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Tag: FIXX

  • Homology Medicines Inc. (FIXX) stock Plunges Deep After Hours on Clinical Hold of HMI-102 Trial

    On February 18, Homology Medicines Inc. (FIXX) disclosed notification of clinical hold of its pheNIX gene therapy trial of HMI-102 from the FDA. As a result, the stock plunged further deep in the after-hours on Friday.

    In the regular trading session, the stock fluctuated between a high of $3.9200 and a low of $3.7450. FIXX stock closed the session in the red at $3.8600 with a slight decline of 0.26% at 315.36K shares. Following the announcement, the stock lost a further 37.31% or $1.44 in the after hours. Hence, the stock was trading at a value of $2.4200 per share in the after-hours on Friday.

    The clinical-stage genetic medicine company, Homology Medicines Inc. was founded in 2015. Currently, the company has a market capitalization of $220.6 million with 57.15 million shares outstanding. FIXX stock stands at a year-to-date gain of 6.04% while it lost 67.97% last year.

    HMI-102 Clinical Trial Hold

    On Friday, the company announced that the FDA has notified the company about the clinical hold of the HMI-102 trial. Furthermore, an official clinical hold letter is expected within 30 days.

    The reason for the clinical hold is the observations of elevated liver function tests. Thus, there is a need for the modification of risk mitigation measures in the study. FIXX will provide further updates about the trial after the FDA provides more details and clarity to the company.

    FIXX’s Recent Presentations

    Recently, the company presented at the 18th Annual WORLDSymposiumTM Meeting. During the event, the company presented data on HMI-203 gene therapy candidates for Hunter syndrome (MPS II). Currently, HMI-203 is being evaluated in juMPStart, which is a Phase 1 dose-escalation clinical trial. Moreover, data on FIXX’s AAVHSWC platform was also presented at the event.

    FIXX’s Financial Overview

    On November 15, the company declared its financial results for the third quarter of 2021.

    In Q3 2021, FIXX incurred a net loss of $30.6 million, against $28.2 million in the year-ago period. Therefore, the net loss per basic and diluted share was $0.54 and $0.62 in Q3 of 2021 and 2020 respectively.

    Additionally, the company has collaboration revenues of $1.7 million in Q3 2021, against $0.6 million in the prior-year period.

    The company ended the quarter with cash, cash equivalents, and short-term investments of $187.6 million.

    Conclusion

    With the rise of certain observations in the clinical trial of HMI-102, the FDA placed a clinical hold on the trial. This announcement led to the stock’s downfall in the after-hours. Thus, the stock plunged deep in the after-market session when the news came out.

  • Biotech Roundup: Nurse in New York City was first vaccinated against COVID-19

    Biotech Roundup: Nurse in New York City was first vaccinated against COVID-19

    As the U.S. reached 300,000 deaths connected with Covid-19, the first shots were given. The nurse in New York City was first vaccinated against COVID-19. On Monday, during the American mass vaccine drive, the first shot was rendered, which opened a new chapter in the fight against coronavirus’s pandemic.

    This week’s total number of shipments could exceed 2.9 million doses of Pfizer vaccine, which the FDA approved last Friday night for emergency use. A further 2.9 million supplies are eligible three weeks from now for recipients to receive a second dose.

    Phase 3 clinical trials found that the vaccine is 95 percent successful over a spectrum of age, ethnic and racial groups when administered in two doses. The first vaccination this week is obtained by front-line community staff and others who work with long-term care.

    BioCardia Inc. (NASDAQ:BCDA) shares were trading up 58.87% at $4.48 at the time of writing on Monday following the company reported that it has entered into definitive agreements with investors for the purchase and sale of 1,789,474 shares of its common stock at a purchase price of $4.75 per share in a registered direct offering priced at-the-market under Nasdaq rules.

    BioCardia Inc. (NASDAQ:BCDA) share price went from a low point around $1.91 to briefly over $6.75 in past 52 weeks, though shares have since pulled back to $4.48. BCDA market cap has remained high, hitting $60.84M at the time of writing, giving it price-to-sales ratio of more than 200.

    Rubius Therapeutics Inc. (RUBY) last closed at $8.73, in a 52-week range of $3.35 to $14.44. Analysts have a consensus price target of $10.67.

    AnPac Bio-Medical Science Co. Ltd. (ANPC) stock soar by 35.07% to $5.70 after reporting that it has made significant progress in detecting pre-cancer diseases.

    Synlogic Inc. (NASDAQ:SYBX) Shares headed rising, higher as much as 13.39% following the announcement of advancement of SYNB1891 to combination arm dosing with PD-L1 checkpoint inhibitor in the on-going phase 1 study for the treatment of solid tumors and lymphoma. The most recent rating by Oppenheimer, on August 21, 2019, is at a Perform.

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) rose 29.20% after gaining more than $35.33 on Monday.

    Arbutus Biopharma Corporation (ABUS) last closed at $4.88, in a 52-week range of $0.88 to $9.02. Analysts have a consensus price target of $6.40.

    Amarin Corporation plc (AMRN) stock soar by 1.60% to $5.09 after announcing the presentation of important VASCEPA® (icosapent ethyl)-related scientific findings during the National Lipid Association (NLA) Scientific Sessions 2020. The most recent rating by JP Morgan, on September 29, 2020, is at a Neutral.

    Arvinas Inc. (NASDAQ:ARVN) Shares headed rising, higher as much as 95.06% after revealing that it is commencing an underwritten public offering of $250.0 million of its common stock. The most recent rating by Oppenheimer, on December 14, 2020, is at an Outperform.

    BioLineRx Ltd. (NASDAQ:BLRX) rose 26.97% after gaining more than $0.72 on Monday. The company on November 23, 2020 reported its financial results for the quarter ended September 30, 2020.

    Homology Medicines Inc. (FIXX) last closed at $11.97, in a 52-week range of $8.70 to $22.50.

    BioCryst Pharmaceuticals Inc. (BCRX) stock soar by 4.68% to $8.50. The firm is presenting at the JMP Securities Hematology Summit, which is being conducted as a virtual event, on Tuesday, December 15, 2020 at 3:30 p.m. ET. The most recent rating by JP Morgan, on September 29, 2020, is at an Overweight.

    BioNTech SE (NASDAQ:BNTX) Shares headed falling, lower as much as -14.95% after the company and Pfizer Inc. (PFE) declared additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany. The most recent rating by BofA Securities, on December 01, 2020, is at a Neutral.

    Akebia Therapeutics Inc. (NASDAQ:AKBA) rose 10.80% after gaining more than $0.31 on Monday. The firm reported the latest scheduled program of AkebiaShares, a peer-to-peer educational series for the kidney community.

    Seelos Therapeutics Inc. (SEEL) last closed at $1.28, in a 52-week range of $0.42 to $1.71 after announcing the sale of a $12.0 million senior secured convertible note and shares of Seelos common stock to investors.

    VBI Vaccines Inc. (VBIV) stock soar by 6.71% to $3.34. The company recently revealed a partnership for the commercialization of VBI’s 3-antigen prophylactic hepatitis B (HBV) vaccine in the United States, Europe, and Canada, pending regulatory approvals. The most recent rating by Raymond James, on August 27, 2020, is at a Strong buy.