Streetbeat News

Regulatory

DMAC

DiaMedica Therapeutics has received regulatory approval to start a Phase 2 trial for DM199, a treatment for preeclampsia. The trial will begin dosing in Q4 2024, with preliminary results expected in the first half of 2025. The trial will be conducted in South Africa.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 12:27 pm

WINT

Windtree Therapeutics has announced that the trial design for its Istaroxime Phase 2b study has been published by the European Society of Cardiology Heart Failure. This development is significant for the company as it highlights progress in their clinical trials.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 12:06 pm

BIAF

bioAffinity Technologies has secured a U.S. Federal Supply Schedule contract for its CyPath Lung test, a noninvasive diagnostic for early-stage lung cancer. This will provide U.S. Veterans and other federal health services patients with access to the test.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 12:04 pm

PYPL

V

Rep. Maxine Waters has proposed a deal to advance stablecoin legislation in the U.S. before the end of 2024. The legislation is crucial as companies like PayPal and Visa are entering the stablecoin market. The outcome depends on political negotiations and the 2024 elections.

Portfolio Pulse from Khyathi Dalal

October 09, 2024 | 12:01 pm

BABA

BIDU

JD

PDD

US-listed Chinese stocks are experiencing a decline due to Chinese planning officials not meeting investor expectations for economic stimulus.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:58 am

OGEN

Oragenics has made significant progress in 2024 with its concussion drug ONP-002, including successful safety tests, preparation for Phase II trials, and a partnership with Avance Clinical. Key advancements include improved drug formulation and temperature stability, enhancing its potential for effective treatment.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:34 am

BIIB

Biogen announced that its drug Felzartamab has received FDA Breakthrough Therapy Designation for treating late antibody-mediated rejection in kidney transplant patients. This designation could expedite the drug's development and review process.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:31 am

TRDA

Entrada Therapeutics presented positive clinical and preclinical data at the World Muscle Society Congress, supporting its Duchenne franchise. The data reinforces the safety of ENTR-601-44 and supports upcoming regulatory filings for Phase 2 trials.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:15 am

KYMR

Kymera Therapeutics has received FDA clearance for its investigational new drug application for KT-621. The company plans to start a Phase 1 trial in October 2024 and expects to report data in the first half of 2025.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:13 am

ALNY

Alnylam Pharmaceuticals has submitted a supplemental New Drug Application to the FDA for Vutrisiran, targeting ATTR amyloidosis with cardiomyopathy. This submission could potentially expand the use of Vutrisiran, impacting Alnylam's market position.

Portfolio Pulse from Benzinga Newsdesk

October 09, 2024 | 11:10 am