Tag: TXMD

  • Multiple SEC Filings: TherapeuticsMD Inc. (TXMD) stock Falls After Hours

    On March 23, TherapeuticsMD Inc. (TXMD) submitted multiple filings with the U.S. Securities Exchange Commission. Consequently, the stock suffered a downfall in the after-hours session.

    During the regular session, the stock went up by 8.87% at its closing price of $0.4356. The volume of shares traded during the session was just above the average at 8.06 million against 7.76 million. In the following after-hours session, TXMD saw a reversal with a loss of 12.76%. Hence, the stock was trading at a price of $0.3800 per share in the after-hours while the volume of shares exchanged was 782.16K.

    The pharmaceutical company, TherapeuticsMD Inc. develops products for women. Currently, the company has a market capitalization of $170.01 million with its 424.93 million shares outstanding.

    TXMD’s SEC Filings

    On Wednesday, the company submitted three SEC filings: i) 10-K: Annual report for the year ending December 31, 2021; ii) POSASR: Post-effective Amendment to an automatic shelf registration statement; and iii) SC 13D/A: General statement of acquisition of beneficial ownership – amendment.

    Source: Uni of Utah

    Previously, on March 18, the company had filed a current report on Form 8-K regarding Nasdaq’s notification and certain changes in the company’s leadership. As per the filing, having failed to regain compliance with Nasdaq’s minimum bid requirement in the given period, TXMD has requested a hearing before Nasdaq’s hearing panel. Moreover, the company’s CFO and Principal Financial Officer James C. D’Arrecca will be resigning on April 1, 2022. Thus, VP-Finance & Chief Accounting Officer Michael C. Donegan will succeed Mr. D’Arrecca on an interim basis.

    Q4 2021 Financial Results

    On March 10, the company declared its financial results for the fourth quarter of 2021.

    In Q4 2021, TXMD generated net product revenue of $7.8 million for ANNOVERA, $6.7 million for IMVEXXY®, and $2.7 million for BIJUVA®.

    Furthermore, the company incurred a net loss of $43.0 million in Q4 2021, against $42.1 million in Q4 2020. Resultantly, the net loss per share was $0.10 and $0.15 in Q4 of 2021 and 2020 respectively.

    Additionally, the cost of goods was $4.7 million while the product gross margin was 75% in the quarter.

    The company ended the quarter with $65.1 million in cash on hand on December 31, 2021.

    TXMD’s Divestiture of vitaCare

    On March 7, TXMD announced its definitive agreement for divesting its vitaCare Prescriptions Services to GoodRx for $150 million in cash. The agreement also includes additional consideration of $7 million based upon vitaCare’s performance through 2023. The transaction is expected to close in Q2 2022.

  • FDA’s Response: TherapeuticsMD Inc. (TXMD) Plummets Further Aftermarket

    TherapeuticsMD Inc. (TXMD) stock extended losses by 5.41% aftermarket when the company announced FDA’s response. The FDA declined TXMD’s Annovera’s previously submitted sNDA.

    During regular trading, the stock lost 3.30% at a volume of 4.71 million, closing the session at $0.4510. Following the announcement, the stock plunged further down to reach $0.4266 in the after-hours at 431.79K shares.

    The current market capitalization of TXMD is $191.64 million with its 424.93 million outstanding shares.

    FDA’s Response to TXMD

    On December 10, the company announced the response of the FDA to some manufacturing testing limits for ANNOVERA. The company had previously submitted an sNDA with the FDA for this purpose. As per the announcement, FDA did not approve the company’s revisions in the sNDA. Further, the FDA requested additional information and also suggested some recommendations.

    TXMD’s Annovera is the only long-lasting, reversible, procedure-free birth control, approved in August 2018 by the FDA. The president of TXMD said in the announcement that Annovera’s supply will be continued under existing specifications. Furthermore, the company will continue working with the FDA regarding the revisions.

    U.S. Patent Litigation with Amneal

    Previously, TXMD announced the settlement of U.S. litigation for Bijuva® with Amenal, on December 08. As per the previous announcement, the company was under patent litigation with Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals, LLC, and Amneal Pharmaceuticals of New York LLC.

    According to the announcement, TXMD granted a license to Amneal for the commercialization of a generic version of Bijuva in the U.S. This will start on May 25, 2032, with earlier commencement under specific circumstances. Further, TXMD’s last patent for Bijuva with FDA is set to expire on November 21, 2032.

    In addition, this litigation was pending in the U.S. District Court for New Jersey District since the year 2020.

    TXMD’s Financials

    On November 11, TXMD announced its financial results for the third quarter of 2021. As per the Q3 of 2021, the total net products revenue was $25.4 million. This shows an increase of 41.1% from the year-ago quarter.

    Moreover, the company incurred a net loss of $47.4 million in the third quarter of 2021, against $32.6 million in Q3 of 2020. Consequently, the net loss per basic and diluted share was $011 in Q3 of 2021, against $0.12 in the year-ago quarter.

  • TherapeuticsMD Inc. (TXMD) stock soared in the pre-market trading session: here’s why

    TherapeuticsMD Inc. (TXMD) stock recently traded in the premarket at $1.57 which is an 18.94% rise. TXMD’s stock closed at $1.32 which is the same price to its prior session close thus a 0.00% change. The number of shares that exchanged hands in the day was 6.57 million. However, this was lower than the average daily volume of 17.1 million shares within the past 50 days. The volume in the past week was down by -1.49%. TXMD stock has risen by 47.67% in the last 12 months but shed -17.50%. In the last 3 months, it then gained 2.33%. Furthermore, the company’s current market share values at $493.52 million and its outstanding shares stood at 286.69 million.

    The recent positive movement of TXMD stock in the recent pre-market trading session has come adjacent to the press release by the Company announcing approval of its Hormone Replacement Therapy (HRT)

    TherapeuticsMD healthcare provides special care for women

    TherapeuticsMD, Inc. is a healthcare company which is focused towards the production of novel and unique products. These healthcare products are made specifically for women and innovation comes through the design and accordance with the unmet needs/challenges of women. The company looks at various experiences and stages of a woman’s life to keep in mind while designing these products especially for menopause, family planning and reproductive health.

    Approval of HRT capsule, BIJUVA® in UK and BIJUVE®in Belgium.

    TherapeuticsMDInc (TXMD) along with its collaborating partner Theramex announced the approval of BIJUVE® Capsules in the United Kingdom and under the trade name BIJUVA® in Belgium. Theramex is a global specialty pharmaceutical company and like TXMD stock it is dedicated to women’s health. Its vision is to be a lifetime partner for women and has a portfolio of contraceptive, fertility, menopause, and osteoporosis related products covered under established brand names.

    United Kingdom and Belgium are not the first countries where the Hormone Replacement Therapy has been released; USA had BIJUVA made commercially available in April 2019, while Canada and Israel have these commercially available as well. However BIJUVA is Europe’s first and only oral HRT with bio-identical hormones; specifically Estradiol and micronized Progesterone made available.

    Theramex signed an exclusive licensing and supply agreement with TherapeuticsMD Inc. in June 2019, to make BIJUVA available outside of these countries, especially in the European market. This agreement states Theramex paying TherapeuticsMD, certain royalties and milestone fees based upon aggregate net sales.

    The approval in European countries is a major positive move for TXMD stock

    The process of regulatory approval was a decentralized procedure that took place in February and afterwards each country has its own terms and conditions for medical approval. The approval for other significant EU countries will take place shorty, as expected by Theramex. It is possible to see a positive trend of TXMD stock maintain for longer period if commercial availability and approvals come further down the year.

  • Early Morning Vibes: Top 4 Stocks To Buy Right Now

    Early Morning Vibes: Top 4 Stocks To Buy Right Now

    US stock indices closed with growth on Monday. The last week rally in US government bond yields stalled, easing investors’ concerns about the prospects of raising interest rates.

    The S&P 500 jumped 90.67 points, or 2.4%, to 3901.82, the largest percentage gain in a single session since June 5 last year. The Dow Jones Industrial Average rose 603.14 points, or 1.9%, to 31,535.51, and the Nasdaq Composite rose 396.48 points, or 3%, to 13588.83.

    All three indices declined last week under pressure from the plummeting tech sector. Their recovery on Monday took place against the backdrop of a decrease in the yield of 10-year US Treasury bonds (a benchmark for the cost of borrowing in world markets) from Friday 1.459% to 1.444%.

    The stock market, especially the tech sector, has been hit in recent sessions by volatility in government bond markets. The rise in long-term bond yields, fueled by an improved economic outlook, makes technology stocks and other fast-growing companies less attractive to investors. Even with Monday’s gains, the Nasdaq remains 3.6% below its Feb 12 record close.
     Yields on bonds soared higher last week, calling into question the prospect of continued low-interest rates that saw the rally in equities last year. In addition, the likelihood of the end of the loose monetary policy used by the Fed to fight inflation has increased.

    After the House passed a $ 1.9 trillion package of measures, Biden called on the Senate for swift action over the weekend. Democrats are aiming to formalize the package by March 14, when some federal unemployment benefits are due to expire.Some investors are worried that rising government bond yields and mounting inflationary pressures could destabilize the stock market, especially in light of the expected huge federal spending as part of Biden’s stimulus package.

    Meanwhile, according to data released on Monday, manufacturing activity in the US grew at the fastest pace since the start of the pandemic in February. The purchasing managers’ index (PMI) of the Institute of Supply Management for February was 60.8 points against 58.7 in January. Economists’ forecast suggested that the index will be 58.9 points. Index readings above 50 indicate increased activity.
     Several Fed officials are due to speak later this week, and investors will be watching these speeches closely for signs of concern about government bond yields.

    The improvement in investment sentiment was noticeable outside the United States as well. Thus, the pan-European index Stoxx Europe 600 rose by 1.8%. The growth was led by shares of retail and travel companies, whose fate depends on the recovery of economic activity.

    Today Top Movers

    Great Elm Group Inc (GEG) share price surged 96.52% to $6.78 in pre-market trading today. 

    TherapeuticsMD Inc. (TXMD) stock soared 16.26% to $1.68 in the pre-market trading. 

    Inuvo Inc. (AMEX: INUV) shares are trading up 20.61% at $1.58 at the time of writing. 

    STRATA Skin Sciences Inc. (SSKN) grew over 56.07% at $2.7 in pre-market trading today after declaring inducement grants under Nasdaq Listing Rule 5635(c)(4).

    Top Upgrades & Downgrades

    KeyBanc turned bullish on Akamai Technologies Inc. (AKAM), upgrading the stock to “Overweight” and assigning a $119.0 price target, representing a potential upside of 24.04% from Monday’s close. 

    Repay Holdings Corporation (RPAY) has won the favor of Wells Fargo’s equity research team. The firm upgraded the shares from Equal-Weight to Overweight and moved their price target to $29. 

    Morgan Stanley (MS) received an upgrade from analysts at Daiwa, who also set their one-year price target on the stock to $86. They changed their rating on MS to Outperform from Neutral in a recently issued research note. 

    Earlier Tuesday SVB Leerink reduced its rating on Athenex Inc. (ATNX) stock to Market Perform from Outperform and assigned the price target to $5. 

    JPMorgan analysts reduced their investment ratings, saying in research reports covered by the media that it’s rating for Viatris Inc. (VTRS) has been changed to Neutral from Overweight and the new price target is set at $18. 

    Analysts at B. Riley Securities downgraded Service Properties Trust (SVC)’s stock to Neutral from Buy Tuesday.

    Latest Insider Activity

    Facebook Inc. (FB) COB and CEO Zuckerberg Mark announced the sale of shares taking place on Feb 26 at $261.38 for some 44,750 shares. The total came to more than $11.7 million. 

    Morphic Holding Inc. (MORF) Director Omega Fund V, L.P. sold on Mar 01 a total of 2,551,555 shares at $45.93 on average. The insider’s sale generated proceeds of almost $0.32 million. 

    Abbott Laboratories (ABT) Director Kumbier Michelle declared the purchase of shares taking place on Feb 23 at $122.50 for some 2,040 shares. The transaction amount was around $0.25 million. 

    United Parcel Service Inc. (UPS) Director Hewett Wayne M. bought on Feb 24 a total 868 shares at $159.82 on average. The purchase cost the insider an estimated $99,887.

    Important Earnings

    Top US earnings releases scheduled for today include Kopin Corporation (KOPN). It will announce its Dec 2020 financial results. The company is expected to report earnings of -$0.01 per share from revenues of $21.89M in the three-month period. 

    Analysts expect Hewlett Packard Enterprise Company (NYSE:HPE) to report a net income (adjusted) of $0.41 per share, when the company releases its quarterly results shortly. Revenue for the fiscal quarter ended Jan 2021 is predicted to come in at $9.33M. 

    fuboTV Inc. (FUBO), due to announce earnings after the market closes today, is expected to report earnings of -$0.73 per share from revenues of $93.94M recently concluded three-month period.

  • 15 Top Performing Stocks In Healthcare Industry

    15 Top Performing Stocks In Healthcare Industry

    The health care industry is considered to be the opportunity-rich industry. The demand in this industry is continuously increasing. Emerging technologies also play a very important role in the health care industry. Complex health and technology ecosystems and increasing consumer expectations are the major challenges which the health care industry is facing. Customers’ main priority is affordable and efficient drugs.

    If we look at the Drug manufacturers and specialty generic industry, this industry has seen a huge transformation over the last two decades. This industry is always striving to change fast enough to keep up with regulatory and patients needs. Currently, the healthcare industry has faced the major challenge of the COVID-19 pandemic. It is important to focus on what is happening in the market to increase industry growth.

    Here are the 15 leading companies in the Drug Manufacturers and specialty and generic industry:

    Zomedica Pharmaceuticals Corp. (AMEX: ZOM)

    Zomedica Pharmaceuticals Corp. (AMEX: ZOM) shares were trading up 42.86% at $0.10 at the time of writing on Monday. Zomedica Pharmaceuticals Corp. (AMEX: ZOM) share price went from a low point around $0.07 to briefly over $0.50 in past 52 weeks, though shares have since pulled back to $0.10. ZOM market cap has remained high, hitting $79.71M at the time of writing.

    Zomedica Pharmaceuticals Corp. has earlier revealed its proxy solicitor, Alliance Advisors, mailed the letter to selected shareholders in advance of its Annual and Special Virtual-Only Meeting of Shareholders. The virtual meeting is scheduled to hold on September 25, 2020.

    AcelRx Pharmaceuticals Inc. (NASDAQ: ACRX)

    AcelRx Pharmaceuticals Inc. (NASDAQ: ACRX) last closed at $1.81, in a 52-week range of $0.70 to $2.68. AcelRx Pharmaceuticals Inc. (ACRX) announced today that the U.S. Army has granted AcelRx with an initial contract of up to approximately $3.6 million for the purchase of DSUVIA to support a study to aid the development of clinical practice guidelines. This company’s market capitalization has remained high, hitting $142.61 million at the time of writing.

    PPD Inc. (NASDAQ: PPD)

    PPD Inc. (NASDAQ: PPD) stock soar by 0.92% to $34.16. The most recent rating by KeyBanc Capital Markets, on June 04, 2020, is at an Overweight. PPD Inc. (PPD) has earlier revealed that it has received the honor of employer of choice around the world. PPD was recognized as a top 50 desirable employer in Bulgaria, according to the second annual Employer of Choice Survey organized by the employer brand and business consulting agency To The Top. This company market capitalization has remained high, hitting $11.61 billion at the time of writing.

    Adamis Pharmaceuticals Corporation (NASDAQ: ADMP)

    Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) last closed at $0.80, in a 52-week range of $0.27 to $1.51. Analysts have a consensus price target of $1.25. Adamis Pharmaceuticals Corporation (ADMP) has earlier revealed the pricing of its previously announced underwritten public offering of 16,129,032 shares of its common stock at a public offering price of $0.62 per share, resulting in gross proceeds of approximately $10,000,000.

    Rockwell Medical Inc. (NASDAQ: RMTI)

    Rockwell Medical Inc. (NASDAQ: RMTI) last closed at $1.76, in a 52-week range of $1.10 to $3.85. Rockwell Medical Inc. (RMTI) has earlier named Russell L. Skibsted, M.B.A., as Executive Vice President, Chief Financial Officer  and Chief Business Officer (CBO), effective from September 15, 2020. This company market capitalization has remained high, hitting $96.44 million at the time of writing.

    TherapeuticsMD Inc. (NASDAQ: TXMD)

    TherapeuticsMD Inc. (NASDAQ: TXMD) stock soars 2.75% to $1.44. The most recent rating by Jefferies, on August 07, 2020, is at an Underperform. TherapeuticsMD Inc. (TXMD) Knight Therapeutics Inc. and TherapeuticsMD, Inc. revealed that they received the approval of BIJUVA® (estradiol and progesterone) capsules by Health Canada. This company has a market capitalization of $368.06 million at the time of writing.

    Zoetis Inc. (NYSE: ZTS)

    Zoetis Inc. (NYSE: ZTS) rose 0.06% after gaining more than $0.01 on Tuesday. Zoetis Inc. (ZTS) has been recognized by Working Mother magazine for its career advancement opportunities, female representation and work-life programs. in the past 52-weeks of trading, Zoetis stock has fluctuated between the low of $90.14 and a high of $165.82. ZTS has moved up 78.59% from its 52-weeks low and moved down -2.92% from its 52-weeks high.  ZTS market cap has remained high, hitting $76.29 billion at the time of writing.

    DURECT Corporation (NASDAQ: DRRX)

    DURECT Corporation (NASDAQ: DRRX) stock drop by -5.41% to $1.75. The most recent rating by Oppenheimer, on July 31, 2020, is at an Outperform. DURECT Corporation (DRRX) has revealed the study design for the Phase 2b AHFIRM clinical trial of DUR-928 in severe alcoholic hepatitis (AH) patients. DURECT Corporation market cap has remained high, hitting $333.92 million at the time of writing.

    Elanco Animal Health Incorporated (NYSE: ELAN)

    Elanco Animal Health Incorporated (NYSE: ELAN) shares headed rising, higher as much as 0.56%. The most recent rating by Morgan Stanley, on August 20, 2020, is at an Overweight. In the past 52-weeks of trading, this company stock has fluctuated between the low of $15.17 and a high of 32.66. Elanco Animal Health Incorporated (ELAN) has moved up 76.01% from its 52-weeks low and moved down -18.25% from its 52-weeks high.

    Guardion Health Sciences Inc. (NASDAQ: GHSI)

    Guardion Health Sciences Inc. (NASDAQ: GHSI) rose 1.22% on Monday. Guardion Health Sciences Inc. (GHSI) share price went from a low point around $0.17 to briefly over $0.95 in the past 52 weeks, though shares have since pulled back to $0.25. Guardion Health Sciences Inc.’s market cap has remained high, hitting $22.26 million at the time of writing.

    Agile Therapeutics Inc. (NASDAQ: AGRX)

    Agile Therapeutics Inc. (NASDAQ: AGRX) shares headed falling, lower as much as -6.89%. The most recent rating by Janney, on April 12, 2019, is at a Buy. In the past 52-weeks of trading, Agile Therapeutics Inc. stock has fluctuated between the low of $0.35 and a high of $4.77. Agile Therapeutics Inc. has moved up 807.14% from its 52-weeks low and moved down -33.37% from its 52-weeks high.

    Momenta Pharmaceuticals Inc. (NASDAQ: MNTA)

    Momenta Pharmaceuticals Inc. (NASDAQ: MNTA) stock drops 0.02% after losing -0.01 on Tuesday. Momenta Pharmaceuticals Inc. (MNTA) share price went from a low point around $12.21 to briefly over $52.45 in the past 52 weeks, though shares have since pulled back to $52.36. Momenta Pharmaceuticals Inc.’s market cap has remained high, hitting $6.24 billion at the time of writing.

    Catalent Inc. (NYSE: CTLT)

    Catalent Inc. (NYSE: CTLT) stock drop 0.86% to $84.81. The most recent rating by Argus, on June 25, 2020, is at a Buy. In the past 52-weeks of trading, Catalent Inc. (CTLT) stock has fluctuated between the low of $31.04 and a high of $95.70. Catalent Inc. has moved up 173.23% from its 52-weeks low and moved down -11.38% from its 52-weeks high.  Catalent Inc. market cap has remained high, hitting $13.94 billion at the time of writing.

    Ironwood Pharmaceuticals Inc. (NASDAQ: IRWD)

    Ironwood Pharmaceuticals Inc. (NASDAQ: IRWD) shares headed falling, lower as much as 2.22%. The most recent rating by Northland Capital, on June 17, 2020, is at an Outperform. Ironwood Pharmaceuticals Inc. (IRWD) share price went from a low point around $7.91 to briefly over $14.10 in the past 52 weeks, though shares have since pulled back to $9.48. Ironwood Pharmaceuticals Inc.’s market cap has remained high, hitting $1.54 billion at the time of writing.

    Athenex Inc. (NASDAQ: ATNX)

    Athenex Inc. (NASDAQ: ATNX) last closed at $12.80, in a 52-week range of $5.63 to $18.35. Athenex Inc. (ATNX) has moved up 127.35% from its 52-weeks low and moved down -30.25% from its 52-weeks high.  Athenex Inc. market cap has remained high, hitting $1.14 billion at the time of writing.