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MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmopla...
MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by positive results from the Phase 2 LEDA trialThe upcoming Phase 3 program will therefore be expected to benefit from earlier and more frequent interactions with the FDA under the Fast Track program, potentially enabling a more efficient development pathway This regul...
- Wedbush Research
GOOGL ALPHABET INC. CLASS A
GERN GERON CORP.
BMRN BIOMARIN PHARMACEUTICAL INC.
BCRX BIOCRYST PHARMACEUTICALS INC.
ACRS ACLARIS THERAPEUTICS INC.
PTGX PROTAGONIST THERAPEUTICS
ARGX ARGENX ADS
ISR ISORAY
AAPL APPLE INC.
APLS APELLIS PHARMACEUTICALS
SRRK SCHOLAR ROCK HOLDING CORPORATION
KNSA KINIKSA PHARMACEUTICALS
ORIC ORIC PHARMACEUTICALS
COGT COGENT BIOSCIENCES INC
NUVB NUVATION BIO INC (A)
PL PLANET LABS PBC
GMTX GEMINI THERAPEUTICS INC
MLTX MOONLAKE IMMUNOTHERAPEUTICS
NUVL NUVALENT INC
SYRE SPYRE THERAPEUTICS INC.
ORKA ORUKA THERAPEUTICS INC
BCAX BICARA THERAPEUTICS INC.
- Yun Zhong
MoonLake Immunotherapeutics Announces Positive Outcome from Type B Mee...
MoonLake Immunotherapeutics Announces Positive Outcome from Type B Meeting with U.S. FDA and Announces Investor Day MoonLake requested a Type B meeting with the U.S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy for submission of a Biologic License Application (BLA) for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS)FDA feedback confirms that the Company may establish substantial evidence of effectiveness (SEE), without additional clinical trials in HS, with a BLA consisting of data from its existing VELA-1, VELA-2 and MIRA tri...
- Yun Zhong
BLA Submission For SLK In HS Confirmed For 2H26; PT To $34
MLTX is Hosting an Investor Day on 2/23. Management plans to further discuss FDA feedback and value opportunities for SLK in HS and to share new clinical data, in HS and other indications. Recall management had guided for data from the Ph3 VELA-TEEN study in adolescent HS, which will be available i
- Wedbush Research
SIMON SILICON MOTION TECHNOLOGY CORPORATION SPONSORED ADR
PSTG PURE STORAGE INC. CLASS A
NVDA NVIDIA CORPORATION
NTAP NETAPP INC.
MU MICRON TECHNOLOGY INC.
INTC INTEL CORPORATION
BCRX BIOCRYST PHARMACEUTICALS INC.
AXTI AXT INC.
ACRS ACLARIS THERAPEUTICS INC.
2330 TAIWAN SEMICONDUCTOR MANUFACTURING CO. LTD.
2303 UNITED MICROELECTRONICS CORP.
WVE WAVE LIFE SCIENCES
AMD ADVANCED MICRO DEVICES INC.
GM GENERAL MOTORS COMPANY
KNSA KINIKSA PHARMACEUTICALS
ORIC ORIC PHARMACEUTICALS
VRDN VIRIDIAN THERAPEUTICS INC
STX SEAGATE TECHNOLOGY HLDGS PLC
GLUE MONTE ROSA THERAPEUTICS INC
GFS GLOBALFOUNDRIES INC
CMPX COMPASS THERAPEUTICS
MLTX MOONLAKE IMMUNOTHERAPEUTICS
TYRA TYRA BIOSCIENCES INC
EWTX EDGEWISE THERAPEUTICS INC
ARTV ARTIVA BIOTHERAPEUTICS INC
SGMT SAGIMET BIOSCIENCES INC
ORKA ORUKA THERAPEUTICS INC
BBOT BRIDGEBIO ONCOLOGY THERAPEUTICS INC
- David Nierengarten
- Dennis Pak
- Geoffrey Von Der Ahe
- Laura Chico
- Martin Fan
- Ritika Das
- Robert Driscoll
- Thomas Yip
- Yun Zhong
ACRS ACLARIS THERAPEUTICS INC.
WVE WAVE LIFE SCIENCES
KNSA KINIKSA PHARMACEUTICALS
ORIC ORIC PHARMACEUTICALS
VRDN VIRIDIAN THERAPEUTICS INC
GLUE MONTE ROSA THERAPEUTICS INC
CMPX COMPASS THERAPEUTICS
MLTX MOONLAKE IMMUNOTHERAPEUTICS
TYRA TYRA BIOSCIENCES INC
EWTX EDGEWISE THERAPEUTICS INC
ARTV ARTIVA BIOTHERAPEUTICS INC
ORKA ORUKA THERAPEUTICS INC
BBOT BRIDGEBIO ONCOLOGY THERAPEUTICS INC
- Wedbush Research
SHOP SHOPIFY INC.
WDC WESTERN DIGITAL CORPORATION
TSLA TESLA INC
TRIP TRIPADVISOR INC.
SIMON SILICON MOTION TECHNOLOGY CORPORATION SPONSORED ADR
PSTG PURE STORAGE INC. CLASS A
PEGA PEGASYSTEMS INC.
PANW PALO ALTO NETWORKS INC.
NVDA NVIDIA CORPORATION
NTAP NETAPP INC.
MU MICRON TECHNOLOGY INC.
MELI MERCADOLIBRE INC.
INTC INTEL CORPORATION
GOOGL ALPHABET INC. CLASS A
FB FACEBOOK INC. CLASS A
EXPE EXPEDIA GROUP INC.
ETSY ETSY INC.
EBAY EBAY INC.
CHKP CHECK POINT SOFTWARE TECHNOLOGIES LTD.
AXTI AXT INC.
ASND ASCENDIS PHARMA A/S SPONSORED ADR
2330 TAIWAN SEMICONDUCTOR MANUFACTURING CO. LTD.
2303 UNITED MICROELECTRONICS CORP.
CVNA CARVANA CO. CLASS A
ARGX ARGENX ADS
SE SEA ADS
AMZN AMAZON.COM INC.
AMD ADVANCED MICRO DEVICES INC.
AAPL APPLE INC.
MSFT MICROSOFT CORPORATION
IBM INTERNATIONAL BUSINESS MACHINES CORPORATION
BKNG BOOKING HOLDINGS INC.
LYFT LYFT
PINS PINTEREST INC. CLASS A
UBER UBER TECHNOLOGIES INC.
SMCI SUPER MICRO COMPUTER
DASH INC.
ABNB DOORDASH
PHVS AIRBNB INC. CLASS A
XMTR PHARVARIS NV
STX XOMETRY
TTD INC.
GFS SEAGATE TECHNOLOGY HLDGS PLC
CINT THE TRADE DESK
YOU INC.
MLTX GLOBALFOUNDRIES INC
RUM CI&T INC
CART CLEAR SECURE INC
ORKA MOONLAKE IMMUNOTHERAPEUTICS
SERV RUMBLE INC
BBOT MAPLEBEAR INC.
ORUKA THERAPEUTICS INC
SERVE ROBOTICS INC
BRIDGEBIO ONCOLOGY THERAPEUTICS INC
- David Nierengarten
- Dennis Pak
- Martin Fan
- Wedbush Research
XNCR XENCOR INC.
WDC WESTERN DIGITAL CORPORATION
SIMON SILICON MOTION TECHNOLOGY CORPORATION SPONSORED ADR
PSTG PURE STORAGE INC. CLASS A
NVDA NVIDIA CORPORATION
NTAP NETAPP INC.
MU MICRON TECHNOLOGY INC.
INTC INTEL CORPORATION
FTNT FORTINET INC.
CNK CINEMARK HOLDINGS INC.
AMC AMC ENTERTAINMENT HOLDINGS INC. CLASS A
2330 TAIWAN SEMICONDUCTOR MANUFACTURING CO. LTD.
2303 UNITED MICROELECTRONICS CORP.
AMD ADVANCED MICRO DEVICES INC.
ARVN ARVINAS HOLDING
LYFT LYFT
GOSS GOSSAMER BIO
DT DYNATRACE INC.
RVMD REVOLUTION MEDICINES
ACET ADICET BIO INC
KROS KEROS THERAPEUTICS
LRMR LARIMAR THERAPEUTICS INC
PRAX PRAXIS PRECISION MEDICINES
U UNITY SOFTWARE
DASH DOORDASH
FHTX FOGHORN THERAPEUTICS
STX SEAGATE TECHNOLOGY HLDGS PLC
ALIT FOLEY TRASIMENE ACQUISITION CORP
APP APPLOVIN CORP
CCSI CONSENSUS CLOUD SOLUTIONS INC
CMPX COMPASS THERAPEUTICS
MLTX MOONLAKE IMMUNOTHERAPEUTICS
TYRA TYRA BIOSCIENCES INC
DNTH DIANTHUS THERAPEUTICS INC
DBD DIEBOLD NIXDORF INCORPORATED
- Yun Zhong
MoonLake Immunotherapeutics Announces Pricing of $75 Million Underwri...
MoonLake Immunotherapeutics Announces Pricing of $75 Million Underwritten Offering ZUG, Switzerland, November 5, 2025 – MoonLake Immunotherapeutics (Nasdaq: MLTX) (“MoonLake”), a clinical-stage biotechnology company focused on advancing therapies to address significant unmet needs in inflammatory skin and joint diseases, today announced the pricing of an underwritten offering of 7,142,857 Class A ordinary shares at an offering price per share of $10.50. The gross proceeds from the offering to MoonLake, before deducting the underwriting discounts and commissions and other offering expenses ...
MoonLake Immunotherapeutics Reports Third Quarter 2025 Financial Resul...
MoonLake Immunotherapeutics Reports Third Quarter 2025 Financial Results and Announces New Data from Clinical Trials of its Nanobody® Sonelokimab Ended the third quarter with $380.5 million in cash, cash equivalents and short-term marketable debt securities which, together with funds from a previously announced debt-facility, are expected to provide runway into the second half of 2027Reported results of its Phase 2 LEDA clinical trial in Palmoplantar Pustulosis (PPP) where sonelokimab (SLK) demonstrated clinically meaningful and statistically significant benefitReported an interim analysis ...
- Wedbush Research
TRIP TRIPADVISOR INC.
EXPE EXPEDIA GROUP INC.
NFLX NETFLIX INC.
EA ELECTRONIC ARTS INC.
ANAB ANAPTYSBIO INC.
BKNG BOOKING HOLDINGS INC.
LYFT LYFT
UBER UBER TECHNOLOGIES INC.
LRMR LARIMAR THERAPEUTICS INC
U UNITY SOFTWARE
DASH DOORDASH
ABNB AIRBNB INC. CLASS A
RBLX ROBLOX
APP APPLOVIN CORP
YOU CLEAR SECURE INC
MLTX MOONLAKE IMMUNOTHERAPEUTICS
PEPG PEPGEN INC
- Yun Zhong
SLK Still Approvable In HS; Competitiveness A Big Question; PT To $18
The second Ph3 study failed in 2016, also due to a higher-than-usual placebo effect, but Intra-Cellular submitted the NDA in 2018, relying on a data package that included positive data from a large Ph2 study. The drug received FDA approval in 2019, after Intra-Cellular reported positive data from t
- Wedbush Research
WDC WESTERN DIGITAL CORPORATION
TTWO TAKE-TWO INTERACTIVE SOFTWARE INC.
TRIP TRIPADVISOR INC.
SIMON SILICON MOTION TECHNOLOGY CORPORATION SPONSORED ADR
RARE ULTRAGENYX PHARMACEUTICAL INC.
PSTG PURE STORAGE INC. CLASS A
NVDA NVIDIA CORPORATION
NTAP NETAPP INC.
MU MICRON TECHNOLOGY INC.
MELI MERCADOLIBRE INC.
INTC INTEL CORPORATION
GOOGL ALPHABET INC. CLASS A
FB FACEBOOK INC. CLASS A
EXPE EXPEDIA GROUP INC.
ETSY ETSY INC.
EBAY EBAY INC.
BIIB BIOGEN INC.
AXTI AXT INC.
7974 NINTENDO CO. LTD.
2330 TAIWAN SEMICONDUCTOR MANUFACTURING CO. LTD.
2303 UNITED MICROELECTRONICS CORP.
EA ELECTRONIC ARTS INC.
ARGX ARGENX ADS
SE SEA ADS
AMZN AMAZON.COM INC.
AMD ADVANCED MICRO DEVICES INC.
AAPL APPLE INC.
MSFT MICROSOFT CORPORATION
BKNG BOOKING HOLDINGS INC.
LYFT LYFT
PINS PINTEREST INC. CLASS A
UBER UBER TECHNOLOGIES INC.
CHWY CHEWY INC. CLASS A
SMCI SUPER MICRO COMPUTER
DASH INC.
ABNB DOORDASH
STX AIRBNB INC. CLASS A
GFS SEAGATE TECHNOLOGY HLDGS PLC
YOU GLOBALFOUNDRIES INC
MLTX CLEAR SECURE INC
RUM MOONLAKE IMMUNOTHERAPEUTICS
EMBRAC B RUMBLE INC
CART EMBRACER GROUP AB
MAPLEBEAR INC.
- Yun Zhong
MoonLake Immunotherapeutics reports on week 16 results of the VELA Pha...
MoonLake Immunotherapeutics reports on week 16 results of the VELA Phase 3 hidradenitis suppurativa program with the Nanobody® sonelokimab VELA-1 and VELA-2 are two identical trials to evaluate the efficacy and safety of sonelokimab in adult participants with moderate to severe hidradenitis suppurativa (HS) and the first Phase 3 program using the higher clinical response level of HS Clinical Response (HiSCR) 75 as primary endpoint at week 16Data was analyzed, as per protocol and in accordance with regulatory agency feedback, using a composite strategy as the primary analysis and a treat...
- David Nierengarten
- Dennis Pak
- Geoffrey Von Der Ahe
- Laura Chico
- Martin Fan
- Ritika Das
- Robert Driscoll
- Yun Zhong
- Wedbush Research
XNCR XENCOR INC.
WDC WESTERN DIGITAL CORPORATION
TSLA TESLA INC
SIMON SILICON MOTION TECHNOLOGY CORPORATION SPONSORED ADR
PSTG PURE STORAGE INC. CLASS A
PANW PALO ALTO NETWORKS INC.
NVDA NVIDIA CORPORATION
NTAP NETAPP INC.
MU MICRON TECHNOLOGY INC.
KURA KURA ONCOLOGY INC.
INTC INTEL CORPORATION
GOOGL ALPHABET INC. CLASS A
CYBR CYBERARK SOFTWARE LTD.
CXW CORECIVIC INC.
AXTI AXT INC.
ACRS ACLARIS THERAPEUTICS INC.
2330 TAIWAN SEMICONDUCTOR MANUFACTURING CO. LTD.
2303 UNITED MICROELECTRONICS CORP.
BLDR BUILDERS FIRSTSOURCE INC.
PTGX PROTAGONIST THERAPEUTICS
ANAB ANAPTYSBIO INC.
ARGX ARGENX ADS
MDB MONGODB INC. CLASS A
AMZN AMAZON.COM INC.
AMD ADVANCED MICRO DEVICES INC.
AAPL APPLE INC.
MSFT MICROSOFT CORPORATION
ZS ZSCALER INC.
CRWD CROWDSTRIKE HOLDINGS INC. CLASS A
SMCI SUPER MICRO COMPUTER
STTK INC.
NUVB SHATTUCK LABS
STX NUVATION BIO INC (A)
ATXS SEAGATE TECHNOLOGY HLDGS PLC
GFS ASTRIA THERAPEUTICS INC
MLTX GLOBALFOUNDRIES INC
SYRE MOONLAKE IMMUNOTHERAPEUTICS
ORKA SPYRE THERAPEUTICS INC.
ORUKA THERAPEUTICS INC
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