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On 7/20/09, Trinity Biotech (NASDAQ:TRIB) ($4.88) announced the submission
of a CLIA application for its TRI-stat point-of-care HbA1c product to the
FDA.TRI-stat is designed to measure HbA1c, also known as glycated hemoglobin
, a measure of a patient's average blood sugar control over the trailing two
to three month period. Utilizing a patented boronate affinity and two-phase
optical system, together with a simple, fully automated, plug-and-play
instrument design, TRI-stat offers highly accurate results in minutes while
eliminating the need for refrigeration found with the other three competing
products.
On 5/29/09, Theratechnologies (TSE:TH) (PINK:THTCF) ($2.00)filed a New Drug
Application (NDA) with the FDA for tesamorelin, an analogue of the growth
hormone releasing factor, proposed for the treatment of excess abdominal fat
in HIV patients with lipodystrophy. Several factors including the
antiretroviral drug regimen and the virus itself are thought to contribute
to HIV-associated lipodystrophy, which is characterized by body composition
changes, dyslipidemia and glucose intolerance. The changes in body
composition include excess abdominal fat accumulation. There is currently no
approved treatment available for the excess abdominal fat related to HIV-
associated lipodystrophy, a condition that can stigmatize patients and
discourage HIV treatment adherence. The estimated PDUFA decision date for a
standard, 10-month review by the FDA is expected to occur in late 1Q10.
On 7/20/09, A.P. Pharma (NASDAQ:APPA) ($0.88) announced that the FDA
accepted for review the Company's New Drug Application (NDA) for APF530 for
the potential treatment of chemotherapy-induced nausea and vomiting (CINV)
with a PDUFA action date set for late 1Q10 for a possible FDA decision.
APF530 is a long-acting formulation of granisetron that utilizes the Company
’s proprietary Biochronomer drug delivery system. The NDA was submitted
under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby
the Company can rely upon the FDA’s prior safety and efficacy findings for
APF530's active ingredient, granisetron, which is already approved by the
Agency.
On 7/14/09, Genta (OTC:GETA) ($0.34) announced the publication of a paper
that independently confirms the link of a key biomarker to overall survival
in patients with advanced melanoma. The biomarker, a tumor-derived enzyme
known as lactate dehydrogenase (LDH), is measured by a widely available
blood test. Genta’s recently completed Phase 3 trial of Genasensein
advanced melanoma, known as AGENDA, specified low-normal LDH as an
enrollment criterion. Results for progression-free survival (PFS), a co-
primary endpoint of AGENDA along with overall survival (OS), are anticipated
during 4Q09 and, if positive, are expected to support global regulatory
applications for Genasense in this indication.
On 5/19/09, Genta announced that the independent Data Monitoring Board (DMB)
for AGENDA notified the Company that the study passed its final futility
analysis for progression-free survival (PFS). Accordingly, the Board has
recommended that the study should continue to completion. Coincident with
this recommendation, Genta submitted an “intent-to-file” notice via the
centralized procedure to the European Medicines Agency (EMEA), which is
required prior to submission of a Marketing Authorization Application (MAA)
for marketing approval in Europe.
On 7/13/09, Genta began trading under a new ticker (GETA.OB) after
implementing a previously announced one-for-fifty reverse stock split of its
common stock which reduced the number of outstanding shares from about 5.4
billion to around 108 million shares.
On 6/30/09, AspenBio Pharma (NASDAQ:APPY) ($2.20) announced a 510(k)
submission to the FDA for its AppyScore Test, which represents the first
blood-based test designed as an aid in the diagnosis of human appendicitis
with the proposed indication of use: AppyScore is an ELISA test system that
is used to quantitatively measure S100A8/A9 heterodimer complex in blood. It
is an in vitro diagnostic device that is intended to be used as an
adjunctive tool for the diagnosis of acute appendicitis in conjunction with
additional diagnostic modalities (such as clinical exam, basic lab testing,
imaging) in patients with abdominal pain that is suspicious for acute
appendicitis.
This filing advances the Company's commercialization plan for AppyScore,
which involves initially filing the 510(k) based on the ELISA test format.
Upon receiving market clearance for this device, the company plans to use
the ELISA device as a predicate for a rapid assay device that includes a
reader instrument. AspenBio plans to begin initial hospital testing of the
rapid assay device in late 2009. Assuming the company receives FDA clearance
of the AppyScore ELISA test and development work is completed, clinical
trials of the rapid assay are planned to begin in early 2010.
Javelin Pharma (AMEX:JAV) ($1.60): Ereska is a non-opiate pain drug being
developed by JAV for the acute treatment of moderate to severe pain in
military, trauma, post-operative, and emergency room settings with the
potential for treating breakthrough pain from cancer as well. The drug is
delivered by a disposable manual pump with a rapid onset and duration of
pain relief of about two hours without opiate side effects such as
respiratory depression. JAV expects to release the primary endpoint data
from the Ereska (intranasal ketamine) Phase 3 pivotal trial in mid-2009,
which consists of 220 adult patients to evaluate the safety and
effectiveness of the drug in the treatment of acute pain (arising from
surgery, trauma, or injury). The stock price for JAV has increased by about
24% in the last five trading days and the volume was over 2X its average on
7/20/09.
In late March, Arena Pharma (NASDAQ:ARNA) ($4.25) announced top-line results
from its BLOOM clinical trial of experimental weight loss drug lorcaserin,
and the Company expects to report results from the second pivotal trial,
BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity
Management), by the end of September 2009 and expects to submit a NDA for
FDA approval by year-end. Vivus (NASDAQ:VVUS) ($6.85) expects to report
pivotal Phase 3 clinical trial results during 3Q09 for its experimental
weight loss drug Qnexa.
On 7/20/09, Orexigen Therapeutics (NASDAQ:OREX) ($7.20) announced that all
three remaining Phase 3 trials evaluating Contrave (bupropion SR/naltrexone
SR) met their co-primary endpoints. The results from the successfully
completed Contrave Obesity Research, or COR, program of more than 4,500
patients exceed the FDA categorical efficacy benchmark for clinically
significant weight loss, supporting the Company's plan to file a New Drug
Application (NDA) with the FDA during 1H10. Contrave was generally well
tolerated by patients across the COR Phase 3 program, and the data continue
to be analyzed and compiled for submission to relevant scientific
conferences, peer-reviewed journals and regulatory agencies.
Hemispherx Biopharma (AMEX:HEB) ($2.49): Ampligen (Poly I: Poly C12U) NDA (
three month PDUFA decision date delay was announced on 2/18/09 as additional
data was submitted by HEB within three months of original decision date).
Ampligen is an experimental treatment for chronic fatigue syndrome (which
has no FDA-approved treatments) and the drug has an Orphan Drug Status with
a PDUFA decision date of 5/25/09. On 5/26/09, HEB announced that the FDA
advised the Company that it may require up to 1-2 additional weeks to take
action beyond the original PDUFA action date of 5/25/09. Click here for an
exclusive interview of HEB's CEO, Dr. William A. Carter, which was posted at
BioMedReports.com on 6/12/09.
On 7/20/09, Labopharm (NASDAQ:DDSS) ($2.00) announced it has received a
complete response letter (CRL) from the FDA for its new drug application (
NDA) for a novel formulation (rapid onset) of the antidepressant trazodone (
DDS-04A). The CRL indicates the Company's application cannot be approved in
its present form due to deficiencies following an FDA inspection of the
active pharmaceutical ingredient (API) manufacturing facility, which was
completed 7/3/09. The FDA letter states that, "Satisfactory resolution of
these deficiencies is required before this application may be approved." No
efficacy or safety issues were raised by the Agency for the NDA. The API
manufacturer, Angelini, has informed DDSS that it can confirm that the
observations raised by the FDA are not critical and that it has not been
questioned about the continued supply of trazodone to the U.S. market.
Angelini intends to address the observations raised by the FDA in an action
plan to be submitted to the Agency by 7/24/09.
On 6/8/09, Dyax Corp. (NASDAQ:DYAX) ($3.26) announced today that the FDA
accepted the Company’s submission in response to the FDA’s March 2009
Complete Response Letter (CRL), which outlined requirements for approval of
DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In
connection with the acceptance, the FDA assigned Dyax’s BLA a new PDUFA
action date of 12/1/09, which represents a six-month, Class 2 Review. In the
CRL received 3/25/09, the FDA requested submission of a Risk Evaluation and
Mitigation Strategy (REMS) and additional information with respect to the
chemistry, manufacturing and controls (CMC) section of the BLA. Dyax
believes these issues are fully addressed in its reply, which was submitted
6/1/09, and the Company’s share price has increased by about 58% in the
past month.
On 6/11/09, Transcept Pharma (NASDAQ:TSPT) ($4.65) announced that the FDA
has informed the Company that it should expect to receive formal notice of a
three month extension of the review period for the new drug application (
NDA) for Intermezzo (zolpidem tartrate sublingual tablet). The Intermezzo
NDA had been assigned a PDUFA action date of 7/30/09. Under this revised
timeline, TSPT now anticipates action from the FDA on the NDA on or before
10/31/09. In the normal course of the Intermezzo NDA review, the FDA
previously requested additional information regarding middle of the night
dosing instructions. As both the request and the TSPT response occurred late
in the review cycle, the FDA has informed the company that it will extend
the NDA review cycle by three months to consider the new information.
On 6/4/09, Somaxon Pharma (NASDAQ:SOMX) ($1.22) announced that it has
resubmitted its New Drug Application (NDA) to the FDA for Silenor (doxepin)
for the treatment of insomnia in response to a 2/25/09 Complete Response
Letter (CRL) and following a 4/6/09 meeting with the FDA. The resubmission
includes additional statistical analyses of the Company’s clinical data
relating to the durability of subjective sleep maintenance efficacy. It also
includes the results of the Company’s completed clinical trial of doxepin
that evaluated the potential for electrocardiogram (ECG) effects. The
results of that clinical trial demonstrated that Silenor had no effect on QT
interval prolongation when administered at 6 mg or under exaggerated
exposure conditions of 50 mg. The FDA has indicated that the review cycle
for the resubmission will be six months (a Class 2 Review designation) for
an estimated decision date of 12/4/09 on the Silenor NDA resubmission.
Shares of SOMX have increased by about 239% over the past three months and
the Company raised $6 million in a private placement in early July –
providing adequate liquidity through 2Q10.
On 7/8/09, Noveko (TSE:EKO) (PINK:NKOFF) ($1.39) announced that its
management recently held constructive discussions with the FDA regarding its
pending 510(k) submission for the Noveko 3xEZ Antibacterial Surgical Mask
to obtain clarifications on and narrow FDA's remaining data requests so that
the Company can timely respond to them. As such, the Company received
confirmation that it has now until 10/23/09 to submit the requested
remaining data. The Company believes that when the 510(k) is cleared for the
Noveko 3xEZ Antibacterial Surgical Mask, it will likely be the first mover
in the U.S. market, further protected by its underlying product patent
portfolio.
On 6/24/09, Cell Therapeutics (NASDAQ:CTIC) ($1.46) announced that it has
completed the submission of the New Drug Application (NDA) to the FDA for
pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's
lymphoma (NHL). CTIC requested a six-month priority review, which if granted
by the Agency would result in a possible FDA decision during 4Q09. On 5/5/
09, CTIC announced that pixantrone is available on a named-patient basis for
use in Europe to treat patients with aggressive NHL that has either
relapsed or is refractory to standard treatment options. CTIC is now
awaiting a likely mid to late August response from the FDA to accept the NDA
filing, rule on the status of the priority review request, and issue a
PDUFA action date for pixantrone.
Nuvo Research (PINK:NRIFF) (TSE:NRI) ($0.36) has a pending NDA re-submission
for Pennsaid with a PDUFA action date of 8/5/09 for a possible FDA decision
. On 6/16/09, Nuvo announced a deal with Covidien (NYSE:COV) granting it
exclusive rights to market and sell Pennsaid, and its follow-on product,
Pennsaid Plus, in the U.S. Pennsaid and Pennsaid Plus are Nuvo's topical non
-steroidal anti-inflammatory drug (NSAID) candidates that deliver diclofenac
through the skin directly to the site of pain. Nuvo receives an up-front,
non-refundable payment of US$10 million and is also eligible to receive a US
$15 million milestone payment on Pennsaid's approval by the FDA, which will
increase to US$20 million if certain labeling criteria are agreed to by the
FDA.
Advanced Life Sciences (OTC:ADLS) ($0.46): Cethromycin NDA (a once-daily
antibiotic for the treatment of community acquired pneumonia - CAP) with an
expected PDUFA decision date of 7/31/09. On 6/2/09, ADLS announced that the
FDA's Anti-Infective Drugs Advisory Committee voted in the majority that
Restanza (cethromycin) demonstrated safety for the outpatient treatment of
adults with mild-to-moderate CAP (11 positive, 3 negative, 1 abstaining).
However, the committee voted that Restanza did not demonstrate efficacy in
the treatment of CAP (3 positive, 11 negative, 1 abstaining).
On 7/1/09, CombinatoRx (NASDAQ:CRXX) ($0.75) and privately-held Neuromed
Pharma announced they have entered into a definitive merger agreement under
which CRXX and Neuromed will merge in an all-stock transaction. Under the
terms of the merger agreement, CRXX is expected to issue approximately 36
million new shares of its common stock to Neuromed stockholders with each
party owning approximately 50% of the voting power of the merged
organization upon closing. Relative ownership of CRXX will then be adjusted
based upon the outcome of a FDA review for Neuromed’s New Drug Application
(NDA) product candidate, Exalgo (a once-daily, extended-release oral
formulation of the opiate pain drug hydromorphone).
The rights to Exalgo have been acquired by Mallinckrodt Inc., a subsidiary
of Covidien (NYSE:COV), for $15 million in upfront payments, additional
development funding of up to $16 million to cover internal and external
costs associated with Exalgo, an approval milestone of $30 million, which
could potentially increase up to $40 million, and tiered royalties on net
sales after approval. Neuromed has a pending NDA for Exalgo with the FDA,
which has a PDUFA action date during 4Q09 for a possible FDA decision.
On 7/8/09, Transdel Pharma (OTC:TDLP) ($1.40) announced the successful
completion of patient enrollment in a pivotal Phase 3 clinical study for
Ketotransdel, which is a topical cream based non-steroidal anti-inflammatory
drug (NSAID) for the treatment of acute pain. As previously announced, TDLP
.OB expects to report the top-line results from this Phase 3 trial later in
3Q09. The multi-center trial is being conducted at about 30 sites in the U.S
. and has enrolled over 350 patients. The primary efficacy endpoint is the
change from baseline in pain intensity as measured by a Visual Analog Scale
(VAS) during daily activities over the past 24 hours at Day 3. The Company
also stated that it is either engaged in or pursuing discussions with U.S.
and foreign based potential partners with sales and marketing
infrastructures to support Ketotransdel in the event that the product is
approved and commercialized.
On 7/8/09, Vical (NASDAQ:VICL) ($2.68) announced that its TransVax
therapeutic DNA cytomegalovirus (CMV) vaccine provided promising results
compared with placebo across a broad range of clinical efficacy endpoints at
the four-month interim analysis in an ongoing Phase 2 trial. The trial is
evaluating the potential for TransVax to prevent CMV reactivation in
immunosuppressed CMV-seropositive hematopoietic stem cell transplant (HCT)
recipients, which could reduce antiviral usage and CMV-associated disease.
The interim efficacy data for evaluable subjects, unblinded by treatment
groups, also reinforced encouraging immunogenicity data from an initial
group of HCT recipients in the trial reported previously in 4Q08. Vical
expects the trial to be completed during 4Q09 with final data available
during 1H10.
On 11/14/08, Nephros (OTC:NEPH) ($1.25) submitted a 510(k) application to
the FDA for approval of its HDF products for ESRD in the U.S. market.
Following its review of the application, the FDA requested additional
information, and Nephros replied to the Agency on 3/13/09. Per FDA
guidelines, the FDA has 90 days to review the additional information
provided by the Company, but a response from the Agency is still pending for
the OLpur H2H Hemodiafiltration (HDF) Module and OLpur MD 220 Hemodiafilter. |
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