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Tag: ITRM

  • Iterum Therapeutics plc (ITRM) stock drops in Pre-Market today : Here’s to know why

    Shares of the Iterum Therapeutics plc (ITRM) stock were dropping in the pre-market trading session today on July 28, 2021, after rising to a good height in the last trade. ITRM stock price saw a decline of 6.88% to drop at $0.69 a share at the time of this writing. The penny stock went high by 17.53% at the previous closing. Let’s try to figure out the reason behind this fall.

    What’s Happening?

    Iterum Therapeutics plc is the clinical-stage biotechnology stock that develops anti-infectives to treat infectious diseases that cause due to multi-drug resistant pathogens.  ITRM stock is falling in pre-market today despite any obvious reason related to it. No specific news or announcement in today’s date is available to justify the bearish sentiment. ITRM stock dropped 68.73% in the last 30 days and in the past 12 months, the penny stock dropped by 32.64%. Let’s take a look at some recent events of the Iterum.

    ITRM stock received Response Letter from FDA:

    Iterum stock received a complete response letter(CRL) from U.S Food and Drug Administration for its new drug application(NDA) oral sulopenem on July 23, 2021. The FDA did not approve the new drug application in its present form. According to CRL, FDA acknowledged the significant statistical data of the overall response rate of the oral sulopenem against ciprofloxacin in the population resistant to ciprofloxacin. However, FDA mentioned in the CRL that this data is not sufficient and demanded additional data for the approval of the drug.

    FDA recommendations to ITRM stock:

    The FDA recommended Iterum stock to conduct at least one more well-controlled and adequate clinical trial by using a different comparator drug. Moreover, the recommendations also included a nonclinical investigation of the NDA in order to determine the optimal dose prescription. However, this recommendation was not connected with approvability of the drug.

    Financial View of ITRM stock:

    According to the first quarter 2021 financial results, Iterum stock suffered a net loss of  $98.9 million as compared to a $16.1 million net loss in the same quarter of the prior year. The penny stock spent $2.5 million and $3.4 million in R&D expenses and general and administrative expenses respectively. At the end of the first quarter, Iterum had $100.5 million in cash, cash equivalents, and short-term investments.

    Wrap Up:

    The penny stock is now red in Wednesday’s pre-market trading session after a strong gain in the last trade. ITRM stock has a market cap of 132.7 million and a 13,786,501 average trading volume.

  • Here is why Iterum Therapeutics plc (ITRM) stock plummeted on Thursday?

    Iterum Therapeutics plc (ITRM) shares plunged 39.74% in after-hours on Thursday, July 1, 2021, and closed the day at $1.38 per share. earlier in the morning session, ITRM’s stock lost 0.87% to close Thursday’s normal session at $2.29 per share. ITRM shares have risen 92.44% over the last 12 months, and they have moved up 12.81% in the past week. Over the past three months, the stock has gained 56.85%, while over the past six months, it has declined 140.55%.

    Let’s have a look at ITRM recent developments.

    Recent Regulatory Update about sulopenemetzadroxil/probenecid

    On July 01, 2021, Iterum Therapeutics plc received a letter from the U.S. Food and Drug Administration (FDA) stating that as part of their ongoing review of the Company’s New Drug Application (NDA) for sulopenemetzadroxil/probenecid.

    The FDA identified deficiencies that prevent the continuation of the discussion of labeling and post-marketing requirements. The notification does not reflect a final decision on the information under review and FDA has set July 25, 2021, for completion of its review of the NDA.

    Recent financial results

    On May 14, 2021, Iterum Therapeutics plc announced its financial results for the first quarter ended March 31, 2021.

    Q1 2021 financial highlights

    • Research and development expenses were $2.5 million inQ1 2021 compared to $9.7 million for the same period in 2020.
    • General and administrative expenses were $3.4 million in Q1 2021 compared to $3.2 million in Q1 2020.
    • Iterum suffered from a non-GAAP net loss of $6.1 million in Q1 2021 compared to a non-GAAP net loss of $13.4 million for Q1 2020.
    • Iterum reported a net loss of $98.9 million in Q1 2021 compared to a net loss of $16.1 million in Q1 2020.
    • Net loss per share attributable to ordinary shareholders, basic and diluted was $0.81 in Q1 2021 compared to $1.08 in Q1 2020.
    • Iterum had cash, cash equivalents and short-term investments of $100.5 million on March 31, 2021. 

    Participation in the investor and health conferences

    Iterum Therapeutics participated in the 20th Annual Needham Virtual Healthcare Conference which held on Thursday, April 15, 2021. The company was presented by Chief Executive Officer, Corey Fishman.

    The company took part in HC Wainwright Global Life Sciences Conference which held on March 9, 2021.

    The company also participated in SVB Leerink Annual Global Healthcare Conference which held on Thursday, February 25, 2021.

    New Board member

    On March 16, 2021, Iterum Therapeutics appointed Beth P. Hecht to the Company’s Board of Directors replacing Patrick Heron, who left the Board on March 12, 2021. Ms. Hecht will also serve as a member of the Audit Committee and Compensation Committee of the Board.

    Conclusion

    The recent letter from the FDA identifying the deficiencies in its NDA for sulopenemetzadroxil was the reason behind its poor performance on Thursday. ITRM can face more headwinds on Friday as well.

  • Early Morning Vibes: 4 Trending Stocks To Watch Right Now

    Early Morning Vibes: 4 Trending Stocks To Watch Right Now

    On February 12, American stock markets closed in the green. The S&P 500 Index climbed 0.47% to 3935 points, the NASDAQ rose 0.50%, and the Dow Jones added a symbolic 0.09%. Prospects for the adoption of another fiscal stimulus program in the States continued to support quotations. The healthcare sector outperformed the market, climbing 0.75% on a positive Illumina report. The finance sector grew 0.95% on the back of rising Treasury yields.

    Company news

    Illumina (ILMN: + 11.9%) quarterly results exceeded expectations on strong demand for DNA instruments.

    PayPal (PYPL: + 4.7%) expects to double the number of users of the payment system by 2025 from its current 377 million, tripling the volume of transactions.

    HubSpot (HUBS: + 16.4%), a cloud-based marketing and sales solutions provider, delivered strong reporting on the digitalization trend in small and medium-sized businesses.

    Today, global stock markets are showing mixed dynamics. The news background remains quite calm. Market participants’ optimism is boosted by the improved epidemiological situation in Europe and the USA, accelerated vaccination, and the prospects for fiscal stimulus. The seven-day average number of coronavirus cases in the United States for the first time since November fell below 100 thousand, and the number of hospitalized people fell from 80 thousand to 65 thousand in just a week. The situation is improving in all 50 states. Pessimists expect new outbreaks of disease due to the spread of virus mutations, however, if the current positive trends continue, the anticoid restrictions will begin to be lifted everywhere pretty soon.

    Joe Biden plans to make his first trip outside Washington as president today. He will deliver a speech in Wisconsin on the fiscal stimulus package. The president is also expected to speak out on the pandemic and its impact on the US economy. The purpose of the speech is ultimately to speed up the negotiating process in Congress. No new information is expected, but the broadcast of the president’s speech may have a positive effect on the sentiment of private investors, whose share in trade turnover continues to increase.

    The Freedom Finance Sentiment Index climbed to 71 out of 100. The indicator reflects market participants’ hope for a global economic recovery in 2021. Worries about the negative impact of the coronavirus pandemic continue to ease thanks to the prospect of mass vaccinations.

    Technically, the S&P 500 remains in an uptrend. Resistance at its upper boundary is still a significant obstacle. A breakthrough of this resistance at 3950 points will mean an acceleration of growth. However, the RSI indicator is already close to the overbought level, so the positive potential in the short-term is limited.

    Today Top Movers

    Strongbridge Biopharma plc (SBBP) share price jumped 53.01% to $5.08 during the early morning ‎trading session on ‎Tuesday.‎ 

    ‎Socket Mobile Inc (SCKT), a Computer Hardware company, soared about 72.44% ‎at $5.59 in pre-market ‎trading Tuesday after the company launched the first enterprise-grade scanners for Apple iPhone 12 series. 

    ‎Denison Mines Corp (DNN) stock ascended 17.11% at $1.30 in the pre-market trading today.‎‎ 

    ‎Sundial Growers Inc (SNDL) gained over 9.13% at $2.27 in pre-market ‎trading on Tuesday.‎‎

    Top Upgrades & Downgrades

    Wells Fargo turned bullish on Extraction Oil & Gas Inc. (XOG), upgrading the stock to “Overweight” and assigning a $38.0 price target, representing a potential upside of 19.5% from Friday’s close. 

    Anaplan Inc. (PLAN) has won the favor of Morgan Stanley’s equity research team. The firm upgraded the shares from Equal-Weight to Overweight and moved their price target to $100.0, suggesting a 21.49% additional upside for the stock. 

    Albemarle Corporation (ALB) received an upgrade from analysts at Deutsche Bank, who also set their one-year price target on the stock to $190.0. They changed their rating on ALB to Buy from Hold in a recently issued research note. 

    Earlier Sunday Baird reduced its rating on American Express Company (AXP) stock to Neutral from Outperform and assigned the price target to $126. 

    Baird analysts reduced their investment ratings, saying in research reports covered by the media that it’s rating for Republic Services Inc. (RSG) has been changed to Neutral from Outperform and the new price target is set at $96. 

    Analysts at Baird downgraded Waste Management Inc. (WM)’s stock to Neutral from Outperform Tuesday.

    Latest Insider Activity

    Iterum Therapeutics plc (ITRM) 10% Owner DENNER ALEXANDER J announced the sale of shares taking place on Feb 12 at $2.27 for some 10,619,949 shares. The total came to more than $24.11 million. 

    Uber Technologies Inc. (UBER) Hazelbaker Jill sold on Feb 12 a total of 126,953 shares at $60.12 on average. The insider’s sale generated proceeds of almost $1.25 million. 

    InspireMD Inc. (NSPR) Director Kester Thomas J declared the purchase of shares taking place on Feb 08 at $0.62 for some 120,960 shares. The transaction amount was around $74995. 

    Dun & Bradstreet Holdings Inc. (DNB) Chief Financial Officer Hipsher Bryan T. bought on Feb 11 a total 9,000 shares at $23.30 on average. The purchase cost the insider an estimated $116,500.

    Important Earnings

    Top US earnings releases scheduled for today include Sabre Corporation (NASDAQ: SABR). It will announce its Dec 2020 financial results. The company is expected to report earnings of -$0.66 per share from revenues of $328.57M in the three-month period. 

    Analysts expect Genworth Financial Inc. (NYSE: GNW) to report a net income (adjusted) of $0.22 per share when the company releases its quarterly results shortly. Revenue for the fiscal quarter ended Dec 2020 is predicted to come in at $2.06B. 

    Occidental Petroleum Corporation (OXY), due to announce earnings after the market closes today, is expected to report earnings of -$0.58 per share from revenues of $4.37B recently concluded three-month period.

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

    Early Morning Vibes: Top 4 Stocks To Buy Right Now

    The session on February 8, American stock markets ended in the green zone. The S&P 500 index rose 0.74% to 3916 points, the Dow Jones rose 0.76% and the NASDAQ surged 0.57%. All three indices renewed their all-time highs. The growing prospects for a major economic support package in the US remain in focus. The energy sector climbed 4.17% on the back of an ongoing rally in oil. Increased risk appetite triggered a 0.78% correction in the defensive utility sector.

    Company news

    Children’s goods maker Hasbro (HAS: -4.3%) beat expectations, but management noted weak holiday sales.

    Palantir (PLTR: + 5.9%) announced a partnership with IBM (IBM: + 1.5%) to develop technology products.

    Tesla (TSLA: + 1.3%) invested $ 1.5 billion in bitcoin and announced that it will accept cryptocurrency as payment for electric cars.

    Today, global stock markets are showing mixed dynamics. Discussions on the fiscal stimulus package remain in the spotlight. The passage of a bill on public spending in the amount of about $ 1.9 trillion threatens to accelerate inflation. Some experts warn about this, in particular, former Treasury Secretary Larry Summers. Investors in the debt market are reacting to this risk, so the day before, the rate on 30-year Treasuries rose above 2% for the first time in a year. Rising bond rates could put pressure on the attractiveness of the stock market, primarily on growth stocks, of which tech companies are prime examples.

    The epidemiological situation in the United States continues to improve rapidly, despite the circulation of new strains of coronavirus. The number of hospitalized people dropped to 80 thousand, more than 10% of Americans have already received the first dose of the vaccine. However, the risk of another jump in the incidence remains, so the CDC is not yet recommending state authorities to remove the antiquated restrictions.

    Technical picture

    Technically, the S&P 500 is still in a medium-term uptrend. The session ended the day before at the upper trend line, which is still a significant obstacle. The S & P500 index recorded growth for the sixth session in a row, so short-term consolidation is likely.

    Today Top Movers

    Iterum Therapeutics PLC (ITRM) stock ascended 61.69% at $2.04 in the pre-market trading today.‎‎ Ra Capital Management reportedly disclosed ownership of 13,730,376 shares of Iterum Therapeutics plc by filing a 13G form with the Securities and Exchange Commission. 

    ‎Assertio Therapeutics Inc (ASRT) gained over 25.24% at $1.29 in pre-market ‎trading on Tuesday.‎‎ Assertio is a leading commercial pharmaceutical company bringing differentiated products to patients. The Company has a robust portfolio of branded prescription products in three areas: neurology, hospital and pain and inflammation. 

    ‎Aurora Mobile Ltd (JG) grew over 13.91% at $6.55 in pre-market trading ‎today following the receipt of the InfoQ 2020 Best Technology Community Award at the Developer Ecosystem Co-creation Program virtual conference, hosted by InfoQ.‎

    ‎Marathon Patent Group Inc (MARA) stock moved up 16.93 percent to $37.50 in the pre-market ‎trading.‎‎ MARA stock is rallying because of the spike in Bitcoin. Marathon Patent Group bills itself as one of the largest Bitcoin self-mining companies.

    Top Upgrades & Downgrades

    JP Morgan turned bullish on KKR Real Estate Finance Trust Inc. (KREF), upgrading the stock to “Overweight”.

    Twilio Inc. (TWLO) has won the favor of JP Morgan’s equity research team. The firm upgraded the shares from Neutral to Overweight and moved their price target to $465.0, suggesting a 1.39% additional upside for the stock. 

    The Community Financial Corporation (TCFC) received an upgrade from analysts at Piper Sandler, who also set their one-year price target on the stock to $34.0. They changed their rating on TCFC to Overweight from Neutral in a recently issued research note. 

    Earlier Tuesday JP Morgan reduced its rating on Ladder Capital Corp (LADR) stock to Underweight from Neutral and assigned the price target to $10. 

    Needham analysts reduced their investment ratings, saying in research reports covered by the media that its rating for Cubic Corporation (CUB) has been changed to Hold from Buy.

    Latest Insider Activity

    Advanced Micro Devices Inc. (AMD) EVP, Computing & Graphics Bergman Rick announced the sale of shares taking place on Feb 04 at $88.29 for some 2,000 shares. The total came to more than $0.18 million. 

    Facebook Inc. (FB) COB and CEO Zuckerberg Mark sold on Feb 05 a total of 44,750 shares at $267.92 on average. The insider’s sale generated proceeds of almost $11.99 million. 

    Accuray Incorporated (ARAY) Director WHITTERS JOSEPH E declared the purchase of shares taking place on Feb 01 at $5.02 for some 20,000 shares. The transaction amount was around $0.1 million. 

    Consolidated Edison Inc. (ED) President & CEO CET Nachmias Stuart bought on Jan 31 a total 1,078 shares at $70.78 on average. The purchase cost the insider an estimated $667.

    Important Earnings

    Top US earnings releases scheduled for today include Cisco Systems Inc. (NASDAQ: CSCO). It will announce its Jan 2021 financial results. The company is expected to report earnings of $0.76 per share from revenues of $11.92B in the three-month period. 

    Analysts expect Isoray Inc. (AMEX: ISR) to report a net income (adjusted) of -$0.01 per share when the company releases its quarterly results shortly. Revenue for the fiscal quarter ended Dec 2020 is predicted to come in at $2.39M. 

    Twitter Inc. (TWTR), due to announce earnings after the market closes today, is expected to report earnings of $0.31 per share from revenues of $1.19B recently concluded three-month period.

  • 21 Stocks Taking Bigger Strides in Pre Market Session

    21 Stocks Taking Bigger Strides in Pre Market Session

    ‎Velodyne Lidar Inc. (VLDR) stock soared 7.5% to $26.53 in the pre-market trading ‎after reporting that it has joined the Qualcomm® Smart Cities Accelerator Program to promote using ‎lidar technology in smart city solutions. The most recent rating by Needham, on December 15, 2020, is ‎a Buy. ‎

    ‎MicroVision Inc. (MVIS) grew over 14.38% at $6.6 in pre-market trading today.‎

    ‎Aurora Mobile Limited (NASDAQ: JG) shares are trading up 48.9% at $4.75 at the ‎time of writing following the announcement from the firm that it has entered into a partnership ‎agreement with a global leading new energy vehicle manufacturer. Company’s 52-week ranged ‎between $1.40 to $5.43.‎

    ‎Castor Maritime Inc. (CTRM) stock moved down -3.97 percent to $0.1522 in the pre-‎‎‎‎market trading.‎

    ‎HEXO Corp. (HEXO), a Drug Manufacturers – Specialty & Generic company, rose ‎about 8.0% at $1.08 in pre-market trading Tuesday after reporting lapse of base shelf prospectus.‎

    ‎Novan Inc. (NOVN) stock plunged -5.8% to $0.6396 in the pre-market trading after ‎declaring that it has entered into a Master Services Agreement (MSA) with Catalent.‎

    ‎Nano Dimension Ltd. (NNDM) gained over 2.38% at $8.61 in pre-‎‎‎market ‎trading ‎Tuesday December 22, 2020.‎

    ‎Gevo Inc. (NASDAQ: GEVO) shares are trading up 8.39% at $3.1 at the time of ‎writing following the declaration from the company that it has optioned the right to purchase ‎approximately 239 acres of land near Lake Preston, SD Company’s 52-week ranged between $0.46 to ‎‎$2.87. Gevo Options Site for Expansion Project.‎

    ‎electroCore Inc. (ECOR) gained over 7.36% at $1.75 in pre-market trading Tuesday ‎December 22, 2020 after reporting agreement with Pro Medical Baltic to be exclusive distributor for ‎gammaCore Sapphire in Eastern Europe.‎

    ‎Nxt-ID Inc. (NXTD), a Security & Protection Services company, dropped about -‎‎‎‎4.41% at $1.3 in pre-market trading Tuesday.‎

    ‎Iterum Therapeutics plc (NASDAQ: ITRM) shares are trading up 2.35% at $1.0 at the ‎time of writing after receiving approval to transfer to Nasdaq Capital Market. Company’s 52-week ‎ranged between $0.45 to $6.47. Analysts have a consensus price target of $2. ‎

    ‎Aurora Cannabis Inc. (ACB) stock moved up 2.13 percent to $9.13 in the pre-‎‎‎market ‎trading.‎

    ‎Venus Concept Inc. (VERO) tumbled over -16.14% at $2.13 in pre-market trading ‎today following the announcement of proposed public offering.‎

    ‎UP Fintech Holding Limited (NASDAQ: TIGR) shares are trading up ‎‎7.97% ‎at ‎‎$6.37 ‎at ‎the time of writing. Company’s 52-week ranged between $2.03 to $7.60.‎

    ‎IZEA Worldwide Inc. (IZEA) lost over -1.78% at $1.38 in pre-‎‎market ‎trading ‎Tuesday ‎December 22, 2020.‎

    ‎500.com Limited (WBAI), a Gambling company, rose about 9.14% at $4.18 in pre-‎market trading Tuesday following the declaration from the firm that it has entered into a definitive ‎share subscription agreement with Good Luck Information Technology Co., Limited , a company ‎incorporated in Hong Kong, for the issuance and sale of newly issued Class A ordinary shares of the ‎Company.‎

    ‎Liminal BioSciences Inc. (LMNL) stock soared 2.76% to $5.21 in the pre-‎‎‎market ‎trading. The most recent rating by Piper Sandler, on December 21, 2020, is an Overweight.‎

    ‎Palantir Technologies Inc. (PLTR) gained over 1.72% at $29.0 in pre-market trading ‎Tuesday December 22, 2020 after declaring that the U.S. Army’s Program Executive Office for ‎Enterprise Information Systems (PEO EIS) opted to execute the second year of its partnership with ‎Palantir on the Army Vantage program, for a total price of $113.8 million for the year.‎

    ‎EyeGate Pharmaceuticals Inc. (EYEG) is down more than -3.84% at $5.01 in pre-‎market hours Tuesday December 22, 2020 after announcing the acquisition of Panoptes Pharma. The ‎stock had jumped over 45.94% to $5.21 in the last trading session. ‎

    Before the trading started on December 22, 2020, Kopin Corporation (KOPN) ‎is ‎up ‎‎8.43% to reach $2.83. It has been trading in a 52-week range of $0.19 to $2.16.‎

    ‎Bit Digital Inc. (BTBT) grew over 4.96% at $6.56 in pre-market trading today following ‎the release of its third quarter of fiscal year 2020 financial results.‎

  • Biotech Roundup &The delivery of the Pfizer’s vaccine to U.S. – starts Today

    Biotech Roundup &The delivery of the Pfizer’s vaccine to U.S. – starts Today

    This weekend, the U.S. government is packaging millions of doses of the coronavirus vaccine from Pfizer and BioNTech for distribution to places around the country, a mammoth logistics task in favor of what could be the most difficult immunization campaign in history.

    In delivering the vaccine, which is delicate and needs careful care, FedEx and UPS would play key roles. At the terminal, shipments can gain preferential entry. If a plane arrives to land with vaccinations, other passenger flights may have to loop around to wait for their chance.

    The arrival of the first vaccines comes as the virus continues to rage through the USA, with more than 207,000 new cases identified on Saturday by authorities. That took the number to more than 16 million, the most in the world by far. For the first time on Wednesday, more than 3,000 deaths were reported, and the country’s number is nearing 300,000.

    vTv Therapeutics Inc. (NASDAQ:VTVT) shares were trading up 41.55% at $3.10 at the time of writing on Friday. The firm on November 25, 2020 announced common stock purchase agreement for up to $47 million with Lincoln Park Capital.

    vTv Therapeutics Inc. (NASDAQ:VTVT) share price went from a low point around $1.44 to briefly over $4.23 in past 52 weeks, though shares have since pulled back to $3.10. VTVT market cap has remained high, hitting $161.79M at the time of writing, giving it price-to-sales ratio of more than 7350.

    If we look at the recent analyst rating VTVT, H.C. Wainwright initiated coverage on VTVT shares with a Buy rating.

    aTyr Pharma Inc. (LIFE) last closed at $4.64, in a 52-week range of $2.13 to $7.62. The company on November 13, 2020 released third quarter results and provided a corporate update.

    ADiTx Therapeutics Inc. (ADTX) stock soar by 3.77% to $2.48. The firm reported on December 8, 2020, that it will present at the 13th annual LD Micro main event conference on Tuesday, December 15, 2020 at 11:00 AM EST / 8:00 AM PST.

    9 Meters Biopharma Inc. (NASDAQ:NMTR) Shares headed falling, lower as much as -11.75%.

    Iterum Therapeutics plc (NASDAQ:ITRM) rose 11.72% after gaining more than $0.1 on Friday. The biotechnology firm declared on December 7,2020, filing of US patent application based on favorable written opinion of the International Search Authority.

    Vaxart Inc. (VXRT) last closed at $7.44, in a 52-week range of $0.28 to $17.49.

    Catabasis Pharmaceuticals Inc. (CATB) stock soar by 14.51% to $2.21. The most recent rating by Wedbush, on November 02, 2020, is at a Neutral.

    Advaxis Inc. (NASDAQ:ADXS) Shares headed rising, higher as much as 3.56%. The company on November 27, 2020 reported the closing of $9.2 million public offering. The most recent rating by Barclays, on August 03, 2016, is at an Overweight.

    Xeris Pharmaceuticals Inc. (NASDAQ:XERS) rose 11.74% after gaining more than $0.48 on Friday following an announcement from the company that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive Opinion for Ogluo™ (glucagon).

    Novavax Inc. (NVAX) last closed at $124.88, in a 52-week range of $3.65 to $189.40. The firm on December 9, 2020, declared the appointment of Margaret G. McGlynn, R. Ph. to its board as an independent director. Analysts have a consensus price target of $186.20.

    Corbus Pharmaceuticals Holdings Inc. (CRBP) stock soar by 1.52% to $1.34. The most recent rating by ROTH Capital, on September 08, 2020, is at a Neutral.

    Adaptimmune Therapeutics plc (NASDAQ:ADAP) Shares headed falling, lower as much as -1.23%. The most recent rating by Mizuho, on April 22, 2020, is at a Neutral.

    Novan Inc. (NASDAQ:NOVN) rose 1.10% after gaining more than $0.01 on Friday.

    Nabriva Therapeutics plc (NBRV) last closed at $2.44, in a 52-week range of $3.26 to $18.29. The company recently announced pricing of $15 million public offering.

    Salarius Pharmaceuticals Inc. (SLRX) stock drop by -31.34% to $0.92 after declaring that it has entered into agreements with several institutional and accredited investors to exercise of warrants for $3.5 million of gross proceeds to be used for ongoing development of Seclidemstat. The most recent rating by Ladenburg Thalmann, on April 27, 2020, is at a Buy.

  • Iterum Therapeutics plc (Nasdaq: ITRM) saw big hike in after-market with the news of New Drug Proposal to FDA

    Iterum Therapeutics plc (Nasdaq: ITRM) saw big hike in after-market with the news of New Drug Proposal to FDA

    Iterum Therapeutics plc (Nasdaq: ITRM) shares surged 39.31% to $0.9055 in the after-hours session, after a drug company involved in developing oral and IV antibiotics of the next generation to treat infections caused by multidrug-resistant pathogens plunged -1.52% in yesterday’s normal trading session.

    The company has applied its New Drug Proposal (NDA) to the U.S. Food and Drug Administration for sulopenem etzadroxil/probenecid in patients with a quinolone non-susceptible pathogen, to treat uncomplicated urinary tract infections (uUTIs).

    Corey Fishman, Chief Executive Officer, said The submission of the oral sulopenem NDA filing is an important step forward in bringing new antibiotics to patients to help address the antibiotic resistance challenge.” Oral sulopenem, if licensed, will provide doctors and patients the ability to benefit from the proven effectiveness and protection of penem antibiotics found only in IV formulations to date in the U.S..’ We are now one step closer to fulfilling the target of getting this desperately needed drug to the U.S. every year for more than six million patients with Cipro-resistant UTIs.

    The NDA request contains evidence from the phase 3 clinical trials of SURE-1, SURE-2, and SURE-3, in which oral sulopenem was well received with no major adverse drug-related events. The SURE-1 clinical trial (uUTIs) found that oral sulopenem was statistically superior to the commonly used comparator, ciprofloxacin, for the primary clinical and microbiological reaction efficacy endpoint the test-of-cure visit in patients with a non-susceptible quinolone pathogen.

  • 3 Biotech Stocks Going Parabolic Today and With Potential for More Gains

    3 Biotech Stocks Going Parabolic Today and With Potential for More Gains

    The markets are up to slow day as investors continue to digest yesterday’s presidential debate.  The marker is still unsure of who is likely to win the election and this is likely to keep markets volatile in coming weeks.  The uncertainty comes not just from the polarized nature of the upcoming election, but also the fact that the policies of the two contenders are very different and could have a direct effect on the markets.

    There is also the fact that the markets still need a stimulus package and so far none has been agreed upon. Democrats have already advanced a $2.2 trillion stimulus package, but there are no guarantees that it will be agreed upon. The COVID-19 pandemic also continues to be a major risk to the economy. Recently, COVID-19 death numbers hit one million and until a vaccine is found, the economy will remain vulnerable.

    So vulnerable is the economy that oil prices have dropped as a reflection of declining demand in the economy. Despite the overall market weakness, biotech stocks have been performing quite well. This is largely due to the excitement that comes with positive biotech news. Some of the biotech stocks that have been gaining since pre-market and could keep gaining all through the day are as below:

    CTI Biopharma Corp [NASDAQ: CTIC]

    CTI Biopharma Corp gained by over 100% pre-market and doesn’t seem to be easing up. This follows the company’s announcement that would it had submitted an NDA requesting for accelerated approval for its treatment for people suffering from severe thrombocytopenia called pactrinib.  According to CEO Adam R. Craig, the company has been working closely with the FDA since it completed phase 2 dosing of this trial treatment in a bid to fast track the approval of this treatment of severe thrombocytopenia an unmet need that has very few treatment options. He added that the company’s treatment had so far shown the potential to become a new treatment.

    Iterum Therapeutics PLC [NASDAQ: ITRM]

    Iterum Therapeutics PLC is another stock that is gaining momentum and was up by over 100% pre-market.  Its upside momentum comes after the company announced that it had a positive pre-NDA meeting with the FDA for its treatment for uncomplicated urinary tract infections called Sulopenem. The company is targeting 6 million people with UUTI in the U.S.

    BioHiTech Global Inc [NASDAQ: BHTG]

    This stock is another top performer this morning and is gaining upside momentum. This comes after the company provided its first disinfectant system targeting the cruise industry. It’s exciting because it opens a new revenue stream for the company.