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Familiar T/A on ITRM Well, doesn't this look familiar? ITRM tested is previous level of support AND resistance in a wide channel today. IDK what the sell-off was but I'm guessing the re-entry had something to do with speculation on the FDA data set to come out next month. "At the end of May, Iterum provided an update on its New Drug Application with the U.S. Food and Drug Administration. Currently, the NDA is still under review by the FDA, and the PDUFA goal date is July 25th, 2021. Since the application review for Sulopenem is on track at the moment, ITRM stock is performing well as a result. ITRM stock price has nearly doubled in the last month." Not sure if it gets the approvals necessary but "buy the rumor" might be playing a role here. Quote Source: Top 9 Penny Stocks With High Volume to Watch Right Now
NASDAQ:ITRM
by PennyStocks101
2
NOVAN a biotech stock that might fly very soonDisclaimer: I do own a position and you may want to do your own DD, since this post maybe bias even if its not. Please do your own research. Novan is a pennystock biotech that picked up steam last fall like many pennystocks, but through out 2021 stocks have been getting hit with biotech and pennystocks/low caps being the worst hit sectors. Cathie Woods states in her investment strategy is buy sectors that are hurt the most and that have the protentional to move higher. Novan is its own patient product of nitric oxide throughout United States and Europe and wants to expand on it. News -March 29th The CEO bought 70,000 shares, which is bullish when the CEO is buying -Voting has started and results come in on May 4th. There are many things in here such as increasing the share count by 15million, which shares off 200million doesn't seem much. This doesn't mean shares will get dumped it just means they have the option to do offerings in the future. -Q2 (current quater that last till the end of May possibly June) they will get the results of sb206 B, which looks positive. sb206 will the first every treatment for a skin condition called Mollescum. In doing a quick google search, business wire estimates in 2017 there was over 12million cases and half was in the United States. Googling Mollescum cases in the United States go up 200k a year. Now how does Novan fit into this? Well they would be the only FDA treatment on the market, which would send market shares shoring to a billion dollar valution in a short period time (pt would be around $7). -They also partnered up with Catalent to develop a COVID treatment, which has shown with Novan's product that can reduce the spread of Covid of around 90%. Which catalyst would send Novan to a 10billion dollar valuation, but its up to Catalent. This product is suppose to hit in Q3/Q4, but leans more of a Q3. Pipeline -Like ZOM, Novan is also entering the pet care field, but not a device to do testing. On the last webinar investor prestation, they are working to test their product to help skin dieses in dogs and atm are targeting K9s. This would pickup after sb206 and would get more news sometime around q4 or early next year (most likely when they get the marketing of sb206 going). TA: Now that was alot of "shilling," but its great to know the protentional of a mid/long term play of Novan. It begs the question is if the pennystock is under the radar. Zack Investments and a big advocate in Novan and gave Novan a pt of $4, but 2021 hit and crashed the market. So heres some TA that might help you keep your risk at check if you enter. -Resistance in the short term is at $1.08, but closing was $1.10 on April 16, so $1.13 would act more of a challenge. After that is $1.32, $1.45, and then $1.63. With tight consolidation in the past between $1.63-$1.76, breaking that could shoot up to $1.96 or $2+ -Support: support is tricky cause we are free falling like most pennystocks such as ZOM. I would say a micro 5min scale, Every $0.02 is support, but on the hourly we could fall as low $0.96, but its unlikely. Last year we gain compliance of the $1, so there's a lot of buyers from here too $0.96 that will keep it above $1. Now if we get a negative catalyst we could drop too $0.86-$0.81 -MACD leans bearish as we look for a reversal -RSI is oversold and leans bullish for a bounce back with resistance at 46.89. If people wondering where I get these RSI lines, I look at where its uptrending and make a guess where it breaks and the price starts dropping and the RSI goes from overbought to oversold levels. -VPVR means shit like ZOM's TA, but in the past a lot of support at these levels in the past. -Current EMA 50 is at $1.27, 128 is at $1.40, and the 200 is at $1.45. Final Thoughts Biotechs are risky, but with the CEO buying at $1.40 and seeing the price way below that is a sign to toss in some money or go all in. Its up too you, but I would take the bet and wait this storm out. The confidence between ZOM and Novan is I would pick a stock that has a bigger upside in a near term timeline. Again its best too do your own your research.
NLong
by nathanielx9
3
$KMPH Announces FDA Approval of AZSTARYS™KemPharm Announces FDA Approval of AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), A New Once-Daily Treatment for ADHD Corium, Inc. will lead the commercialization of AZSTARYS per the definitive collaboration and license agreement. Corium expects to make AZSTARYS commercially available in the U.S. as early as the second half of 2021. Under the License Agreement, KemPharm may be eligible for up to $468 million in regulatory and sales milestone payments, as well as tiered royalty payments, on a product-by-product basis for net sales, with potential percentages up to the mid-twenties for U.S. net sales, and up to the mid-single digits of net sales in each country outside of the U.S. finance.yahoo.com
K
by AlenCiken
1
$SLDB FDA Lifts Clinical Hold case studySolid Biosciences Announces FDA Lifts Clinical Hold on IGNITE DMD Phase I/II Clinical Trial As announced in July 2020, the FDA had requested further manufacturing information, updated safety and efficacy data for all patients dosed, and provided direction on total viral load to be administered per patient. Based on the Company’s response to these requests, the FDA acknowledged that the Company satisfactorily addressed all clinical hold questions. “We are working diligently to complete all activities necessary to resume dosing, which we expect to occur in the first quarter of 2021.” finance.yahoo.com
NASDAQ:SLDB
by AlenCiken
SESN to $5 or more by August. I like the stock.On the verge of FDA approval for a new product, multiple analysts recently adjusting price targets to $6 plus. In a market full of mania, a stock with good fundamentals may get overhyped especially about something as legitimate as FDA approval. Who's not talking about SESN and ENZC right now??? If FDA approval falls through both stocks will suffer a lot, so be careful here and watch for the breakout off support lines before going hard. The trend is your friend unil the end. Look for confirmations of your (or my) predictions, thats what TA is all about. Hit me with a like, follow this chart, tell me your thoughts and give me a follow. If you haven't upgraded yout TV account, use my link to upgrade. Cheers, traders!!
SLong
by RickSmash
5
MYCO - Next Move? MYCO has formed a prefect cup & handle on the daily - 4 hits against an important 0.60 resistance - handle dropped perfectly on the 0.5 fib support level - price is currently consolidating right below resistance Fundamentals in the psychedelic space are lining up perfectly for a MYCO breakout. - they are 1 in only 4 companies currently approved for phase 2 FDA trials - confirmed listing on the first ever psychedelic ETF - PSYK However, a breakout will only be confirmed after a daily close above 0.60 - volume and a newly approved catalyst will be key Good Luck to All!
CSE:MYCOLong
by LibraTradesNY
1
Synthetic Biologics Bullish MomentumSynthetic Biologics Announces Washington University School of Medicine in St. Louis IRB Approval of the SYN-004 (ribaxamase) Phase 1b/2a Clinical Protocol. A previously completed placebo-controlled Phase 2b clinical trial of 412 patients demonstrated SYN-004 protected the gut microbiome from antibiotic-mediated dysbiosis. Patients receiving SYN-004 also demonstrated significantly better maintenance and recovery of the gut microbiome as well as lower incidences of new colonization by opportunistic and potentially pathogenic microorganisms such as VRE. (Source: prnewswire.com) Please leave me a message if you want to test the buy and sell indicators that i am using.
SLong
by BuySellMarketMaker
2
Easy 10%er upcoming Consolidation at LQDA in range of their all time low after FDA issued the biotech company a CRL due to COVID restrictions. After speaking with regulators at the FDA, The company expressed this CRL had nothing to do with the underlying data. Options activity has been healthy. I believe price will increase from here, which is why I have started a position and continue to add on any meaningful dips (eg yesterday, the company issued PR for $200 mln mixed securities shelf offering) causing week hands to sell. Stop loss under previous low, friends. let’s go!! Disclaimer: this is not recommendation to buy or sell, this information is to be used for educational purposes only. Trade at your own risk.
NASDAQ:LQDALong
by follow_the_money
MESOBLAST (MSB) - FDA will likely approve Ryoncil (analysis)MSB is developing Ryoncil - an IV stem cell therapy for the treatment of acute graft versus host disease (aGVHD) in paediatrics. aGCHD is a potentially life threatening (up to 70-90% mortality) complication of bone marrow transplants (indicated for leukemia/lymphoma etc). Ryoncil has been accepted by the FDA for priority review with a PDUFA action date of US 30th September (1st Oct in AUS). Why might the FDA approve Ryoncil? Probability wise: - Oncology therapy's have an average 88% probability of being approved once they have been accepted for review (data averaged from results from Wong et al (2018), Thomas et al (2016), Hay et al (2014), and DiMasi et al (2010)). - As part of the review, the FDA requested a recommendation from the Oncologist Drugs Advisory Committee (clinical oncology academics and statisticians) who on Aug 13th voted 9:1 that the available data supports the efficacy of Ryoncil. - Ryoncil has been approved in Japan for the last 5 years with strong yoy growth. Benefit-risk ethics analysis: - There are no FDA approved treatments for aGCHD in pediatrics and no therapies are considered standard of care. - Ryoncil is effective vs placebo (28d survival 64% vs 38%, 100d survival 79% vs 54%). - Adverse Effects of Ryoncil were not statistically different from placebo. In fact unapproved treatments (steroids) carry high risk of toxicity. - aGCHD has a 70-90% mortality rate, there are no FDA approved treatments, Ryoncil appears to be effective, risk of doing harm by approving Ryoncil is low. It seems like the ethical decision is to approve Ryoncil. Why might not the FDA approve Ryoncil? - The FDA prefers double-blinded, placebo-controlled RCT's to show effectiveness. However, due to the high mortality rate of aGCHD, enrolling children into an RCT is clearly not ethical. I'd argue that the single arm study comparing to an external control population is as good as you're gonna get. It also does not need to be blinded as the primary endpoint is mortality. The 9:1 ODAC vote seems to support this. - The study was small (N=14, N=13). It might be reasonable for the FDA to ask for another (potentially larger) study to replicate the results which is a risk. - Quality control concerns. The FDA raised concerns that the way MSB measure the potency of the Ryoncil (CQA's) may not be enough to ensure the clinical effectiveness of the product. I'm no expert in this part but when MSB responded to these concerns in the webcast, they kind of just reiterated the CQA's from their manufacturing were very high but didn't really address the concern that the CQA's might not translate to clinical effectiveness. It might be reasonable for the FDA to ask for more data on this. - Even if more data is requested, Ryoncil can still be provisionally approved. Conclusion: The FDA will likely approve or provisionally approve (with the request of more data) Ryoncil therapy for pediatric aGVHD in the US which will strongly improve the revenue potential of MSB.
ASX:MSBLong
by Sean_Kenworthy
NSPR still getting beat downNow like you and many others I'm shocked by NSPR price action, so what could have caused it? Well theres one and that was the FDA IDE approval, yet today was ann that they got the full FDA IDE approval green light. News -Got FDA IDE approval in the US today -Last week they where at LD Micro 500 they gave us some company insights 1: Theres already sales in Brazil for next er. At this time er expectations didn't factor that in, so it is nearly 100% they will be making money instead of losing money. 2: They were very confident in getting the FDA IDA approval last week along with the expansion in France and Asia. Can be shown on the company website roadmap. TA Now the news is bullish, yet why hasn't price action reflect that? Well only thing it can be said is that people waited for the FDA IDE approval too long, so where can we go from here? -Well be shot up 40% this morning so even though I have resistance lines from .4194-.4594, it looks like its a very week in the grandscale of this company, so are primary resistance will be .4397-.4594 with .4922 being the true goal to go full rocket. On webull we went passed it, yet on tradingview we didn't so I'll stand with .4922 being the biggest hurdle. -Support is nothing since we kept waterfalling lower, yet if any support it ranges at .3913,.3713, and with the red zone .3506 and .3368 -Atm we are makingout withe the ema, which if we can hold it and have a good bounce off of it we can stop buying and it can confirm bullish price action. If it dips below it, it could mean I final acculation zone before we moon. -MACD is very bullish atm, but if we rise and it gets closer it might be the end short term -RSI is oversold, so we could suspect sideways movement with massive ranges, slow rise up, or a pure dump. A dump is unlikely in my opinion. Overall I've been dca every week, due to the fact of the being in the Brazil market and already having sales. I think this will produce massive gains in the near term, so i'll be holding and will update you guys if we hit lower lows or break the massive resistance.
NLong
by nathanielx9
NSPR still dippingOkay I'm gonna start off with the news News -NSPR beat earnings by 44%, yet still losing money. It has been making more money due to its past performance and not losing as much. We can project that they might be profitable next year. -Their offering that was held in June came out that it was so they can remain compliant with the exchange. That Friday they have became fully compliant so they won't get delisted. -On their earnings report they got mostly compliant FDA IDE approval, yet on that they will get fully compliant FDA IDE approval in 45days. This should be on the 27th, so next week, which I labeled on the graph. -Upcoming catalist: they hope to get into the France and China markets soon. Plus with approval in Brazil we could see that profit from the company in q4/ another earnings beat. Maybe over 100%, yet with COVID not sure, but certain in q1 next year. TA -Not sure what to say since an earnings beat should have pushed the price higher, yet we saw a sell off with no FDA IDE approval to common investors liking. At the same time the volume showed it being very low compared to the past showing its just small sellers and yesterday someone bought 200k shares touching our old trading zone. -the low at .4194 was in the middle of the gap of the intial drop from .80 to .39 then gaping up to .42-.47 Final thoughts I'm DCAing this stock and think its gonna pay off pretty soon. Recent SEC filing shows that their CFO has sign a contract starting in 2022 that he will get an annual renewal of his job. This shows there is some long term potential if a CFO is entering this contract and wants to see growth in this company or he will get fired. There was alot more in the earnings report like and they don't want to do any more offerings and they also have alot of cash on hand to play with, so upside potential is pretty high.
NLong
by nathanielx9
What to expect on ER?Well seems like we continue the sell off of the Brazil news that I didn't sell. So what news is there to push it higher? Well if ER repeats the same pattern we can suspect them beating EPS and and Beating Revenue. News -Earnings this wednesday, a week early -They are hitting their road map this year www.inspiremd.com -Atm the FDA IDE is awaiting its pr, yet questions on their recent tweet suggesting it got approved twitter.com -The filed for some 8-ks on a past offering that happen over two years ago. These changed the pricing of these investors to .49-.50. Heres some links to the offering it refers too and to a definetion to prospectus supplement. www.globenewswire.com prospectus supplement definition: the link looks funny so just google the definition Now TA -We been in a downward trend, yet the volume has been low. The average volume ranges from 2.5-over 4million, yet the past week its been dropping and Friday we didn't even hit a million. The only thing I could find is a low volume downward trend article titled "Low Volume Pullback" Again we going back to the FDA IDE news that many common investors suspect the news to already be dropped. Now I'm no expert on how this process works, so I'm just waiting till ER update. www.investopedia.com -MACD looks like its gonna turn over, but is neutral on that it is possible for a pretty big move this week in either direction. -RSI is trending downward suggesting its becoming oversold and we could go bullish, yes it's not super oversold yet. -I put in a new trade zone that we could just go sideways till earnings from .4499-.4594 Other notes -I did some DD on the current CEO and notice over 2 years he produces returns for a company from when he gets hired till he leaves. If you can hold for another year and 2/3months you could see a price target of .9023 or a pt of 1.2293. This data is from his recent jobs at ticker ITAMAR and IART, which he produced returns at rougly round 4-44% as he worked for them. -According to Fintel: on 06/09/2020 Lind Global Macro Fund LP acquired just over 3.9million shares and L1 Capital Global Opportunities Master Fund, Ltd acquired over 650k shares on 06/19/2020 fintel.io Final thoughts I'll hold my position, but till earnings. I'll be neutral on the buy half, yet long term you could make 100%-170% return in the next year and 3 months with the CEO past performance. They have hit the Brazil market and is growing in the US. You could see massive market cap growth.
N
by nathanielx9