BIOTECH / PHARMA - was gibt es Neues (Tipps & Trends, FDA-Termine, IPOs, News etc.)? (Seite 254)

[Wertvoll01]

Wie immer eine Tolle Arbeit von dir. Danke

[Malecon]

Scholar Rock Holding Corporation hat News zur Phase 2 veröffentlicht.

Scholar Rock Announces Positive Proof-of-Concept Data from TOPAZ Phase 2 Trial Interim Analysis of SRK-015 in Patients with Type 2 and Type 3 Spinal Muscular Atrophy

https://investors.scholarrock.com/news-releases/news-release…

[Malecon]

Noch eine Tasse&Henkel-Formation, allerdings ist diese auf der linken Seite zerrissen:





Die Aktie heißt Quidel Corporation





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[Malecon]

Bei SELLAS Life Sciences Group Inc hat sich seit dem 12. Oktober eine Mini Tasse&Henkel-Formation gebildet.






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[Malecon]

Antwort auf Beitrag Nr.: 65.305.187 von Malecon am 07.10.20 09:30:34

Zitat von Malecon: Bei PolarityTE Inc hat der Indikator die überverkaufte Zone verlassen:

Check nach 2 Wochen:



Zuckt gerade + 22 % auf Tradegate.

🎵

[Malecon]

TERMINE DIESE WOCHE

Es kommen immer mehr Quartalsberichte. 🤠 Außerdem stehen zwei PDUFA-Termine (bei Kala und Merck) und vieles mehr an.


Conferences

American Society of Nephrology, or ASN, Kidney Week 2020 Annual Meeting: Oct. 22-25

EORTC-NCI-AACR Annual, or ENA 2020, Symposium on Molecular Targets and Cancer Therapeutics: Oct. 24-25

ASTRO Annual Meeting 2020: Oct. 24-28

Macrophage-directed Therapies Summit: Oct 27-29

American Society of Human Genetics, or ASHG, Virtual Meeting 2020: Oct. 27-30

Cantor Fitzgerald "Key Considerations for Gene Therapy Manufacturing and Platforms" virtual panel: Oct. 28

B. Riley Securities Liver Disease Therapeutics Day: Oct. 29

European Academy Dermatology and Venereology, or EADV, Virtual 29th Congress: Oct. 29-31


PDUFA Dates

The FDA is scheduled to rule on Kala Pharmaceuticals Inc's (NASDAQ: KALA) NDA for Eysuvis, or loteprednol etabonate ophthalmic suspension, 0.25%, which is being evaluated for the short-term treatment of the signs and symptoms of dry eye disease. The PDUFA action date is Oct. 30.

By the same day, the agency is set to rule on Merck & Co., Inc.'s (NYSE: MRK) sBLA for Keytruda as a monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin's lymphoma.


Clinical Readouts

Applied Therapeutics Inc (NASDAQ: APLT) is due to present at the ASHG meeting animal model efficacy data and adult clinical data on the safety and biomarker efficacy of its investigational candidate for Galactosemia, AT-007. (Monday)

Jazz Pharmaceuticals PLC (NASDAQ: JAZZ) has scheduled a webcast on Monday at 4:30 pm to provide investors with an update on Xywav oral solution, which was approved by the FDA in late July for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.

Retrophin Inc (NASDAQ: RTRX) is scheduled to present at the ASN Kidney Week 2020 Reimagined, new data from a post-hoc analysis examining the proportion of patients with focal segmental glomerulosclerosis that achieved complete remission of proteinuria in the Phase 2 DUET Study of sparsentan. Sparsentan has been licensed from Ligand Pharmaceuticals Inc. (NASDAQ: LGND).

Galera Therapeutics Inc (NASDAQ: GRTX is due to present at the ASTRO annual meeting data from its Phase 1b/2a clinical trial of avasopasem manganese (GC4419) in combination with stereotactic body radiation therapy for locally advanced pancreatic cancer (Tuesday).

Concert Pharmaceuticals Inc (NASDAQ: CNCE) will present clinical data on CTP-543 for the treatment of alopecia areata as a late-breaker oral presentation at the 29th EADV Virtual Congress (Thursday).

Axovant Gene Therapies Ltd (NASDAQ: AXGT) is due to present at its virtual Parkinson's disease R&D day individual patient-level data from Cohort 2 of the Phase 2 SUNRISE-PD study that is evaluating its AXO-Lenti-PD gene therapy for the treatment of Parkinson's disease (Friday).


October schedule

Pfizer Inc. (NYSE: PFE) and BioNTech SE – ADR (NASDAQ: BNTX) are scheduled to release results of the Phase 2/3 study of coronavirus vaccine candidate BNT162b2.

Dynavax Technologies Corporation's (NASDAQ: DVAX) partner Medicago is scheduled to release safety and immunogenicity results from the Phase I clinical trial for its plant-derived COVID-19 vaccine candidate that uses Dynavax' adjuvant CpG 1018.


Earnings

Monday

Medpace Holdings Inc (NASDAQ: MEDP) (before the market open)

Tuesday

Laboratory Corp. of America Holdings (NYSE: LH) (before the market open)
Merck & Co., Inc. (NYSE: MRK) (before the market open)
Pfizer Inc. (NYSE: PFE) (before the market open)
NeoGenomics, Inc. (NASDAQ: NEO) (before the market open)
Masimo Corporation (NASDAQ: MASI) (after the close)
DexCom, Inc. (NASDAQ: DXCM) (after the close)
Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) (after the close)
Omnicell, Inc. (NASDAQ: OMCL) (after the close)

Wednesday

Integra Lifesciences Holdings Corp (NASDAQ: IART) (before the market open)
United Therapeutics Corporation (NASDAQ: UTHR) (before the market open)
PPD Inc (NASDAQ: PPD) (before the market open)
Boston Scientific Corporation (NYSE: BSX) (before the market open)
Aethlon Medical, Inc. (NASDAQ: AEMD) (after the close)
Amgen, Inc. (NASDAQ: AMGN) (after the close)
Alimera Sciences Inc (NASDAQ: ALIM) (after the close)
Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (after the close)
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) (after the close)
Globus Medical Inc (NYSE: GMED) (after the close)
Gilead Sciences, Inc. (NASDAQ: GILD) (after the close)
Merit Medical Systems, Inc. (NASDAQ: MMSI) (after the close)
Penumbra Inc (NYSE: PEN) (after the close)
Viking Therapeutics Inc (NASDAQ: VKTX) (after the close)

Thursday

Evelo Biosciences Inc (NASDAQ: EVLO) (before the market open)
Baxter International Inc (NYSE: BAX) (before the market open)
Blueprint Medicines Corp (NASDAQ: BPMC) (before the market open)
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) (before the market open)
Agenus Inc (NASDAQ: AGEN) (before the market open)
ABIOMED, Inc. (NASDAQ: ABMD) (before the market open)
Pacira Biosciences Inc (NASDAQ: PCRX) (before the market open)
Protalix Biotherapeutics Inc (NYSE: PLX) (before the market open)
Insmed Incorporated (NASDAQ: INSM) (before the market open)
Moderna Inc (NASDAQ: MRNA) (before the market open)
Novocure Ltd (NASDAQ: NVCR) (before the market open)
Syneos Health Inc (NASDAQ: SYNH) (before the market open)
Xtant Medical Holdings Inc (NYSE: XTNT) (before the market open)
Constellation Pharmaceuticals Inc (NASDAQ: CNST) (before the market open)
Alkermes Plc (NASDAQ: ALKS) (before the market open)
AxoGen, Inc Common Stock (NASDAQ: AXGN) (after the close)
BioTelemetry Inc (NASDAQ: BEAT) (after the close)
PTC Therapeutics, Inc. (NASDAQ: PTCT) (after the close)
Illumina, Inc. (NASDAQ: ILMN) (after the close)
Natus Medical Inc (NASDAQ: NTUS) (after the close)
LeMaitre Vascular Inc (NASDAQ: LMAT) (after the close)
ResMed Inc. (NYSE: RMD) (after the close)
NuVasive, Inc. (NASDAQ: NUVA) (after the close)
Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the close)
Opko Health Inc. (NASDAQ: OPK) (after the close)
Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO) (after the close)
Quidel Corporation (NASDAQ: QDEL) (after the close)
EXACT Sciences Corporation (NASDAQ: EXAS) (after the close)
Cerus Corporation (NASDAQ: CERS) (after the close)
CareDx Inc (NASDAQ: CDNA) (after the close)

Friday

AbbVie Inc (NYSE: ABBV) (before the market open)
Ligand Pharmaceuticals Inc. (NASDAQ: LGND) (before the market open)


IPOs

Boulder, Colorado-based Biodesix, Inc., a data-driven diagnostic solutions company, has filed to offer 4.17 million shares in an initial public offering, or IPO, at an estimated price range of $17-$19. The company has applied for listing its shares on the Nasdaq under the ticker symbol BDSX.

Galecto, Inc., a Wilmington, Delaware-based clinical-stage biotech company developing therapeutics for fibrosis, is proposing to offer 5.67 million shares at an estimated price range of $14-$16. The company expects its shares to trade on the Nasdaq under the ticker symbol GLTO.

Atlanta, Georgia-based Inhibikase Therapeutics, Inc. has filed for offering 2.272 million shares of its common stock to be priced between $10 and $12 apiece. The shares are to be listed on the Nasdaq under the ticker symbol IKT. Inhibikase is a clinical stage pharmaceutical company developing therapeutics for Parkinson's disease.


IPO Quiet Period Expiry

Pulmonx Corp (NASDAQ: LUNG)

Oncorus Inc (NASDAQ: ONCR)

Immunome Inc (NASDAQ: IMNM)

C4 Therapeutics Inc (NASDAQ: CCCC)


Other Events

CDC's Advisory Committee on Immunization Practices panel will meet Oct. 28-30, which is one of its customary three yearly meetings to review scientific data and vote on vaccine recommendations.


Quelle: https://finance.yahoo.com/news/week-ahead-biotech-kala-fda-1…

[Malecon]

Ich habe am Sonntag ein Paket aus weniger bekannten Aktien aus dem Medizinbereich zusammengestellt.


eHealth Inc

https://www.wallstreet-online.de/diskussion/1332876-1-10/ehe…


SOLITON Inc

https://www.wallstreet-online.de/diskussion/1332879-1-10/sol…


AMPIO Pharmaceuticals Inc

https://www.wallstreet-online.de/diskussion/1332894-1-10/amp…


CHECK-CAP Ltd

https://www.wallstreet-online.de/diskussion/1332905-1-10/che…


AILERON Therapeutics Inc

https://www.wallstreet-online.de/diskussion/1332908-1-10/ail…


Regional Health Properties Inc

https://www.wallstreet-online.de/diskussion/1332911-1-10/reg…


BioVie Inc

https://www.wallstreet-online.de/diskussion/1332937-1-10/bio…


MIRAGEN Therapeutics Inc

https://www.wallstreet-online.de/diskussion/1332940-1-10/mir…


BENITEC Biopharma Inc

https://www.wallstreet-online.de/diskussion/1332943-1-10/ben…


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[Malecon]

BÖRSENGÄNGE KOMMENDE WOCHE

Fibrosis biotech Galecto (GLTO) plans to raise $85 million at a $395 million market cap. The company’s lead candidate is an inhaled inhibitor of galectin-3 for the treatment of severe fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). The company has conducted a Phase 2a trial in 24 IPF patients and has initiated a Phase 2b trial in 450 IPF patients, with topline results expected in 2022.

Diagnostics provider Biodesix (BDSX) plans to raise $75 million at a $521 million market cap. The company provides data-driven diagnostic solutions to discover, develop, and commercialize solutions for clinical unmet needs, with a primary focus in lung disease. The company’s operations have been impacted by COVID-19, with revenue and gross margin falling in the 1H20.

G Medical Innovations (GMVD), which provides app-connected medical devices for monitoring vital signs, plans to raise $30 million at a $362 million market cap. The Israel-based company generated just $2 million in revenue in the 1H20 and is highly unprofitable, with a -26% gross margin.

Neurological disorder biotech Inhibikase Therapeutics (IKT) plans to raise $25 million at a $152 million market cap. Its lead candidate is a c-Abl protein kinase inhibitor being developed for Parkinson’s disease (PD). The company has filed two INDs and expects to begin the first dosing PD patients following the IPO.

While not included in Renaissance Capital’s stats, medical test developer GBS (GBS) plans to raise $20 million at a $167 market cap by offering units with warrants attached. The company is currently developing saliva-based tests for SARS-CoV-2 and diabetes management.

Quelle: https://www.renaissancecapital.com/IPO-Center/News/72646/US-…

[Malecon]

Bei AILERON Therapeutics Inc steht morgen ein Investor Call an.

https://www.wallstreet-online.de/diskussion/1332908-1-10/ail…

[Malecon]

Leise und schüchtern hat der Kurs von Soliton Inc eine Lückenschließung in kleinen Schritten gestartet:

https://www.wallstreet-online.de/diskussion/1332879-1-10/sol…

Die Lücke geht bis ca. $ 11. Der Kurs ist schon in der Lücke drin, diese ist komplett offen.