Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced
financial results and provided a business update for the third
quarter of 2018.
“The third quarter was marked by multiple
successes on the clinical and regulatory front, including the
approval and launch of AZEDRA, the first-ever U.S. approved
treatment for advanced or metastatic pheochromocytoma and
paraganglioma. The broader medical community has recognized the
importance of AZEDRA in treating these deadly tumors, and we are
pleased with the high level of interest from across the entire
spectrum of the healthcare system and well as the rapid addition of
AZEDRA to the NCCN guidelines,” commented Mark Baker, Chief
Executive Officer of Progenics.
Mr. Baker continued, “We are pleased that
clinicians and pharmaceutical industry leaders increasingly
recognize the value of radiopharmaceuticals to address a range of
unmet needs in oncology. Consistent with our strategy to maximize
the full value of our PSMA-targeted radio pharmaceutical
candidates, we are advancing our prostate cancer pipeline.
Following encouraging data from our PyL Phase 2/3 OSPREY study, we
are on track to initiate a Phase 3 study this year. In addition, we
are moving forward a Phase 2 study for 1095 in patients with
metastatic castration-resistant prostate cancer (mCRPC) in early
2019.”
Third Quarter and Recent Key Business
Highlights
AZEDRA (iobenguane I 131) 555 MBq/mL injection
for intravenous use, Ultra-orphan Radiotherapeutic
- AZEDRA Launch Progressing Following FDA Approval in
July In July, Progenics received U.S. Food and Drug
Administration (FDA) approval of its New Drug Application for
AZEDRA. AZEDRA is the first and only approved therapy in the U.S.
for the treatment of adult and pediatric patients 12 years and
older with iobenguane scan positive, unresectable, locally advanced
or metastatic pheochromocytoma or paraganglioma who require
systemic anticancer therapy.
- AZEDRA Added to NCCN Guidelines and Four CMS-Recognized
Drug Compendia In September 2018, AZEDRA was added to
the National Comprehensive Cancer Network® (NCCN) Clinical Practice
Guidelines in Oncology for Neuroendocrine and Adrenal Tumors v
3.2018. NCCN Guidelines® are widely recognized and used as the
standard for clinical policy in oncology by clinicians and payors.
Since AZEDRA’s approval by the FDA, it has also been added to four
drug compendia: Clinical Pharmacology©; DRUGDEX®; Lexi-Drugs®; and
NCCN. These compendia are recognized by private and public payers,
including Centers for Medicare and Medicaid Services (CMS) as
authoritative sources to be considered in determining drug
reimbursement.
- Pivotal trial of AZEDRA published in The Journal
of Nuclear Medicine In October 2018, the study
entitled, “Efficacy and Safety of High-Specific-Activity I-131 MIBG
Therapy in Patients with Advanced Pheochromocytoma or
Paraganglioma,” was published in The Journal of Nuclear Medicine.
This article reported the complete results of the pivotal study of
AZEDRA, which was the largest multicenter, prospective trial to
evaluate the safety and efficacy of any therapy in patients with
pheochromocytoma and paraganglioma and formed the basis of AZEDRA’s
approval by the FDA.
- AZEDRA Safety and Tolerability Data to be presented at
a Special Interest Session at RSNA In November,
Progenics will present updated safety and tolerability data for
High-Specific-Activity MIBG (AZEDRA®) at the Special Interest
Session: High Impact Clinical Trials the 104th Scientific Assembly
and Annual Meeting of the Radiological Society of North America
(RSNA).
PSMA-Targeted Prostate Cancer Pipeline
- Advancing 1095 Therapeutic into Phase 2
Development In October 2018, following discussions
with the FDA, Progenics announced plans for a Phase 2 study of 1095
in combination with enzalutamide in chemo-naïve patients with
metastatic castration-resistant prostate cancer (mCRPC). 1095
is a small molecule radiotherapeutic designed to selectively bind
to the extracellular domain of prostate specific membrane antigen
(PSMA), a protein that is highly expressed on prostate cancer
cells. It is believed that once 1095 binds to the prostate cancer
cells, the drug is internalized and the beta radiation kills the
tumor cells. Enrollment is expected to begin in early 2019 and
PyL, Progenics’ PET/CT imaging agent, will be used to select
patients most likely to benefit from 1095 treatment.
- Company decides to focus PSMA-Targeted Imaging Agent
Efforts on PyL, Not Investing in Additional 1404
Trials After review of the results of its Phase 3
study of 1404, a PSMA-targeted small molecule SPECT/CT imaging
agent to visualize cancer; and an assessment of the PSMA-targeted
imaging agent commercial landscape, the Company has decided to
focus its efforts on PyL, its PSMA-targeted PET/CT imaging agent,
and will not further invest in 1404.
- Phase 3 Study of PyL Imaging Agent to Begin by Year
End In September 2018, the Company announced topline
results of its Phase 2/3 OSPREY study evaluating the diagnostic
accuracy of its PSMA-targeted PET/CT imaging agent, PyL, in
prostate cancer. The study data highlights the strong positive
predictive values of PyL to detect prostate cancer in pelvic lymph
nodes and metastatic lesions and supports continued development of
PyL. Progenics expects to initiate a Phase 3 study of PyL for the
detection of biochemical recurrence of prostate cancer by the end
of 2018.
- Initiation of Phase 1 Study for PSMA-TTC by Bayer
Expected in 2018 Progenics expects its partner Bayer
to initiate a Phase 1 study of PSMA-Targeted Thorium Conjugate
(PSMA-TTC) in patients with mCRPC by year end 2018. Bayer was
previously granted exclusive worldwide rights to develop and
commercialize products using Progenics’ PSMA antibody technology in
combination with Bayer’s alpha-emitting radionuclides.
Digital Technology Portfolio
- Artificial Intelligence Imaging Analysis Technology to
Use 1404 and PyL Data Progenics’ imaging analysis
technology uses artificial intelligence and machine learning to
quantify and automate the reading of PSMA targeted imaging. Data
from the company’s pipeline of PSMA-targeted imaging agents (1404
and PyL) is being used to develop deep learning algorithms
delivered through compliant medical device software for the
automatic detection and quantification of prostate cancer images.
The use of AI applications can boost performance, increases
objectivity and repeatability, and makes complex but clinically
relevant assessments available to physicians in the interpretation
of large and complex image data.
RELISTOR, Treatment for Opioid-Induced
Constipation (partnered with Bausch Health Companies Inc.)
- Third Quarter 2018 RELISTOR Net Sales of $34.5
Million The third quarter 2018 net sales of RELISTOR,
as reported to Progenics by its partner Bausch Health Companies,
Inc. (formerly known as Valeant Pharmaceuticals, Inc.), translated
to $5.2 million in royalty revenue for Progenics for the
quarter.
Third Quarter 2018 Financial
Results
Third quarter revenue totaled $5.3 million, up
from $2.7 million in the third quarter of 2017, reflecting RELISTOR
royalty income of $5.2 million compared to $2.6 million in the
corresponding period of 2017.
Third quarter research and development expenses
decreased by $2.3 million compared to the corresponding prior year
period, resulting primarily from lower external costs associated
with the completion of the Phase 2 study for AZEDRA and the Phase 3
trial for 1404. Third quarter selling, general and administrative
expenses increased by $1.1 million compared to the corresponding
prior year period, primarily attributable to higher costs
associated with the commercial launch of AZEDRA. Progenics also
recorded a net non-cash charge of $15.2 million in the third
quarter 2018, resulting from changes in estimated fair values of
intangible assets and contingent consideration liability, primarily
related to 1404. For the three months ended September 30, 2018,
Progenics recognized interest expense of $1.2 million related to
the RELISTOR royalty-backed loan and $1.5 million income tax
benefit associated with the non-cash charge recorded as a result of
the change in estimated fair value of 1404 intangible assets
mentioned above.
Net loss for the third quarter was $24.4
million, or $0.30 per diluted share, compared to net loss of $15.4
million, or $0.22 per diluted share, in the corresponding 2017
period.
Progenics ended the third quarter with cash and
cash equivalents of $148.9 million, an increase of $58.2 million
compared to cash and cash equivalents as of December 31, 2017.
During the quarter, the Company raised net proceeds of $70.0
million in an underwritten public offering of 9.1 million shares of
common stock at a public offering price of $8.25 per share and an
additional $4.8 million in at-the-market (“ATM”) transactions of
0.6 million shares of common stock at an average selling price of
$8.36 per share. Progenics intends to use the proceeds to support
the launch of AZEDRA, to advance its pipeline and for potential
business development opportunities.
Conference Call and Webcast
Progenics will review third quarter financial
results in a conference call today at 8:30 a.m. ET. To participate,
please dial (877) 250-8889 (domestic) or (720) 545-0001
(international) and reference conference ID 6409609. A live webcast
will be available in the Media Center of the Progenics website,
www.progenics.com, and a replay will be available for two
weeks.
- Financial Tables follow -
PROGENICS PHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(In thousands, except per share data)
|
|
For the Three Months
EndedSeptember 30, |
|
|
For the Nine Months
EndedSeptember 30, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
Revenues: |
|
(Unaudited) |
|
Royalty income |
$ |
5,169 |
|
|
$ |
2,562 |
|
|
$ |
11,757 |
|
|
$ |
7,282 |
|
|
Other revenues |
|
148 |
|
|
|
135 |
|
|
|
627 |
|
|
|
527 |
|
|
Total revenues |
|
5,317 |
|
|
|
2,697 |
|
|
|
12,384 |
|
|
|
7,809 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
8,090 |
|
|
|
10,344 |
|
|
|
25,547 |
|
|
|
31,641 |
|
|
Selling, general and administrative |
|
7,075 |
|
|
|
5,958 |
|
|
|
21,341 |
|
|
|
17,986 |
|
|
Intangible impairment charge |
|
23,200 |
|
|
|
- |
|
|
|
23,200 |
|
|
|
- |
|
|
Change in contingent consideration liability |
|
(8,000 |
) |
|
|
700 |
|
|
|
(5,900 |
) |
|
|
3,300 |
|
|
Total operating expenses |
|
30,365 |
|
|
|
17,002 |
|
|
|
64,188 |
|
|
|
52,927 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(25,048 |
) |
|
|
(14,305 |
) |
|
|
(51,804 |
) |
|
|
(45,118 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
(expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest (expense) income, net |
|
(762 |
) |
|
|
(1,047 |
) |
|
|
(2,698 |
) |
|
|
(3,230 |
) |
|
Total other (expense) income |
|
(762 |
) |
|
|
(1,047 |
) |
|
|
(2,698 |
) |
|
|
(3,230 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
before income tax benefit |
|
(25,810 |
) |
|
|
(15,352 |
) |
|
|
(54,502 |
) |
|
|
(48,348 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit |
|
1,453 |
|
|
|
- |
|
|
|
1,549 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(24,357 |
) |
|
$ |
(15,352 |
) |
|
$ |
(52,953 |
) |
|
$ |
(48,348 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted |
$ |
(0.30 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.70 |
) |
|
$ |
(0.69 |
) |
|
Weighted average shares outstanding – basic and
diluted |
|
80,325 |
|
|
|
70,270 |
|
|
|
75,648 |
|
|
|
70,233 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands) |
|
|
September
30,2018 |
|
December
31,2017 |
|
|
|
|
|
|
|
(unaudited) |
|
(audited) |
Cash and cash
equivalents |
$ |
148,851 |
$ |
90,642 |
Accounts receivable,
net |
|
5,821 |
|
3,972 |
Property and equipment,
net |
|
3,977 |
|
4,122 |
Intangible assets, net
and goodwill |
|
19,967 |
|
43,443 |
Other assets |
|
3,766 |
|
3,778 |
Total assets |
$ |
182,382 |
$ |
145,957 |
|
|
|
|
|
Current
liabilities |
$ |
16,495 |
$ |
15,359 |
Contingent
consideration liability |
|
10,900 |
|
16,800 |
Long-term debt,
deferred tax and other liabilities |
|
40,104 |
|
50,345 |
Total liabilities |
|
67,499 |
|
82,504 |
Total stockholders’
equity |
|
114,883 |
|
63,453 |
Total liabilities and stockholders’ equity |
$ |
182,382 |
$ |
145,957 |
|
|
|
|
|
Indication
AZEDRA® (iobenguane I 131) is indicated for the
treatment of adult and pediatric patients 12 years and older with
iobenguane scan positive, unresectable, locally advanced or
metastatic pheochromocytoma or paraganglioma who require systemic
anticancer therapy.
Important Safety
Information
Warnings and Precautions:
- Risk from Radiation
Exposure: AZEDRA contributes to a patient’s overall
long-term radiation exposure. Long-term cumulative radiation
exposure is associated with an increased risk for cancer. These
risks of radiation associated with the use of AZEDRA are greater in
pediatric patients than in adults. Minimize radiation exposure to
patients, medical personnel, and household contacts during and
after treatment with AZEDRA consistent with institutional good
radiation safety practices and patient management procedures.
- Myelosuppression:
Among the 88 patients who received a therapeutic dose of AZEDRA,
33% experienced Grade 4 thrombocytopenia, 16% experienced Grade 4
neutropenia, and 7% experienced Grade 4 anemia. Five percent of
patients experienced febrile neutropenia. Monitor blood cell counts
weekly for up to 12 weeks or until levels return to baseline or the
normal range. Withhold and dose reduce AZEDRA as recommended in the
prescribing information based on severity of the cytopenia.
- Secondary myelodysplastic
syndrome, leukemia, and other malignancies:
Myelodysplastic syndrome (MDS) and acute leukemias were reported in
6.8% of the 88 patients who received a therapeutic dose of AZEDRA.
The time to development of MDS or acute leukemia ranged from 12
months to 7 years. Two of the 88 patients developed a
non-hematological malignancy.
- Hypothyroidism:
Hypothyroidism was reported in 3.4% of the 88 patients who received
a therapeutic dose of AZEDRA. Initiate thyroid-blocking medications
starting at least 1 day before and continuing for 10 days after
each AZEDRA dose to reduce the risk of hypothyroidism or thyroid
neoplasia. Evaluate for clinical evidence of hypothyroidism and
measure thyroid-stimulating hormone (TSH) levels prior to
initiating AZEDRA and annually thereafter.
- Elevations in blood
pressure: Eleven percent of the 88 patients who received a
therapeutic dose of AZEDRA experienced a worsening of pre-existing
hypertension defined as an increase in systolic blood pressure to
≥160 mmHg with an increase of 20 mmHg or an increase in diastolic
blood pressure to ≥ 100 mmHg with an increase of 10 mmHg. All
changes in blood pressure occurred within the first 24 hours post
infusion. Monitor blood pressure frequently during the first 24
hours after each therapeutic dose of AZEDRA.
- Renal toxicity: Of
the 88 patients who received a therapeutic dose of AZEDRA, 9%
developed renal failure or acute kidney injury and 22% demonstrated
a clinically significant decrease in glomerular filtration rate
(GFR) measured at 6 or 12 months. Monitor renal function during and
after treatment with AZEDRA. Patients with baseline renal
impairment may be at greater risk of toxicity; perform more
frequent assessments of renal function in patients with mild or
moderate impairment. AZEDRA has not been studied in patients with
severe renal impairment.
- Pneumonitis: Fatal
pneumonitis occurred 9 weeks after a single dose in one patient in
the expanded access program. Monitor patients for signs and
symptoms of pneumonitis and treat appropriately.
- Embryo-fetal
toxicity: Based on its mechanism of action, AZEDRA can
cause fetal harm. Verify pregnancy status in females of
reproductive potential prior to initiating AZEDRA. Advise females
and males of reproductive potential of the potential risk to a
fetus and to use effective contraception during treatment with
AZEDRA and for 7 months after the final dose. Advise males with
female partners of reproductive potential to use effective
contraception during treatment and for 4 months after the final
dose.
- Risk of
infertility: Radiation exposure associated with AZEDRA may
cause infertility in males and females. Radiation absorbed by
testes and ovaries from the recommended cumulative dose of AZEDRA
is within the range where temporary or permanent infertility can be
expected following external beam radiotherapy.
Adverse Reactions:The most
common severe (Grade 3–4) adverse reactions observed in AZEDRA
clinical trials (≥ 10%) were lymphopenia (78%), neutropenia
(59%), thrombocytopenia (50%), fatigue (26%), anemia (24%),
increased international normalized ratio (18%), nausea (16%),
dizziness (13%), hypertension (11%), and vomiting (10%). Twelve
percent of patients discontinued treatment due to adverse reactions
(thrombocytopenia, anemia, lymphopenia, nausea and vomiting,
multiple hematologic adverse reactions).
Drug Interactions:Based on the
mechanism of action of iobenguane, drugs that reduce catecholamine
uptake or that deplete catecholamine stores may interfere with
iobenguane uptake into cells and therefore interfere with dosimetry
calculations or the efficacy of AZEDRA. These drugs were not
permitted in clinical trials that assessed the safety and efficacy
of AZEDRA. Discontinue the drugs listed in the prescribing
information for at least 5 half-lives before administration of
either the dosimetry dose or a therapeutic dose of AZEDRA. Do not
administer these drugs until at least 7 days after each AZEDRA
dose.
For important risk and use information
about AZEDRA, please see Full Prescribing
Information.
To report suspected adverse reactions,
contact Progenics Pharmaceuticals, Inc. at 844-668-3950 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Reference:
AZEDRA® prescribing information. New York, NY:
Progenics Pharmaceuticals, Inc.; 08 2018.
Reference:AZEDRA® prescribing
information. New York, NY: Progenics Pharmaceuticals, Inc.; 07
2018.
About RELISTOR®
Progenics has exclusively licensed development
and commercialization rights for its first commercial product,
RELISTOR, to Bausch Health Companies, Inc. RELISTOR Tablets (450 mg
once daily) are approved in the United States for the treatment of
opioid-induced constipation (OIC) in patients with chronic
non-cancer pain. RELISTOR Subcutaneous Injection (12 mg and 8 mg)
is a treatment for OIC approved in the United States and worldwide
for patients with advanced illness and chronic non-cancer pain.
IMPORTANT SAFETY
INFORMATION - RELISTOR (methylnaltrexone
bromide) tablets, for oral use and RELISTOR (methylnaltrexone
bromide) injection, for subcutaneous use
RELISTOR tablets and injection are
contraindicated in patients with known or suspected
gastrointestinal obstruction and patients at increased risk of
recurrent obstruction, due to the potential for gastrointestinal
perforation.
Cases of gastrointestinal perforation have been
reported in adult patients with opioid-induced constipation and
advanced illness with conditions that may be associated with
localized or diffuse reduction of structural integrity in the wall
of the gastrointestinal tract (e.g., peptic ulcer disease,
Ogilvie's syndrome, diverticular disease, infiltrative
gastrointestinal tract malignancies or peritoneal metastases). Take
into account the overall risk-benefit profile when using RELISTOR
in patients with these conditions or other conditions which might
result in impaired integrity of the gastrointestinal tract wall
(e.g., Crohn's disease). Monitor for the development of severe,
persistent, or worsening abdominal pain; discontinue RELISTOR in
patients who develop this symptom.
If severe or persistent diarrhea occurs during
treatment, advise patients to discontinue therapy with RELISTOR and
consult their healthcare provider.
Symptoms consistent with opioid withdrawal,
including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety,
and yawning have occurred in patients treated with RELISTOR.
Patients having disruptions to the blood-brain barrier may be at
increased risk for opioid withdrawal and/or reduced analgesia and
should be monitored for adequacy of analgesia and symptoms of
opioid withdrawal.
Avoid concomitant use of RELISTOR with other
opioid antagonists because of the potential for additive effects of
opioid receptor antagonism and increased risk of opioid
withdrawal.
The use of RELISTOR during pregnancy may
precipitate opioid withdrawal in a fetus due to the immature fetal
blood brain barrier and should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
Because of the potential for serious adverse reactions, including
opioid withdrawal, in breastfed infants, advise women that
breastfeeding is not recommended during treatment with RELISTOR. In
nursing mothers, a decision should be made to discontinue nursing
or discontinue the drug, taking into account the importance of the
drug to the mother. A dosage reduction of RELISTOR tablets
and RELISTOR injection is recommended in patients with moderate and
severe renal impairment (creatinine clearance less than 60
mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of
RELISTOR tablets or RELISTOR injection is needed in patients with
mild renal impairment.
A dosage reduction of RELISTOR tablets is
recommended in patients with moderate (Child-Pugh Class B) or
severe (Child-Pugh Class C) hepatic impairment. No dosage
adjustment of RELISTOR tablets is needed in patients with mild
hepatic impairment (Child-Pugh Class A). No dosage adjustment of
RELISTOR injection is needed for patients with mild or moderate
hepatic impairment. In patients with severe hepatic impairment,
monitor for methylnaltrexone-related adverse reactions. In the
clinical studies, the most common adverse reactions were:
OIC in adult patients with chronic non-cancer
pain
- RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater
incidence than placebo): abdominal pain (14%), diarrhea (5%),
headache (4%), abdominal distention (4%), vomiting (3%),
hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea
(2%), and chills (2%).
- RELISTOR injection (≥ 1% of RELISTOR patients and at a greater
incidence than placebo): abdominal pain (21%), nausea (9%),
diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and
chills (1%).
OIC in adult patients with advanced illness
- RELISTOR injection (≥ 5% of RELISTOR patients and at a greater
incidence than placebo): abdominal pain (29%) flatulence (13%),
nausea (12%), dizziness (7%), and diarrhea (6%).
Please see complete Prescribing Information for
RELISTOR at www.bauschhealth.com. For more information about
RELISTOR, please visit www.RELISTOR.com.
About PROGENICS
Progenics develops innovative medicines and
other technologies to target and treat cancer, including: 1)
therapeutic agents designed to treat cancer (AZEDRA®, PSMA TTC and
1095), 2) PSMA-targeted imaging agents for prostate cancer (1404
and PyL™), and 3) imaging analysis technology (PSMA AI and aBSI).
Progenics has two commercial products, AZEDRA, for the treatment of
unresectable, locally advanced or metastatic pheochromocytoma or
paraganglioma (rare neuroendocrine tumors of neural crest origin)
who require systemic anticancer therapy; and
RELISTOR® (methylnaltrexone bromide) for opioid-induced
constipation, which is partnered with Bausch Health Companies,
Inc.
This press release contains projections and
other "forward-looking statements" regarding future events.
Statements contained in this communication that refer to Progenics'
estimated or anticipated future results or other non-historical
facts are forward-looking statements that reflect Progenics'
current perspective of existing trends and information as of the
date of this communication. Forward looking statements generally
will be accompanied by words such as "anticipate," "believe,"
"plan," "could," "should," "estimate," "expect," "forecast,"
"outlook," "guidance," "intend," "may," "might," "will,"
"possible," "potential," "predict," "project," or other similar
words, phrases or expressions. Such statements are predictions
only, and are subject to risks and uncertainties that could cause
actual events or results to differ materially. These risks and
uncertainties include, among others, market acceptance for approved
products; the risk that the commercial launch of AZEDRA may not
meet revenue and income expectations; the cost, timing and
unpredictability of results of clinical trials and other
development activities and collaborations; the unpredictability of
the duration and results of regulatory review of New Drug
Applications (NDA) and Investigational NDAs; possible product
safety or efficacy concerns, general business, financial,
regulatory and accounting matters, litigation and other risks. More
information concerning Progenics and such risks and uncertainties
is available on its website, and in its press releases and reports
it files with the U.S. Securities and Exchange Commission,
including those risk factors included in its Annual Report on Form
10-K for the annual period ended December 31, 2017, as updated in
its subsequent Quarterly Reports on Form 10-Q. Progenics is
providing the information in this press release as of its date and,
except as expressly required by law, Progenics disclaims any intent
or obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or
circumstances or otherwise.
Additional information concerning Progenics and
its business may be available in press releases or other public
announcements and public filings made after this release. For more
information, please visit www.progenics.com. Information on or
accessed through our website or social media sites is not included
in the company's SEC filings.
(PGNX-F)
Contact:Melissa DownsInvestor
Relations(646) 975-2533mdowns@progenics.com
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