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11/30/2020
Hookipa Pharma price target raised to $25 from $19 at JMP Securities
HOOK JMP Securities analyst Roy Buchanan raised the firm's price target on Hookipa Pharma to $25 from $19 and keeps an Outperform rating on the shares after the company announced interim results from the Phase 2 trial of HB-101 to vaccinate CMV- transplant patients receiving a CMV+ kidney. The analyst believes that good immune and viremia results for the three-dose group indicate that HB-101 can produce clinical benefit for this important and difficult indication, and provide additional validation of the platform.
VDE: Don't Miss Out On The Next Oil Wave
https://seekingalpha.com/article/4387827-vde-dont-miss-out-on-next-oil-wave
Saudi Aramco's Recent Earnings Highlight Weakening Power Over The Oil Markets
https://seekingalpha.com/article/4387278-saudi-aramcos-recent-earnings-highlight-weakening-power-over-oil-markets
AGEN Agenus: Milestone payment from Merck triggered as MK-4830 enters Phase 2
Agenus (AGEN) announced that a milestone payment of $10M from Merck (MRK) has been triggered with the advancement of an ILT4 antibody, MK-4830, into a Phase 2 clinical trial. Agenus discovered this novel checkpoint antibody, designed to target immune-suppressive myeloid cells in the tumor microenvironment for the treatment of advanced solid tumors, and licensed the molecule to Merck."Novel myeloid cell targeting antibodies have the potential to treat patients who currently do not benefit from primary checkpoint antibodies," said Garo Armen, Chairman and CEO of Agenus. "We are excited about the progress of MK-4830 and look forward to delivering our own wholly- owned novel myeloid tuning agent to the clinic next year." Merck is evaluating MK-4830 in combination with KEYTRUDA in a Phase 2 study in patients with PD-L1 positive advanced non-small cell lung cancer with data presented at ESMO earlier this year. Under the terms of the agreement, Merck is responsible for all product development expenses for MK-4830 and Agenus is eligible to receive up to $85M in additional potential milestone payments, as well as royalties on worldwide product sales. Under its Royalty Purchase Agreement with XOMA LLC, Agenus retains 90% of all milestones from Merck and 67% of future royalties.
This will be a game changer for Kala and a big help for patients having a dry eye approved option for rescue use is great…
What appears to be glossed over and not overtly said in any KALA analyst report was how important it is to have the first corticosteroid approved for dry eye disease is to doc's. We are treating currently either with inadequate substandard meds, or going off label. The degree to which this is a game changing paradigm shift to a new first line treatment and resorting all immunosuppresses to second line has yet to be felt, but I just don't see how it can't be. Regardless of my investment I would be excited to have this drug in my arsenal. Most doc's don't Rx more then 10 or so drugs that we rely on. This will be one of them.
Some may think that the more Covid-19 candidate drug in the pipeline, the better, because in the end, the more likely some of them will eventually be approved. But I think this is not a correct thinking, because it is not about quantity, but quality.
As an example of behavior in the Covid race totally contrary to Sorrento we find the biotechnology BioCryst Pharmaceuticals (NASDAQ:BCRX). This company has been researching for several years with an antiviral "Galidesivir" that has shown high efficacy in “in vitro” tests against a wide range of different types of virus (filovirus, coronavirus, etc). Its safety profile is excellent according to a phase 1 trial conducted last year. And now it is immersed in trials with Covid patients, to verify its effectiveness in several hospitals in Brazil under the direction of one of the most prestigious Brazilian doctors specialized in infectious diseases; Dr. Esper Kallas. Results are expected before the end of this year 2020. Well, with this great efficacy and safety profile shown by Galidesivir, BioCryst has only reported one PR in the last 7 months: the one that reported the start of the trial last April. It is true that this lack of updating of the Galidesivir trial is weighing on BioCryst's share price, but I believe that in the end, shareholders will be rewarded for the long wait with the report of good results and the consequent appreciation of the share price.
Hookipa Pharma initiated with a Buy at Truist
Truist analyst Asthika Goonewardene initiated coverage of Hookipa Pharma with a Buy rating and $21 price target. The analyst is positive on the company's efforts in building an immuno-oncology and infectious disease pipeline around its proprietary viral vector platform, which he finds "compelling" given the "profound" immune priming effect that it has demonstrated to date.
KALA- Wedbush analyst Liana Moussatos raised the firm's price target on Kala Pharmaceuticals to $47 from $39 due to an increase in the multiple assigned to EYSUVIS from 8-times to 9-times as a result of approval.
has an Outperform rating on the shares.
https://thefly.com/landingPageNews.php?id=3183672&headline=KALA-Kala-Pharmaceuticals-price-target-raised-to--from--at-Wedbush
Kala Pharmaceuticals (KALA) PT Raised to $22 at Oppenheimer, After Receiving FDA Approval
https://www.streetinsider.com/Analyst+PT+Change/Kala+Pharmaceuticals+%28KALA%29+PT+Raised+to+%2422+at+Oppenheimer%2C+After+Receiving+FDA+Approval/17517677.html
Just some unbelievable facts screams a BUY:
Kala Pharmaceuticals Down Over 14%, on Pace for Largest Percent Decrease Since October 2018 --
12:35 pm ET October 27, 2020 (Dow Jones) Print
Kala Pharmaceuticals, Inc. (KALA) is currently at $6.61, down $1.11 or 14.38%
-- Would be lowest close since March 16, 2020, when it closed at $6.13
-- On pace for largest percent decrease since Oct. 3, 2018, when it fell 15.52%
-- Earlier Tuesday, Kala Pharmaceuticals announced the U.S. Food and Drug Administration has approved Eysuvis for the short-term treatment of the signs and symptoms of dry-eye disease. The company said Eysuvis is the first approved prescription therapy specifically for short-term treatment of the chronic, episodic disease that affects the tears and ocular surface
-- Currently down five of the past six days
-- Currently down three consecutive days; down 15.26% over this period
-- Worst three day stretch since the three days ending Sept. 24, 2020, when it fell 15.77%
-- Down 11.87% month-to-date
-- Up 79.13% year-to-date; on pace for best year on record (Based on available data back to July 20, 2017)
-- Down 75.08% from its all-time closing high of $26.53 on Sept. 14, 2017
-- Up 89.94% from 52 weeks ago (Oct. 29, 2019), when it closed at $3.48
-- Down 52.07% from its 52-week closing high of $13.79 on June 2, 2020
-- Up 89.94% from its 52-week closing low of $3.48 on Oct. 29, 2019
-- Traded as low as $6.07; lowest intraday level since March 17, 2020, when it hit $5.04
-- Down 21.37% at today's intraday low; largest intraday percent decrease since Jan. 5, 2018, when it fell as much as 31.85%
Once rejected, Kala's dry eye drug now gains entry to a field where Novartis is grooming its own blockbuster
Amber Tong
Editor
When the FDA slapped a rejection on Kala Pharma’s dry eye drug last August, the biotech’s execs promised investors that a third Phase III study — they had already started at that point — would reverse their fortune.
Today they made good on that promise, clinching an approval for Eysuvis, an ocular corticosteroid being positioned as a first-line, short term treatment of dry eye disease.
Boasting a technology invented by Bob Langer out of MIT, Eysuvis is a corticosteroid, loteprednol etabonate, delivered by mucus-penetrating particles. It promises to enhance penetration into target tissue on the ocular surface, achieving an effect quicker than systemic corticosteroids and stronger than over-the-counter eye drops.
Kala, with $159.1 million in cash, cash equivalents and short-term investments that it expects to last until Q3 of 2022, expects to launch the drug by year’s end pending some final touches on the salesforce (125 reps to start with) and manufacturing.
The top team, led by CEO Mark Iwicki, has repeatedly emphasized that the market is huge yet untapped, with just a few prescription drugs available in the category. One of them, Shire’s Xiidra, was bought by Novartis for $3.4 billion upfront.
Over 30 million people in the United States live with dry eye disease, of which over 17 million have already been diagnosed by an eye care professional.
Our market research suggests that 80% to 90% of these patients suffer from episodic flares rather than continuous symptoms, and feedback from eye care professionals suggest that these flares are – will be under-managed by current therapies.
In a note from September, Jefferies analyst Biren Amin wrote that steroids are commonly prescribed off-label for flares but risks of elevated intraocular pressure discourage non-corneal specialists from doing so.
Data from STRIDE3, the final Phase III study that finally satisfied regulators, suggested that Eysuvis induced a statistically significant improvement in ocular discomfort severity over placebo.
Doctors Amin spoke to “see the opportunity for it to be adopted by corneal specialists and should remove the barrier for non-corneal specialists to prescribe a steroid type treatment for DED flares.”
AUTHOR
Amber Tong
Editor
amber@endpointsnews.com
@AmberTongPW
Amber Tong on LinkedIn
https://endpts.com/once-rejected-kalas-dry-eye-drug-now-gains-entry-to-a-field-where-novartis-is-grooming-its-own-blockbuster/
AFMD Affimed N.V. NKMax America to study AFM24, SNK01 combination
Affimed N.V. and NKMax America announced that they entered into a clinical collaboration agreement to investigate the combination of AFM24, a CD16A/EGFR-targeted ICE, with the autologous NK cell product SNK01. Pursuant to the collaboration, the companies plan to explore the combination in a first-in-human proof-of-concept trial in patients with EGFR-expressing tumors. The agreement follows a previous collaboration between the two companies in the preclinical setting to better understand the combined activity of their respective platforms. The results of the preclinical collaboration have shown substantive synergy between Affimed's ICE molecules and NKMax America's autolo gous and cryopreserved allogeneic natural killer cell products. Under the agreement, the companies will contribute their respective product candidates and resources towards submitting an Investigational New Drug application to the U.S. FDA and a subsequent clinical trial. The clinical trial will combine NKMax America's SNK01 with AFM24 in the autologous setting with the option to expand the clinical trial to the allogeneic setting. The cost of the clinical study will be shared by Affimed and NKMax America. The agreement also provides for the opportunity to pursue further clinical study combinations with additional product candidates from both parties.
Affimed and NKMax America to Study the Combination of AFM24, an EGFR-Targeted Innate Cell Engager, with SNK01 Natural Killer Cell Therapy
https://www.globenewswire.com/news-release/2020/10/20/2110884/0/en/Affimed-and-NKMax-America-to-Study-the-Combination-of-AFM24-an-EGFR-Targeted-Innate-Cell-Engager-with-SNK01-Natural-Killer-Cell-Therapy.html
Investors in Kala Pharmaceuticals, Inc. $KALA need to pay close attention to the stock based on moves in the options market lately. That is because the Nov 20, 2020 $10.00 Call had some of the highest implied volatility of all equity options today.
What is Implied Volatility?
Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other. It could also mean there is an event coming up soon that may cause a big rally or a huge sell-off. However, implied volatility is only one piece of the puzzle when putting together an options trading strategy.
What do the Analysts Think?
Clearly, options traders are pricing in a big move for Kala Pharmaceuticals shares, but what is the fundamental picture for the company? Currently, Kala Pharmaceuticals is a Hold in the Medical - Biomedical and Genetics industry that ranks in the 26% range. Over the last 60 days, no analysts have increased their earnings estimates for the current quarter, while one analyst has revised the estimate downward.
Given the way analysts feel about Kala Pharmaceuticals right now, this huge implied volatility could mean there’s a trade developing. Oftentimes, options traders look for options with high levels of implied volatility to sell premium. This is a strategy many seasoned traders use because it captures decay. At expiration, the hope for these traders is that the underlying stock does not move as much as originally expected.
Company: Kala Pharmaceuticals Inc (NASDAQ: KALA)
Type of Application: NDA
Candidate: Eysuvis
Indication: Dry eye disease
Date: Oct. 30
Eysuvis, or loteprednol etabonate ophthalmic suspension, is being evaluated for the short-term treatment of the signs and symptoms of dry eye disease.
Kala's original Eysuvis NDA was handed down a complete response letter in August 2019, with the FDA seeking positive data from an additional clinical trial. Following positive results from the STRIDE 3 Phase 3 trial, the company resubmitted the NDA in April. The company communicated FDA's acceptance of the resubmitted application on May 26.
Kinross Gold: Looks Very Cheap Compared To The Sector At Large
Oct. 13, 2020 2:48 AM ET
https://seekingalpha.com/article/4378769-kinross-gold-looks-cheap-compared-to-sector-large
$KALA TP $39 Kala Pharmaceuticals (KALA)
Developing treatments for inflammatory ocular conditions, Kala Pharmaceuticals wants to improve the lives of patients everywhere. With the October 30 PDUFA date for its EYSUVIS product fast-approaching, several analysts think that now is the time to get on board.
EYSUVIS is a corticosteroid designed for the short-term treatment of signs and symptoms of dry eye disease (DED). DED is a multifactorial disease of the tears and ocular surface of the eye that causes discomfort, visual disturbances and tear film instability, which is usually accompanied by hyperosmolarity (higher concentration of salt than water in tears) and inflammation. Affecting about 16.4 million adults in the U.S., the condition has a major impact on a patient’s quality of life, and in some cases, can lead to declines in work productivity.
Wedbush analyst Liana Moussatos is optimistic about the therapy’s prospects, noting that approval could come before the PDUFA date. To this end, a U.S. launch is forecasted for early 2021, with KALA set to be launch ready in Q4 2020, and the analyst believes blockbuster revenue ($1 billion) could be in store.
Citing presentations from Key Opinion Leaders (KOLs), Moussatos highlights the broad market opportunity for the asset given the current unmet need and its potential position as the first approved corticosteroid in this indication.
Additionally, based on clinical data, unlike already approved drugs RESTASIS, CEQUA and XIIDRA, the therapy generated a rapid onset of action, with it also overcoming well-known adverse events associated with ketosteroids such as increases in intraocular pressure (IOP).
Moussatos mentioned, “Dr. Holland made specific reference in his remarks to both EYSUVIS’ rapid onset of action as well as its favorable safety profile with respect to IOP elevation as reason for his choice to use it as first-line therapy for a high percentage of his patients if approved.”
Summing it all up, the analyst stated, “Given the inadequate control of dry eye flares on current standard-of-care treatments and the unwillingness of eye care professionals (except cornea specialists) to use corticosteroids off-label, we feel EYSUVIS is uniquely positioned to immediately address an underserved portion of the market using corticosteroids off-label as a short-term therapy for rapid relief while gradually addressing chronic users of immunomodulatory agents such as cyclosporine (RESTASIS, CEQUA) and lifitegrast (XIIDRA) on maintenance therapy.”
To this end, Moussatos rates KALA an Outperform (i.e. Buy) along with a $39 price target. This puts the upside potential at a massive 430%
BioCryst's BCX9930: Alexion's Biggest Headache Now
Oct. 5, 2020 12:33 PM ET|8 comments | About: BioCryst Pharmaceuticals, Inc. (BCRX), Includes: ALXN, APLS
Francisco Javier Garcia
Value, Momentum, Contrarian
Summary
On September 30, BioCryst reported the results of BCX9930's Proof of Concept as an oral treatment for PNH as Monotherapy.
The results have been very promising confirming the good expectations that existed.
We can say without any doubt that BCX9930 has a good chance of becoming the first oral drug to treat PNH as monotherapy in the future.
My strategy is to keep buying small amounts of stocks for the duration of the current downtrend.
On September 30, BioCryst (NASDAQ:BCRX) reported the results of BCX9930's Proof of Concept as an oral treatment for PNH as Monotherapy.
The results have been very promising confirming the good expectations that existed.
Total of seven patients were in the trial, and data from four treatment naïve patients showed clinical benefit who received more than six weeks of BCX9930 monotherapy dose of 400 mg.
In the trial, the main objective was achieved, that is, to raise hemoglobin levels in the blood to healthy levels, so Hemoglobin levels increased by a mean of 3.8 g/dL from baseline and maintained without transfusions. Three of four patients have responded with hemoglobin levels over 11 g/dL to date. Hemoglobin in the fourth patient with compromised bone marrow function from aplastic anemia PNH responded with an increase from 6 g/dL at baseline to 9.5 g/dL on treatment.
All four patients showed reduction in LDH (Lactate dehydrogenase), commonly used as a biomarker of cell damage or death.
On the safety front, most common adverse event was mild to moderate headache lasting one to three days. One patient had a mild rash that resolved after continued BCX9930 dosing at 100 mg bid. One patient developed a mild rash at 200 mg bid that is resolving during uninterrupted dosing after dose escalation to 400 mg bid.
Although this Proof of Concept still represents an initial first step, with a small number of patients and a limited time, we can say without any doubt that BCX9930 has a good chance of becoming the first oral drug to treat PNH as monotherapy in the future.
In addition, the FDA is confident in the success of BCX9930, as on 08/31/2020, it reported the approved orphan drug designation for BCX9930 for the treatment of paroxysmal nocturnal hemoglobinuria. The FDA has also granted fast track designation for BCX9930 in PNH.
Currently, there are only two drugs on the market (Soliris and Ukltomiris) marketed by Alexion Pharmaceuticals (NASDAQ:ALXN) administered by intravenous injection to treat PNH. These drugs have been around for several years and are currently lagging behind, with limited efficacy and many side effects.
In 2019, Alexion, aware that could lose his monopoly on PNH treatment (with a market of around $3 billion in the US alone), bought the pharmaceutical company Achillion Pharmaceuticals for $930 million. This purchase secured two promising oral drugs that Achillion was developing to treat PNH (ACH4471 and ACH5228). Here, it is interesting to note that the phase II results of ACH4471 (Danicopan) given in combination with Soliris to treat PNH were worse than those reported by BioCryst's BCX9930:
ACH4471:
1) Increases in mean hemoglobin of approximately 2 g/dL at week 4 (n=11); for the 4 patients that have reached 24 weeks their mean rise in hemoglobin is 2.6 g/dL
2) A reduction in blood transfusions from 34 transfusions totaling 58 units in the 24 weeks prior to screening to only 1 transfusion of 2 units during treatment with ACH-4471
3) Increase in the percentage of PNH RBC Type III clone size from 40% at baseline to 71% at week 12 (n=8)
BCX9930:
1) Hemoglobin levels increased by a mean of 3.8 g/dL from baseline
2) No blood transfusion was needed during the trial
3) In all four patients, the size of the PNH red blood cell clone approached that of the PNH granulocyte clone, indicating near-complete control of complement-mediated hemolysis. The mean relative (red blood cells/granulocytes) PNH red blood cell clone size increased from 48 percent at baseline to 94 percent on treatment
Alexion is currently carrying out trials with both drugs to achieve an oral drug effective enough to replace Soliris and Ultomiris. Thus, ACH4471 is currently being tested in a phase III trial as an oral treatment in combination with Soliris to treat PNH, and with ACH5228, a Proof of Concept trial for PNH has not yet begun.
Another pharmaceutical company researching a drug to treat PNH is Apellis Pharmaceuticals (APLS). On 09/15/2020, the Company submitted a marketing application request to the FDA and the EMA for their subcutaneous injectable drug Pegcetacoplan to treat PNH as monotherapy. The results obtained from phase III were very promising. BCX9930's results have been similar to those reported by Pegcetacoplan.
Therefore, BCX9930, currently, represents the only oral drug that is being tested to treat PNH as monotherapy and with excellent results in both efficacy and safety.
At Alexion, they will surely be watching with some concern the positive results that BCX9930 has achieved in the Proof of Concept trial to treat PNH. A juicy multi-trillion dollar market is at stake, and Alexion won't want to lose the monopoly that has so far gained thanks to Soliris and Ultomiris.
From BioCryst, it is stated that at the end of this year, the results of a trial to test BCX9930 in inadequate responder PNH patients will be reported. Most likely the results will be very good confirming the superiority of BCX9930 over Soliris.
In summary, BCX9930 has taken a first step towards becoming the first oral drug to treat PNH as monotherapy, a situation that will give Alexion some headache.
Following the decline in BCRX's share price of the last 3 months, which has currently brought it to around $3.40, the upside potential that BCRX currently presents is enormous.
We can assure that the Company, with a market capitalization of only $623 million, is currently clearly undervalued.
I have to say that BioCryst is a biopharma with a very volatile price action, and that we have to be very patient.
In my last article: "BioCryst Pharmaceuticals: Enter Now Before The End Of Next September 2020" I recommended entering before the end of September. I still think that now is a very good time to enter, and that we are very close to strong revaluations in the share price. In the short term, it is likely that the stock will continue to decline as long as we do not have any further news on Galidesivir. We have been in a decreasing trend for 3 months that will surely end up breaking. I have been taking advantage of the last few days to make small purchases between $3.45 and $3.75. And I'll keep buying more as long as the current decline continues. If all goes well in the last quarter of 2020, with the approval of Berotralstat in the US and Japan, and good results from Galidesivir and BCX9930, I expect to see the share price above $10 by the end of the year.
Main conclusions:
1) Currently, Alexion's Soliris is the only drug approved to treat PNH in the world. It is an intravenous injectable drug, with little efficacy and many side effects.
2) On 09/15/20, Apellis submitted a marketing application to the FDA and EMA for Pegcetacoplan in the US and Europe. Most likely, it will be approved for the second half of 2021, so it will become the best drug to treat PNH by improving Soliris. It is a drug for subcutaneous administration for the PNH treatment as monotherapy.
3) Alexion will likely submit a marketing application for ACH4471 in 2021, making it, if approved, the first oral drug to treat PNH as combination therapy in 2022.
4) If the upcoming trials with BioCryst's BCX9930 confirm the positive results of the proof of concept, BCX9930 will become, if approved, the first oral drug as monotherapy to treat PNH with high efficacy and very few side effects within 2-3 years. Thus, BCX9930 will manage to agglutinate a large part of the PNH market valued at several trillions of dollars.
Update on Galidesivir
Regarding the antiviral Galidesivir, we have had two positive news lately:
1 - The NIAID has awarded BioCryst an extra fund of $44M to continue funding the Galidesivir trials.
2 - The University of Florida published a report a few days ago stating that Galidesivir, together with Remdesivir, were the two antiviral drugs that seemed to have the most powerful action in invitro tests against Covid-19. In fact, BCRX is expected to report data on Galidesivir in vitro and animal models soon.
But on the negative side, we have the delay until this last quarter in updating the phase 1 data, which should have arrived at the end of last quarter. Perhaps this delay and the lack of constant updating have been responsible for the current downward trend in the stock.
This lack of information by the company may be penalizing the stock price. In fact, there is a lot of hype in the data on the in vitro tests that are being carried out. This data is expected to be reported very soon and could be an important milestone that could reverse the current downward trend in the share price.
I am optimistic about the results that Galidesivir will finally report, both the in vitro and animal models, and the results of part 1 of the trial in Covid patients. The fact that the Government has provided more funds to continue the trial and the positive report from the University of Florida make me increase my confidence. Of the three drugs that are currently been testing (Berotralstat, BCX9930 and Galidesivir), any positive data from Galidesivir is the one that will be able to move the share price upwards with the greatest force in the coming days or weeks.
I believe that at the end of this long wait, we will see the reward.
Cash status
BCRX ended Q2 with $192 million in cash. With a current cash burn of around $40 million per quarter, it gives the Company cash runway through Q2 of next year.
An offering will probably be made by the first half of 2021.
Possible risks
As in all biopharma, there are some risks that must be taken into account:
- Galidesivir part 1 update won't show sufficient efficacy against Covid to continue the trials of part 2.
- The FDA and/or the Japanese Health Authorities finally do not approve Berotralstat.
Conclusion
The recent Proof-of-Concept data for BCX9930, while still in a very early stage, make us very optimistic about the possibility that it will become the first oral drug to treat PNH as monotherapy in the future.
Despite the multiple drugs currently competing for a share of the PNH market, BCX9930 appears to have the best profile in terms of efficacy, safety, and mode of administration. Although it must be said that since it is still in a very early stage, we will still have to wait 2 or 3 years to see the drug approved.
Alexion Pharmaceuticals must be looking with concern at the results that BCX9930 will achieve in the future.
Despite the current downward trend in the share price, thanks to the multitude of upcoming catalysts (Galidesivir, Berotralstat, BCX9930), I think we will see a strong recovery in the fourth quarter.
My strategy is to keep buying small amounts of stocks for the duration of the current downtrend.
The wait will bring the reward.
Disclosure: I am/we are long BCRX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
https://seekingalpha.com/article/4377644-biocrysts-bcx9930-alexions-biggest-headache-now
ETFs With Ping Identity Holding Corp.
ETF.com Insight
Ping Identity Holding Corp. is a company in the U.S. stock market and it is a holding in 33 U.S.-traded ETFs. PING has around 3.8M shares in the U.S. ETF market. The largest ETF holder of PING is the ETFMG Prime Cyber Security ETF (HACK), with approximately 1.25M shares. Investors may also find of interest that the ETF with the largest allocation to PING stock is Global X Cybersecurity ETF (BUG), with a portfolio weight of 3.30%. On average, U.S. ETFs allocate 0.31% of PING to their portfolios.
Additionally, PING is a favorite stock for Vanilla and Growth ETFs. It is also most likely to belong to Broad-based ETFs. The best-performing ETF in the past 12 months with PING as a holding is the iShares Expanded Tech-Software Sector ETF (IGV), with a return of 43.63%.
https://www.etf.com/stock/PING
From Peter on the Yahoo message Board and I agree with this assessment:
Potential price movers over the next 12 mo (roughly in order):
1) SITC 1181 data monotherapy and combination, likely presented in a similar format to the MK4830 data
2) 2373 monotherapy data
3) European bali and zali/bali partnership
4) zalifrielimab data for anti-PD1 progressors
5) 1223 data
6) 1777 IND approved
7) bal BLA filing
8) zal/bal BLA filing
9) iNKT COVID early data
10) 1531 IND approved
11) iNKT early cancer data and move into ICI combo
12) early 1777 data
13) bal FDA approval
14) zal/bal FDA approval
15) First 1181 BLA and 1181/bal BLA filed
16) First commercial sales numbers of bal and zal/bal (perhaps later)
17) QS21 news?
18) Prophage GBM trial data
19) zal/bal + chemo in sarcoma data
20) zal/bal + chemo in bladder data
21) GS 1423 data
22) INCY GITR data (among others)
23) China approves bal and zal/bal and commercial sales begin
24) Zal data for URGN in invasive bladder cancer
25) GSK 25m royalty payment
26) European partner begins bal and zal/bal sales
27) Data for zal/bal expanded indications
28) Multiple partners or purchases of bal for non Agenus combos
29) Merck option money (50m each) for 1223 or 2373 or both.
30) Various milestone payments
Undoubtedly there are more i have not considered
Take some solace, looks as though the $IBB & $XBI may of put in a short term bottom. TBD
RedHill Biopharma Corporate Presentation (Sept 22 2020)
https://seekingalpha.com/article/4373795-redhill-biopharma-rdhl-investor-presentation-slideshow
Or
Presentations
https://ir.redhillbio.com/events
Nothing to post about as we wait on the company. All one can do is add on the dips or set some buy GTC orders especially in this market as you may get some discounts on share price.
BCYC-Presentations
ESMO
SEPTEMBER 17, 2020
BT8009-100 Phase I/II Study of the Safety, Pharmacokinetics, & Preliminary Clinical Activity of BT8009 in Patients with Nectin-4 Expressing Advanced Malignancies
https://www.bicycletherapeutics.com/publications/
DorseyE
Yes that is what is outstanding in ADR`s in the U.S. listing of American Depository Receipts for RedHill. That works out to about 10 shares israeli for every 1 share ADR. Hope that helps and it is also shown in the presentation slides below.
Morgan Stanley Virtual 18th Annual Global Healthcare Conference
Sep 17, 2020
8:45 AM EDT
Fireside chat and Q&A session details:
Date: Thursday, September 17, 2020
Time: 8:45 AM ET
Link to Webcast:https://ir.redhillbio.com/events/event-details/morgan-stanley-virtual-18th-annual-global-healthcare-conference
Speaker
Dror Ben-Asher
CEO
Not sure if this has already been posted as i`m just getting back into the stock after having success in Agenus a few years back. The company has come a long way in a few short years.
18 Minutes With is a discussion series from Scientific American Custom Media, produced with support from and in collaboration with Agenus. Please visit Agenus to learn more about the company’s work in immuno-oncology.
https://www.scientificamerican.com/custom-media/cancer-covid-19-and-access-to-combination-therapies/
This can happen EOD due to Friday being quadruple witching.
Quadruple witching refers to a date on which derivatives of stock index futures, stock index options, stock options, and single stock futures expire simultaneously. ... Quadruple witching days witness heavy trading volume, in part, due to the offsetting of existing futures and options contracts that are profitable.
Could not resist buying more on the dip Fri. at $10.10. Just mid week Redhill Biopharma (NASDAQ: RDHL) shares were up 3.16% on Wednesday to hit a new 52-week high of $11.35 for a change of up 3.16%.
Remember depositary receipts are a small Float of 3.2M with Shares Outstanding of just 3.5M. When one of their phase 3 trials announces again stock could run big time as the shorts will have to cover too. Short interest is a ridiculous 2M shares GLTA
ARAVIVE, INC.: INITIATION OF RESEARCH COVERAGE
William Blair & Company initiated research coverage of Aravive, Inc. (ARAV $5.81), a clinical-stage biotechnology company that leverages deep insights into essential cancer signaling pathways. The company's lead asset AVB-500 completed a Phase Ib study earlier this year, and will soon enter midstage trials in ovarian and kidney cancer.
Analyst Andy Hsieh said, "Aravive's wholly owned asset, AVB-500, targets two large pharmaceutical markets with significant unmet medical need; furthermore, the patient enrichment strategy with a biomarker could provide a competitive moat for the company. AVB-500 perturbs AXL signaling by sequestering the GAS6 ligand; AXL has been implicated in drug resistance, metastasis, and disease progression. In our view, AVB-500 acts as a ‘trap' for the GAS6 ligand, thereby disrupting its interaction with the AXL receptor, which ultimately results in the abrogation of the downstream AXL signaling axis. According to scientific literature, GAS6 is the sole ligand for AXL and their interactions promote cancer cell proliferation, survival, and migration. Aravive optimized AVB-500 to bind to GAS6 at 200-fold higher affinity compared to AXL, which could provide a broad therapeutic window."
Hsieh continued, "Based on our analysis, the total addressable markets for platinum-resistant ovarian cancer and treatment-experienced RCC are $930 million and $1.5 billion, respectively, in the United States, and $540 million and $720 million, respectively, in Europe. In the event that AVB-500 expands into the platinum-sensitive disease setting, the opportunity stands at $1.6 billion in the United States and $1.1 billion in Europe. In both indications, we believe there could be potential upside from longer treatment duration, driven by new modalities and combination regimens that provide significant benefit to patients in the frontline setting."
https://www.williamblair.com/en/News-Items/2020/September/18/Aravive-Inc-Initiation.aspx
KALA - JP Morgan has weighed in here, slamming Jefferies' thesis.
With volatile trading this week and Eysuv is pricing emerging as a point of controversy, we wanted to share our latest thoughts on key incoming investor questions and on the Kala story more broadly. Overall, our core thesis for Kala remains unchanged despite the recent selloff and we remain highly confident that Eysuv is’ product pricing will allow for strong payer coverage, relatively fast payer reimbursement decisions, and reasonable copay levels, which support strong uptake for a potential product launch. More broadly, we see the recent KALA share pullback as a significant buying opportunity ahead of an expected Eysuv is approval next month (Oct 30th PDUFA) and product launch immediately post-approval. Reiterate OW.? How are you thinking about pricing for Eysuv is? We see Kala pricing Eysuv is at a discount to current dry eye therapies. Although Eysuv is has not yet finalized pricing, we expect the product to price at a discount to current branded dry eye therapies Restas is and Xiidra (~$700/script gross price) and at a premium to branded post-surgical steroids such as Inveltys, Lotemax, and Durezol (~$300/script gross price). For our modeling estimates, we are assuming $400/$200 per script gross/net price range falling closer the post-surgical market, which could prove conservative in our view.? Could Eysuvis pricing limit the dry eye market opportunity?We do not see meaningful pricing concerns and view the product’s profile facilitating broad payer coverage and reimbursement. While Eysuvis pricing has emerged as a point of controversy, we believe the gross/WAC price level is less relevant data for patients and physicians compared to 1) the availability of drug payer coverage and copay requirements and 2) the cost to patients relative to other branded/generic products. Importantly, we expect broad payer coverage, relatively fast reimbursement decisions, and reasonable copay levels ($20-$50 range for most patients) based on Eysuvis’ product profile (only FDA approved prescription treatment for acute dry eye) and market research (significant physician interest, high unmet patient need). ? Overall, we expect strong uptake and market penetration for Eysuvis if the product achieves strong payer access in-line with our expectations. We see a significant Eysuvis dry eye market opportunity as the key value driver for Kala shares and our forecast >$750mm peak sales underpins significant share upside from here (which could prove conservative).? What are the prospects for Eysuvis relative to existing product alternatives?We highlight significant dry eye market opportunity with high unmet need and under served patient population.We see a significant market opportunity for Eysuvis based on conservative pricing and market penetration assumptions with >17 million diagnosed patients and few treatment alternatives.We see Eysuvis being used in both chronic and episodic patients. For chronic dry eye, we see a role for Eysuvis as patients are initiating therapy (as current chronic treatments have a delayed onset of action) and as flares continue to occur even after chronic therapy has been initiated. In episodic dry eye, we see a large opportunity to address flares that are associated with the condition, which are largely treated with OTC drops or less frequently with off-label steroids. Importantly, we believe a potent, FDA-approved prescription alternative to existing products would address a clear unmet need in the market. We currently forecast peak market share of approximately 8% of the diagnosed dry eye market for Eysuvis over time.
What’s your view of the probability of an Eysuvis FDA approval? We see the Eysuvis refiling as a very high POS (95%+) event. We see a high likelihood of an Eysuvis approval based on very clean efficacy and safety profile for the Phase 3 STRIDE-3 study, which fully addresses the FDA’s request for an additional study demonstrating statistically significant benefit for dry eye symptoms. Further, we have higher confidence on Eysuvis’ CMC and GMP related filing requirements given that the FDA has already approved Inveltys (same molecule and manufacturing sites) and the second pass FDA filing process.
What drove the first pass FDA CRL for Eysuvis and requirement for a third Phase 3 trial? As a reminder, KALA hit on 3 of 4 of its primary endpoints in its previous STRIDE 1 and 2 studies (with a near miss on the 4th endpoint) and received a CRL on its NDA filing with the FDA requiring a second trial to meet the requirement for demonstrated efficacy on the signs and symptoms of dye eye disease in two studies. Kala’s positive STRIDE 3 results earlier this year fulfill this requirement, and the company now has a EysuvisOct 30th PDUFAnext month(6-month second-pass review)setting up an expected late 2020 product launch.
What are the key catalysts ahead for Kala? We highlight the KOL investor and analyst event later this week on Thursday (Sept 17th), followed by the Eysuvis Oct 30th PDUFAnext month and Eysuvis product launch immediately post-approval. We also watching ongoing Inveltys product trends as COVID-19 disruptions recede in the post-surgical ocular pain/inflammation market.
Goldman Sachs Group Inc. Grows Position in BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX)
Posted by Joseph Griffin on Sep 14th, 2020
https://www.tickerreport.com/banking-finance/6297742/goldman-sachs-group-inc-grows-position-in-biocryst-pharmaceuticals-inc-nasdaqbcrx.html
Out again at $7.82. Overall market looking too sluggish, so back to watch list.
Aravive files $150M mixed securities shelf
A shelf offering is a Securities and Exchange Commission (SEC) provision that allows an equity issuer (such as corporation) to register a new issue of securities without having to sell the entire issue at once. The issuer can instead sell portions of the issue over a three-year period without re-registering the security or incurring penalties.
Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates
Eton's In-licensed Pediatric Adrenal Insufficiency Drug Awaits FDA Clearance
Company: Eton Pharma
Type of Application: NDA
Candidate: Alkindi Sprinkle
Indication: pediatric adrenal insufficiency
Date: Sept. 29
Eton acquired U.S. marketing rights to Alkindi Sprinkle from AIM-listed Diurnal Group plc in late March. Alkindi Sprinkle, a taste neutral sprinkle or granule formulation of hydrocortisone, is being evaluated as a replacement therapy for pediatric adrenal insufficiency, including congenital adrenal hyperplasia in patients from birth to less than 17 years of age.
The product, which is approved in Europe, is to be available strengths 0.5mg, 1mg, 2mg, and 5mg to provide pediatric atients with optimal precision and flexibility.
Eton estimates the market opportunity of Alkindi Sprinkle to be $100 million annually.
Catalyst Biosciences, Inc. Is Maintained at Outperform by Raymond James
Buying dips and will trade it if runs 50% from here. But otherwise accumulating and holding. Have a reasonable COST BASIS $4.03
Added back some, could not resist the selloff buying opportunity.One of my few plays that was in the green.
Cramer will probably be right one this one. Just the fact T-Moble/AT&T are using the desktop model will go a long way to the mobile hotpot model box being bought up once 5-G is the norm.....So far we are the top brand for the majors and it will broaden out to overseas next year too.