佐藤雄二

🚨 $TVTX in forte rally a 4104.00 +33,68% dopo l'approvazione allargata della FDA per il farmaco di Travere Therapeutics contro una rara malattia renale, un chiaro segnale di forza fondamentale; considerate un'aggiunta in portafoglio?

$CL1 $TVTX 🚨 米株相場が上昇、米イラン和平への期待とPPIの下振れが支え

🚨 $TVTX a 4102.00 +33,61%. Livelli critici dopo la notizia? La FDA USA ha approvato l'uso esteso del farmaco di Travere per una rara malattia renale. Il processo di certificazione è completo. Attenzione ai nuovi massimi. 💭

The literature on analyst writings and the company’s is mostly about cash flow and scaling. Approval I anticipated, but nothing is a sure thing. Please read #3 1. 72% of NDA's receive Approval 2. 76% of the 28% of NDAs that received a CRL receive an Approval within 6-12 months 3. That means 93% of all NDA submissions receive Approval with the first sNDA 4. The easiest CRL to get an sNDA approval is a CMC, the one UNCY received in June

$UNCY - What are the odds of getting another CRL? Logic says not high. But it’s the FDA and drug approval. So logic may not apply sometimes.

@kWN_TRA 自販機の下見て回った方が増えてる笑 取引規制中で買えなかった、ティッカーだけで何も調べずに選んだ　$UNCY 💩。 まさかの4月頭から高値のときは19%ほどプラス。

@elpistollero_ Et $UNCY en bio qui devrait pop fin juin avec la réponse de la FDA. Un premier refus en 2025 à cause d'un sous traitant, problème réglé depuis. Les signaux sont aux verts.

@surferbackpack Loved your report. Go $UNCY ! Do you have any idea how much the stock price will rise by the time of the PDUFA in June?

I believe there is a 95% chance $grce will be approved. The trial was aimed to show proper dosage. It did and led to better results. This is a slam dunk. Commercialization will be easy because it's easier to administer. Bullish no position.

$RVMD - Phase 3 daraxonrasib data released Median overall survival was 13.2 months vs 6.7 months for chemotherapy. Company plans to submit to FDA for future NDA.

$GRCE — FDA decision in 9 days GTx-104 for subarachnoid hemorrhage. Phase 3 met primary endpoint: 19% reduction in hypotension vs oral nimodipine. No meaningful innovation in aSAH treatment in 40 years. $18.7M cash. Survival depends on this approval. April 23.

Grace Therapeutics Announces Abstract Highlighting STRIVE-ON Phase 3 Trial Results Accepted for Presentation at AAN 2026 $GRCE stocktitan.net/news/GRCE/grac…

$GRCE - Grace Therapeutics Announces Abstract Highlighting STRIVE-ON Phase 3 Trial Results Accepted for Presentation at AAN 2026

$GRCE — Very Bullish 🚀 🏷️ $3.908 Grace Therapeutics Announces Abstract Highlighting STRIVE-ON Phase 3 Trial Results Accepted for Presentation at AAN 2026 Bull Case: + Grace Therapeutics announced positive Phase 3 STRIVE-ON trial results for GTx-104, meeting its primary safety endpoint with a 19% reduction in clinically significant hypotension compared to oral nimodipine. + Several secondary endpoints also favored GTx-104, including significantly higher relative dose intensity, improved favorable functional outcomes at 90 days (29% more patients), and fewer ICU readmissions, ICU days, and ventilator days. + GTx-104 is a lead asset with Orphan Drug Designation, targets a serious unmet medical need (aSAH), and offers a superior IV delivery method compared to oral administration, potentially improving patient care and outcomes. Bear Case: − The GTx-104 arm had more deaths (8 vs. 4) than the oral nimodipine arm, although all deaths were attributed to the severity of the underlying disease and not the drug. − The data will be presented as a poster, which can sometimes be perceived as less impactful than an oral presentation at a major conference. #pennystocks #daytrading Not financial advice. DYOR.

Hope you caught the $GRCE news? Their STRIVE-ON Phase 3 data for GTx-104 was accepted for presentation at AAN 2026. This is a key catalyst, but given the volatility expected, prudent risk management says wait for confirmation. 📝

🚨 $GRCE: STRIVE-ON Phase 3 Data Accepted for AAN 2026 Presentation 📉 Grace Therapeutics' GTx-104 abstract acceptance signals upcoming catalyst. Monitor for elevated volatility and volume around the event. Risk management is key. 📢

$NUVB #Esai エーザイ と NuvationBio 、 ROS1陽性進行非小細胞肺がん 治療薬 タレトレクチニブ の 欧州医薬品庁 による販売承認申請の受理を発表。 #NuvationBio #Nuvation #EisaiCo #Eisai #NUVB ⬇️

Eisai and Nuvation Bio Announce Marketing Authorisation Application for Taletrectinib for the Treatment of Advanced ROS1-Positive Non-Small Cell Lung Cancer Validated by the European Medicines Agency $NUVB, #NuvationBio, #Nuvation, #EisaiCo, #Eisai crweworld.com/article/news-p…

Stifel reiterated $NUVL Buy/$135, and said—Last week, we hosted a series of investor meetings with Jim Porter (CEO) and Alex Balcom (CFO) from Nuvalent (NUVL). $PFE RHHBY TAK NVS $NUVB Stifel added—Main takeaways: Investors felt management sounded solid on expectations for the ROS1 launch later this year. Clinical data at AACR should provide additional insight into zidesamtinib durability in more heavily pre-treated patients. Neladalkib NDA filing is on track for 1H26, management seems confident that data package will support a 2L label. Enrollment is strong in the global EAPs - patients only need 1 prior TKI to enroll (e.g., prior lorlatinib for ALK+ or taletrectinib for ROS1+ is not required). While investors await the launches and are eager for more clarity on catalyst cadence, management implies the NUVL story could be far from boring; they have an abundance of clinical data (including in ROS1, ALK, HER2 NSCLC) that could be presented at future medical meetings.

$NUVB 第一三共から safusidenib の日本権利を取得することで、グローバルなオンコロジー展開を拡大し、実験的な IDH1阻害剤 の独占的グローバル開発及び商業化権を確保した。 ⬇️