-
Soligenix | Receives FDA IND Clearance for Phase 2 Clinical Trial of Dusquetide in the Treatment of Aphthous Ulcers in Behçet’s Disease
NASDAQ: SNGX Introduction to Soligenix’s Phase 2 Clinical Trial Soligenix, a biopharmaceutical company focused on developing innovative therapies, has recently received FDA Investigational New Drug (IND) clearance for the Phase 2 clinical trial of Dusquetide in the treatment of aphthous ulcers in Behçets Disease. This clearance marks a significant milestone in the development of potential…
-
Carisma Therapeutics | Announces FDA Clearance of IND Application for CT-0525, a Novel HER2-Targeting CAR-Monocyte
NASDAQ: CARM Carisma Therapeutics, a leading biotechnology company committed to developing innovative cancer treatments, recently made a groundbreaking announcement. The company has successfully obtained clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application. This is a significant milestone for Carisma Therapeutics, as it paves the way for the…
-
Biomea Fusion | Presenting New Data from Ongoing Phase II Study (COVALENT-111) of BMF-219 in Patients with Type 2 Diabetes at the World Congress Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC)
NASDAQ: BMEA BMF-219 is an investigational novel covalent menin inhibitor designed to regenerate insulin-producing beta cells with the aim to cure type 2 diabetes STOCK & PRESS RELEASE INFO
-
BrainStorm Cell Therapeutics | Announces FDA Advisory Committee Meeting to Review NurOwn® PDUFA Target Action Date Scheduled for December 8, 2023
BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced that the US FDA has granted the company a meeting to discuss the regulatory path forward for NurOwn® in ALS. The meeting, scheduled for December 6, 2023, will focus on plans for a Special Protocol Assessment (SPA) for a confirmatory Phase 3 trial in ALS. BrainStorm aims to…
-
Arcutis Biotherapeutics | FDA Acceptance of New Drug Application for Roflumilast Foam 0.3% for the Treatment of Seborrheic Dermatitis in Individuals Aged 9 Years and Older
NASDAQ: ARQT WESTLAKE VILLAGE, Calif., April 18, 2023 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s new drug application (NDA) for roflumilast foam 0.3% for the treatment of seborrheic…
-
Incyte | Spotlighting More Than 40 Hematology and Oncology Abstracts Including a Plenary Presentation at the ASH Annual Meeting
Incyte (NASDAQ:INCY) will present more than 40 abstracts at the ASH 2023 conference, featuring data from its hematology and oncology products. The Plenary Scientific Session will showcase the results of the AGAVE-201 trial evaluating axatilimab in patients with chronic GVHD. Incyte will also host an analyst and investor event to discuss the key data presentations…
-
Aptose Biosciences | Tuspetinib Clinical Data Selected for Oral Presentation at the 2023 ASH Annual Meeting
NASDAQ: APTO Aptose Biosciences Inc. announced that clinical data for tuspetinib has been selected for oral presentation at the 65th American Society of Hematology Annual Meeting. The presentation will include safety and efficacy data from Aptose’s ongoing APTIVATE trial of tuspetinib in relapsed/refractory acute myeloid leukemia patients. The presentation will take place on December 9,…
-
BIO-TECH STOCK CATALYST REPORT FOR WEEK OF OCTOBER 29 – NOVEMBER 4, 2023
October 28, 2023 EVENT EVENT DATE SYMBOL PRICE POTENTIAL % (+/-) OPEN INTEREST PRICE Conference 11/02/2023 ARDX 22.5 27,193 $3.49 Conference 11/02/2023 ELDN 44.2 278 $1.59 Conference 11/03/2023 ACET 36.3 90 $1.26 Conference 11/03/2023 AUPH 23.5 11,055 $7.19 FDA Event 11/04/2023 CRBP 94.6 6,911 $5.21 WEEK: 10/29/2023 – 11/04/2023
-
BIO-TECH STOCK CATALYST REPORT FOR WEEK OF OCTOBER 22-28, 2023
October 20, 2023 EVENT EVENT DATE SYMBOL PRICE POTENTIAL % (+/-) OPEN INTEREST PRICE FDA Event 10/22/2023 REGN 3.0 600 $808.47 Conference 10/22/2023 RVMD 37.7 33,800 $27.97 Conference 10/23/2023 HARP 52.4 307 $6.88 FDA Event 10/26/2023 CPRX 13.9 2,074 $12.80 WEEK: 10/22/2023 – 10/28/2023
-
Rocket Pharmaceuticals | Unlocking the Potential: RP-L201 and its FDA Designations – A Breakthrough in Pediatric Medicine
NASDAQ: RCKT Rocket Pharmaceuticals has achieved significant milestones with their groundbreaking therapy, RP-L201. The FDA has granted several prestigious designations to RP-L201, including Regenerative Medicine Advanced Therapy (RMAT), Rare Pediatric, Fast Track, and Orphan Drug designations. These designations highlight the immense potential of RP-L201 in treating pediatric patients and emphasize the urgent need for innovative…