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BioLineRx Wins Dismissal of Investor Suit Over Company’s Cash
https://news.bloomberglaw.com/securities-law/biolinerx-wins-dismissal-of-investor-suit-over-companys-cash
Matthew Bultman
A federal judge dismissed a lawsuit against BioLineRx Ltd. alleging the biopharmaceutical company misled shareholders about its financial condition.
The proposed class action alleged BioLineRx and certain executives lied when they told investors the company had enough money to get through the first half of 2024, underscored by the company agreeing to a $40 million loan in late 2022.
The complaint hinges on the assumption that a company wouldn’t raise capital unless it immediately needed money, Judge Brian Martinotti in the US District Court for the District of New Jersey said in a Monday opinion.
RedHill Biopharma Strengthens Cash Balance, Settles Obligations and Removes Talicia® Lien
https://finance.yahoo.com/news/redhill-biopharma-strengthens-cash-balance-110000660.html
TEL-AVIV, Israel and RALEIGH, NC, July 22, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the signing of a Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, LLC, and HCR Redhill SPV, LLC (the "Agreement"). As a result of the Agreement, RedHill received approximately $9.9 million in cash and gained full control over an additional $0.74 million currently held in a restricted account, leading to an increase of approximately $12.2 million in liabilities for RedHill, reflecting assumed and settled liabilities between the parties, resulting in a net balance sheet reduction of approximately $2.3 million. In addition, the Agreement ends all existing credit ties with the Agreement parties, removes the existing lien against Talicia® and restores control over cash collections back to RedHill.
Razi Ingber, RedHill's Chief Financial Officer, said: "We are very pleased to reach this smooth conclusion, which strengthens RedHill's cash position and greatly enhances our ability to manage our cash. The Agreement eliminates substantially all encumbrances related to the previous Movantik divestment and Credit Agreements, allowing us to better focus on our R&D and commercial activities and return the Company to a growth mode. This is a new chapter for RedHill."
What appeals to them is not only NexoBrid which is a complimentary
product to theirs, but EscharEx® the bioactive, multimodal debridement
therapy for the treatment of chronic and other hard-to-heal wounds.
In other words, Mölnlycke is buying into a potential product which
in case of approval is not a step forward for them, but a major
development for the company.
Collaboration and Rights Agreement
Form SC 13D
In connection with the 2024 Offering, Mölnlycke and the Issuer entered into a Collaboration and Rights Agreement, dated July 15, 2024 (the “Collaboration Agreement”), whereby the Issuer shall be able to benefit from Mölnlycke’s comprehensive global expertise in advanced wound care. Accordingly, if requested by the Issuer, Mölnlycke shall provide the Issuer with commercial insights, clinical and regulatory experience, and educational resources.
Besides the parties’ collaboration in that manner, the Collaboration Agreement also grants Mölnlycke certain specific rights, including: (a) attendance/discussion rights with the Research & Development Committee of the Issuer’s board of directors (the “Board”) in a non-voting, observer capacity, and the Chief Executive Officer of Mölnlycke and the Executive Vice President, Wound Care of Mölnlycke will be invited to attend quarterly meetings with the Issuer’s Chief Executive Officer and the Issuer’s Chairman of the Board; (b) strategic evaluation rights related to EscharEx®; (c) a right of first participation in the process for an acquisition of the Issuer; provided, however, if the Issuer enters into, and the Board recommends in favor of, a definitive agreement with any third party with respect to an acquisition, Mölnlycke has agreed to vote the Ordinary Shares held by it in favor of such acquisition; (d) shareholdings exclusivity, whereby the Issuer may not sell or issue any equity securities to any entity having a significant commercial business in the field of wound-care until the earlier of (i) the two-year anniversary of the closing of the 2024 Offering and (ii) the termination of the agreement; and (e) customary preemptive rights to maintain its ownership percentage in the Issuer, subject to customary exceptions, until the earlier of (i) the two-year anniversary of the closing of the 2024 Offering and (ii) the termination of the agreement.
The Collaboration Agreement also contains stand-still provisions that limit Mölnlycke’s ownership to no more than 9.99% of the Issuer’s issued and outstanding Ordinary Shares during the duration of the agreement, including pursuant to any voting or other agreement.
The foregoing descriptions of the Share Purchase Agreement, the Registration Rights Agreement and the Collaboration Agreement do not purport to be complete and are qualified in their entirety by reference to the forms thereof filed as exhibits to this Schedule 13D, which exhibits are hereby incorporated by reference into this Item 4.
Mölnlycke acquired the Ordinary Shares for strategic investment purposes and to strengthen the partnership and collaboration between the parties. Depending on their review and evaluation of the business and prospects of the Issuer and the price level of the securities of the Issuer, or such other factors as they may deem relevant, the Reporting Persons may acquire additional securities of the Issuer; may sell all or any part of its securities of the Issuer in the open market, in privately negotiated transactions or in sales registered or exempt from registration under the Securities Act of 1933, as amended; may transfer shares to affiliated entities or may engage in any combination of the foregoing. Subject to applicable law and contractual limitations, the Reporting Persons may enter into derivative transactions, margin loans, hedging transactions or alternative structures with respect to the securities of the Issuer. Any open market or privately negotiated purchases, sales, distributions or other transactions may be made at any time without additional prior notice. Any alternative that the Reporting Persons may pursue will depend upon a variety of factors, including without limitation, current and anticipated future trading prices of the securities of the Issuer, the financial condition, results of operations and prospects of the Issuer and general economic, financial market and industry conditions, other investment and business opportunities available to the Reporting Persons, general stock market and economic conditions, tax considerations and other factors.
Other than as described above, Reporting Persons do not currently have any plans or proposals that relate to, or would result in, any of the matters listed in Items 4(a)–(j) of Schedule 13D, although, depending on the factors discussed herein, Reporting Persons may change their purpose or formulate different plans or proposals with respect thereto at any time.
ICL and Lavie Bio Leverage Artificial Intelligence to Make Significant Advancement in Development of Yield Increasing Bio-Stimulants
https://finance.yahoo.com/news/icl-lavie-bio-leverage-artificial-120000358.html
More than one dozen novel microbes identified for row crops suffering from extreme weather conditions
TEL AVIV and REHOVOT, Israel, July 17, 2024 /PRNewswire/ -- ICL (NYSE: ICL) (TASE: ICL), a leading global specialty minerals company, and Lavie Bio Ltd., a leading ag-biologicals company and subsidiary of Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN), today announced a significant milestone in their collaboration to develop bio-stimulant solutions for key row crops facing various abiotic stresses. By leveraging artificial intelligence (AI), Lavie Bio has computationally identified more than a dozen novel microbial candidates believed to have commercial viability as bio-stimulants for crops grown under extreme weather conditions, including drought. While this process can normally take several years, the collaboration achieved success within its first 12 months – thanks to Lavie Bio's proprietary Biology Driven Design (BDD) technology platform.
The ambitious AI-driven program, jointly developed by ICL and Lavie Bio, has identified novel microbe-based biological solutions that, when combined with fertilizers, are expected to be a game changer in overcoming various abiotic stresses under different weather conditions. By focusing on bio-stimulants that enhance crop resilience to such conditions, the collaboration has aimed to deliver tangible benefits to farmers, including a 5% to 10% increase in yield, on average.
As part of this AI-driven achievement, more than a dozen novel microbe candidates, which met the product requirements for efficacy, stability, shelf life and fertilizer compatibility, were computationally identified and verified in multiple greenhouse trials. The microbes were discovered and validated using Lavie Bio's BDD technology platform, powered by Evogene's MicroBoost AI tech-engine, and achieved a remarkable prediction rate from computer modelling to greenhouse validation – a rate ten times higher than the industry standard, according to company estimates.
This success paves the way for field trials in both the U.S. and Brazil in the second half of 2024, with results available by year-end. Lavie Bio will continue to leverage AI to drive product development and optimization, while ICL will guide the development and lead the way to product commercialization. The parties aim to start the regulatory process in 2026, just three years from program initiation.
"We are pleased to collaborate with Lavie Bio in the search for a novel solution to address a significant and proven market need in regions strategic to ICL," said Dr. Elinor Erez, vice president of R&D for ICL Growing Solutions. "This partnership exemplifies our commitment to pioneering advanced and unique biostimulant solutions for our customers, which aligns with our strategic vision to lead in agricultural innovation and sustainability and ensuring food security. The discovery process yielded candidate microbes that were validated in the green house, thanks to Lavie Bio's exceptional capabilities and their structured and efficient discovery platform. We are excited to move forward to field trials and are confident any future novel product will revolutionize how the agricultural community approaches plant resilience and productivity."
"We are very proud of the collaborations' significant progress, which was achieved by leveraging artificial intelligence to drive rapid advancements in our research," said Amit Noam, CEO of Lavie Bio. "Using ICL's deep agricultural expertise has been essential in focusing Lavie Bio's discovery efforts and has enabled us to advance to field trials in multiple target geographies quickly. Our team did a remarkable job of pushing our discovery process and platform to new heights, continuously improving computational accuracy and reducing both the time and cost to market for our novel products."
Recent research underscores the economic impact of climate change on global row crops, with extreme weather events, like droughts and floods, potentially causing billions in annual losses. Reports from the World Economic Forum and World Meteorological Organization highlight the rising costs, noting that extreme weather and climate-related disasters resulted in $4.3 trillion in losses from 1970 to 2021.[1][2][3] The agricultural sector urges the adoption of resilient strategies, technological innovations, and policy interventions to safeguard food security and mitigate economic vulnerabilities.
About ICL
ICL Group is a leading global specialty minerals company, which creates impactful solutions for humanity's sustainability challenges in the food, agriculture and industrial markets. ICL leverages its unique bromine, potash and phosphate resources, its global professional workforce, and its sustainability focused R&D and technological innovation capabilities, to drive the company's growth across its end markets. ICL shares are dual listed on the New York Stock Exchange and the Tel Aviv Stock Exchange (NYSE and TASE: ICL). The company employs more than 12,000 people worldwide, and its 2023 revenues totaled approximately $7.5 billion.
For more information, visit ICL's website at icl-group.com.
To access ICL's interactive CSR report, visit icl-group-sustainability.com.
Join Can-Fite’s Exclusive Live Investor Webinar and Q&A Session on August 8
https://finance.yahoo.com/news/join-fite-exclusive-live-investor-110000511.html
RAMAT GAN, Israel, July 17, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, invites investors to a webinar on August 8, 2024, at 4:15 p.m. ET.
The exclusive event, hosted by RedChip Companies, will feature Can-Fite Chief Executive Officer Motti Farbstein and Executive Chairperson and Chief Scientific Officer Dr. Pnina Fishman, who will share insight into the Company’s current development pipeline and upcoming milestones. Strategically positioned with multiple out-licensing deals and potential milestone payments totaling over $130 million, Can-Fite has already received $20 million in upfront and milestone payments, underscoring the potential of its therapies. With advanced-stage assets, Can-Fite is targeting unmet medical needs in markets with a combined value in excess of $70 billion.
To register for the free webinar, please visit: https://redchip.zoom.us/webinar/register/WN_thDEQfqTRGyltKan2_GS2w#/registration
Questions can be pre-submitted to CANF@redchip.com or online during the live event.
MediWound Announces €16.25 Million Funding from the European Innovation Council Accelerator Program
https://finance.yahoo.com/news/mediwound-announces-16-25-million-113000453.html
Funds to be used for clinical development of EscharEx® to treat diabetic foot ulcers (DFUs)
Award advances MediWound’s DFU program and its future revenues four years ahead of original schedule
YAVNE, Israel, July 16, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, announced today it has been selected to receive €16.25 million in blended funding from the European Innovation Council (EIC) through its accelerator program. The funding will significantly advance the Company’s EscharEx development program for patients with diabetic foot ulcers (DFUs). Pending FDA and EMA approval, the funding will enable the Company to expedite the market introduction of this innovative biologic by four years, well ahead of MediWound’s original schedule.
The EIC Accelerator offers grants and equity investments to support innovative, game-changing products. In addition to financial support, selected projects benefit from a range of business acceleration services that provide access to global experts, businesses, investors and ecosystem players. The funding package includes a €2.5 million grant and an investment, with terms to be finalized between the Company and the EIC.
"We are honored to be selected for this prestigious and highly competitive program," stated Ofer Gonen, Chief Executive Officer of MediWound. "The EIC's support recognizes EscharEx's potential to profoundly impact patients, especially those living with the significant challenges of DFUs. This funding will enable MediWound to develop EscharEx for DFU in parallel with our advanced program for treating venous leg ulcers (VLUs), substantially increasing the overall market."
With 70% of DFU patients requiring debridement, EscharEx addresses a staggering market of up to 34 million diabetic patients (US and Europe) who are at risk of developing a DFU in their lifetime. If not properly treated, DFUs can lead to serious complications including amputations, infections and death. Accelerating this program will have a revolutionary impact on the future DFU treatment for the millions of patients in this underserved population.
For more information about the EIC Accelerator, visit https://eic.ec.europa.eu/eic-funding-opportunities/eic-accelerator_en.
Funnily enough, share price has not
declined too steeply:
20.41 -0.75 (-3.54%)
At close: July 15 at 4:00 PM EDT
FORM 6-K
Amendment to Settlement Agreement with Teva
On July 15, 2024, MediWound Ltd. (the “Company”) and Teva Pharmaceutical Industries Ltd. (“Teva”) entered into Amendment No. 2 (the “Amendment”) to the settlement agreement and mutual general release, dated March 24, 2019, as previously amended by Amendment No. 1, dated December 13, 2020, by and between the Company and Teva (the “Agreement”). Under the terms of the Amendment, the Company will prepay Teva US$4 million as the final payment due from the Company under the Agreement, with 50% of such prepayment in cash and 50% in the form of ordinary shares of the Company to be issued by the Company to Teva, all in accordance with the terms and timeframe specified in the Amendment.
0.7600 +0.0463 (+6.49%)
At close: July 15 at 4:00 PM EDT
0.7700 +0.01 (+1.32%)
After hours: 7:54 PM EDT
On the right tracks?
Will not be sold soon: Mediwound raises 25 million dollars
The fundraising was led by the Swedish Molenlik and at a discount of 19% on the share price this morning
• The fundraising currently postpones a possible purchase of the company, but the agreement does not block the possibility of its existence in the future •
Mediwoundd is the most significant holding of Clal Biotechnology whose stock has increased by 23% thanks to Mediwound in the past year.
Mölnlycke® Health Care announces US $15m investment in next-generation enzymatic therapeutics company MediWound Ltd
https://finance.yahoo.com/news/m-lnlycke-health-care-announces-113800644.html
GOTHENBURG, Sweden, July 15, 2024 /PRNewswire/ -- Mölnlycke Health Care, a world-leading MedTech company specialising in solutions for wound care and surgical procedures, announced today an investment of US $15m in MediWound Ltd. (Nasdaq: MDWD) (MediWound) through a definitive share purchase agreement in a private investment in public equity (PIPE). MediWound, a global leader in next-generation enzymatic therapeutics focused on non-surgical wound debridement, has a vision to improve the existing standards of care and patient experiences, while reducing costs and unnecessary surgeries.
Debridement is a standard of care step to prepare the wound bed for healing and can help in the management of infection. It involves the removal of dead or devitalised tissue from a wound.
"We are very excited to make this strategic investment in MediWound. It aligns with our strategy to bring radical innovations into the wound care space and provide alternative solutions to the more traditional debridement options to improve clinical outcomes and patient experience," said Zlatko Rihter, CEO of Mölnlycke. "This investment will support Mölnlycke's Wound Care mission to 'help free patients from the burden of wounds' and I look forward to this partnership."
Mölnlycke and MediWound have also entered into a collaboration agreement to strengthen their partnership. Under the key terms of this agreement, Mölnlycke is granted specific rights, including having a representative attend meetings of MediWound's R&D Committee and will also be able to participate in potential strategic partnership discussions and M&A processes under certain circumstances.
"We are delighted to have Mölnlycke's support. This substantial investment will empower us to strengthen our strategic plans, creating significant long-term value for our stakeholders and help to improve standards of care for patients" said Ofer Gonen, CEO of MediWound.
For more information, please conatct:
Jennifer Doak
Global Communications Director Wound Care
Email: jennifer.doak@molnlycke.com
Phone: +1 678 206 6179
Ellie Hanson
FINN Partners for MediWound
Email: ellie.hanson@finnpartners.com
Phone: +1 929 588 2008
This information was brought to you by Cision http://news.cision.com.
https://news.cision.com/molnlycke/r/molnlycke--health-care-announces-us--15m-investment-in-next-generation-enzymatic-therapeutics-compan,c4015001
MediWound Announces $25 Million Strategic Private Placement Financing
https://finance.yahoo.com/news/mediwound-announces-25-million-strategic-110000594.html
Mölnlycke Health Care, a global leader in innovative wound care solutions, leads the PIPE with a $15 million investment
YAVNE, Israel, July 15, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the world leader in next-generation enzymatic therapeutics for tissue repair, today announced it has entered into a definitive share purchase agreement with several new and existing investors, including Mölnlycke Health Care ("Mölnlycke"), a world-leading MedTech company specializing in solutions for wound care and surgical procedures.
The agreement includes the sale and purchase of 1,453,488 shares of the Company’s ordinary shares, each with a par value NIS 0.07 (the “Ordinary Shares”), in a private investment in public equity (the “PIPE Offering”). The purchase price is set at $17.20 per share. The gross proceeds from the PIPE Offering are $25 million. MediWound plans to use the net proceeds to advance EscharEx pre-commercial activities, expedite the development of large-scale manufacturing capabilities specifically for EscharEx, and support general corporate purposes. The PIPE Offering is expected to close within several days, subject to satisfaction of customary closing conditions.
“We are proud to have the strong support of Mölnlycke, and of our new and existing investors in this financing,” said Ofer Gonen, Chief Executive Officer of MediWound. “This significant investment will enable us to further strengthen our strategic plans for EscharEx, creating substantial long-term value for our stakeholders and help improve the standard of care for patients.”
“We are very excited to make this strategic investment in MediWound. It aligns with our strategy to bring radical innovations into the wound care space and provide alternative solutions to the more traditional debridement options to improve clinical outcomes and patient experience,” said Zlatko Rihter, CEO of Mölnlycke. “This investment, coupled with the initiation of the EscharEx Phase III clinical trial, positions both companies for a successful future partnership.”
Concurrently with the PIPE Offering, MediWound and Mölnlycke entered into a collaboration agreement to strengthen their partnership (the "Collaboration Agreement"). Under the key terms of this agreement, Mölnlycke is granted specific rights, including a representative to attend meetings of the Company's R&D Committee. Additionally, Mölnlycke will be able to participate in potential strategic partnership discussions and M&A processes under certain circumstances. The Collaboration Agreement also contains a stand-still clause that limits Mölnlycke's ownership to no more than 9.99% of the Company's issued and outstanding Ordinary Shares.
The Company also entered into a registration rights agreement with several investors named in the Share Purchase Agreement (the “Registration Rights Agreement”), providing them with customary registration rights in connection with the Ordinary Shares.
The Ordinary Shares being sold to investors in the PIPE Offering are being offered and sold in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any other applicable state securities laws. Accordingly, those securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to the Registration Rights Agreement, the Company has agreed to file a registration statement with the SEC registering the resale of the Ordinary Shares issued in the PIPE Offering.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these Company securities, nor shall there be any sale of these Company securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
So far your prediction:
0.7137 +0.0610 (+9.35%)
At close: July 12 at 4:00 PM EDT
0.7149 +0.00 (+0.17%)
After hours: 7:39 PM EDT
Can-Fite Applies for FDA Orphan Drug Designation for Namodenoson in the Treatment of Pancreatic Cancer
https://finance.yahoo.com/news/fite-applies-fda-orphan-drug-110000546.html
PETACH TIKVA, Israel, July 11, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for its drug candidate Namodenoson in the treatment of pancreatic carcinoma.
An orphan drug is defined in the 1984 amendments of the U.S. Orphan Drug Act (ODA) as a drug intended to treat a condition affecting fewer than 200,000 persons in the United States. Orphan designation qualifies the sponsor of the product for seven-year marketing exclusivity to the first sponsor obtaining FDA approval of a designated drug, a tax credit equal to 50% of clinical investigation expenses, exemption/waiver of the Prescription Drug User Fee Act (PDUFA) application filing fees, assistance in the drug development process, and Orphan Products Grant funding eligibility.1
Can-Fite plans to start shortly a Phase IIa clinical study that will be a multicenter open-label trial in patients with advanced pancreatic adenocarcinoma whose disease has progressed on at least first line therapy. The trial will evaluate the safety, clinical activity, and pharmacokinetics (PK) of Namodenoson in this population. All patients will receive oral Namodenoson 25 mg administered twice daily for consecutive 28-day cycles. Patients will be evaluated regularly for safety. Approximately 20 evaluable patients will be enrolled. The primary objective of this trial is to characterize the safety profile of Namodenoson and the secondary objective is to evaluate the clinical activity as determined by the Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), Progression-Free Survival (PFS), Disease Control Rate (DCR), Duration of Response (DoR), and Overall Survival (OS). Can-Fite has already been granted Orphan Drug Status for Namodenoson for the indication of advanced liver cancer by the FDA and also by the EMA.
“The Orphan Drug application for Namodenoson underscores the high unmet medical need for a safe and efficacious drug for this devastating disease," said Motti Farbstein, CEO of the Company. "This application further validates our belief that Namodenoson may potentially offer efficacy on top of the drug safety that has been already proved in other clinical indications. Upon marketing approval, receiving market exclusivity for Namodenoson would be significantly beneficial to Can-Fite.”
0.6185 +0.0406 (+7.03%)
As of 1:53 PM EDT. Market Open.
Volume 357,970
Avg. Volume 341,198
Something's up?
RedHill Biopharma Terminates License Agreement for Aemcolo®
https://finance.yahoo.com/news/redhill-biopharma-terminates-license-agreement-120000000.html
TEL-AVIV, Israel and RALEIGH, NC, July 9, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the mutual decision with Cosmo Technologies Ltd. ("Cosmo") to voluntary terminate their exclusive U.S. license agreement for Aemcolo, a treatment for traveler's diarrhea (the "License Agreement"). The License Agreement, initially dated October 17, 2019, will be officially terminated on October 8, 2024.
Per the terms of the License Agreement, RedHill will immediately cease any Aemcolo commercialization of Aemcolo upon termination of the License Agreement, at which point all rights previously ascribed in the License Agreement to RedHill will revert to Cosmo.
Rick Scruggs, RedHill's Chief Commercial Officer, said: "This decision to stop the commercialization of Aemcolo was made following careful mutual consideration and we would like to offer our sincere thanks to the Cosmo team for their partnership over the past years."
MediWound jumps on reports of $400m bid by Solventum
Ofer Gonen credit: Eran Lavi
7 Jul, 2024 16:20
Shiri Habib-Valdhorn
The Israeli company has developed a pineapple-plant based product for treatment of burns and wounds.
Israeli biopharmaceutical company MediWound (Nasdaq: MDWD) saw its share price jump 35% on Friday on Wall Street to $19.60, giving it a market cap of $182 million. At one point in trading on Friday, the share price was up 60%, after media reports that US company Solventum (NYSE: SOLV) had offered to acquire MediWound for $400 million, or $34 per share.
Last year MediWound, which has developed a pineapple-plant based product for treatment of burns and wounds, almost doubled its market cap. Even so its share price is well below its peak in 2021.
MediWound, which is managed by CEO Ofer Gonen, has made no official comments on the reports of Solventum's offer but market sources believe that any negotiations are still in their early stages and no deal is yet on the table.
Published by Globes, Israel business news - en.globes.co.il - on July 7, 2024.
The trial showed absolute superiority of Medivand's product over Santyl in terms of the percentage of cases that reached complete wound healing during the first two weeks of treatment (63% vs. 0%); The median time for complete healing of the wound (nine days compared to not reaching complete healing in the two weeks of treatment); and complete closure of the wound (50% compared to 0% for Santyl).
These results in themselves placed Medivend in a good position to become the leading product in the market - and the company's situation was further improved two months later. The CMS, the American federal agency that manages the insurance coverage policy of the American state health insurance companies Medicaid and Medicare, has published a hearing on the background of its intention to make a fundamental change in the insurance coverage policy for skin graft products - which are intended for the treatment of diabetic wounds and wounds that are difficult to heal. This is to ensure that the federal insurance companies will not waste their money on products that did not show evidence of therapeutic effectiveness within four treatments and for a maximum of 12 weeks.
If the intention becomes policy, 85 out of 100 preparations will be removed from the market, mainly those based on tissue transplantation for the treatment of diabetic wounds and wounds caused by venous insufficiency.
In this situation, Askerx - which is expected to receive insurance coverage based on the price of the market-leading product Santyl, and assuming that it will successfully pass the clinical trial, in which 216 patients will participate in the third and decisive phase - will become an even more attractive asset for wound care companies, and with it Medivand. This, assuming that these companies will lose the solution they had for this market, following the policy change.
Among those companies is the Danish Coloplast, which has lost $2.9 billion of its value since the end of April - among other things, because less than a year ago it purchased the Icelandic company Kerecis for $1.2 billion, whose product lost the insurance coverage it had until now.
Ofer Gonen, CEO of Medivand, said in response: "The company's policy is not to respond to rumors. We are focused on building a long-term future for Medivend and ensuring the supply of essential medicines to millions of patients around the world. We have Nexobride, a drug for severe burns that saves lives, and we see its importance, especially in the difficult days since October 7. In addition, we have Ascarax, a chronic wound healing drug that is in advanced development. It is the only drug in the world that threatens Santyl's dominance
Medivend, which developed a product for healing wounds, became an attractive target for acquisition
A successful trial of the flagship product that showed superiority over the leading product for healing chronic wounds, fundamental changes in insurance policy in the US and the product's success in treating the burns of the war-wounded in Gaza - all of these made Medivand an attractive asset for wound healing companies ¦ The American Solventum is interested in purchasing Medivand at a premium of 118% at its current price
Ofer Gonen, CEO of Medivand: "The company's policy is not to respond to rumors" Photo: Eran
July 4, 2024
The Medivend company recently received an application for its purchase from the Solventum company (Solventum) according to a company value of 400 million dollars. This value reflects a price of $34 per fully diluted Mediwind share.
The appeal sparked internal disputes in the company: on the one hand, board members who prefer to wait for the results of the third and decisive clinical trial of the company's main product, and believe that the proposal does not reflect the company's economic value; On the other hand, factors in the company's management who believe that it would be a mistake to ignore the risk of failure in the trial or a delay in receiving marketing approval from the American Food and Drug Administration (FDA), and the fact that the deal reflects a premium of 118% compared to the current price of the stock and a premium of 370% compared to the low price of the stock in September 2023.
Solventum is a pharmaceutical and medical preparations company that was split in early April 2024 from the 3M industrial concern, which continues to own 19.9% ??of its shares. It trades at a value of 9 billion dollars, having lost 35% since it started trading.
Clal's Mediwind takes advantage of the momentum: raised $27 million in Nasdaq | Yoram Gavizon
Medivend received FDA approval for an innovative treatment for moderate to severe burns Yoram Gavizon
Medivand's stock, which develops preparations for the treatment of burns and chronic wounds using an enzyme extracted from the stem of the pineapple, has faltered for years following the disappointment of sales of NexoBrid, the product it developed for the debridement (removal of the dead tissue) of moderate to severe burns, and the marketing agreement for the product in the US, that the company signed with Vericel in 2019.
In the last few months Medivand recovered and completed a 116% increase to a value of 147 million dollars. The improvement is due to several main events. The first is the war against Hamas, which proved the effectiveness of Nexobride in treating severe burns of civilians who were hit by the Hamas attack on October 7. The effectiveness of Nexobride was also proven in the treatment of fighters who suffered severe burns in the battles in Gaza, and in some cases there was fear for their lives.
Prof. Yosef Chaik, Director of the Department of Plastic Surgery and Head of the National Center for Intensive Care of Burns, explained that the accepted assessment is that a person's chances of dying from burns in a multi-casualty incident and in war is a combination of his age and the extent of the burn. That is, a 30-year-old patient with burns on 40% of his body surface has a 70% chance of dying from his wounds.
According to him, the Nexobride treatment - a non-surgical alternative to removing the dead tissue with a special knife - saves blood doses and an operating room, which is a resource in short supply especially in war; and shortens the hospitalization and recovery time.
Hayek noted that the Ministry of Health purchased large quantities of the preparation from Medivend already on October 8 for the benefit of the hospitals, according to his recommendation as the chairman of the Israeli Association for Plastic and Aesthetic Surgery, and with the help of Medivend, which diverted most of its production in favor of the Israeli health system.
Approved for marketing in more than 44 countries
One of the company's employees experienced firsthand - almost literally - the effectiveness of Nexobride. His son is an armor fighter, who was injured in early April fighting in Gaza along with three of his friends, as a result of a shell igniting in a tank. He suffered 40% burns. The son was treated with Nexobride, which has become the hospital's standard of care, and shows a good recovery which is reflected in the fact that he did not need a skin graft, and his scarring is relatively good - that is, there are no bubbles and no lifting of the scar area. Israel is not the only country that discovered Nexobrid - the product has been approved for marketing in 44 countries.
As part of the phenomenon of the renewed preparation of countries following the Ukraine war, Medivend reported in a presentation to investors that global demand exceeds three times its production capacity. Medivand is currently investing in increasing the production capacity at its factory in Yavne sixfold. The company estimated that sales of the product would grow at an annual rate of 40%, from $19 million in 2023 (65% of this amount to the US Department of Defense) to $39 million in 2026.
However, Nexobride is probably not the product for which Medivand receives inquiries from multinational companies in the field of wound medicine such as Solventum, Coloplast, Convatec, Integra and Molnlycke.
Not just burns
Medivend is developing another product based on the same enzyme, albeit at a different concentration. This is Escharex, which is intended for the lubrication of chronic and difficult-to-heal wounds - for example, wounds on the feet of diabetic patients and wounds due to venous insufficiency. This product addresses a much larger market—$2 billion in the US—and should challenge the dominance of Smith & Nephew's Santyl product, whose sales are $360 million per year.
Medivand published the results of the phase II clinical trial in February, which included a head-to-head comparison of the effectiveness of Ascarax with Santyl, which is an enzyme-based gel.
The experiment showed absolute superiority of Medivend's product
Medivend, which developed a product for healing wounds, became an attractive target for acquisition
A successful trial of the flagship product that showed superiority over the leading product for healing chronic wounds, fundamental changes in insurance policy in the US and the product's success in treating the burns of the war-wounded in Gaza - all of these made Medivand an attractive asset for wound healing companies ¦ The American Solventum is interested in purchasing Medivand at a premium of 118% at its current price
Ofer Gonen, CEO of Medivand: "The company's policy is not to respond to rumors"
July 4, 2024
The Medivend company recently received an application for its purchase from the Solventum company (Solventum) according to a company value of 400 million dollars. This value reflects a price of $34 per fully diluted Mediwind share.
The appeal sparked internal disputes in the company: on the one hand, board members who prefer to wait for the results of the third and decisive clinical trial of the company's main product, and believe that the proposal does not reflect the company's economic value; On the other hand, factors in the company's management who believe that it would be a mistake to ignore the risk of failure in the trial or a delay in receiving marketing approval from the American Food and Drug Administration (FDA), and the fact that the deal reflects a premium of 118% compared to the current price of the stock and a premium of 370% compared to the low price of the stock in September 2023.
Solventum is a pharmaceutical and medical preparations company that was split in early April 2024 from the 3M industrial concern, which continues to own 19.9% ??of its shares. It trades at a value of 9 billion dollars, having lost 35% since it started trading.
Clal's Mediwind takes advantage of the momentum: raised $27 million in Nasdaq | Yoram Gavizon
Medivend received FDA approval for an innovative treatment for moderate to severe burns Yoram Gavizon
Medivand's stock, which develops preparations for the treatment of burns and chronic wounds using an enzyme extracted from the stem of the pineapple, has faltered for years following the disappointment of sales of NexoBrid, the product it developed for the debridement (removal of the dead tissue) of moderate to severe burns, and the marketing agreement for the product in the US, that the company signed with Vericel in 2019.
In the last few months Medivand recovered and completed a 116% increase to a value of 147 million dollars. The improvement is due to several main events. The first is the war against Hamas, which proved the effectiveness of Nexobride in treating severe burns of civilians who were hit by the Hamas attack on October 7. The effectiveness of Nexobride was also proven in the treatment of fighters who suffered severe burns in the battles in Gaza, and in some cases there was fear for their lives.
Prof. Yosef Chaik, Director of the Department of Plastic Surgery and Head of the National Center for Intensive Care of Burns, explained that the accepted assessment is that a person's chances of dying from burns in a multi-casualty incident and in war is a combination of his age and the extent of the burn. That is, a 30-year-old patient with burns on 40% of his body surface has a 70% chance of dying from his wounds.
According to him, the Nexobride treatment - a non-surgical alternative to removing the dead tissue with a special knife - saves blood doses and an operating room, which is a resource in short supply especially in war; and shortens the hospitalization and recovery time.
Hayek noted that the Ministry of Health purchased large quantities of the preparation from Medivend already on October 8 for the benefit of the hospitals, according to his recommendation as the chairman of the Israeli Association for Plastic and Aesthetic Surgery, and with the help of Medivend, which diverted most of its production in favor of the Israeli health system.
Approved for marketing in more than 44 countries
One of the company's employees experienced firsthand - almost literally - the effectiveness of Nexobride. His son is an armor fighter, who was injured in early April fighting in Gaza along with three of his friends, as a result of a shell igniting in a tank. He suffered 40% burns. The son was treated with Nexobride, which has become the hospital's standard of care, and shows a good recovery which is reflected in the fact that he did not need a skin graft, and his scarring is relatively good - that is, there are no bubbles and no lifting of the scar area. Israel is not the only country that discovered Nexobrid - the product has been approved for marketing in 44 countries.
As part of the phenomenon of the renewed preparation of countries following the Ukraine war, Medivend reported in a presentation to investors that global demand exceeds three times its production capacity. Medivand is currently investing in increasing the production capacity at its factory in Yavne sixfold. The company estimated that sales of the product would grow at an annual rate of 40%, from $19 million in 2023 (65% of this amount to the US Department of Defense) to $39 million in 2026.
However, Nexobride is probably not the product for which Medivand receives inquiries from multinational companies in the field of wound medicine such as Solventum, Coloplast, Convatec, Integra and Molnlycke.
Not just burns
Medivend is developing another product based on the same enzyme, albeit at a different concentration. This is Escharex, which is intended for the lubrication of chronic and difficult-to-heal wounds - for example, wounds on the feet of diabetic patients and wounds due to venous insufficiency. This product addresses a much larger market—$2 billion in the US—and should challenge the dominance of Smith & Nephew's Santyl product, whose sales are $360 million per year.
Medivand published the results of the phase II clinical trial in February, which included a head-to-head comparison of the effectiveness of Ascarax with Santyl, which is an enzyme-based gel.
The experiment showed absolute superiority of Medivend's product
This is company's CEO comment in Goog auto translation:
Yoram Gavizon - A reputable reporter for the financial newspaper
https://www-themarker-com.translate.goog/markets/2024-07-04/ty-article/.premium/00000190-7990-db4b-ab98-7ddee62e0000?_x_tr_sl=iw&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=wapp&_x_tr_hist=true
Mediwound which developed a product for healing wounds, became an attractive target for acquisition
A successful trial of the flagship product that showed superiority over the leading product for healing chronic wounds, fundamental changes in insurance policy in the US and the product's success in treating the burns of the war-wounded in Gaza - all of these made Mediwound an attractive asset for wound healing companies ¦ The American Solventum is interested in acquiring Mediwound at a premium of 118% at its current price
TheMarker is an Israeli financial newspaper:
https://www.themarker.com/markets/2024-07-04/ty-article/.premium/00000190-7990-db4b-ab98-7ddee62e0000
Yes it does:
Vericel Enters into Exclusive License Agreement with MediWound for North American Rights to
NexoBrid, a Biological Orphan Product for Debridement of Severe Thermal Burns
May 7, 2019 at 1:59 AM EDT
MediWound jumps amid report of $34 a
share takeover offer from Solventum
BLRX - A sad sight to see.
Does anybody see any possibility of recovery?
Comments appreciated.
Tia.
Improvement in Patient with Decompensated Liver Cirrhosis Upon Treatment with Namodenoson
Can-Fite BioPharma Ltd.
Liver cirrhosis treatment global market is estimated to reach $29.2 billion by 2030
Ramat Gan, Israel, July 01, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, announced today that a patient with liver decompensated cirrhosis who was treated with Namodenoson at the Soroka Medical Center in Israel under compassionate use showed an improvement in liver indices. This drug candidate is currently used in a pivotal Phase III study for patients with advanced liver cancer and a Phase IIb study for MASH (metabolic dysfunction-associated steatohepatitis).
Decompensated cirrhosis is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage. While some drugs can treat symptoms, there is no therapeutic approach that has shown efficacy in slowing disease progression.
In the past year Can-Fite has initiated a compassionate use program at the Soroka Medical Center, Beersheva, Israel, for the treatment of decompensated patients with Namodenoson. The first patient, a 63-year-old female with a history of decompensated primary biliary cirrhosis is now treated for one year with Namodenoson. Prior to the treatment with Namodenoson and despite best medical care for her underlying disease, she developed ascites and was admitted to the hospital with acute variceal bleeding. Currently, the patient shows improvement in liver function tests hematological parameters and FibroScan values and has not experienced any event of decompensation since starting treatment with Namodenoson. Namodenoson is known to induce liver protective effects in other liver pathologies, and Phase IIa data in patients suffering from MASH (metabolic dysfunction-associated steatohepatitis), responded positively to the drug, showing anti-inflammatory, anti-steatotic, and antifibrotic effects with a very favorable safety profile.
Ohad Etzion, MD, Director, Department of Gastroenterology and Liver Diseases at the Soroka Medical Center, Beer Sheva, Israel, the Investigator and Initiator of this study commented, “We were very much encouraged by the response of the first patient with decompensated liver cirrhosis who showed a rapid and sustained response to the drug with an improvement with liver indices. We plan to treat more patients and hopefully see an improvement of liver function in this devastating disease.
Decompensated cirrhosis is defined as an acute deterioration in liver function, with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage. While some drugs can treat symptoms, there is no therapeutic approach that has shown efficacy in slowing disease progression. An estimated 10.6 million people globally had decompensated cirrhosis in 2017, with few treatment options available aside from liver transplants if the decompensated cirrhosis has reached an advanced stage. Underscoring the need for an effective treatment, the American Liver Foundation states there are more people who need a liver than supply available, and some people can be on the wait list for a liver transplant for more than 5 years. The treatment of liver cirrhosis globally is estimated to become an approximately $29.2 billion market by 2031.
Positive Results from Osteoarthritis Clinical Study in Dogs Reported by Can-Fite’s Partner Vetbiolix
https://finance.yahoo.com/news/positive-results-osteoarthritis-clinical-study-
The canine osteoarthritis market is projected to reach $3 billion by 2028
RAMAT GAN, Israel, June 28, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that its veterinary partner Vetbiolix reported positive results in an osteoarthritis multicenter clinical study in dogs treated with Piclidenoson. Vetbiolix, Can-Fite’s veterinary commercialization partner which is covering all costs associated with veterinary clinical development, concluded successfully the study interim analysis.
After Piclidenoson proved efficacious, Vetbiolix can exercise the option to enter into a full in license agreement with Can-Fite and be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval.
The study looked at the effect of 90 days treatment with Piclidenoson at 100 µg/kg and 500 µg/kg twice daily orally in dog patients with osteoarthritis. The primary objective was the Liverpool OsteoArthritis in Dogs (LOAD) questionnaire for the assessment of symptoms severity evaluated on dog’s mobility. The secondary objectives included Visual Analog Scale (VAS) for pain assessment by pet parents and Numerical Rating Score (NRS) for (i) lameness and (ii) pain assessment by the veterinarian. The study reached the primary and secondary end points with a dose and time dependent inhibitory effect of piclidenoson on LOAD and VAS and NRS, demonstrating significant improvement in clinical status and decrease in pain in the 500 µg/kg dose.
The canine osteoarthritis market is projected to reach $3 billion by 2028.
There is a clear need in the market for a safe and effective canine osteoarthritis drug. Current treatments for canine osteoarthritis include oral non-steroidal anti-inflammatory drugs (NSAIDs) which only treat symptoms and carry significant harmful side effects and an injectable disease-modifying osteoarthritis drug (DMOAD) that targets the progression of the disease.
"We are very much encouraged by the positive results in the osteoarthritis dog clinical study and hope Piclidenoson can be used as an efficacious drug with this unmet clinical indication," stated Can-Fite CSO Dr. Pnina Fishman. "This veterinary indication offers Can-Fite the opportunity to get Piclidenoson onto the market faster to benefit canines, while also potentially contributing near-term revenues. We are very pleased to work productively with the team at Vetbiolix."
About Piclidenoson
Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with an excellent safety and efficacy profile demonstrated in a Phase III clinical study in psoriasis. The drug’s mechanism of action entails inhibition of the inflammatory cytokines interleukin 17 and 23 (IL-17 and IL-23) and the induction of apoptosis of patients’ skin cell keratinocytes involved with the disease pathogenicity.
Can-Fite: Breakthrough Findings Demonstrate Namodenoson Anti-cancer and Protective Effect Mechanism in the Liver
https://finance.yahoo.com/news/fite-breakthrough-findings-demonstrate-namodenoson-110000011.html
PETACH TIKVA, Israel, June 24, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announces that company scientists came up with breakthrough findings showing that the anti-cancer and protective effects in the liver are conferred via the signalling protein adiponectin. This very important positive cytokine plays a pivotal role in regulating anti-inflammatory, anti-cancer, metabolic and insulin resistance. Namodenoson increases adiponectin production in pre-clinical studies and in humans.
The data will be presented at the 20th Annual Congress of International Drug Discovery Science & Technology, China Branch (IDDST-2024), September 12-14, Shanghai, China. This conference will host 300 leading scientists from the academia and industry worldwide to discuss the latest developments in drug discovery and therapy.
"We are very much enthused by the breakthrough findings that explain the dual mechanism of Namodenoson working as an anti-cancer agent in the liver and also inducing a liver protective effect," stated Dr. Pnina Fishman, Can-Fite CSO & Chairperson.
Namodenoson is currently being evaluated in LiverationTM, a pivotal Phase III study for advanced liver cancer that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and also in a Phase IIb study in patients with MASH.
Form 6-K - Report of foreign issuer
On June 16, 2024, Biokine Therapeutics Ltd. (“Biokine”), filed a complaint with the District Court of Jerusalem against BioLineRx Ltd. (the “Company”), entitled Biokine Therapeutics Ltd. v. BioLineRx Ltd., T.A. 31677-06-24. The complaint alleges breach of contract and a purported failure to make certain payments to Biokine under the Company’s in-licensing agreement with Biokine for motixafortide. The lawsuit seeks compensatory damages in the amount of approximately $6.5 million and a declaratory judgment in favor of Biokine. The Company intends to vigorously defend itself against such action.
Another example:
GeoVax Receives BARDA Project NextGen Award to Conduct Phase 2b Clinical Study Evaluating the Company's Next-Generation COVID-19 Vaccine Candidate, GEO-CM04S1
https://finance.yahoo.com/news/geovax-receives-barda-project-nextgen-110000120.html
The direct award to GeoVax of approximately $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made separate awards through its Clinical Studies Network to support execution of the study. That funding will represent approximately $343M from the Project NextGen program for a CRO to execute the clinical trial using GeoVax's vaccine.
Compugen to Present at Upcoming Antibody Industrial Symposium
https://finance.yahoo.com/news/compugen-present-upcoming-antibody-industrial-110000879.html
HOLON, Israel, June 17, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that Pierre Ferré, Ph.D, SVP, Preclinical Development and Corporate Operations, Compugen will present a case study on clinical dose selection for TIGIT monospecific and bispecific antibodies at the Antibody Industrial Symposium taking place June 20-21, 2024, Montpellier, France.
Event: 12th Antibody Industrial Symposium, Montpellier, France
Date: Friday, June 21, 2024
Presenter: Pierre Ferré, Ph.D., SVP, Preclinical Development and Corporate Operations, Compugen
Presentation title: Case study on clinical dose selection for TIGIT monospecific and bispecific antibodies
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Momentum continues, I wonder what's up.
BioLineRx (NASDAQ:BLRX) is a company attempting to commercialize therapeutics for the treatment of various cancers and rare diseases including sickle cell disease. The company’s recent announcements around those projects deserve particular attention and make the stock attractive.
BioLineRx truly does look like a biotech stock that’s about to move much higher. Interested investors should read this recent portfolio update from May 28. The company’s FDA-approved multiple myeloma treatment, Aphexda, is growing steadily in its first full quarter of post-approval adoption.
The drug is quickly making its way into the network of transplant centers and is placed at 26% of all institutions in the U.S. currently. BioLineRx expects that number to rise to 35% by the end of the second quarter and could rise to 60% by the end of the year.
The biotech is currently running at a slight net loss of $0.7 million but benefits from continued progress in clinical trials relating to other diseases including sickle cell disease. In short, there seem to be multiple reasons to bet on BLRX stock at the moment.
https://finance.yahoo.com/news/millionaire-makers-7-stocks-buy-191700533.html
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Something's Cooking!