SAD

Biora Therapeutics Further Reduces Net Debt and Monetizes Legacy Asset

Retrieved on: 
Monday, March 11, 2024

SAN DIEGO, March 11, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced an agreement with institutional investor Context Capital to invest $2.8 million in new capital alongside a convertible note exchange, and announced the monetization of its investment in privately held Enumera Molecular, Inc. (“Enumera”) in a separate transaction that results in $3 million of nondilutive funding for Biora.

Key Points: 
  • By monetizing our interest in Enumera, which is related to our legacy business, we are also bringing in additional funding to complement our shareholders’ capital investment,” said Eric d’Esparbes, Chief Financial Officer of Biora Therapeutics.
  • “We continue to make substantive progress toward optimizing the capital structure of Biora, and developing our therapeutics programs, which are progressing well.
  • In May 2022, Biora contributed legacy assets related to its single-molecule detection platform to Enumera in exchange for a minority ownership stake in Enumera.
  • On March 8, 2024, Biora sold its minority stake to Enumera investors for $3 million.

PepGen Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, March 6, 2024

BOSTON, March 06, 2024 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023, and highlighted recent corporate developments.

Key Points: 
  • “With important data readouts expected from our two lead programs, 2024 has the potential to be a transformational year for PepGen.
  • People with myotonic dystrophy type 1 (DM1) currently have no approved treatment options that target the root cause of the disease.
  • Financial Results for the Three Months and Twelve Months ended December 31, 2023
    Cash and cash equivalents were $110.4 million as of December 31, 2023.
  • Net loss was $78.6 million for the year ended December 31, 2023, compared to $69.1 million for the same period in 2022.

Apogee Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases, Exceeding its Trial Objectives Ahead of Sc

Retrieved on: 
Tuesday, March 5, 2024

Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.

Key Points: 
  • Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.
  • At Apogee, we refuse to stop at good enough and are dedicated to advancing innovative solutions for patients.
  • The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate safety and PK of APG777 in healthy volunteers.
  • A live webcast of the call will be available on the Investor Relations page of Apogee’s website at https://investors.apogeetherapeutics.com/news-events/events .

Gain Therapeutics Announces the Initiation of the Multiple Ascending Dose (MAD) Part of the Phase 1 Clinical Trial of GT-02287, a Novel GCase-targeting Small Molecule Therapy for GBA1 Parkinson’s Disease

Retrieved on: 
Tuesday, February 27, 2024

Following the HREC approval, administration of GT-02287 in the MAD part of the study has been initiated.

Key Points: 
  • Following the HREC approval, administration of GT-02287 in the MAD part of the study has been initiated.
  • “Our Phase 1 clinical trial of GT-02287 remains on track and according to plan,” said Matthias Alder, Chief Executive Officer of Gain Therapeutics.
  • Compelling preclinical data presented at WORLDSymposium™ earlier in February 2024 demonstrated that treatment with GT-02287 completely restored motor function and reduced plasma levels of the emerging neurodegeneration biomarker NfL back to normal levels.
  • Based on these data, GT-02287 may have the potential to slow or even stop the progression of Parkinson’s disease.

Biora Therapeutics Announces Successful Completion of Single-Ascending Dose (SAD) Cohorts of Phase 1 Clinical Study of BT-600

Retrieved on: 
Monday, February 26, 2024

SAN DIEGO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced completion of the single-ascending dose (SAD) cohorts for its phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers. BT-600 is a drug-device combination consisting of the orally administered NaviCap™ device which delivers a unique, liquid formulation of tofacitinib to the colon for the potential treatment of moderate to severe ulcerative colitis.

Key Points: 
  • (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced completion of the single-ascending dose (SAD) cohorts for its phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers.
  • “Completion of the SAD cohorts of the clinical study is an exciting step advancing clinical development for BT-600, and we are pleased with the execution of the study and its progress so far,” said Ariella Kelman, MD, Chief Medical Officer of Biora Therapeutics.
  • The study, which is being conducted in the United States, consists of two parts.
  • The first is a single-dose ascending cohort comprised of 24 participants receiving BT-600 with tofacitinib at 5 mg and 10 mg doses or placebo.

Gabather reports initial positive results from the EEG/fMRI target engagement study

Retrieved on: 
Thursday, March 7, 2024

STOCKHOLM, March 7, 2024 /PRNewswire/ -- Gabather AB (Nasdaq First North Growth Market: GABA) today reports initial positive results from the EEG/fMRI target engagement study, a double-blinded placebo-controlled, cross-over phase Ib study of Gabather's GABAA-receptor positive allosteric modulator, GT-002, in healthy volunteers.

Key Points: 
  • STOCKHOLM, March 7, 2024 /PRNewswire/ -- Gabather AB (Nasdaq First North Growth Market: GABA) today reports initial positive results from the EEG/fMRI target engagement study, a double-blinded placebo-controlled, cross-over phase Ib study of Gabather's GABAA-receptor positive allosteric modulator, GT-002, in healthy volunteers.
  • The study met the primary objective to confirm a favourable safety and tolerability profile of GT-002.
  • The secondary objective to demonstrate target engagement in human brain was also met.
  • The study clearly demonstrated that GT-002 is safe and well tolerated at dose levels expected to be effective for treatment of patients with neuropsychiatric disorders.

Gabather reports initial positive results from the EEG/fMRI target engagement study

Retrieved on: 
Thursday, March 7, 2024

STOCKHOLM, March 7, 2024 /PRNewswire/ -- Gabather AB (Nasdaq First North Growth Market: GABA) today reports initial positive results from the EEG/fMRI target engagement study, a double-blinded placebo-controlled, cross-over phase Ib study of Gabather's GABAA-receptor positive allosteric modulator, GT-002, in healthy volunteers.

Key Points: 
  • STOCKHOLM, March 7, 2024 /PRNewswire/ -- Gabather AB (Nasdaq First North Growth Market: GABA) today reports initial positive results from the EEG/fMRI target engagement study, a double-blinded placebo-controlled, cross-over phase Ib study of Gabather's GABAA-receptor positive allosteric modulator, GT-002, in healthy volunteers.
  • The study met the primary objective to confirm a favourable safety and tolerability profile of GT-002.
  • The secondary objective to demonstrate target engagement in human brain was also met.
  • The study clearly demonstrated that GT-002 is safe and well tolerated at dose levels expected to be effective for treatment of patients with neuropsychiatric disorders.

Seasonal Affective Disorder: Shedding Light on the Winter Blues with AltaPointe Health

Retrieved on: 
Tuesday, February 27, 2024

MOBILE, Ala., Feb. 26, 2024 /PRNewswire/ -- As winter settles in and daylight hours diminish, many individuals find themselves grappling with a condition known as Seasonal Affective Disorder (SAD). SAD is a type of depression that typically occurs when exposure to sunlight is limited.

Key Points: 
  • As winter settles in and daylight hours diminish, many individuals find themselves grappling with a condition known as Seasonal Affective Disorder (SAD).
  • MOBILE, Ala., Feb. 26, 2024 /PRNewswire/ -- As winter settles in and daylight hours diminish, many individuals find themselves grappling with a condition known as Seasonal Affective Disorder (SAD).
  • "If you have Seasonal Affective Disorder, it can cause you to be depressed up to 40% of the year."
  • Light therapy, which involves exposure to a bright light that mimics natural sunlight, is a commonly prescribed treatment.

MycoMeditations Surveys Show Lasting Benefits of Psilocybin Therapy for Major Depression and Anxiety Disorders

Retrieved on: 
Tuesday, February 20, 2024

TREASURE BEACH, Jamaica, Feb. 20, 2024 /PRNewswire-PRWeb/ -- MycoMeditations, a pioneer in legal psilocybin-assisted therapy retreats, today announced the results of two years of longitudinal (long-term) client surveys exploring the impact of its psilocybin retreats on individuals suffering with Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), and Social Anxiety Disorder (SAD). The findings complement MycoMeditations' previously released surveys focused on Post-Traumatic Stress Disorder (PTSD).

Key Points: 
  • The findings complement MycoMeditations' previously released surveys focused on Post-Traumatic Stress Disorder (PTSD).
  • MycoMeditations employed the PHQ-9, GAD-7, and SM-SAD-Adult questionnaires to measure self-reported symptom severity and long-term outcomes across MDD, GAD, and SAD, respectively.
  • Clinically significant improvements were maintained for one year following retreat for each Major Depressive Disorder, Generalized Anxiety, and Social Anxiety, suggesting possible long-term efficacy of psilocybin-assisted therapy.
  • The data suggests the viability of multiple psilocybin treatments in a short period of time when coupled with therapy, as MycoMeditations retreats are 7-nights with 3 psilocybin sessions on alternating days.

Prothena Reports Fourth Quarter and Full Year 2023 Financial Results, and Provides Financial Guidance and Business Highlights

Retrieved on: 
Thursday, February 15, 2024

In addition, the Company provided 2024 financial guidance and business highlights.

Key Points: 
  • In addition, the Company provided 2024 financial guidance and business highlights.
  • “2023 was a year of strong progress for Prothena as we advanced our protein dysregulation portfolio and moved closer to becoming a fully integrated commercial company.
  • Total revenue for the fourth quarter and full year of 2023 included BMS collaboration revenue of $0.3 million and $91.3 million, respectively.
  • As of December 31, 2023, Prothena had $621.0 million in cash, cash equivalents and restricted cash, and no debt.