DAX ®13.058,63+0,86%TecDAX ®3.104,32+0,75%Dow Jones27.871,78+0,67%NASDAQ 10011.141,41+2,44%
finanztreff.de

DGAP-Adhoc: MorphoSys AG: Ad hoc: FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

| Quelle: Dow Jones Newsw... | Lesedauer etwa 5 min. | Text vorlesen Stop Pause Fortsetzen


DGAP-Ad-hoc: MorphoSys AG / Key word(s): Regulatory Approval
MorphoSys AG: Ad hoc: FDA Approves Monjuvi(R) (tafasitamab-cxix) in
Combination with Lenalidomide for the Treatment of Adult Patients with
Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

01-Aug-2020 / 01:35 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation
(EU) No 596/2014, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

*Ad hoc release according to article 17 para. 1 MAR*
Planegg/Munich, Germany, August 1, 2020

*Ad hoc: FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with
Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory
Diffuse Large B-cell Lymphoma (DLBCL)*

MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR)
today announces that the U.S. Food and Drug Administration (FDA) has
approved Monjuvi*(R)* (tafasitamab-cxix) in combination with lenalidomide
for the treatment of adult patients with relapsed or refractory diffuse
large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL
arising from low grade lymphoma, and who are not eligible for autologous
stem cell transplant (ASCT). Monjuvi, a humanized Fc-modified cytolytic
CD19-targeting monoclonal antibody, has been approved under accelerated
approval by the U.S. FDA based on overall response rate (ORR). Continued
approval may be contingent upon verification and description of clinical
benefit in a confirmatory trial(s). The FDA decision represents the first
approval of a second-line treatment for adult patients who progressed during
or after first-line therapy.

The FDA approval was based on data from the MorphoSys-sponsored Phase 2
L-MIND study, an open label, multicenter, single arm trial of Monjuvi in
combination with lenalidomide as a treatment for adult patients with
relapsed or refractory DLBCL. The FDA previously granted Fast Track and
Breakthrough Therapy Designation for this combination in relapsed or
refractory DLBCL, and the Biologics License Application (BLA) for Monjuviwas
granted Priority Review and approved under the FDA's Accelerated Approval
program.

Monjuvi is expected to be commercially available in the United States
shortly. MorphoSys and its partner Incyte (Nasdaq: INCY) will
co-commercialize Monjuvi in the United States. Incyte has exclusive
commercialization rights outside the United States.

***

*END OF AD HOC RELEASE*

Information and Explanation of the Issuer to this News:

*MorphoSys Forward-Looking Statements*
This communication contains certain forward-looking statements concerning
the MorphoSys group of companies, including the expectations regarding
tafasitamab's ability to treat patients with relapsed or refractory diffuse
large B-cell lymphoma, the further clinical development of tafasitamab,
including ongoing confirmatory trials, additional interactions with
regulatory authorities and expectations regarding future regulatory filings
and possible additional approvals for tafasitamab as well as the commercial
performance of tafasitamab. The words 'anticipate,' 'believe,' 'estimate,'
'expect,' 'intend,' 'may,' 'plan,' 'predict,' 'project,' 'would,' 'could,'
'potential,' 'possible,' 'hope' and similar expressions are intended to
identify forward-looking statements, although not all forward-looking
statements contain these identifying words. The forward-looking statements
contained herein represent the judgment of MorphoSys as of the date of this
release and involve known and unknown risks and uncertainties, which might
cause the actual results, financial condition and liquidity, performance or
achievements of MorphoSys, or industry results, to be materially different
from any historic or future results, financial conditions and liquidity,
performance or achievements expressed or implied by such forward-looking
statements. In addition, even if MorphoSys' results, performance, financial
condition and liquidity, and the development of the industry in which it
operates are consistent with such forward-looking statements, they may not
be predictive of results or developments in future periods. Among the
factors that may result in differences are MorphoSys' expectations regarding
risks and uncertainties related to the impact of the COVID-19 pandemic to
MorphoSys' business, operations, strategy, goals and anticipated milestones,
including its ongoing and planned research activities, ability to conduct
ongoing and planned clinical trials, clinical supply of current or future
drug candidates, commercial supply of current or future approved products,
and launching, marketing and selling current or future approved products,
the global collaboration and license agreement for tafasitamab, the further
clinical development of tafasitamab, including ongoing confirmatory trials,
and MorphoSys' ability to obtain and maintain requisite regulatory approvals
and to enroll patients in its planned clinical trials, additional
interactions with regulatory authorities and expectations regarding future
regulatory filings and possible additional approvals for tafasitamab as well
as the commercial performance of tafasitamab, MorphoSys' reliance on
collaborations with third parties, estimating the commercial potential of
its development programs and other risks indicated in the risk factors
included in MorphoSys' Annual Report on Form 20-F and other filings with the
U.S. Securities and Exchange Commission. Given these uncertainties, the
reader is advised not to place any undue reliance on such forward-looking
statements. These forward-looking statements speak only as of the date of
publication of this document. MorphoSys expressly disclaims any obligation
to update any such forward-looking statements in this document to reflect
any change in its expectations with regard thereto or any change in events,
conditions or circumstances on which any such statement is based or that may
affect the likelihood that actual results will differ from those set forth
in the forward-looking statements, unless specifically required by law or
regulation.

*For more information, please contact:*

*MorphoSys AG*

Dr. Anja Pomrehn
Senior Vice President
Tel: +49 (0)89 / 899 27 26972
_anja.pomrehn@morphosys.com_

Dr. Julia Neugebauer
Director
Tel: +49 (0)89 / 899 27 179
_julia.neugebauer@morphosys.com_

01-Aug-2020 CET/CEST The DGAP Distribution Services include Regulatory
Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de
Language: English
Company: MorphoSys AG
Semmelweisstr. 7
82152 Planegg
Germany
Phone: +49 (0)89 899 27-0
Fax: +49 (0)89 899 27-222
E-mail: investors@morphosys.com
Internet: www.morphosys.com
ISIN: DE0006632003
WKN: 663200
Indices: MDAX, TecDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover,
Munich, Stuttgart, Tradegate Exchange; Nasdaq
EQS News ID: 1107909

End of Announcement DGAP News Service

1107909 01-Aug-2020 CET/CEST



(END) Dow Jones Newswires

July 31, 2020 19:35 ET ( 23:35 GMT)
Werbung

Das könnte Sie auch interessieren

Im Artikel erwähnt...

MorphoSys
MorphoSys - Performance (3 Monate) 109,60 -0,81%
EUR -0,90
Porträt - Chart - Kennzahlen - Firmenprofil
Fundamentale Analysen Urteil
07.08. DEUTSCHE BANK Positiv
06.08. RBC Neutral
06.08. JPMORGAN Positiv
Nachrichten
16:00 DGAP-PVR: MorphoSys AG: Release according to -2- MorphoSys 109,60 -0,81%
16:00 DGAP-PVR: MorphoSys AG: Release according to -3- MorphoSys 109,60 -0,81%
16:00 DGAP-PVR: MorphoSys AG: Release according to -4- MorphoSys 109,60 -0,81%
Weitere Wertpapiere...
MORPHOSYS AG SP.ADR(TEMP) 27,20 +0,74%
EUR +0,20

News-Suche

Suchbegriff:

Aktuelle Videos

HSBC Trading TV

Werbung

Trading-Tipp

Börsen & Märkte

US-Marktüberblick

zur Mediathek
Werbung

Werbung
Diese Seite empfehlenschliessen
Interessant, oder?
Teilen Sie diese Seite auf Facebook oder Twitter
Wenn Sie auf die Teilen-Buttons klicken und sich bei den Betreibern einloggen, werden Daten an den jeweiligen Betreiber übermittelt. Bitte beachten Sie die Datenschutzerklärung.
Aktuelle Umfrageschliessen
Glauben Sie, dass Microsoft TikTok komplett übernehmen wird?
Jetzt abstimmen!
Alle Umfragen ansehen