PDUFA Termine 2019

Dienstag, 16. Juli
 MRK MERCK PDUFA
Sonntag, 21. Juli
 CELG CELGENE CORPORATION PDUFA
Donnerstag, 15. August
 KALA KALA PHARMACEUTICALS, INC. PDUFA
Freitag, 16. August
 VNDA Vanda Pharmaceuticals Inc. PDUFA
Montag, 19. August
 NBRV Nabriva Therapeutics plc PDUFA
 SGEN SEATTLE GENETICS, INC. PDUFA
Donnerstag, 29. August
 NKTR NEKTAR THERAPEUTICS PDUFA
Dienstag, 3. September
 CELG CELGENE CORPORATION PDUFA
Dienstag, 10. September
 XERS XERIS PHARMACEUTICALS INC PDUFA
Donnerstag, 12. September
 ARDX Ardelyx PDUFA
Freitag, 20. September
 MRK MERCK PDUFA
Freitag, 27. September
 ITCI Intra-Cellular Therapies Inc. PDUFA
Samstag, 28. September
 AMRN AMARIN CORP PLC UK PDUFA
Montag, 7. Oktober
 PFNX Pfenex Inc PDUFA
Montag, 14. Oktober
 FLXN Flexion Therapeutics Inc PDUFA
Samstag, 19. Oktober
 ALXN ALEXION PHARMACEUTICALS, INC. PDUFA
 CLSD Clearside Biomedical, Inc. PDUFA
Montag, 21. Oktober
 ETON Eton Pharmaceuticals Inc PDUFA
Mittwoch, 30. Oktober
 AGRX AGILE THERAPEUTICS INC PDUFA
Samstag, 2. November 2019
 RDHL RedHill Biopharma Ltd PDUFA
Samstag, 9. November 2019
 LPCN Lipocine Inc PDUFA
Sonntag, 10. November 2019
 OCUL OCULAR THERAPEUTIX PDUFA
Samstag, 16. November 2019
 AGRX AGILE THERAPEUTICS INC PDUFA
Samstag, 30. November 2019
 AQST Aquestive Therapeutics, Inc. PDUFA
Mittwoch, 4. Dezember 2019
 CELG CELGENE CORPORATION PDUFA
 XLRN ACCELERON PHARMA INC PDUFA

https://www.fdatracker.com/fda-calendar/

 

https://kalarx.com/

http://investors.kalarx.com/static-files/...63-4b06-aa18-4e6e15f7d26a

https://kalarx.com/pipeline/

• KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.  KPI-121 0.25% is our product candidate for patients with dry eye disease utilizing a two-week course of therapy. In January 2018, we announced topline results from two completed Phase 3 clinical trials, which we refer to as STRIDE 1 and STRIDE 2 (STRIDE – Short Term Relief In Dry Eye), evaluating the safety and efficacy of KPI-121 0.25% versus placebo in patients with dry eye disease. In the STRIDE 1 trial, statistical significance was achieved for the primary sign endpoint of conjunctival hyperemia and the primary symptom endpoint of ocular discomfort severity change from baseline to day 15 in the intent to treat, or ITT, population. In the STRIDE 2 trial, statistical significance was achieved for the primary sign endpoint of conjunctival hyperemia, but statistical significance was not achieved for the primary symptom endpoint of ocular discomfort severity. KPI-121 0.25% was generally well tolerated in both STRIDE 1 and STRIDE 2, with no clinically significant treatment-related adverse events observed during the course of either trial, and with elevations in IOP in both trials similar to placebo. If approved, KPI-121 0.25% could be the first FDA-approved product for the short-term treatment of dry eye disease.
  

There were 33,882,857 shares of Common Stock, outstanding as of May 7, 2019

Cash 31.3.19  ca.139 Mio$

MK rund 190 Mio$

http://investors.kalarx.com/node/7731/html

 

http://www.vandapharmaceuticals.com/

https://vandapharmaceuticalsinc.gcs-web.com/...4d25-ba5a-17e4edb363c5

http://www.vandapharma.com/pipeline.html

HETLIOZ®

Jet LagDisorder sNDA PDUFA target action date 8/16/2019

http://www.vandapharma.com/dev-hetlioz.html

As of April 24, 2019, there were 52,963,676 shares of the registrant’s common stock issued and outstanding.

https://www.ariva.de/forum/vanda-pharmaceuticals-rebound-329096

 

 

 

 

https://www.nabriva.com/

https://investors.nabriva.com/static-files/...-46be-a66f-a8869e8aabb3

https://www.nabriva.com/pipeline-research

PDUFA date of August 19, 2019 for lefamulin.

 

Lefamulin is the lead molecule of a new class of antibiotics with positive results in two pivotal Phase 3 trials for CABP

https://www.ariva.de/nabriva_therapeut-_dl-01-aktie

As of April 30, 2019, the registrant had 72,557,253 ordinary shares outstanding.

6.7.19   MK ca. 176 Mio$

https://investors.nabriva.com/node/8896/html

 

https://www.xerispharma.com/

https://www.xerispharma.com/api/files/697

Gvoke HypoPen™ / Gvoke PFS™                 FDA decision       9.10.19

Der PDUFA Termin wurde um 3 Mon auf den 9.10.19 verschoben!

https://seekingalpha.com/article/4246895-xeris-looking-entry-pdufa

Xeris Submits Glucagon Rescue Pen to FDA: A Dramatically Easier and Faster Treatment for Severe Hypoglycemia https://diatribe.org/...sier-and-faster-treatment-severe-hypoglycemia

Glucagon Pen - EU                                         Ph 3 Results        1H ‘19
Self-Administered Glucagon                      Ph 2 (Vial/Syringe)    2H ’19
Continuous Glucagon                                     Initiate Ph 3          2H ’19
Continuous Glucagon                      Ph 2 Treatment Results       2H ’19
Self-Administered Glucagon             Ph 2 in-clinic data                2H’19
Diazepam                                                 Initiate Ph 2                 2H ’19
Pramlintide-Insulin                                     Initiate Ph 2                2H ’19

https://www.xerispharma.com/research-development/pipeline

As of April 30, 2019, the registrant had 26,940,229 shares of common stock outstanding

Cash and cash equivalents	$	61,984
Short-term investments	85,687

MK ca 328 Mio$

https://www.ariva.de/xeris_pharmac-aktie

 

Wenns Arscherl brummt, ist's Herzerl g'sund

If you have irritable bowel syndrome and constipation, you have the makings of something totally uncomfortable.         The other symptoms of IBS -- changing bowel habits, bloating, cramping, constipation and diarrhea -- come and go. Many happen at the same time. IBS is a persistent, chronic, often confusing disorder.

https://www.webmd.com/ibs/how-to-deal-with-ibs-with-constipation#1

Ardelyx, Inc. (NASDAQ: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment choices for people with cardiorenal diseases

https://ardelyx.com/

https://www.ariva.de/ardelyx-aktie

Tenapanor

The company's New Drug Application for U.S. marketing authorization of tenapanor for patients with IBS-C has a target action date under the Prescription Drug User Fee Act (PDUFA) of September 12, 2019.

http://ir.ardelyx.com/node/9516/html

Ardelyx's Pivotal Phase 3 Study of Tenapanor for IBS-C Hits Primary and All Secondary Endpoints to Support NDA Submission in 2018

https://www.drugs.com/clinical_trials/...oints-support-nda-17631.html

Pipeline :https://ardelyx.com/what-we-do/

Aus Q1

Expected 2019 Milestones

·

The PHREEDOM clinical trial, the company’s second Phase 3 clinical trial of tenapanor for hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis, is currently expected to read out in the fourth quarter of 2019.

·

The AMPLIFY clinical trial, the company’s  additional Phase 3 clinical trial of tenapanor as adjunctive therapy with phosphate binders for hyperphosphatemia in patients with ESRD who are on dialysis,  is currently expected to read out in the second half of 2019.

Amplify read out ist für Q3 angesetzt!

·

The company’s  New Drug Application for U.S. marketing authorization of tenapanor for patients with IBS-C has a target action date under the Prescription Drug User Fee Act (PDUFA) of September 12, 2019.

First Quarter 2019 Financial Results

·

Cash Position: As of March 31, 2019, Ardelyx had total capital resources including cash, cash equivalents and short-term investments of $151.6 million compared to total capital resources including cash, cash equivalents and short-term investments of $168.1 million as of December 31, 2018.

Net Loss: Net loss for the quarter ended March 31, 2019, was $26.1 million compared to a net loss of $17.0 million for the quarter ended March 31, 2018.

http://ir.ardelyx.com/node/9511/html

The number of issued and outstanding shares of the registrant’s Common Stock, as of May 2, 2019, was 62,600,443.

 7.7.19  MK ca. 170 Mio$

 

 "Ich habe Rücken!       Auch Horst Schlämmer ist betroffen!

Donnerstag, 29. August  PDUFA

https://www.nektar.com/

https://www.ariva.de/nektar_therapeutics-aktie

A study published in the American Pain Society's The Journal of Pain in October 2014 estimated that 19 percent of the U.S. population, or 39 million people, suffer from persistent pain.

In July 2018, the U.S. Food and Drug Administration filed and accepted a New Drug Application (NDA) for NKTR-181, a first-in-class opioid analgesic, to treat chronic low back pain in adult patients new to opioid therapy. In February 2019, Nektar received notification from the FDA that the review period for NKTR-181 has been extended by three months.....The FDA extended the action date to allow time to review data from two additional preclinical studies that Nektar conducted which were requested by the FDA early on in our review process. The new preclinical data are supportive of the company's abuse liability package included in the NDA filing for NKTR-181. https://ir.nektar.com/node/18031/html

About NKTR-181

NKTR-181 is the first long-acting, selective mu-opioid agonist designed to provide potent pain relief without the inherent high levels of euphoria which lead to abuse and addiction with standard opioids.  https://www.nektar.com/pipeline/rd-pipeline/nktr-181

Pipeline:  https://www.nektar.com/pipeline/rd-pipeline

The number of outstanding shares of Common Stock was 174,306,995 on May 1, 2019.

MK ca. 6 Mrd $

We estimate that we have working capital to fund our current business plans through at least the next twelve months. As of March 31, 2019, we had approximately $1.8 billion in cash and investments in marketable securities and had debt of $250.0 million in principal of senior secured notes due in October 2020.

Q1 2019 https://ir.nektar.com/node/18126/html

   

https://investors.merck.com/news/...ozane-and-Tazobactam/default.aspx

Habe mich nicht eingelesen.
Das dürfte aber auch keinen großen Kurssprung verursachen.  

WASHINGTON, July 22, 2019 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that on July 19, 2019, it received a notification from the U.S. Food and Drug Administration (FDA) stating that as part of its ongoing review of Vanda's supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of Jet Lag Disorder, the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. No deficiencies were disclosed by the FDA in this notification, and the FDA stated that this notification does not reflect a final decision on the information under review. In a letter dated December 19, 2018, the FDA had assigned a Prescription Drug User Fee Act ("PDUFA") target date for completion of its review by August 16, 2019.
https://www.ariva.de/news/...ls-fda-update-for-hetlioz-in-the-7718342  

Q2

https://www.ariva.de/news/...ts-second-quarter-2019-financial-7741272

The FDA's review of the supplemental New Drug Application (sNDA) of HETLIOZ® for the treatment of jet lag disorder is ongoing with a Prescription Drug User Fee Act (PDUFA) target date of August 16, 2019. On July 19, 2019, Vanda received a "Deficiencies Preclude Discussion" letter  from the FDA.  The letter does not specify any deficiencies in the file at this time.  Vanda will await the PDUFA action and work expeditiously to resolve any potential deficiencies.

 

Ist das jetzt der Zock auf die Zulassung?   Noch 10 Handelstage!



https://www.ariva.de/kala_pharmaceuticals_inc-aktie  

Die FDA gab an, dass Wirksamkeitsdaten aus einer zusätzlichen klinischen Studie benötigt werden, um eine erneute Einreichung zu unterstützen.

Kala nimmt weiterhin Patienten an der laufenden klinischen Phase-3-Studie STRIDE 3 (STRIDE - Short Term Relief In Dry Eye) teil und geht davon aus, dass diese Studie als Grundlage für die Reaktion auf die CRL dienen wird. Kala plant, die Daten aus STRIDE 3 bis Ende 2019 vorzulegen und die NDA im ersten Halbjahr 2020 erneut vorzulegen. Das Unternehmen geht davon aus, dass diese Wiedervorlage einer sechsmonatigen Überprüfung gemäß dem Prescription Drug User Fee Act unterliegen wird.

http://investors.kalarx.com/node/7846/html
Soweit zu KALA  

HETLIOZ® (tasimelteon)

   The FDA's review of the supplemental New Drug Application (sNDA) of HETLIOZ® for the treatment of jet lag disorder is ongoing with a Prescription Drug User Fee Act (PDUFA) target date of August 16, 2019. On July 19, 2019, Vanda received a "Deficiencies Preclude Discussion" letter  from the FDA.  The letter does not specify any deficiencies in the file at this time.  Vanda will await the PDUFA action and work expeditiously to resolve any potential deficiencies.

https://vandapharmaceuticalsinc.gcs-web.com/...quarter-2019-financial

Gute Q2 2019
https://www.ariva.de/forum/...ticals-rebound-329096?page=3#jumppos100
https://vandapharmaceuticalsinc.gcs-web.com/node/13681/html  

Aus dem Q2 vom 8.8.19

Kaum Verwässerung
As of April 30, 2019, the registrant had 72,557,253 ordinary shares outstanding.
As of July 30, 2019, the registrant had 73,361,410 ordinary shares outstanding.

For the three months ended June 30, 2019, Nabriva Therapeutics reported a net loss of $21.7 million
As of June 30, 2019, Nabriva Therapeutics had $73.9 million in cash, cash equivalents and short-term investments ...................Existing cash resources are expected to fund operations into the second quarter of 2020.

We have two product candidates that have been submitted to the U.S. Food and Drug Administration, or the FDA, for approval:

Aber jetzt erstmal

Lefamulin is a semi-synthetic pleuromutilin antibiotic discovered and developed by our team with the potential to be first-in-class for IV and oral in humans. It inhibits the synthesis of bacterial protein, which is required for bacteria to grow by binding with high affinity, high specificity and at molecular targets that are different than other antibiotic classes. Based on results from two global, Phase 3 clinical trials, we believe that lefamulin is well-positioned for use as a first-line monotherapy for the treatment of CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, availability of oral and IV formulations and a generally well-tolerated safety profile. We believe lefamulin represents a potentially important new treatment option for the five to six million adults in the United States diagnosed with CABP each year.
https://investors.nabriva.com/node/9086/html

 

Freitag, 16. August VNDA Vanda Pharmaceuticals
Montag, 19. August NBRV Nabriva Therapeutics  

Ein kleiner Vorgeschmack auf den PDUFA am 12.9

Ardelyx Announces Positive Results from the Pivotal Phase 3 AMPLIFY Study Evaluating Tenapanor in Dialysis Patients Who Have Uncontrolled Hyperphosphatemia Despite Phosphate Binder Treatment

http://ir.ardelyx.com/news-releases/...-pivotal-phase-3-amplify-study