Hoth Therapeutics' Pre-IND Submission For HT-KIT For Advance Systemic Mastocytosis Accepted By FDA

RTTNews | 602 dagar sedan
Stocktwits
Hoth Therapeutics' Pre-IND Submission For HT-KIT For Advance Systemic Mastocytosis Accepted By FDA

(RTTNews) - Biopharmaceutical company Hoth Therapeutics, Inc. (HOTH) announced Monday it has submitted a request for a Pre-Investigational New Drug (IND) meeting to the U.S. Food and Drug Administration (FDA) to discuss the proposed drug development program for HT-KIT, a new molecular entity, for the treatment of advance systemic mastocytosis (AdvSM), a rare aggressive form of cancer.

HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT by inducing mRNA frame shifting and already has Orphan Drug Designation from the FDA.

Currently in the preclinical stage of development of HT-KIT, Hoth anticipates a meeting with the FDA to be scheduled during the fourth quarter of 2023.

During the pre-IND meeting with the FDA, Hoth Therapeutics plans to discuss the overall proposed drug development program for HT-KIT including requirements for nonclinical, clinical pharmacology, clinical, chemistry, and manufacturing controls.

Hoth also plans to present clinical trial designs for the IND-opening, phase 1 dose ranging and dose extension studies as well as a proposed follow-up phase 2 safety and efficacy study; both studies will be conducted in adult patients with advanced systemic mastocytosis (AdvSM).

AdvSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SMAHN), and mast cell leukemia (MCL).

Taggar: HOTH
Stocktwits
read more
Indonesia Shares Due For Profit Taking On Tuesday

Indonesia Shares Due For Profit Taking On Tuesday

The Indonesia stock market has moved higher in six straight sessions, advancing more than 225 points or 3.6 percent along the way. The Jakarta Composite Index now rests just above the 6,830-point plateau although investors may lock in gains on Tuesday.
RTTNews | 26 minuter sedan
Australian Market Modestly Lower

Australian Market Modestly Lower

The Australian stock market is trading modestly lower on Tuesday, extending the losses in the previous session, following the broadly negative cues from Wall Street overnight. The benchmark S&P/ASX 200 is staying below the 8,200 level, with weakness in iron ore miners, financial and some technology stocks partially offset by strong gains in gold miners.
RTTNews | 41 minuter sedan
Hong Kong Bourse May Spin Its Wheels On Tuesday

Hong Kong Bourse May Spin Its Wheels On Tuesday

Ahead of Monday's holiday for the buddha's birthday, the Hong Kong stock market had finished higher in three straight sessions, collecting almost 550 points or 2.4 percent along the way. The Hang Seng Index now sits just above the 22,500-point plateau although the rally may stall on Tuesday.
RTTNews | 56 minuter sedan
China Shares May Return To The Downside

China Shares May Return To The Downside

Ahead of the long holiday weekend, the China stock market had finished lower in four straight sessions, sliding more than 20 points or 0.7 percent along the way. The Shanghai Composite Index now sits just beneath the 3,280-point plateau and it may open under pressure again on Tuesday.
RTTNews | 1h 26minuter sedan
Continued Consolidation Called For Taiwan Stock Market

Continued Consolidation Called For Taiwan Stock Market

The Taiwan stock market on Monday snapped the five-day winning streak in which it had surged more than 1,300 points or 6.4 percent. The Taiwan Stock Exchange now sits just above the 20,530-point plateau and it may take further damage on Tuesday.
RTTNews | 1h 56minuter sedan
Verktyg
Ekonomisk kalender
Market Hours
Interest Rates
Holidays Calendar
Forex Marknad
Forex Volatilitet
Forex Korrelation
Forex Nyheter
forex analysis
COT Data
Likviditet
Forex Kalkylatorer
Forex värmekarta
Indicators Heatmap
Gemenskapen
Gemenskapen
Systems
De mest populära systemen
Strategier
Tävlingar
Forex Diagram
Forex Sentiment
Indikator för utsikter
Recensioner
Mäklare
Prop Trading Firms
VPS-tjänster
Signalleverantörer
EA-programmeringstjänster
Affiliate Programs
PAMM mäklartjänster
Tjänster för rabattprogram
Trading Plattformar
Expertrådgivare
krypto Börser
Trading Courses
Mäklare
Forex Sprider sig
Forex Citat från mäklare
Forex mäklare Swaps
Forex Volym för mäklare
Forex Kampanjer för mäklare Press Release
Plattform
Widgetar
Funktioner
API
RSS
Stock Portfolio
Affiliate Software
Avancerade diagram
Stöd
FAQ
Hjälp
Kontakta oss
Rapportera en bugg!
Om
Blogg
© 2025 Myfxbook Ltd. Alla rättigheter reserverade
HIGH RISK WARNING: Valutahandel innebär en hög risknivå som kanske inte är lämplig för alla investerare. Hävstångseffekten skapar ytterligare risker och förlustexponering. Innan du bestämmer dig för att handla med utländsk valuta bör du noga överväga dina investeringsmål, din erfarenhetsnivå och din risktolerans. Du kan förlora en del av eller hela din ursprungliga investering. Investera inte pengar som du inte har råd att förlora. Utbilda dig om de risker som är förknippade med valutahandel och sök råd från en oberoende finansiell eller skatterådgivare om du har några frågor. Alla uppgifter och all information tillhandahålls endast i informationssyfte och är inte avsedda för handelsändamål eller rådgivning. Tidigare resultat är inte en indikation på framtida resultat.