Streetbeat News

Regulatory

TSHA

Taysha Gene Therapies has provided updates on its investigational programs TSHA-120 and TSHA-102. The company believes the new data analyses may support an approval pathway for TSHA-120 for the treatment of Giant Axonal Neuropathy (GAN). Initial clinical observations for TSHA-102 in Rett syndrome have been encouraging. Taysha plans to review the potential regulatory pathway for TSHA-120 at a formal meeting with the FDA expected in Q3 2023. The company also plans to submit an IND application to the FDA for TSHA-102 in the second half of 2023.

Portfolio Pulse from Happy Mohamed

June 28, 2023 | 12:17 pm

CKPT

Checkpoint Therapeutics has announced new pharmacokinetic data on cosibelimab, supporting the extension to an every-three-week dosing regimen. The data was presented at the Population Approach Group Europe 2023 annual meeting. The data supports the proposed 1200 mg every-three-week commercial dosing regimen for cosibelimab included in the Biologics License Application for advanced cutaneous squamous cell carcinoma currently under review by the FDA. The company believes cosibelimab has the potential to capture significant market share in the $1.6 billion U.S. market for cutaneous squamous cell carcinoma treatment.

Portfolio Pulse from Happy Mohamed

June 28, 2023 | 12:17 pm

PBLA

Panbela Therapeutics has announced that its PACES S0820 Phase III trial has passed the pre-planned futility analysis. This is a significant milestone for the company as it indicates that the trial is likely to provide meaningful results.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2023 | 12:16 pm

AIQ

BOTZ

IRBO

ROBO

Hong Kong-based biotech company Insilico Medicine has initiated a Phase 2 clinical trial for the first-ever AI-generated drug, INS018_055, targeting idiopathic pulmonary fibrosis (IPF), a chronic lung disease. The drug was developed using AI at 10% of the traditional cost and in a third of the time. The company used PandaOmics to identify disease-causing targets and Chemistry42 to design new molecules. If successful, the drug could potentially address the limitations of current treatments.

Portfolio Pulse from Vandana Singh

June 28, 2023 | 12:16 pm

ESPR

Esperion has submitted an application to the European Medicines Agency for an expanded indication for its NILEMDO and NUSTENDI tablets. This could potentially open up new markets for the company's products.

Portfolio Pulse from Bill Haddad

June 28, 2023 | 12:16 pm

CELZ

Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. The company had previously been notified by Nasdaq that it was not in compliance due to its common stock failing to meet the closing bid price of $1.00 or more for 30 consecutive business days. The requirement was met on June 26, 2023.

Portfolio Pulse from Happy Mohamed

June 28, 2023 | 12:14 pm

ETON

Eton Pharmaceuticals' shares are trading lower after the FDA issued a complete response letter to the company's dehydrated alcohol injection for methanol poisoning.

Portfolio Pulse from Benzinga Newsdesk

June 28, 2023 | 12:12 pm

JOBY

Joby Aviation, Inc. (NYSE:JOBY) has received a Special Airworthiness Certificate for the first aircraft built at its Pilot Production Line in Marina, California, allowing flight testing to begin. The aircraft is expected to be the first ever eVTOL aircraft to be delivered to a customer. The production line and aircraft were built in collaboration with strategic partner and investor, Toyota. Joby plans to begin commercial passenger operations in 2025 and recently partnered with Delta Air Lines for seamless, emissions-free travel for Delta customers.

Portfolio Pulse from Happy Mohamed

June 28, 2023 | 12:10 pm

ASTS

IMBI

NCMI

RIDE

TOVX

Several stocks are experiencing significant pre-market movements. Theriva Biologics (TOVX) surged 76.4% after receiving Orphan Drug Designation from the FDA for a pancreatic cancer treatment. iMedia Brands (IMBI) gained 55.1% following a second Nasdaq non-compliance notice. National CineMedia (NCMI) rose 12.8% after its reorganization plan was confirmed by the US Bankruptcy Court. Biodexa Pharmaceuticals (BDRX) rose 12.5% after announcing a share ratio change. On the downside, AST SpaceMobile (ASTS) fell 22.6% after pricing an upsized offering of Class A common stock, and Lordstown Motors (RIDE) fell 13.1% after filing for Chapter 11 bankruptcy protection.

Portfolio Pulse from Lisa Levin

June 28, 2023 | 12:04 pm

BAYRY

Bayer's subsidiary BlueRock has reported initial success in a Phase I trial for an experimental stem cell therapy for Parkinson's disease. The therapy was well-tolerated and the transplanted cells grew as intended in the patients' brains. This success has led Bayer to advance to the second stage of testing on humans, with patient enrolment expected in the first half of 2024.

Portfolio Pulse from Benzinga Newsbot

June 28, 2023 | 12:03 pm