any thoughts?
Exceeding all my expectations! More to come IMO
rally was based on news that FDA granted Breakthrough Therapy designation for EB-101
Followers
|
54
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
1249
|
Created
|
02/13/07
|
Type
|
Free
|
Moderators |
Abeona Therapeutics Announces Fourth Quarter and Full Year 2015 Summary Financial Results and Recent Operational Highlights |
NEW YORK, NY and CLEVELAND, OH -- (Marketwired) -- 03/08/16 -- Abeona Therapeutics, Inc. (NASDAQ: ABEO), a biopharmaceutical company focused on developing and delivering gene therapy and plasma-based products for severe and life-threatening rare diseases, today announced summary financial results for the fourth quarter and full fiscal year ended December 31, 2015. The Company will provide a business update for investors and other stakeholders on a conference call, Wednesday, March 9th, at 4:45 pm (Eastern). Tim Miller, Ph.D., President and CEO and Jeffrey Davis, Chief Operating Officer, together with other executives, will conduct the call. Interested parties are invited to participate in the call by dialing 877-269-7756 (toll free domestic) or 201-689-7817 (international). The call will consist of an overview of the Company's 4Q15 financials, and a discussion of business highlights. "The past year has led to significant advancements in our goal of building a leadership position in the field of gene therapy and plasma protein therapies towards transforming the lives of patients with rare diseases," stated Steven H. Rouhandeh, Executive Chairman. "In 2015, we expanded our pipeline with two clinical stage AAV gene therapies for Sanfilippo syndrome types A and B, added a third AAV gene therapy product in Juvenile Neuronal Ceroid Lipofuscinosis (JNCL) (also known as juvenile Batten disease), signed a license to an innovative CRISPR-Cas9 gene editing platform in rare blood disorders, with an initial focus in Fanconi anemia, strengthened our team, and added substantial financial resources to our balance sheet. In 2016, our priorities include driving our AAV gene therapy and alpha-1 protease inhibitor programs into the clinic, and advancing our gene editing programs including defining of regulatory pathways to bring our CRISPR product candidates to patients." Tim Miller, Ph.D., President and CEO, stated, "2016 will be an exciting, transformative year for Abeona Therapeutics as we position ourselves to enter multiple human clinical trials with our pipeline of innovative product candidates. As recently announced, the FDA allowance of the IND for the Phase 1/2 clinical study of ABO-102 for patients with Sanfilippo syndrome type A (MPS IIIA) moves our programs into the clinic here in the US, and we look forward to working with our collaborators to expand this program into Europe and Australia later this year. We believe that our gene therapy programs in Sanfilippo syndrome type B (ABO-101) and Juvenile Neuronal Ceroid Lipofuscinosis (ABO-201) will follow shortly. Lastly, we would like to thank our dedicated researchers and clinical collaborators, as well as the many dedicated patient foundations, for their tireless efforts and commitment to advancing new treatment options for these devastating unmet medical needs." Recent Abeona Highlights
|
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |