Free Biopharma Investor Posts

For FDA decision on $SRPT ELEVIDYS (ELEV) DMD gene therapy Currently ... ELEV has conditional approval for 4-5 yr olds only SPRT wants full approval & expanded label for all DMD pts FDA is faced with challenge: Hold a hard line on the 1' endpoint? 17 question NSAA test (rated as 0, 1, or 2) 📸 ELEV missed 1' endpoint 📸 Or give SRPT the benefit of the doubt? DMD trials are very hard to run 1 time gene therapy with well founded MOA ELEV was Directionally favorable for all key

When will smid-cap biopharma (e.g., XBI) stock prices start to increase again? Maybe when the biggest drivers for the downturn end or even reverse? So what are these 2 major drivers? US Federal Reserve interest rate increases U.S. Congress threats/action re: drug price controls/reform Here’s some background on the downturn, to help us understand why we think especially item 1, and to a lesser degree, item 2 are the main drivers. It’s been tough since 2021 for biotech investor

In honor of the Obesity week conference, which starts tomorrow: How can investors profit from weight loss drug (e.g. Wegovy) breakthroughs? Invest in companies that currently lead in this space Invest in companies developing new drugs in this space Large caps Smid-caps Leading type-2 diabetes (T2D)/weight loss drugs are GLP-1 agonists, GIP agonists, Amylin analogues,&  SGLT-2s We will focus on GLP-1s for this post The GLP-1 market was $22B in '22 & projected to reach >$50B by

Hedge Fund Favorites (I) ~30 top biopharma hedge fund holdings based on consensus and/or percent holdings;. This gives you investment ideas based on where top biopharma hedge funds have their money; uses a different strategy than our Hedge Fund Favorites (II) account. Hedge Fund Favorites (II) (Previously Core Value) ~20 top biopharma top hedge fund holdings based on consensus and/or percent holdings; This gives you investment ideas based on where top biopharma hedge funds ha

What is a Big-Mover™ event? Big-Mover™ events are upcoming high-impact biopharma catalyst events, usually clinical trial read-outs, that are expected to move a stock by at least 20% up or down. Big Mover™ events are typically a type of event with the highest chance of moving a stock (e.g. Phase 2, Phase 3, and PDUFA read-outs) given the importance of the clinical asset to the sponsor company. We call clinical events that appear likely to be Big Mover events Suspected Big Move

Access our free PDUFA Report! Calendar of PDUFA events this month. Use this info  To update your holdings before an approval To find bullish or bearish trades before and/or across event Read our PDUFA FAQs to learn more   Want even more info to help you find & analyze PDUFA events for future months? Sign up for ELITE (40% off)  limited time offer: Full PDUFA Calendar Deeper data like prior adcoms, CRLs, and more.. Also see which are the biggest stock moving PDUFAs w/ Big Move

Access our free Big-Mover Report Detailed info on biggest clinical readouts of this quarter Use this info:  To update your holdings before a readout To ID bullish or bearish trades before and/or thru readout Read our Big-Mover FAQs  to learn more   Want even more info to help you find & analyze this quarter's biggest movers, and big movers for future quarters? Sign up for ELITE (40% off)  limited time offer: Suspected movers for future quarters Implied volatility, short inter

Summary: Many exciting Alzheimer's disease catalysts are coming throughout the year See the table below for upcoming catalysts and become a Pro member for all catalyst events & dates Already a Pro member? Check out the full list of Big Movers ! Table 1 . Alzheimer's Disease Catalysts & Assets Sign up for a Pro Membership to see all catalyst event dates! Learn more here              Article history: Originally posted 4/13/23

Doing diligence on clinical trial readouts with our BPIQ team Reminds me of some important considerations for the likelihood of success: ⇨Prior data for the on-test drug ⇨⇨Same endpoints? ⇨⇨Not available? Then prior trial data for other drugs with the same MOA ⇨Trial design ⇨⇨ Are the characteristics of patients allowed into the trial the same? ⇨⇨⇨ Especially the severity of the disease ⇨⇨How many patients? ⇨⇨How many clinical sites? & Likelihood of stock move ⇨Market reactio

Amgen v. Sanofi Sup Ct. oral arguments took place yesterday in the ongoing PCSK9* antibody (Ab) patent case. See the attached transcript and FIG. 1. Who won the oral arguments? Verdict? Although it's hard to predict the outcome of the case from the oral arguments, I give the advantage in the orals to Sanofi Some of the Sup Ct justices don't like that AMGN's patent covers millions of antibodies (Abs) and only discloses 26 Abs And the fact that there is no structure, only funct

Last updated 3/14/23 Summary: Many exciting breast cancer catalysts are coming throughout the year See the table below for upcoming catalysts and become a Pro member for all catalyst event dates Already a Pro member? Check out the full list of Big Movers ! Table 1. Breast Cancer Catalysts & Assets Sign up for a Pro Membership to see all catalyst event dates! Learn more here   Article history: Originally posted 3/14/23

Congrats to $ACAD, its investors, & Rett Syndrome patients on approval of DAYBUE (Trofinetide) for the treatment of Rett Syndrome • Rare genetic disease • 1st approved drug • Supported by Phase 3 Lavender trial data. • No Black Box warning on label • Nice stock runup to approval ~33% • BPIQ Big Mover event • ACAD gets FDA rare pediatric disease voucher • Value ~$100M Competitors from BPIQ Company Screener: $TSHA $AVXL $JAZZ Read more about upcoming PDUFAs https://www.bpiq.com

Summary: Many exciting NASH & Liver diseases catalysts are coming throughout the year See the table below for upcoming catalysts and become a Pro member for all catalyst events & dates Already a Pro member? Check out the full list of Big Movers ! Table 1 . NASH & Liver Diseases Catalysts & Assets Sign up for a Pro Membership to see all catalyst event dates! Learn more here              Article history: Originally posted 3/10/23; last updated 3/29/23

See this post for our current thoughts on ANAB. ANAB piqued our interest since 5 vs 0 hedge funds added them to their top 20 holdings in Q4 vs. Q3. However, the funds were probably looking for a stock jump on alopecia data in early Q1 2023, which unfortunately came back negative and hit the stock pretty hard, but it has rebounded to since the Jan 2023 readout (FIG. 1) FIG. 1 What are Amp's current thoughts and positions on ANAB? Overall, we are cautiously bullish on ANAB fro

Summary: Many exciting rare diseases catalysts are coming throughout the year See the table below for upcoming catalysts and become a Pro member for all catalyst events & dates Already a Pro member? Check out the full list of Big Movers !     Table 1 . Rare Disease Catalysts & Assets Sign up for a Pro Membership to see all catalyst event dates! Learn more here              Article history: Originally posted 2/28/23; last updated 5/1/23

Summary: Many exciting blood cancer & disease catalysts are coming throughout the year See the table below for upcoming catalysts and become a Pro member for all catalyst events & dates Already a Pro member? Check out the full list of Big Movers !     Table 1 . Blood Cancer & Disease Catalysts & Assets Sign up for a Pro Membership to see all catalyst event dates! Learn more here Article history: Originally posted 2/21/23; last updated 4/11/23

Summary: Many exciting eye disease catalysts are coming throughout the year See the table below for upcoming catalysts and become a Pro member for all catalyst event dates Already a Pro member? Check out the full list of Big Movers ! Table 1 . Eye Disease Catalysts & Assets Sign up for a Pro Membership to see all catalyst event dates! Learn more here           Article history: Originally posted 2/15/23 Last updated 4/28/23

Summary: Many exciting heart disease catalysts are coming throughout the year See the table below for upcoming catalysts and become a Pro member for all catalyst event dates Already a Pro member? Check out the full list of Big Movers ! Table 1 . Heart Disease Catalysts & Assets Sign up for a Pro Membership to see all catalyst event dates! Learn more here Article history: Originally posted 2/14/23; last updated 4/26/23

Summary: Many exciting ovarian cancer catalysts are coming throughout the year See the table below for upcoming catalysts and become a Pro member for all catalyst event dates Already a Pro member? Check out the full list of Big Movers ! Table 1 . Ovarian Cancer Catalysts & Assets Sign up for a Pro Membership to see all catalyst event dates! Learn more here          Article history: Originally posted 2/14/23; last updated 4/25/23

Summary: Many exciting mental health catalysts are coming throughout the year See the table below for upcoming catalysts and become a Pro member for all catalyst event dates Already a Pro member? Check out the full list of Big Movers !        Table 1. Mental Health Catalysts & Assets Sign up for a Pro Membership to see all catalyst event dates! Learn more here       Article history: Originally posted 2/13/23; last updated 4/24/23