6-K - GH Research PLC (0001855129) (Filer)

6-K - GH Research PLC (0001855129) (Filer)

6-K - GH Research PLC (0001855129) (Filer)

6-K - GH Research PLC (0001855129) (Filer)

6-K - GH Research PLC (0001855129) (Filer)

6-K - GH Research PLC (0001855129) (Filer)

6-K - GH Research PLC (0001855129) (Filer)

6-K - GH Research PLC (0001855129) (Filer)

6-K - GH Research PLC (0001855129) (Filer)

6-K - GH Research PLC (0001855129) (Filer)

DUBLIN, Ireland, Sept. 03, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today announced the promotion of Dr. Velichka "Villy" Valcheva, MD, MSc. to Chief Executive Officer of the Company. Dr. Valcheva succeeds PD Dr. med. Theis Terwey, co-founder of GH Research. Dr. Valcheva has more than 20 years of experience in various leadership roles in the pharmaceutical and biotech industries. Dr. Valcheva joined the company in August 2023 and has served as the Company's Chief Medical Officer since February 2024 having leadership responsibility, among other thin

DUBLIN, Ireland, Aug. 23, 2023 (GLOBE NEWSWIRE) -- GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the second quarter ended June 30, 2023 and provided business updates. Second Quarter 2023 Financial Highlights Cash position Cash, cash equivalents, other financial assets and marketable securities were $238.1 million as of June 30, 2023, compared to cash, cash equivalents and marketable securities of $251.7 million as of December 31, 2022. Cash equivalents and other financial assets comprise money market funds. Marketable securities comprise inv

Phase 2b clinical trial of GH001 in patients with treatment-resistant depression completed enrolment of the double-blind phase in Q3 2024Phase 1 clinical trial to evaluate proprietary aerosol delivery device in healthy volunteers is ongoing in the UKCash, cash equivalents, other financial assets and marketable securities of $193.8 million DUBLIN, Nov. 14, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the third quarter ended September 30, 2024, and provided updates on its business. Business Updates GH001 in Patients w

Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for expected completion of double-blind phase in Q3 2024 and expected completion of 6-month open-label extension phase in Q1 2025Phase 1 clinical trial to evaluate proprietary aerosol delivery device in healthy adult subjects approved in the UK and recruitingCash, cash equivalents, other financial assets and marketable securities of $204.5 million DUBLIN, Sept. 03, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the second quarter e

DUBLIN, Ireland, Sept. 03, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today announced the promotion of Dr. Velichka "Villy" Valcheva, MD, MSc. to Chief Executive Officer of the Company. Dr. Valcheva succeeds PD Dr. med. Theis Terwey, co-founder of GH Research. Dr. Valcheva has more than 20 years of experience in various leadership roles in the pharmaceutical and biotech industries. Dr. Valcheva joined the company in August 2023 and has served as the Company's Chief Medical Officer since February 2024 having leadership responsibility, among other thin

Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for expected completion of double-blind phase in Q3 2024 and of 6-month open-label extension phase in Q1 2025Phase 2a clinical trial of GH001 in postpartum depression on track for expected completion in Q3 2024Cash, cash equivalents, other financial assets and marketable securities of $214.0 million expected to provide cash runway into 2026 DUBLIN, Ireland, May 03, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the first quarter

Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for expected completion of double-blind phase in Q3 2024Phase 2a clinical trial of GH001 in postpartum depression on track for expected completion in Q3 2024Successfully completed Phase 1, dose-ranging clinical pharmacology trial of intravenous GH002 in healthy volunteersAdditional patents granted in EuropeCash, cash equivalents, other financial assets and marketable securities of $222.7 million expected to provide cash runway into 2026 DUBLIN, Ireland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment o

DUBLIN, Ireland, Jan. 18, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today announced that it recently received a communication from the European Patent Office (EPO) that it has been granted a patent with claims directed to mebufotenin (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating patients diagnosed with major depressive disorder (MDD) and treatment-resistant forms of MDD, such as treatment-resistant depression (TRD). The newly granted patent, EP3927337, which will have an effective date of February 14, 2024, and an expir

DUBLIN, Ireland, Nov. 09, 2023 (GLOBE NEWSWIRE) -- GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the third quarter ended September 30, 2023, and provided business updates. Third Quarter 2023 Financial Highlights Cash position Cash, cash equivalents, other financial assets and marketable securities were $228.7 million as of September 30, 2023, compared to cash, cash equivalents and marketable securities of $251.7 million as of December 31, 2022. Cash equivalents and other financial assets comprise money market funds. Marketable securiti

DUBLIN, Ireland, Sept. 29, 2023 (GLOBE NEWSWIRE) -- GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today provided updates and guidance on its clinical development program for GH001, its proprietary inhalable mebufotenin (5-MeO-DMT) product candidate, in treatment-resistant depression (TRD). Development Strategy As previously announced, following successful completion of our Phase 1/2 trial of GH001 in patients with TRD (GH001-TRD-102), we are recruiting for a European multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in patients with TRD (GH001-TR

DUBLIN, Ireland, Aug. 23, 2023 (GLOBE NEWSWIRE) -- GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the second quarter ended June 30, 2023 and provided business updates. Second Quarter 2023 Financial Highlights Cash position Cash, cash equivalents, other financial assets and marketable securities were $238.1 million as of June 30, 2023, compared to cash, cash equivalents and marketable securities of $251.7 million as of December 31, 2022. Cash equivalents and other financial assets comprise money market funds. Marketable securities comprise inv

DUBLIN, Ireland, May 11, 2023 (GLOBE NEWSWIRE) -- GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the first quarter ended March 31, 2023 and provided business highlights. First Quarter 2023 Financial Highlights Cash position Cash, cash equivalents, other financial assets and marketable securities were $246.1 million as of March 31, 2023, compared to cash, cash equivalents and marketable securities of $251.7 million as of December 31, 2022. Cash equivalents and other financial assets comprise money market funds. Marketable securities comprise i

Gainers ENDRA Life Sciences (NASDAQ:NDRA) stock increased by 79.2% to $0.15 during Wednesday's regular session. The company's market cap stands at $1.6 million. Rezolute (NASDAQ:RZLT) stock moved upwards by 23.91% to $5.76. The company's market cap stands at $231.2 million. Bright Green (NASDAQ:BGXX) shares rose 23.07% to $0.36. The company's market cap stands at $69.0 million. Champions Oncology (NASDAQ:CSBR) shares increased by 22.42% to $5.65. The company's market cap stands at $76.8 million. Kineta (NASDAQ:KA) shares moved upwards by 22.11% to $0.53. The market value of their outstanding shares is at $6.4 million. CVRx (NASDAQ:CVRX) stock moved upwards by 21.57% to $7.89. The marke

HC Wainwright & Co. analyst Patrick Trucchio reiterates GH Research (NASDAQ:GHRS) with a Buy and maintains $40 price target.

Canaccord Genuity analyst Sumant Kulkarni maintains GH Research (NASDAQ:GHRS) with a Buy and raises the price target from $30 to $31.

GH Research (NASDAQ:GHRS) reported quarterly losses of $(0.15) per share which beat the analyst consensus estimate of $(0.22) by 31.82 percent. This is a 28.57 percent increase over losses of $(0.21) per share from the same period last year.

DEA Revisits Proposed Ban On Two Psychedelic Compounds: Researchers Disagree, Insist On Hearings The Drug Enforcement Administration (DEA) is revisiting its stance on the classification of two psychedelic compounds, 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC).   The agency has proposed both be listed as Schedule I substances under the Controlled Substances Act (CSA). If added to the Schedule I list, these compounds would be officially considered as having high abuse potential with no recognized medical use. The evaluation is being disputed by experts. Three formal requests for a hearing were submitted, prompting a reconsideration by the agency.

Intranasal 5-MeO-DMT Clinical Trial Offers Hope For Treatment-Resistant Depression Partners Beckley Psytech and atai Life Sciences (NASDAQ:ATAI) have jointly announced positive initial results from a Phase 2a study of Beckley’s novel formulation of 5-MeO-DMT in Treatment Resistant Depression (TRD.)  BPL-003 is a synthetic and patent-protected benzoate salt formulation of 5-MeO-DMT (aka mebufotenin) designed for intranasal administration. The open-label study assessed safety, tolerability and efficacy of the compound at a single 10mg dose, alongside psychological support, in patients with moderate-to-severe TRD (who withdrew from concomitant antidepressants.) Learn more. Utah Hospita

FDA Grants Cybin Breakthrough Therapy Status For Major Depression Psilocybin Therapy, Company Announces Positive Clinical Data & Canadian $150M Private Placement Clinical-stage psychedelics biopharma company Cybin Inc. (NYSE:CYBN) announced that the Food and Drug Administration has granted Breakthrough Therapy designation to CYB003, its proprietary deuterated psilocybin analog targeting the adjunctive treatment of Major Depressive Disorder (MDD.)  It makes the group of psychedelic-based treatments for mental health conditions that have in recent years received such status granted by the U.S. federal agency five therapies total: Cybin's, MindMed's (NASDAQ:MNMD) LSD-derived treatment for

Psilocybin-Assisted Therapy Achieves Positive Clinical Trial Results For Treating Generalized Anxiety Psilocybin-assisted therapy has hit a milestone as clinical trial results show potential benefits for Generalized Anxiety Disorder (GAD.)  With variable symptoms, the condition typically involves a person suffering from excessive anxiety and worry for over six months, potentially causing significant distress and impairment in social, occupational or other areas of functioning. A relatively common disorder, successful treatment of GAD remains inadequate, bringing on side effects and high costs. The new topline clinical outcomes correspond to a Phase 2 study assessing psilocybin thera

HC Wainwright & Co. analyst Patrick Trucchio reiterates GH Research (NASDAQ:GHRS) with a Buy and maintains $40 price target.

JMP Securities analyst Jason Butler maintains GH Research (NASDAQ:GHRS) with a Market Outperform and lowers the price target from $50 to $39.