midastouch017
4年前
Sol-Gel Technologies Provides Update on FDA Review of EPSOLAY®
https://finance.yahoo.com/news/sol-gel-technologies-provides-fda-140200390.html
NESS ZIONA, Israel, April 27, 2021 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced an update regarding the U.S. Food and Drug Administration (FDA) approval process for EPSOLAY® (benzoyl peroxide) 5% topical cream for the treatment of Inflammatory lesions of rosacea in adults.
In September of 2020, Sol-Gel was informed by the FDA that the PDUFA goal date for EPSOLAY is April 26, 2021. Subsequently, the COVID-19 pandemic restricted the FDA’s ability to conduct pre-approval inspections. In our most recent written communication with the FDA regarding EPSOLAY, the final content of the labeling was discussed and agreed to. As of today, Sol-Gel has received no notification from the FDA, but did receive email confirmation that that action on the NDA for EPSOLAY could not be taken since a pre-approval inspection of the production site of EPSOLAY still needs to be conducted.
The Company continues to follow-up with the FDA on the scheduling of this inspection.
midastouch017
5年前
Sol-Gel Technologies Reports First Quarter 2020 Financial Results and Corporate Update
GlobeNewswire GlobeNewswire•May 14, 2020
New Drug Applications for Epsolay® and Twyneo® remain on track for the second quarter and second half 2020, respectively
Completed a $23 million underwritten public offering in February with an additional $5 million investment from Sol-Gel’s controlling shareholder in April, providing cash runway into mid-2021 and funds pre-commercialization efforts for Epsolay and Twyneo
Top-line generic product revenue of $3.4 million in first quarter 2020
NESS ZIONA, Israel, May 14, 2020 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced financial results for the first quarter ended March 31, 2020 and provided an update on its clinical development programs.
“In the first quarter of 2020, we strengthened our balance sheet through a $23 million underwritten public offering in February and a subsequent $5 million private placement that closed just after the end of the first quarter. This capital from new and existing shareholders, including our controlling shareholder, M. Arkin Dermatology Ltd., extends our cash runway to mid-2021, and funds our pre-commercialization efforts for Epsolay and Twyneo,” commented Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “We remain on track to file our New Drug Application (NDA) for Epsolay with the FDA in the second quarter of this year and our NDA for Twyneo in the second half this year, both exciting milestones for the company.”
“I also want to acknowledge the efforts of our employees and the whole healthcare system in working to keep our community safe during the ongoing COVID-19 pandemic,” continued Dr. Seri-Levy. “At Sol-Gel, we have been fortunate to have seen only minimal impact to our operations to date, largely due to the advanced clinical status of our two lead programs, Epsolay and Twyneo.”
Corporate Highlights and Recent Developments
Strengthened balance sheet with $28.0 million in gross proceeds from the February underwritten public offering of $23.0 million and from the $5.0 million that Sol-Gel’s controlling shareholder, M. Arkin Dermatology Ltd., invested in April. Despite market conditions, the April purchase of ordinary shares and warrants was at the same terms as the February underwritten public offering, $11.00 per ordinary share and an accompanying warrant to purchase 0.80 of an ordinary share. The warrants have an initial exercise price of $14.00 per share, subject to certain adjustments, and will expire on February 19, 2023.
In the first quarter of 2020, Sol-Gel generated revenue of $3.4 million from its collaboration agreement with Perrigo.
In response to COVID-19, Sol-Gel immediately implemented policies and procedures to protect the health, safety and welfare of employees and their families and to help mitigate the spread of the coronavirus including mandatory work-from-home and frequent on-site sterilization.
Clinical Program Updates
Sol-Gel expects to file an NDA for Epsolay (encapsulated benzoyl peroxide, 5%, cream) in the second quarter of 2020. If approved, Epsolay has the potential to be the first FDA-approved single-agent BPO prescription drug product and to redefine the standard of care for the treatment of inflammatory lesions associated with rosacea.
Sol-Gel expects to file an NDA for Twyneo (encapsulated benzoyl peroxide, 3%, and encapsulated tretinoin, 0.1%, cream) in the second half of 2020. If approved, Twyneo has the potential to become a preferred treatment for acne.
In January, Sol-Gel announced positive topline results from an open-label long-term safety study of Epsolay. Of the 209 patients (57.6%) that completed 52 weeks of treatment with Epsolay, 153 (73.2%) reached “clear” or “almost clear”, 46 (22%) reached “mild” rosacea, only 10 (4.8%) had “moderate” rosacea, and none had “severe” rosacea on a Global Assessment (IGA) 5-point scale. Additionally, at the end of the study, more than 90% of these patients had “none” or “mild” cutaneous signs or symptoms (burning or stinging, itching, dryness and scaling) and no “severe” scores were recorded.
A proof of concept clinical study of SGT-210, erlotinib gel, a topical epidermal growth factor receptor inhibitor, for the potential treatment of punctuate palmoplantar keratoderma type 1 initiated in January 2020. This clinical study was recently expanded to include other types of palmoplantar keratoderma. Patient enrollment is expected to be renewed subject to Israel Ministry of Health guidelines for COVID-19. Data is expected in 2021.
In early 2020, Sol-Gel added to its pre-clinical pipeline tapinarof, an aryl hydrocarbon receptor agonist, and roflumilast, a PDE4 inhibitor, each to be developed for potential treatment of psoriasis, as mono or combination therapies and other dermatological indications. Sol-Gel continues to work to advance these assets into the clinic.
Financial Results for the Three Months ended March 31, 2020
Revenue in the first quarter 2020 was $3.5 million. The revenue was mainly due to sales of a generic product from the collaboration arrangement with Perrigo. The decrease in revenue from the previous quarter follows from continued generic competition.
Research and development expenses were $7.9 million in the first quarter of 2020 compared to $10.8 million during the same period in 2019. The decrease of $2.9 million was mainly attributed to a decrease of $2.6 million in clinical trial expenses, mainly related to clinical trials of Epsolay and a decrease of $0.5 million in manufacturing expenses of Epsolay and Twyneo, partially offset by an increase of $0.2 million in regulatory expenses, mainly related to preparing for the NDA submissions for Epsolay and Twyneo.
General and administrative expenses were $2.8 million in the first quarter of 2020 compared to $1.7 million during the same period in 2019. The increase of $1.1 million was mainly attributed to an increase of $1.0 million in commercialization expenses and an increase of $0.1 million in other expenses.
Sol-Gel reported a loss of $7.1 million for the first quarter of 2020 compared to loss of $5.7 million for the same period in 2019.
As of March 31, 2020, Sol-Gel had $20.4 million in cash, cash equivalents and deposits and $45.8 million in marketable securities for a total balance of $66.2 million, excluding the additional $5.0 million investment by Sol-Gel’s controlling shareholder which closed in April. Based on current assumptions, Sol-Gel expects its existing cash resources will enable funding of operational and capital expenditure requirements into mid-2021. As previously disclosed, Sol-Gel does not plan to raise additional dilutive capital to fund pre-commercialization activities for Epsolay and Twyneo.
About Sol-Gel Technologies
Sol-Gel is a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol-Gel leverages its proprietary microencapsulation technology platform for Twyneo, for the treatment of acne vulgaris, and Epsolay, for the treatment of papulopustular rosacea. The Company’s pipeline also includes SGT-210, an early-stage topical epidermal growth factor receptor inhibitor, erlotinib, for the treatment of punctate palmoplantar keratoderma, and preclinical assets tapinarof and roflumilast. For additional information, please visit www.sol-gel.com.
https://finance.yahoo.com/news/sol-gel-technologies-reports-first-110510585.html
midastouch017
5年前
Aquestive Therapeutics Inc. (AQST)
Next up is biotech Aquestive Therapeutics, which uses innovative drug delivery technology to redesign important medicines. With not one but two upcoming PDUFA dates, it’s not surprising that members of the Street think its $3.55 share price represents the ideal entry point.
Weighing in for H.C. Wainwright, five-star analyst Raghuram Selvaraju believes that the most valuable piece of the puzzle is its anti-seizure candidate, Libervant, the PDUFA date for which is slated for September 27. “We estimate that Libervant could generate U.S. sales approaching $300 million by 2030. Libervant has been accorded Orphan Drug status, which would confer seven-year market exclusivity upon the product if approved,” he explained.
Regarding Libervant’s launch, Selvaraju argues the fact that Sympazan (clobazam), an oral film for Lennox-Gastaut syndrome (LGS)-associated seizures, was launched prior to Libervant provides Aquestive with the opportunity to set up its commercial infrastructure.
It should also be noted that Selvaraju sees the recent share price weakness as not fully reflecting AQST’s value, with it boasting several other promising candidates in its pipeline. “In our view, the recent coronavirus crisis-driven market disruption has resulted in massively overdone attrition in Aquestive's share price. The company currently trades at a sub-$60 million market cap, which we believe does not reflect even the value of its manufacturing and licensing-related revenue, let alone revenue generated from its proprietary products,” he commented.
One of these candidates is APL-130277, which could be approved on May 21. On top of this, AQST-108 could enter clinical testing this year, and with the annual U.S. epinephrine product market potentially totaling $5.2 billion by 2026, according to Coherent Market Insights, Selvaraju highlights the large opportunity for the biotech.
As a result, Selvaraju reiterated a Buy rating and $13 price target. Should this target be met, a twelve-month gain of 266% could be in the cards. (To watch Selvaraju’s track record, click here)
Looking at the consensus breakdown, other analysts also see big things in store. With 100% Street support, the message is clear: AQST is a Strong Buy. The $17.33 average price target is more aggressive than Selvaraju’s and suggests 388% upside potential. (See Aquestive stock analysis on TipRanks)
https://finance.yahoo.com/news/3-biotech-stocks-under-4-115140896.html
Good luck Dorseye
midastouch017
5年前
Since i am staying at home, i have lots
of time doing research.
One of my largest holdings is GMDA
Gamida Cell Announces Completion of Patient Enrollment in Ongoing Phase 3 Clinical Study of Omidubicel
January 2, 2020 at 8:01 AM EST
PDF Version
– Topline data expected in first half of 2020 –
BOSTON--(BUSINESS WIRE)--Jan. 2, 2020-- Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases, announced that in December the company completed patient enrollment in its Phase 3 study of the company’s lead clinical program, omidubicel, an investigational advanced cell therapy being evaluated as a potential life-saving treatment option for patients with high-risk hematologic malignancies who are in need of a bone marrow transplant. Topline data from the study are expected in the first half of 2020.
“Completing patient recruitment for the Phase 3 study of omidubicel is a very significant milestone for our company,” stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. “Positive data would enable us to file our first biologics license application in the second half of 2020 and would represent an important step toward becoming a fully integrated company that can bring breakthrough medicines to patients.”
It is estimated that more than 40 percent of eligible patients in the U.S. do not receive a bone marrow transplant for various reasons, including inability to find a matched donor, despite its curative potential.1 Even for patients who do receive a transplant, the procedure is not always effective and can lead to serious complications that dramatically affect quality of life.2 Omidubicel is intended to address the current limitations of bone marrow transplant by providing a therapeutic dose of stem cells while preserving the cells’ functional therapeutic characteristics.
“For many patients with high-risk hematologic malignancies who are in remission, their only hope of remaining cancer-free is to undergo a bone marrow transplant. While the scientific community has made strides in improving bone marrow transplant, there is still a significant need to make this potentially curative treatment option available to more patients,” said Ronit Simantov, M.D., chief medical officer of Gamida Cell. “We truly appreciate the participation of patients and the support we have received from investigators who believe this clinical trial is critical for moving the field forward.”
The international, multi-center, randomized Phase 3 study (NCT02730299) is designed to evaluate the safety and efficacy of omidubicel compared to standard umbilical cord blood in patients with high-risk hematologic malignancies who need a bone marrow transplant and do not have an available matched donor. The primary endpoint is time to neutrophil engraftment. The study includes approximately 120 patients aged 12-65 with acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome or lymphoma. The study is taking place at over 50 clinical centers in the U.S., Latin America, Europe and Asia.
About Omidubicel
Omidubicel (formerly known as NiCord®), the company’s lead clinical program, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU. In a Phase 1/2 clinical study, omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.3 A Phase 3 study evaluating omidubicel in patients with leukemia and lymphoma is ongoing in the U.S., Latin America, Europe and Asia.4 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia.5 The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn®, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.
Omidubicel is an investigational therapy, and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.
About Gamida Cell
Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit
https://www.gamida-cell.com/
Mind you, i am not recommending to follow my footsteps. i
have made many investing mistakes, made a fortune and
encountered HUGE losses as well.
Finally results for both BVXV and GMDA are not too far away!
midastouch017
5年前
What do you guys think?
(copied from the net)
I'm not at all a conspiratorialist, but SOMETHING IS FISHY IN CHINA
*SOMETHING IS FISHY!!*??
Wuhan to Shanghai = 839 km
Wuhan to Beijing = 1,152 km
Wuhan to Milan = 8,684 km
Wuhan to NY = 12,033 km
The Coronavirus started in Wuhan yet there is no effect of Coronavirus in nearby Beijing or Shanghai but many deaths in Italy, Iran, European countries and USA.
All business areas of China are now safe.
*Something is fishy.*
America is not just blaming China without a reason.
Even today, India is locked down but all the cities of China are open. China has also announced the opening of Wuhan from April 08. Not a single leader in China has tested positive for the deadly Coronavirus.
*Something is fishy.*
The virus has ruined many economies around the world. Many have had to close their borders in an attempt to contain and control the spread of the Coronavirus. Thousands have lost their lives, millions have now got this disease, countless people have been locked in their homes and many countries have placed their citizens on lock down.
*Something is fishy.*
The Coronavirus orginated from the city of Wuhan in China and has now reached every corner of the world, but the virus did not reach China's capital Beijing and China's Economic Capital Shanghai, located in close proximity to Wuhan itself.
*Something is fishy*
Today Paris is closed, New York is closed, Berlin is closed, Delhi is closed, Mumbai is closed, Tokyo is closed, the world's major economic and political centers are closed, but Beijing and Shanghai are open. No Coronavirus effect is seen in either cities. There were only a few cases but the virus had no real effect on Beijing and Shanghai.
*Something is fishy.*
Beijing is the city where all the leaders of China live, including their military leaders. There is no lock down in Beijing.
*Something is fishy*
Shanghai is the city that runs China's economy. It is the economic capital of China, where all the rich people of China live and run major industries. There is no lock down here, there is no effect of the Coronavirus there.
*Something is fishy*
Beijing and Shanghai are the areas adjoining Wuhan. The virus from Wuhan reached every corner of the world, but the virus did not affect Beijing and Shanghai.
*Something is fishy*
Another big thing is, that the worldwide share market has fallen by almost half. In India also the Nifty has gone from 12 thousand to 7 thousand, but the share market of China was at 3000 and just merely dropped to 2700.
*Something is fishy*
This leaves one to speculate that the Coronavirus is a bio-chemical weapon of China, which China used to carry out destruction in the world in order to gain economic supremacy.
China has now put this virus under control, maybe they also have the antidote/ vaccine that they are not sharing with the world ever or will do when it is in their best interest to do so.
*Something is fishy*
Hollywood stars, Australia's Home Minister, Britain's Prime Minister and Health Minister, Spain's Prime Minister's wife, Canada's Prime Minister's wife, and Britain's Prince Charles, among others, have contracted the Coronavirus, but NOT A SINGLE POLITICAL LEADER IN CHINA, NOT A SINGLE MILITARY COMMANDER in China have tested positive for Coronavirus*SOMETHING IS FISHY!!!
Copied from the net
midastouch017
5年前
Sol-Gel Technologies Reports Full Year 2019 Financial Results and Corporate Update
GlobeNewswire GlobeNewswire•March 24, 2020
Top-line generic product revenue of $22.8 million in fiscal 2019
New Drug Applications for Epsolay® and Twyneo® remain on track for the second quarter and second half 2020, respectively
NESS ZIONA, Israel, March 24, 2020 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today provided a corporate update and reported financial results for the full year ended December 31, 2019.
“I am very proud of the major milestones that were accomplished by Sol-Gel in 2019. We announced positive top-line data from not one, but two clinical dermatological programs, Epsolay® in papulopustular rosacea and Twyneo® in acne vulgaris,” commented Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. “Our goals for 2020 are no less ambitious as we plan to file two New Drug Applications (NDA) in the U.S. – Epsolay in the second quarter of 2020 and Twyneo in the second half. In parallel, we are planning commercialization efforts and advancing development of our proprietary pipeline, while benefiting from our strong generic collaborations.”
“In terms of COVID-19 impact,” continued Dr. Seri-Levy, “given that Sol-Gel has completed the clinical programs required to support the NDAs for both Epsolay and Twyneo, and given that Sol-Gel recently strengthened its balance sheet, we remain on track to file both NDAs in the previously communicated timelines. This is of course, a dynamic situation which we will be monitoring closely.”
Corporate Highlights and Recent Developments
Strengthened balance sheet with underwritten public offerings of $23 million of gross proceeds in February 2020 and $11.5 million of gross proceeds in August 2019; Sol-Gel’s controlling shareholder, M. Arkin Dermatology Ltd., has agreed to invest an additional $5 million on the same terms as the February 2020 public offering, subject to shareholder approval.
In the fiscal year 2019, Sol-Gel generated revenue of $22.8 million from its collaboration agreement with Perrigo.
In September 2019, Sol-Gel was granted a patent from the United States Patent and Trademark Office for a patent covering Twyneo for the treatment of acne vulgaris. The newly granted patent will extend protection to July 2038, which Sol-Gel believes will prevent the launch of AB-rated generics of Twyneo during the life of the patent
Clinical Program Updates
Story continues
In December 2019, Sol-Gel announced that Twyneo met all co-primary endpoints in the treatment of patients with acne vulgaris. Sol-Gel expects to file a NDA in the second half of 2020. If approved, Twyneo has the potential to become a preferred treatment for acne.
In July 2019, Sol-Gel announced that Epsolay met all primary and secondary endpoints in both Phase 3 trials in papulopustular rosacea. Epsolay also demonstrated a rapid onset of action with statistically significant improvement seen as early as Week 2 compared with vehicle. Sol-Gel expects to file a NDA in the first half of 2020. If approved, Epsolay has the potential to be the first FDA-approved single-agent BPO prescription drug product and to redefine the standard of care for the treatment of inflammatory lesions associated with subtype II rosacea.
A proof of concept clinical study of SGT-210, erlotinib gel, a topical epidermal growth factor receptor inhibitor, for the potential treatment of punctuate palmoplantar keratoderma type 1 initiated in January 2020. Data is expected in the first half of 2021.
In early 2020, Sol-Gel added to its pre-clinical pipeline tapinarof, an aryl hydrocarbon receptor agonist, and roflumilast, a PDE4 inhibitor, each to be developed for potential treatment of psoriasis, as mono or combination therapies and other dermatological indications.
https://finance.yahoo.com/news/sol-gel-technologies-reports-full-200510067.html
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