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It is going to be a bumpy ride. They have good pipelines. And management execution is better than Frost
This is just simple math here. This is not Rayaldee. They will get sales done!
The other two drugs in their pipeline have even big market potential!!!!
Only risk is offering. But they have cash and sales starts TODAY!
It is simple math here. $500k revenue per patient is the standard price for that patient group. And they have the best drug.
You can see my posts there https://investorshub.advfn.com/BioCryst-Pharmaceuticals-Inc-BCRX-7948/
The only risk is they might do an offering. However, right now they have 150m on hand and the sale starts today!
Liisa Bayko Evercore ISI pt Upgrade $14 ... calling her one of the best biotech analyst I have ever seen won’t be a stretch
BioCryst price target raised to $10 from $8 at Piper Sandler
Read more at:
https://thefly.com/n.php?id=3087569 https://thefly.com/landingPageNews.php?id=3087569&headline=BCRX-BioCryst-price-target-raised-to--from--at-Piper-Sandler
The ORLADEYO market is a game-changer. RAPIVAB is just a starter for Gali and
I agree. Shorts are going out of bullets now
$bcrx
0.4 % 150,000 2020-12-04 09:15:03
0.4 % 200,000 2020-12-04 09:00:03
0.4 % 950,000 2020-12-03 16:45:02
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0.4 % 950,000 2020-12-03 16:15:03
0.4 % 950,000 2020-12-03 16:00:03
0.4 % 950,000 2020-12-03 15:45:03
0.4 % 950,000 2020-12-03 15:30:03
0.4 % 950,000 2020-12-03 15:15:03
0.4 % 950,000 2020-12-03 15:00:02
0.4 % 950,000 2020-12-03 14:30:02
0.4 % 950,000 2020-12-03 14:15:03
0.4 % 950,000 2020-12-03 14:00:03
0.4 % 950,000 2020-12-03 13:45:03
0.4 % 950,000 2020-12-03 13:30:02
0.4 % 950,000 2020-12-03 13:15:03
0.4 % 950,000 2020-12-03 13:00:03
0.4 % 950,000 2020-12-03 12:45:03
NDA news any time now.
We just need to get 1k patients to hit $500m revenue!
But it is an oral pill!
ORLADEYO cost is similar to competitors
Imagine what a CRL would do to the PPS. So undervalued.
Some math Stockwise user posted. Insanely undervalued here
Dr_Van_Nostrend
03:34 AM
$BCRX
I know many Stock Twitters don't do math
Not that you CAN'T or WON'T... but most don't. Math is the FIRST thing I do when looking at an investment because numbers don't lie, people do. (I don't)
BCRX valuation:
Orladeyo - US sales estimated taking 40% to 60% of patients. I go WAY more conservative and say 20%. 7500 currently treated patients in US. 7500 X .2 = 1500 peak patients. 500K per patient minus costs / commissions etc.. call it 400K net. 1500 X 400K = 600M net US. The EU has about 6500 currently receiving treatment... 20% = 1300. EU charges much less than US... net we'd get is only 150K per patient. 150K X 1300 = 195M. Japan has about 500 patients clicically diagnosed. With Sakigake designation, there is a premium, though not as high as US. About 300K net. On avg we get 25% of that from Torii. 500 x .2 = 100 patients X 300K =30M x .25 royalty =7.5 mil annually.
600M US + 195M EU + 7.5M Japan = 802.5M annually at a super conservative HALF anticipated
Gali on Covid-19 was a while ago. Did they say anything about the results?
https://www.globenewswire.com/news-release/2020/04/09/2014672/0/en/BioCryst-Begins-Clinical-Trial-with-Galidesivir-for-Treatment-of-Patients-with-COVID-19.html
BioCryst Announces FDA Approval of ORLADEYO™ (berotralstat), First Oral, Once-daily Therapy to Prevent Attacks in Hereditary Angioedema Patients
—Significant and sustained reduction in HAE attacks—
—Oral, once-daily prophylactic option enables HAE patients to reduce burden of therapy1 —
—ORLADEYO approved for adult and pediatric patients 12 years and older—
RESEARCH TRIANGLE PARK, N.C., Dec. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved oral, once-daily ORLADEYO™ (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
“ORLADEYO offers people with HAE and their physicians the first orally administered non-steroidal option for preventing HAE attacks and represents an important and welcome step in making more treatment options available to physicians and patients,” said Anthony J. Castaldo, president and chief executive officer of the US Hereditary Angioedema Association (HAEA).
In the pivotal Phase 3 APeX-2 trial, ORLADEYO significantly reduced attacks at 24 weeks, and this reduction was sustained through 48 weeks. HAE patients who completed 48 weeks of treatment (150 mg) saw reductions in their HAE attack rates, from a mean of 2.9 attacks per month at baseline to a mean of 1.0 attacks per month after 48 weeks of therapy. In the long-term open label APeX-S trial, patients completing 48 weeks of therapy (150 mg) had a mean attack rate of 0.8 attacks per month.
ORLADEYO was safe and well tolerated in both trials. The most frequently reported adverse reactions in patients receiving ORLADEYO compared with placebo were gastrointestinal reactions. These reactions generally occurred early after initiation of treatment with ORLADEYO, became less frequent with time and typically self-resolved.
“Patients and physicians acknowledge that HAE treatments can add a burden to patients’ lives.? As an oral, once-daily option, ORLADEYO can provide significant attack reduction and lessen the burden associated with injections and infusions,” said Marc Riedl, M.D., professor of medicine and clinical director, U.S. Hereditary Angioedema Association Center at the University of California, San Diego, and an investigator in the APeX-2 trial.
“With this new treatment option, physicians and patients can continue to have collaborative discussions to choose the treatment that meets each patient’s needs, life circumstances and preferences,” Riedl added.
HAE patients note a significant treatment burden associated with existing prophylactic therapy. In addition to reducing HAE attack rate, data from APeX-2 show that patients reported meaningful improvements in both quality of life and overall patient-reported satisfaction, and significant reductions in their monthly use of standard of care on-demand medicine, while taking oral, once-daily ORLADEYO (150 mg).2,3
“The FDA approval of ORLADEYO fulfills a promise BioCryst made to HAE patients that we were committed to helping them achieve the dream of an oral, once-daily medicine to prevent and reduce the burden of their attacks,” said Jon Stonehouse, president and chief executive officer of BioCryst.
“Thank you to the HAE patients who participated in our clinical trials, to the investigators around the world who conducted these trials, to the HAEA for their patient advocacy and to our employees who never forgot that patients were waiting. We will stay focused on enabling access and providing personalized support to HAE patients and physicians,” Stonehouse added.
Commitment to Patient Access
BioCryst is committed to supporting HAE patients taking ORLADEYO through a new program designed to streamline access to therapy. Through EMPOWER Patient Services, each HAE patient and their healthcare provider will have a single point of contact for access to ORLADEYO. A dedicated care coordinator will support access for each patient with comprehensive financial support tools and reimbursement support.
EMPOWER Patients Services is administered by Optime Care Inc., the exclusive specialty pharmacy provider for ORLADEYO. Physicians can begin writing prescriptions for ORLADEYO immediately, with direct to patient shipments from Optime Care expected to begin by the end of December 2020.
Additional information is available at www.ORLADEYO.com and 1-866-5-EMPOWER (1-866-536-7693).
About ORLADEYO™ (berotralstat)
ORLADEYO™ (berotralstat) is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
U.S. Indication and Important Safety Information
INDICATION
ORLADEYO™ (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
Limitations of use
The safety and effectiveness of ORLADEYO for the treatment of acute HAE attacks have not been established. ORLADEYO should not be used for the treatment of acute HAE attacks. Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.
IMPORTANT SAFETY INFORMATION
An increase in QT prolongation was observed at dosages higher than the recommended 150 mg once-daily dosage and was concentration dependent.
The most common adverse reactions (≥10% and higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.
A reduced dosage of 110 mg taken orally once daily with food is recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) and in patients taking chronically administered P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors (eg, cyclosporine).
Berotralstat is a substrate of P-gp and BCRP. P-gp inducers (eg, rifampin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO.
ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 or CYP3A4, appropriate monitoring and dose titration is recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (eg, digoxin) when coadministering with ORLADEYO.
The safety and effectiveness of ORLADEYO in pediatric patients <12 years of age have not been established.
There are insufficient data available to inform drug-related risks with ORLADEYO use in pregnancy. There are no data on the presence of berotralstat in human milk, its effects on the breastfed infant, or its effects on milk production.
To report SUSPECTED ADVERSE REACTIONS, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO™ (berotralstat) is approved in the United States for the prevention of HAE attacks in adults and pediatric patients 12 years and older, and under regulatory review for approval in Japan and the European Union. BioCryst has several ongoing development programs including, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.biocryst.com.
https://www.globenewswire.com/news-release/2020/12/04/2139588/0/en/BioCryst-Announces-FDA-Approval-of-ORLADEYO-berotralstat-First-Oral-Once-daily-Therapy-to-Prevent-Attacks-in-Hereditary-Angioedema-Patients.html
Wait for all the institution buyins
Too cheap for approval for a $484k per patient drug
Got 30k position. Good risk reward here
This is the real deal at the current price!
The NCPL ticker looks so good right now!
Short attach with lawsuits. They always come together. Good loading opportunity. Easy double once Q2 numbers are out and Biden locks everyone at home like LA is doing now!
Pfizer now has to bid with other buyers. Anish Monga who controls Sian Capital has a history of making big deals.
Likely Blackstone buyout OPK for the Smartrogon, sell Renal to Vifor. BRL might just get spinned out by themself
I bot some LRN today. The NEVDF went up over 30% after I PMed you.
Lol.
Hold tight guys. Buyout on the horizon!
OPKO Health (NASDAQ: $OPK) was in focus Wednesday amid chatter Blackstone (NYSE: BX) could be interested in the company. The source of the rumor was said to be http://theDeal.com
@Street_Insider
Got a position on the drop!
Safe-T Partners with Systematika to Distribute Proprietary Cybersecurity Solutions in Italy
Stocks mentioned: SFET
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Partner to Distribute Safe-T’s ZoneZero™ SDP Solution, Which Allows Access to Applications and Services Only After Trust Has Been Verified
HERZLIYA, Israel, Dec. 01, 2020 (GLOBE NEWSWIRE) -- Safe-T® Group Ltd. (NASDAQ, TASE: SFET), a provider of Secure Access solutions for on-premise and hybrid cloud environments, and Systematika Distribution Srl (“Systematika”), one of the leading operating companies in the distribution of solutions for the Professional Information Technology market, has signed an agreement for the distribution of Safe-T’s ZoneZeroTM SDP in Italy.
Safe-T's ZoneZero SDP solution is a valuable addition to any organization, enabling enterprises to provide secure and transparent access to internal applications, services, and data. Safe-T’s patented reverse-access technology eliminates the need to open incoming ports in the organization’s firewall, thereby delivering seamless, effective and secure processes with a true separation between the data plane and the control plane, all built on top of the existing network setups, thus not requiring costly and timely changes in infrastructure.
“With over 35 years as a leading distributor of advanced technology solutions, Systematika is a perfect match for our ZoneZero solutions,” said Avi Rubinstein, Safe-T’s Chief Business Officer. “The addition of Systematika, a high-value partner with an impressive customer base, to our channel network will enable us to expand the introduction of our solutions and further promote our game changing products in Italy.”
The ZoneZero SDP solution is part of Safe-T’s ZoneZero Perimeter Access Orchestration suite, which provides central management of all secure-access technologies and allows organizations to implement a valid Zero Trust Network Access (ZTNA) architecture beyond the perimeter.
“Safe-T’s solutions will enhance our existing product offerings and services in the key area of cybersecurity,” said Franco Puricelli, the Managing Director of Systematika. “Keeping organizations safe from attacks and data leakage by securing the access itself, is critical and crucial, and even more so in this pandemic scenario. Thanks to Safe-T’s solutions, we will be able to support our partners and their customers to accomplish this mission.”
About Systematika
Systematika has been for over 35 years one of the most important operating companies in the distribution of solutions for the Professional Information Technology market.
A real point of reference for ICT operators, Systematika places the accent on "high-tech" distribution: not only an offer of innovative and reliable technologies, but also a series of training services, pre-sales support, workshops, marketing initiatives, incentives and consultancy completely available to its partners.
The core business focused on software - from marketing to consulting, from training to specific support for partners - allows Systematika to acquire and offer valuable skills and high professionalism, without sacrificing the breadth of the offer.
Qualified and professional staff, operational consistency in the choice of Qualified IT Resellers, competence and special attention to the evolution of IT are the main strengths on which Systematika bases the relationship with the customer, guaranteeing reliability, continuity and growth. For more information, please visit, https://systematika.it/.
Great news today!
Opk no longer a 5% holder because cocp os increased. That is my understanding
Not sure. Looks to me OPK has some shares and Dr. Frost has his own holding. Those forms always confuse me.
It is long over due. Everyone here knows