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Regulatory

SPY

Fed's Bostic, in a CNBC interview, indicated a more patient approach to monetary policy, forecasting a single rate cut in Q4 this year. He expects inflation to decrease incrementally through 2024, not returning to the 2% target until 2026.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 1:02 pm

SPY

Fed's Bostic commented on CNBC that the economy is maintaining its strong momentum, with any weakening being very incremental. He believes that over a longer period, the economy needs to slow to reach its longer-run potential. Bostic is optimistic that growth can continue while inflation gradually decreases, albeit more slowly than expected.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 1:02 pm

VNDA

Vanda Pharmaceuticals Inc's (NASDAQ:VNDA) Fanapt (iloperidone) tablets received FDA approval for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. This approval expands Fanapt's market, previously approved for schizophrenia treatment since 2009. Bipolar disorder affects approximately 2.8% of the U.S. adult population, with a significant portion classified as severe. The approval was based on a pivotal study showing statistically significant improvement in patients treated with Fanapt over placebo. Despite this positive development, Vanda's net product sales for 2023 decreased by 4% Y/Y, with sales of another major drug, Hetlioz, declining due to increased competition. VNDA shares surged 27.9% in premarket trading following the announcement.

Portfolio Pulse from Vandana Singh

April 03, 2024 | 12:48 pm

GNPX

Genprex is expanding its clinical trial sites for the Acclaim-3 clinical study, which tests Reqorsa Therapy in combination with Tecentriq for treating small cell lung cancer. This expansion is in collaboration with a large network of community-based oncology practices. The Acclaim-3 study has received support from the FDA in the form of Orphan Drug and Fast Track Designations.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 12:32 pm

SYRA

Syra Health announced that its 'Syrenity' research study protocol has been approved by the Institutional Review Board. This approval marks a significant milestone for the company, potentially advancing its position in health research and development.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 12:20 pm

AMRN

Amarin has been granted a new patent by the European Patent Office for VAZKEPA, extending its exclusivity by eight additional years until 2039. This development is significant for Amarin as it ensures prolonged market protection for VAZKEPA in Europe, potentially enhancing the company's revenue and market position in the cardiovascular treatment sector.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 12:10 pm

BHC

Bausch Health, Canada has announced that its product, (Pr)UCERIS(R) Aerosol Foam, designed for the treatment of mild to moderate distal ulcerative colitis in adults, has been listed for the first time on public drug plans. This development is aimed at addressing the unmet medical needs in this patient population.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 12:08 pm

IKT

Inhibikase Therapeutics has scheduled a pre-IND meeting with the FDA on April 5 to discuss IkT-001Pro, a potential treatment for Pulmonary Arterial Hypertension.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 12:07 pm

LIPO

Lipella Pharmaceuticals announced it will have an FDA Type C meeting regarding LP-10 for Hemorrhagic Cystitis on May 21. This step is crucial for advancing LP-10's regulatory pathway.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 12:02 pm

SXTP

60 Degrees Pharmaceuticals will sponsor a pilot study of Tafenoquine, the active molecule in its FDA-approved malaria prevention medication, Arakoda, for treating Babesiosis in dogs.

Portfolio Pulse from Benzinga Newsdesk

April 03, 2024 | 12:01 pm