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Tag: NASDAQ: ITRM

  • 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.

  • 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.

  • Profitable Stocks to Trade Today for  Exponential Gains

    Profitable Stocks to Trade Today for  Exponential Gains

    Aptinyx Inc [NASDAQ: APTX]

    Clinical-stage biopharmaceutical company Aptinyx Inc., reported today of its positive results from the second phase of its novel NVDA receptor module, NYX-783 clinical trial.

    The study involved 153 patients suffering from post-traumatic-stress disorder (PTSD). In this study, NYX-783 showed statistically and clinically significant efficacy results of this treatment. Following these results, Aptinyx expects to kick-start a serious study in 2021. PTSD is one of the most difficult psychiatric conditions to treat due to multiple debilitating symptoms.

    Murray Stein, the Vice-Chair for Clinical Research in Psychiatry at the University of California San Diego says that it is encouraging to get such positive results and considering the short duration that NYX-783 takes to cure this disorder.

    Uxin Ltd [NASDAQ: UXIN]

    Uxin Limited, an international online Chinese company dealing with used cars recently announced that it has entered into two definitive agreements with two investors that will see the company raise US$25,000,000.

    In these agreements, Uxin plans to issue an aggregate of 84,692,839 Class A ordinary shares through private placements that will occur in October 2020. Additionally, Uxin also entered into a letter agreement with affiliates of TPG, 58.com and Warburg Pincus to alter the conversion of price of the convertible notes in an aggregate total of about US$230 million.

    Based on this letter in two years after the agreement, if the Company issues or sells any equity securities less than the conversion price, the strategic investors will have a right to convert all or a part of their convertible notes at a price that is equal to New Issue Price.

    Iterum Therapeutics Plc  [NASDAQ: ITRM]

    Iterum Therapeutics plc announced today that it will present its data at the Infectious Disease Society of America IDWeek that will take place virtually as from October 21, 2020.

    The data presentations will include results for SURE-2, that will show the effects in complicated urinary tract infections (cUTI) and oral abstract presentation that are results from SURE-1 in uncomplicated urinary tract infections..

    This data shows that oral sulopenem was statistically stronger than oral ciprofloxacin to treat patients with uncomplicated urinary tract infections. Iterum Therapeutics is a clinical-stage pharmaceutical institution that is focussed on developing oral and IV antibiotics for the treatment and management of infections caused by drug resistant pathogens in both hospital and home settings.

  • 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.