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Thoughts? Yeah! Finally!!
She was going to run our investment into the ground! She wanted another 450 million shares to dilute us to nothing. Good riddance and don't let the door hit you in the ass!!
BioPharmX Initiates Phase 2b Trial of BPX-04 for Rosacea
Trial will evaluate 1% concentration of minocycline carried by company's patented HyantX™ delivery system
MENLO PARK, Calif., Oct. 11, 2018 /PRNewswire/ -- BioPharmX Corporation (NYSE American: BPMX), a specialty pharmaceutical company developing products for the dermatology market, today announced that it has enrolled the first subject in a Phase 2b clinical trial of BPX-04, a novel topical gel formulation of minocycline for the treatment of rosacea.
The trial is a randomized, double-blind, vehicle-controlled study in subjects with inflammatory lesions of rosacea. The 12-week, multi-center study will evaluate BPX-04, a 1% topical minocycline, carried by the HyantX™ delivery system, a proprietary, anhydrous hydrophilic topical system developed by BioPharmX. The trial plans to enroll 176 subjects at least 18 years old with an investigator's global assessment (IGA) score of 3 or 4 (moderate or severe), and 15 to 70 inflammatory lesions on their faces at baseline. The study allows for an optional interim analysis to adjust the study's sample size.
"Dermatologists and their patients are still searching for effective innovations in treatments for rosacea," said Neal Bhatia, M.D., director of clinical dermatology at Therapeutics Clinical Research in San Diego who was the principal investigator for the company's Proof-of-Concept (POC) trial. "The goal is to substantiate early research conclusions that suggest BPX-04 may offer the effective treatment of rosacea while minimizing the unwanted adverse effects associated with oral forms of antibiotics."
The primary endpoint for the study is an absolute mean change in the number of inflammatory lesions of rosacea from baseline to week 12. The secondary endpoint is the proportion of subjects with at least a two-grade reduction in IGA to clear (0) or almost clear (1), from baseline to week 12.
"The enrollment of our first subject represents an important milestone for BPX-04," said David Tierney, BioPharmX CEO. "We are optimistic the study will demonstrate that BPX-04 is safe, effective and easy to use, which should significantly improve patient compliance – a serious challenge to rosacea treatment."
Oral minocycline has been widely used in the treatment of skin conditions like rosacea and acne since the 1970s, but the pharmaceutical industry has not previously been able to develop a stable, topical formulation of fully solubilized minocycline, which appears to induce less resistance than other tetracycline-class antibiotics commonly used for these diseases. By applying minocycline topically, a patient will likely reduce the systemic exposure of minocycline and focus the drug's beneficial effects at the skin where they are needed most.
Termination of Anja Krammer
In addition, BioPharmX announced that Anja Krammer has been terminated as BioPharmX's President. Following Ms. Krammer's termination, David S. Tierney, M.D., BioPharmX's CEO, has assumed the role of President. Michael Hubbard, Chairman of the BioPharmX Board, said: "We are confident that Dr. Tierney will provide strong leadership moving forward as our Chief Executive Officer and President."
About HyantX™
The HyantX™ delivery system is a novel, patented drug delivery platform that stabilizes and solubilizes hydrophilic molecules in an anhydrous gel environment. It is capable of carrying a variety of active ingredients – and even combinations of actives - into the skin. Research has shown that the delivery system may allow for maximum solubility for multiple actives, which is intended to enhance skin penetration and increase efficacy and tolerability, has antibacterial properties, and hydrates the skin, making the delivery system a valuable asset in pipeline development and strategic partnering.
David Tierney cleaning house! I love it!
Anja Krammer Fired!
Effective October 10, 2018, Anja Krammer, President of BioPharmX Corporation (the “Company”), was terminated by the Company without Cause (as defined in the Employment Agreement between Anja Krammer and the Company, dated as of April 20, 2017 (the “Employment Agreement”)). A copy of the related press release is attached to this Current Report on Form 8-K as Exhibit 99.1.
Pursuant to the Employment Agreement, Ms. Krammer is entitled to severance payments and benefits provided for under her employment agreement, including (1) continuation of her current salary for nine months from October 10, 2018, payable in lump sum, (2) premium payments for continuing COBRA coverage for the same period or until Ms. Krammer is covered under the health plan of another employer and (3) acceleration of all time-based equity awards with respect to those shares which would have vested as of the nine month anniversary of October 10, 2018.
Effective October 10, 2018, the Company’s Board of Directors (the “Board”) appointed David S. Tierney, M.D., the Company’s Chief Executive Officer and a member of the Board, to serve as the Company’s President, Principal Executive Officer and Principal Financial Officer. Dr. Tierney, age 55, has served as Chief Executive Officer and as a member of the Board since September 2018. From January 2014 to March 2018, Dr. Tierney served as President and Chief Executive Officer of Icon Bioscience, Inc., a specialty biopharmaceutical company that was acquired by EyePoint Pharmaceuticals, Inc. in March 2018. Dr. Tierney received his medical degree from the Royal College of Surgeons in Dublin, Ireland and was subsequently trained in internal medicine. There are no family relationships between Dr. Tierney and any previous or current officers or directors of the Company, and there are no related party transactions reportable under Item 404(a) of Regulation S-K.
In addition, the Board appointed Joyce Goto, age 45, the Company’s Vice President and Controller, to serve as the Principal Accounting Officer, effective October 10, 2018. Ms. Goto has served as the Company’s Vice President and Controller since April 2015. There are no family relationships between Ms. Goto and any previous or current officers or directors of the Company, and there are no related party transactions reportable under Item 404(a) of Regulation S-K.
2% vs competitor's 4% + Results within 2 weeks!
"Holy Grail" of acne medication!
https://www.medpagetoday.com/reading-room/aad/general-dermatology/75446
Topical Minocyclines Present Potential Acne Options
Studies suggest foam and gel formulations are effective in moderate to severe acne,
by Andrew D. Bowser ELS, CHCP
Contributing Writer, MedPage Today
With apparent potent antibacterial activity and minimal side effects, topical minocycline formulations could provide new, non-systemic treatment options for individuals with acne.
Products under investigation include FMX101, a once-daily topical minocycline foam that was well-tolerated, safe, and effective in recent randomized studies, and BPX-01, which investigators described as the first completely solubilized minocycline gel for topical use.
Topical clindamycin and erythromycin remain treatment options for acne, but concerns about resistance has limited their use. According to acne guidelines, these antibiotics are effective, but not recommended as monotherapy because of the risk of bacterial resistance.
Tetracyclines are less susceptible to resistance, and among them, minocycline has the lowest resistance rate, according to investigators. The low resistance led to interest in a topical formulation of minocycline for acne, despite development hurdles along the way.
"It's been quite challenging to develop a formulation that is stable topically and something that's cosmetically acceptable to patients," said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System, Detroit, Mich.
Minocycline Foam
Now, efficacy and safety results for stable formulations are being reported, including one recent report by Stein Gold and co-investigators in the Journal of the American Academy of Dermatology showing that a 4% topical minocycline foam (FMX101) looks safe and potentially efficacious for treating moderate to severe acne.
In two phase III randomized studies, the minocycline foam demonstrated a significant improvement in inflammatory lesions versus vehicle, and in one of the two studies, it showed a significantly greater rate of treatment success defined as a 0-1 score on the Investigator's Global Assessment (IGA) and an improvement of at least 2 grades by week 12.
"When we look at the efficacy data with this minocycline product, it really was not that much different than looking at the efficacy data seen with using this orally," Stein Gold said in an interview for MedPage Today. "So I think that gives the drug a wonderful advantage in minimizing the potential for systemic side effects, and minimizing the exposure of the body to systemic antibiotics with the potential for bacterial resistance."
The trials included a total of 961 subjects, mostly female, with mean ages of 20.3 years in one study and 20.6 years in the other. All subjects had moderate-to-severe facial acne as defined by an IGA score of 3 to 4, 20 to 50 inflammatory lesions, and 25 to 100 noninflammatory lesions. They were randomized 2:1 to receive 4% topical minocycline foam or foam vehicle for 12 weeks.
Less than 1% of patients receiving the 4% topical minocycline foam had skin-related adverse events, according to investigators, who said most of these were mild to moderate and included events such as headache, nasopharyngitis, and pyrexia.
The topical minocycline foam was significantly superior to vehicle in reducing inflammatory lesions in both studies individually, and in pooled results, which at Week 12 showed lesion reduction from baseline of -13.79 and -10.94, respectively (P = 0.0001).
Likewise, pooled results showed IGA treatment success rates of 11.51% versus 6.34% for minocycline and vehicle, respectively (P = 0.0188), though in one of the two studies including 466 patients, the difference did not reach statistical significance (8.09% versus 4.77%; P = 0.2178).
It's not clear why one of the studies did not show statistical significance with regard to the IGA assessment, though it was likely underpowered to show a difference, Stein Gold said. Accordingly, an additional 1,500-patient randomized study is underway to confirm the results.
While the results are promising so far, more data are needed from the confirmatory randomized study, as well as from a recent long-term efficacy and safety study, according to Stein Gold.
Minocycline Gel
Data have also been presented for BPX-01, including results from a randomized, multicenter phase IIb study including 226 subjects. In that study, a 2% minocycline topical gel resulted in rapid improvement and superior outcomes versus vehicle control, according to investigators.
The gel represents a potentially new and effective treatment option with a favorable safety profile and potential for high patient compliance, according to investigator Andrew F. Alexis, MD, MPH, chair of the department of dermatology at Mount Sinai West, New York, N.Y.
"The ability to have a completely solubilized minocycline in a gel form that can be used topically would represent a significant advance for our patients with moderate to severe acne," Alexis said in an interview. "We can potentially get the well-known benefits as far as efficacy from minocycline, and minimize the risk of the side effects from systemic use of minocycline."
Subjects in the study, conducted at 15 U.S. sites, were 9 to 40 years of age and had 20 to 60 inflammatory, non-nodular acne lesions. They were randomized to one of two concentrations of the minocycline gel (1% or 2%) or to vehicle.
At week 12, there was a 58.5% reduction in lesions in the 2% dose arm, versus 43.8% in the vehicle arm (P = 0.0256), according to the report.
Less than 1% of subjects had treatment-related adverse events, and none were serious, according to investigators.
The improvement was rapid, according to Alexis, with a 25% or greater reduction in lesions at week 2, which could translate into improved patient compliance and satisfaction, he said.
"That's a very short time point that's more aligned with what patient's expectations are," Alexis explained. "Whereas physician expectations are usually 6 to 8 weeks or longer to see meaningful clinical improvement, patients' expectations tend to be 2 to 4 weeks or shorter."
Linda Stein Gold, MD, reported being an advisor and investigator for Foamix Pharmaceuticals, which sponsored the studies of the topical minocycline foam. She also provided disclosures related to GlaxoSmithKline, LEO Pharma, Valeant, Janssen, and Novartis.
Andrew F. Alexis, MD, MPH, reported being an investigator in the study of BPX-01 minocycline topical gel, which was sponsored by BioPharmX.
Foamix Announces Additional Positive Topline Results from Third Phase 3 Trial (Study FX2017-22) Evaluating FMX101 Topical Minocycline Foam for Moderate-to-Severe Acne
Statistically significant improvement demonstrated in reduction of non-inflammatory lesions
Dermal tolerability scores consistent with previous Phase 3 studies
Re-analysis including patients from discontinued investigator site consistent with primary ITT analysis for both co-primary endpoints, reflecting highly statistically significant results
REHOVOT, Israel and BRIDGEWATER, N.J., Oct. 01, 2018 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX), ("Foamix"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced additional topline results from its third Phase 3 clinical trial (FX2017-22) of FMX101 for the treatment of moderate-to-severe acne. As the company previously communicated, the study met both co-primary endpoints of (1) absolute change from baseline in inflammatory lesion count at Week 12, and (2) Investigator Global Assessment ("IGA") treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline. Results from both co-primary endpoints demonstrated highly statistically significant results for FMX101 vs vehicle, with p-values <0.0001. The safety profile of FMX101 was consistent with that determined from the two prior Phase 3 studies (FX2014-04 and FX2014-05). Additional study results and analysis are as follows:
Key Secondary Efficacy Assessments
* Significant reduction in the number of non-inflammatory lesions
The mean reduction in non-inflammatory lesion count at Week 12 relative to Baseline was -18.83 for the FMX101 treatment group and -15.67 for the vehicle treatment group (p=0.0080, ANCOVA, ITT, MI).
* Percent change in inflammatory lesion count at Week 3, 6, 9 and 12
At Week 12, the percent change in inflammatory lesion count was -56% for the FMX101 treatment group and -43% for the vehicle treatment group (p<0.0001). A statistically significant difference in percent reduction in inflammatory lesion count between treatment groups was also observed at week 3, 6, and 9 [all assessed timepoints] (p<0.0001).
During the study, quality issues were identified at one clinical site requiring discontinuation of the site from the study and removal of corresponding subject data from the intent-to-treat population (19 enrolled subjects). Supplemental re-analysis of both co-primary endpoints including data from these subjects demonstrated comparable results to the primary analyses with equally high statistical significance between the treatment groups (p<0.0001 for both analyses).
Safety and Tolerability - Dermal Tolerability
Dermal tolerability was assessed by scoring the severity of itching, skin peeling, erythema, hyperpigmentation and dryness on a scale of 0 to 3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. These assessments were made at study weeks 3, 6, 9 and 12.
At Week 12, greater than 95% of scores were 0 (none) or 1 (mild). These tolerability scores were comparable with the equivalent assessments made in the Company's earlier phase 3 studies (FX2014-04 and FX2014-05).
"The data from this confirmatory Phase 3 study are impressive, and the reductions in inflammatory lesions and proportion of patients achieving clinical success appear consistent with prior studies of FMX101, including Study 05," stated Edward Lain, MD MBA, Chief Medical Officer, Sanova Dermatology and Principal Investigator in Study FX2017-22. "The treatment benefits of oral antibiotics, including minocycline, have been well documented in moderate-to-severe acne but their use is limited by systemic side effects, which can be serious. The strong body of clinical data on FMX101, including the results from this most recent Phase 3 trial, suggest that it may offer patients an efficacious treatment in a convenient and safe topical foam formulation. I believe that, if approved, it has the potential to address a significant unmet need in this difficult to treat condition."
David Domzalski, CEO of Foamix, will present these study results along with an overall corporate update at the Cantor Fitzgerald Global Healthcare Conference tomorrow, October 2nd at 12:15pm Eastern Time. Updated presentation materials are available on the company's website under "Investors - Events and Presentations" at www.foamix.com.
Cantor Fitzgerald Global Healthcare Conference 2018
Date: Tuesday, October 2
Time: 12:15pm Eastern Time
Location: InterContinental New York Barclay Hotel
Webcast: http://wsw.com/webcast/cantor7/fomx/
Item 5.02 Departure of Directors or Certain Officers;
On September 26, 2018, Greg Kitchener, Executive Vice President and Chief Financial Officer of the Company, notified the Company of his decision to resign from all positions with the Company, effective October 10, 2018. The Company is in the process of reviewing its management team requirements and expects to have a plan formulated in the near future.
BioPharmX Receives Notice of Noncompliance from NYSE American
MENLO PARK, Calif., Sept. 28, 2018 /PRNewswire/ -- BioPharmX Corporation (NYSE American: BPMX) (the "Company"), a specialty pharmaceutical company developing products for the dermatology market, received a notice on September 24, 2018 from the NYSE American LLC (the "NYSE American") that the Company is not in compliance with the stockholders' equity requirements set forth in Sections 1003(a)(i)-(iii) of the NYSE American Company Guide. The Company reported stockholders' equity of $4.3 million as of July 31, 2018 and net losses in its five most recent fiscal years ended January 31, 2018. The continued listing standards require listed companies to maintain stockholders' equity of $6.0 million or more if they have reported losses from continuing operations and/or net losses in their five most recent fiscal years (Section 1003(a)(iii)).
The Company expects to submit a plan to NYSE American by October 24, 2018 advising how the Company plans to regain compliance with the continued listing standards by September 24, 2019. If the Company is not in compliance with the continued listing standards as of September 24, 2019, or does not make progress consistent with the plan, NYSE American may initiate delisting procedures.
The Company's common stock will continue to be listed and traded on NYSE American during the cure period, subject to the Company's compliance with NYSE American's other applicable continued listing standards. The letter does not affect the company's business operations or its Securities and Exchange Commission reporting requirements.
BioPharmX Corporation (BPMX): Analysts Sets Up An Interesting Tug of War
If you can handle volatility, BioPharmX Corporation (NYSE:BPMX) is the stock to watch now. The stock closed lower on 25 September. The shares dropped 0 points or -2.2 percent at $0.21 with a light trade volume of 3.869 million shares. After opening the session at $0.22, the shares went as high as $0.22 and as low as $0.21, the range within which the stock’s price traded throughout the day. The firm is left with a market cap of $41.03 million and now has 196.02 million shares outstanding. BioPharmX Corporation (BPMX) stock has gained 37.7 percent of market value in 21 trading days.
BPMX stock has a trailing 3-year beta of -0.62, offering the possibility of a lower rate of return, but also posing less risk. The portion of a company’s profit allocated to each outstanding share of common stock was $-0.06 a share in the trailing twelve months. The stock’s value has surged 89.93 percent year to date (YTD) against a decline of -26.56 percent in 12 month’s time. The company’s shares still trade -44.2 percent away from its 1-year high of $0.38 and 109.3 percent up from 52-week low of $0.10. The average consensus rating on the company is 2, on a scale where 5 equates to a unanimous sell rating. In short, the mean analyst recommendations are calling this stock a buy.
BioPharmX Corporation (BPMX) will probably climb -100 percent over the next 12 months, according to price target estimates compiled by finviz. Meanwhile, they have set a $1.5-month high price target. This represents a whopping 614.29 percent increase from where shares are trading today. The 12-month median price target assigned by the analysts stands at $1.05, which represents a return potential of 400 percent when compared to the closing price of the stock of $0.21 on Tuesday, September 25. The lowest price target for the stock is $0.6 — slightly more than 185.71 percent from BPMX’s current share price.
History has shown that shares in BioPharmX Corporation have gone down on 7 different earnings reaction days and are predicted to add 0.1 percent when the company reports upcoming earnings.
Let’s take a look at some insider activity at BioPharmX Corporation (NYSE:BPMX) and see the pattern. The earliest insider trade took place on 09/19/2018. Tierney David S gathered a total of 100 thousand shares of company at average share price of $0.2. The total for the purchase was set at $20 thousand. After this transaction, the CEO account balance stood at 7.5 million shares. The stock grew 5 percent since that insider purchase. On 03/07/2018, Vivo Capital Viii, Llc, 10% Owner, sold 2 million shares at a price per share of $0.36. This removed 720 thousand shares from the insider’s fortune and the stock saw a -41.67 percent retreat in value since the news became public. This transaction left 16.13 million shares in the 10% Owner account.
On 11/24/2017, Director Morlock Stephen performed a purchase transaction worth $49.5 thousand. This purchase at $0.15 each has added 330 thousand shares into the insider’s portfolio position. Meanwhile, shares have recorded 40 percent increase since the transaction was reported. The insider now is left with 1.13 million shares remaining in the account. Vivo Capital Viii, Llc, who performs the 10% Owner job, sold 296.39 thousand shares for $59.28 thousand. The disposal occurred on 11/09/2017 was priced at $0.2 per share. The share price soared 5 percent since the reporting date. Vivo Capital Viii, Llc now left with a stake of 13.8 million BPMX stock worth $2.9 million after the insider selling.
The stock is currently hovering around the first support level of $0.2. Below this, the next support is placed in the zone of $0.19. Till the time, the BPMX stock trades above this level, bulls have nothing to fear. On momentum oscillators front, ‘RSI’ has touched 57.44 on daily chart, which may remain a cause for concern. If the price breaks below $0.19 level on closing basis, then we may see more profit booking and the stock may show further weakness. On the flipside, hitting the $0.22 mark may result into a pull-back move towards $0.23 level.
Further, it is sporting a 519.33 on the Price-to-Sales ratio. Compare this with the industry average P/S of 110.45.
https://www.google.com/amp/s/kymanews.com/2018/09/26/biopharmx-corporation-bpmx-analysts-sets-up-an-interesting-tug-of-war/amp/
Foamix Pharmaceuticals to Participate in the Cantor Fitzgerald Global Healthcare Conference
REHOVOT, Israel and BRIDGEWATER, N.J., Sept. 26, 2018 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq:FOMX), a clinical-stage specialty pharmaceutical company focused on developing and commercializing proprietary, topical therapies to address unmet needs in dermatology, announced today that David Domzalski, Chief Executive Officer, will provide a corporate update at the Cantor Fitzgerald Global Healthcare Conference, taking place October 1-3 at the InterContinental New York Barclay Hotel.
Date: Tuesday, October 2
Time: 12:15pm Eastern Time
Location: InterContinental New York Barclay Hotel
Webcast: http://wsw.com/webcast/cantor7/fomx/
Northern Trust Corp.
Portfolio Value $ 393,808,016,000
Opened Position on BioPharmX
File date - 2018-09-18
Current Shares 92,518
https://fintel.io/so/us/bpmx
Let's make a deal! Staring David S. Tierney!
David S. Tierney, M.D. is President and CEO of Icon Bioscience where he led a team that in 2018 received U.S. FDA approval of its New Drug Application for DEXYCU™. Previously, Dr. Tierney was Co-Founder and President of Oceana Therapeutics, sold to Salix Pharmaceuticals in December 2011. Dr. Tierney served as President and CEO of Valera Pharmaceuticals, between August 2000 and April 2007, when Valera completed a merger with Endo Pharmaceuticals. Prior to this Dr. Tierney was Senior Vice President of Drug Development at Roberts Pharmaceutical Corporation, where he was responsible for all research and development activities. Roberts was acquired by Shire. Before Roberts, Dr. Tierney was employed by Élan Corporation in a variety of management positions.
BioPharmX Corporation Announces David S. Tierney, M.D. Joined the Company as Chief Executive Officer
"BioPharmX is on the threshold of an important and exciting growth phase as is evident from the company's robust product pipeline and its lead product candidate being phase 3-ready for acne."
David S. Tierney
Purchase Confirmed in link.
Here
New BioPharmX CEO showing confidence in the company and their pipeline!
David S. Tierney Acquired 100,000 common stock shares.
http://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=12463957&type=HTML&symbol=BPMX&companyName=BioPharmX+Corporation.+Common&formType=4&dateFiled=2018-09-20&cik=0001504167
Been holding above .20 pretty well. Cone David T. and get a deal signed for BioPharmX!!
I think we all know that as we look at fund raising, we need capital to move forward with the Phase 3 trial and as we look at the landscape of way to do that but non-dilutive and dilutive as you describe, right, there are several scenarios that are ahead of us and I think I talked about this in generally before where clearly partnering and licensing and other things of that, that [ph] would be a non-dilutive event and those are things that accompany with the new technology and innovative drug platform that we have, clearly always wants to explore and look at. And in parallel to that, as we've done previously leading upto now, we always also look at the capital markets as another alternative for raising funds. So I think we're very conscious and thoughtful about that approach, we are looking at all aspects that make the most sense for the shareholders and for the return for all the investors of the business and we'll continue to do that.
Anja Krammer
Up next. Funding! Anja couldn't make sense of the IOI's so they brought in the heavy hitter David Tierney to close the deal!
Sec form4 website for history searching.
https://www.secform4.com/insider-trading/1504167.htm
To clarify, these shares are only an option to buy, one year from now.
Option to purchase common stock.
Exercise Price of $0.22
Date Exercisable 9/11/2019
Expiration Date 9/11/2028
Common Stock 7,400,000
Also to add to your post,
"shareholders with as little as 5-10 percent ownership can push for their own seats on the board or enact changes at shareholder meetings"
Benefits of Controlling Interest
The upside of holding a controlling interest in a company can come in many forms. First, whether the company is public or private, controlling interest gives a person or group of people massive influence. Since, by definition, the party with controlling interest automatically has the majority vote, controlling interest then allows an individual to veto or overturn decisions made by existing board members. This gives people who have controlling interest in a company the ability to take ownership over the operational and strategic decision-making processes.
Further, in some companies, if an individual has the controlling interest of the company, the company will automatically make that person the chairman of a company's board of directors. This gives the individual with controlling interest even more power than the majority vote. In addition to retaining veto power over a board vote, the individual can effectively make board decisions on their own, including hiring C-level executives.
Finally, controlling interest grants an investor leverage to increase their shareholding stake in a company in the event of a merger or acquisition. For example, in the case of a strategic merger that involves a share swap, the investor holding a controlling interest structures the deal in such a way that they continue to have majority voting power over the new entity.
I see this a a terrific move! David is valuable addition to the company. He's been put in place to get the company moving in the right direction.
Investors are still waiting for answers to funding and the start of phase 3. When that day comes, we will fly! Plans developing, stay tuned!
Where there's money to be made, there will always be leaks. Good call
Finally the company has a CEO again. They never filled the position since James Pekarsky left. Maybe this is what the company needs to turn the downtrend around.
David Tierney has a history of getting things done!!
https://www.businesswire.com/news/home/20030626005402/en/Hydro-Med-Sciences-Completes-12-Million-Series
Previous Transformative Acquisition Involvement
https://www.businesswire.com/news/home/20111108007045/en/Oceana-Therapeutics-Announces-Definitive-Agreement-Acquired-Salix
David Tierney commented, “BioPharmX is on the threshold of an important and exciting growth phase as is evident from the company’s robust product pipeline and its lead product candidate being phase 3-ready for acne.” He further noted, “I expect advancements in BioPharmX product development to drive increased corporate visibility and transformational changes in dermatologic pharmaceuticals. I am thrilled to have the opportunity to participate and contribute to BioPharmX’s growth prospects.”
BioPharmX Corporation Announces David S. Tierney, M.D. Joined the Company as Chief Executive Officer
Menlo Park, Calif., Sept. 12, 2018—BioPharmX Corporation (NYSE American: BPMX), a specialty pharmaceutical company developing products for the dermatology market, today announced the appointment of David S. Tierney, M.D., as its chief executive officer. Anja Krammer continues to serve in her roles as president and corporate secretary for BioPharmX. Dr. Tierney was also appointed as a director to the board of directors of BioPharmX. BioPharmX Corporation noted that Dr. Tierney is an accomplished healthcare executive with a proven record of achievements leading the growth of both pharmaceutical and medical device companies. Additionally, Dr. Tierney possesses significant experience in successfully developing and commercializing drug delivery platforms, which will be a particularly valuable asset for BioPharmX as it commercializes its own topical dermatology technology.
"We look forward to having a seasoned industry veteran such as David join our team as we advance our topical dermatology clinical programs and commercialization strategies,” said Michael L. Hubbard, chairman of the board of directors of BioPharmX Corporation. “David brings a wealth of expertise in medical science, clinical, and regulatory affairs, and in overseeing the advancement of healthcare companies from the product development phase to commercial operations.”
David Tierney commented, “BioPharmX is on the threshold of an important and exciting growth phase as is evident from the company’s robust product pipeline and its lead product candidate being phase 3-ready for acne.” He further noted, “I expect advancements in BioPharmX product development to drive increased corporate visibility and transformational changes in dermatologic pharmaceuticals. I am thrilled to have the opportunity to participate and contribute to BioPharmX’s growth prospects.”
About David S. Tierney, M.D.
Prior to his appointment as CEO at BioPharmX, he was president and CEO of Icon Bioscience where he led a team that in 2018 received U.S. FDA approval of its New Drug Application (NDA) for DEXYCU™ (dexamethasone intraocular suspension), a dropless, long-acting therapeutic for treating inflammation associated with cataract surgery. Icon was merged with EyePoint Pharmaceutical in March 2018.
Dr. Tierney served as president and chief operating officer of Oceana Therapeutics, Inc., a specialty therapeutic company he co-founded in 2008. Oceana quickly established a global commercial network and by 2011 was acquired by Salix Pharmaceuticals. In 2000, David was appointed President & CEO of Hydro Med Sciences (HMS), a research firm with a promising drug delivery platform. Under his leadership, HMS emerged as Valera Pharmaceuticals, a fully integrated, commercial, specialty pharma company that successfully completed an initial public offering in 2005. Valera has since been merged into Endo Pharmaceuticals. Prior to Valera, Dr. Tierney was president of Biovail Technologies, a drug delivery division of Biovail Corporation - a predecessor to Valeant Pharmaceuticals International. Earlier in his career, he served as senior vice president of drug development at Roberts Pharmaceutical and in a variety of management positions at Elan Corporation. Dr. Tierney received his medical degree from Royal College of Surgeons in Ireland.
David Tierney is the recipient of two Ernst & Young Entrepreneur of the Year® awards, first in 2005 and again in 2011, respectively, reflecting his accomplishments at Valera and Oceana. He was also featured in the inaugural 2010 Irish Life Science 50, an honor presented by the president of Ireland in conjunction the Irish Voice and Irish America Magazine. Additionally, in 2005, 2006, and 2011, PharmaVOICE 100 named David one of the most inspiring people in health sciences.
Foamix Pharmaceuticals Ltd. (FOMX) shares surged 30% in Wednesday premarket trade after the company reported positive late-stage trial results for its topical acne medication, FMX101. The phase 3 trial met both co-primary endpoints after 12 weeks of daily treatment with the medication. FMX101 is a topical foam made of the antibiotic minocycline and, if approved, would be the first such topical product available in the U.S., according to the company. The trial enrolled 1,507 individuals with moderate-to-severe acne across the U.S. The medication "appeared to be generally safe and well-tolerated," the company said, with a viral upper respiratory tract infection, in 6.5% of trial participants, being the most common safety problem reported. Five participants total dropped out of the study due to safety issues. Foamix said it plans to share further data from the recent study over the course of the year. Company shares have surged 13.9% to $5.92 over the last three months, compare d with a 3.6% rise in the S&P 500 and a 2.6% rise in the Dow Jones Industrial Average
The Dr. still in the house!
You might just get your update tomorrow, or at least this week!
Good to see your still around!
GLTY
I hear ya brother!
What can we expect when real news drops? It looks like things are pulling together finally!
The company files early. Anja receives shares, and not any of the other board members(??). Looks like deals are being made to me! I'd say we're really close now to a long awaited uptrend!
Anja Krammer, BioPharmX president acquired 1,042,000 shares!
http://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=12452478&type=HTML&symbol=BPMX&companyName=BioPharmX+Corporation.+Common&formType=4&dateFiled=2018-09-11
Foamix as you can see is in there phase 3 Program. For them to receive positive results using Minocycline proves that they have a product that works. This builds Institutional Investor confidence in the product and investment.
Now investors will weigh in on which company would be the better investment. Foamix and their oil-based product, or BioPharmX and there water soluble product, which is a much better delivery system, and file patent secured by the way.
In other words, if Foamix flopped using Minocycline why would you want to take a risk in BioPharmX who is using the same formula. Their success brings major confidence in our much better product and delivery system!
BioPharmX is the better investment choice!
50% Peak gains from both Minocycline acne drug pharma's today!
The product works! Now just waiting for BioPharmX P3 announcement...
Nice job Foamix! More eyes on BPMX, the better product, with the better delivery system!
Foamix Announces Positive Topline Results from Third Phase 3 Trial (Study FX2017-22) Evaluating FMX101 Topical Minocycline Foam for Moderate-to-Severe Acne
https://www.nasdaq.com/press-release/foamix-announces-positive-topline-results-from-third-phase-3-trial-study-fx201722-evaluating-fmx10-20180911-00923
Foamix Announces Positive Topline Results from Third Phase 3 Trial (Study FX2017-22) Evaluating FMX101 Topical Minocycline Foam for Moderate-to-Severe Acne
FMX101 Demonstrated Highly Statistically Significant Improvement Compared with Vehicle in Both Co-Primary Efficacy Endpoints
REHOVOT, Israel and BRIDGEWATER, N.J., Sept. 11, 2018 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX), ("Foamix"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced the topline results of its third Phase 3 clinical trial (FX2017-22) of FMX101 for the treatment of moderate-to-severe acne. The study met both co-primary endpoints of (1) absolute change from baseline in inflammatory lesion count at Week 12, and (2) Investigator Global Assessment ("IGA") treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline. The safety profile of FMX101 was found to be consistent with that determined from the two prior Phase 3 studies (FX2014-04 and FX2014-05). Foamix plans to continue to share data from this study as they become available over the remainder of 2018.
"We are extremely pleased with the topline results of this confirmatory Phase 3 trial. These study results should support a finding that FMX101 appears to be safe and effective in the treatment of moderate-to-severe acne," said David Domzalski, CEO of Foamix. "This is the most significant milestone to date for Foamix and brings us closer to helping patients who struggle with the physical and psycho-social effects of acne. If approved, we believe FMX101 would be the first topical minocycline product available for patients in the United States."
Mr. Domzalski further stated, "On behalf of Foamix, I wish to thank all patients, caregivers/guardians, investigators and support staff who participated in the advancement of this clinical program. With the conclusion of this third study, we are now in position to finalize our efforts to submit the company's first NDA."
"The data from this confirmatory Phase 3 study are impressive, and the reductions in inflammatory lesions and the proportions of subjects achieving treatment success highlight significant improvements in disease severity for those that received FMX101 in the study," stated Iain A. Stuart, Ph.D., Senior Vice President, Research & Development, Foamix. "The strong body of clinical data we have generated with FMX101, including the results from this most recent Phase 3 trial, suggest that it may offer patients an efficacious treatment in a convenient and safe topical foam formulation. If approved, it has the potential to address a significant unmet need in this difficult to treat condition."
FX2017-22 Trial Design and Results
The double-blind, randomized, vehicle-controlled Phase 3 trial enrolled 1507 patients with moderate-to-severe acne at 89 sites in the United States. Patients were randomized to receive either FMX101 minocycline foam (4%) or vehicle foam once daily for 12 weeks. The co-primary efficacy endpoints were: (1) the absolute change from baseline in the number of inflammatory lesions, and (2) Investigator Global Assessment (IGA) treatment success, where success is defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline. Safety and tolerability were also evaluated.
Baseline Acne Severity
The mean inflammatory lesion count at baseline was 30.7 and 30.8 for the FMX101 and vehicle treatment groups, respectively. The proportion of subjects with an IGA score of 3 ("moderate") or 4 ("severe") was 84.0% and 16.0%, respectively, in the FMX101 treatment group and 83.5% and 16.5%, respectively, in the vehicle treatment group.
Co-Primary Efficacy Assessments
Significant reduction in the number of inflammatory lesions
The mean reduction in inflammatory lesion count at Week 12 relative to baseline was -16.93 for the FMX101 treatment group and -13.40 for the vehicle treatment group (p<0.0001, ANCOVA, ITT, MI).
Significant improvement in Investigator's Global Assessment (IGA) treatment success
The proportion of subjects that achieved IGA treatment success at Week 12 was 30.80% for the FMX101 treatment group and 19.63% for the vehicle treatment group (p<0.0001, CMH test - stratified by analysis center, ITT, MI).
Safety and Tolerability
The most commonly reported adverse event in the study was (viral) upper respiratory tract infection (6.4% in both FMX101 and vehicle treatment groups). There were no treatment-related serious adverse events. A total of 5 subjects discontinued the study due to an adverse event (3 in the FMX101 treatment group and 2 in the vehicle treatment group). FMX101 appeared to be generally safe and well-tolerated.
I hear you there!