Category - News

Developments

Blue Water Vaccines changes name to Blue Water Biotech

Blue Water Vaccines changed its corporate name to Blue Water Biotech, following its recent acquisition of ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia, which has begun Blue Water’s transition into...

April 25, 2023

Developments

Lantheus, POINT get FDA fast track for mCRPC

The FDA granted Lantheus Holdings (NASDAQ:LNTH) and POINT Biopharma (NASDAQ:PNT) fast track designation for 177Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer (mCRPC). PNT2002 is an...

April 24, 2023

Executive Moves

Jeffrey Dayno named president, CEO of Harmony Biosciences

Harmony Biosciences (NASDAQ:HRMY) appointed Jeffrey Dayno, M.D., as president and CEO, and a member of the board. Dr. Dayno, a nationally recognized neuroscience expert, joined Harmony as CMO and EVP when the company...

April 24, 2023

Markets

Stifel ups IDEAYA to buy; PT to $24 on increased conviction of darovasertib

Stifel upgraded IDEADYA Biosciences (NASDAQ:IDYA) to “buy” from “hold” and raised its price target to $24 from $18 following additional darovasertib data in uveal melanoma, which revealed an improved mPFS in first-line...

April 24, 2023

Markets

Stifel starts Disc Medicine at buy; PT $37

Stifel launched coverage of Disc Medicine (NASDAQ:IRON) with a “buy” rating and $37 price target. The stock closed at $28.10, up $2.34, on April 20. “Our positive thesis is predicated on optimism for the company’s lead...

April 21, 2023

Developments

Visus posts positive Phase 3 data to treat presbyopia

Visus Therapeutics reported positive topline results from its Phase 3 pivotal BRIO-I trial, demonstrating highly statistically significant improvements in near and distance binocular visual acuity at multiple...

April 20, 2023

Developments

MAIA Biotechnology reports preliminary Phase 2 survival data for NSCLC

MAIA Biotechnology (NYSEA:MAIA) announced preliminary survival data in the Part A safety lead-in of its ongoing Phase 2 trial, THIO-101, evaluating THIO in patients with advanced non-small cell lung cancer (NSCLC). The...

April 20, 2023

Developments

Cali initiates Phase 3 studies to decrease post-operative pain; cut opioid use

Cali Biosciences initiated Phase 3 studies of its core product, CPL-01, a long-acting ropivacaine, with dosing in hernia patients already begun and dosing in bunion patients scheduled to start next month. CPL-01 is an...

April 19, 2023

Developments

Zucara receives IND clearance for Phase 2 trial of ZT-01 for prevention of night-time hypoglycemia

The FDA has cleared Zucara Therapeutics’ IND application for a Phase 2a study of ZT-01 for the prevention of nocturnal hypoglycemia in patients with Type 1 Diabetes (T1D), with first patient dosing set in the third...

April 19, 2023

Developments

SAB Biotherapeutics nabs FDA breakthrough status for Influenza immunotherapy

The FDA granted breakthrough therapy designation for SAB Biotherapeutics’ (NASDAQ:SABS) SAB-176, an investigational therapeutic, for post-exposure prophylaxis for Type A and Type B influenza illness in high-risk...

April 18, 2023

Category - News

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