Full Press Release Details
HISTOGENICS AND FDA CONTINUE TO DISCUSS NEOCART
PHASE 3 CLINICAL TRIAL DATA AND POTENTIAL REGULATORY PATHWAY
WALTHAM, Mass., November 29, 2018 /GLOBE NEWSWIRE/
Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today provided an update on the NeoCart regulatory pathway based on its
ongoing dialogue with the U.S. Food and Drug Administration (the FDA). Since the initial Type C meeting in October 2018, Histogenics and the FDA have continued their discussions on the clinical data generated to date, the potential need for any
additional supplemental clinical data (which may include longer-term data from the ongoing Phase 3 trial or additional studies) and potential alternative regulatory pathways for the NeoCart Biologics License Application (BLA). The FDA has not yet
made a final decision regarding a potential BLA submission. Histogenics intends to provide a further update by the end of 2018 or early 2019 based on additional feedback from the FDA, once available.
We very much appreciate the FDA s consideration and active review of our request to evaluate the existing Phase 3 clinical data for a potential
NeoCart BLA submission. We continue to work very closely with the FDA to review the data from the NeoCart development program. Our discussions have covered many areas including the clinical data, patient population and related statistics from the
NeoCart Phase 3 clinical trial, potential alternative pathways for the BLA as well as the current treatment paradigms for knee cartilage defects in relation to the design of the NeoCart Phase 3 clinical trial, said Adam Gridley, President and
Chief Executive Officer of Histogenics. We continue to believe, based on the totality of the data, that NeoCart, if the BLA were accepted and approved by the FDA, may offer patients a treatment alternative that provides a more rapid recovery
from pain and return to daily activity than other currently available options to treat damaged knee cartilage.
About Histogenics Corporation
Histogenics (Nasdaq: HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.
Histogenics lead investigational product, NeoCart, is designed to rebuild a patient s own knee cartilage to treat pain at the source and potentially prevent a patient s progression to osteoarthritis. NeoCart is one of the most
rigorously studied restorative cell therapies for orthopedic use. NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as
compared to the current standard of care. Histogenics technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit
Forward-Looking Statements
Various statements in this release are forward-looking statements under the securities laws. Words such as, but not limited to,
anticipate, believe, can, could, expect, estimate, design, goal, intend, may, might, objective,
plan, predict, project, target, likely, should, will, and would, or the negative of these terms and similar expressions or words, identify
statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in Histogenics forward-looking statements include, among
others: expectations regarding the timing and success of ongoing discussions with the FDA regarding the potential submission or acceptance of a BLA for NeoCart; NeoCart s potential as a treatment for knee cartilage damage; the timing,
associated expenses and ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the market size and potential patient population in markets where Histogenics and its
partners expect to compete; updated or refined data based on Histogenics continuing review and quality control analysis of clinical data; the scope, progress, timing, expansion, and costs of developing and commercializing Histogenics
product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following its technology transfer and manufacturing location transition; Histogenics expectations
regarding its expenses and revenue; Histogenics ability to obtain additional debt or equity capital; and other factors that are described in the Risk Factors and Management s Discussion and Analysis of Financial
Condition and Results of Operations sections of Histogenics Annual Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form
10-Q for the quarter ended September 30, 2018, which are on file with the SEC and available on the SEC s website at www.sec.gov. In addition to the risks described above and in Histogenics
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other
unknown or unpredictable factors also could affect Histogenics results. Histogenics has not yet received the official FDA meeting minutes from the Type C meeting and the information in this Press Release may be altered or supplemented by the
information contained in the official meeting minutes or any subsequent meetings that may be held with the FDA.
There can be no assurance that the actual
results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in
such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to Histogenics or any
person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that
are made on its behalf. The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements,
whether as a result of new information, future events or otherwise.
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