Free Biopharma Investor Posts

Following approvals of JOURNAVX (Vertex) and SYMBRAVO (Axsome) last week, the FDA approved ONAPGO (Supernus) today! Three more PDUFAs are expected this February. See the summary below for details.    🗓️ Last Week’s PDUFAs: VRTX : Approved ✅ ➯  JOURNAVX (suzetrigine) » Non-opioid pain signal inhibitor » Indication: Moderate-to-severe acute pain » PDUFA date: 1/30/25 (NDA)   AXSM : Approved ✅ ➯  SYMBRAVO (meloxicam & rizatriptan) (AXS-07) » NSAID & 5-HT1B/1D agonist combinatio

We’re always excited to find bio/pharma companies nearing their therapeutic product launch! Following Biogen's Leqembi IV maintenance dosing approval last week, this week brings two key FDA decisions: Vertex's Suzetrigine (VX-548) for moderate-to-severe acute pain and Axsome's AXS-07 for migraine. See summary for more details.    📌 This Week’s PDUFA: VRTX : 🤔 ➯  Suzetrigine (VX-548) » Non-opioid pain signal inhibitor » Indication: Moderate-to-severe acute pain » PDUFA date:

2024 was a remarkable year for cell and gene therapies (CGT) with the FDA approving nine innovative products. Read more below about these approved CGT therapies and new indications. FIG 1. CGT Approved Products in 2024 RYONCIL - Mesoblast Limited  (MESO) ➯ RYONCIL (remestemcel-L) is the first FDA-approved mesenchymal stromal cell (MSC) therapy ➯  Indicated for children aged 2 months & older including adolescents & teenagers with steroid-refractory acute graft versus host dise

We identified 5 stocks that are likely to move big on cancer readouts this Q1 2025. We classified these as either Big Mover or Suspected Big Mover catalysts depending on stock options volatility data. We highlight 5 of these catalysts in the graphics below. 👇   $ARVN Vepdegestrant (ARV-471) / Metastatic Breast Cancer / Phase 3 » Phase 3 VERITAC-2 trial designed to position vepdegestrant as a backbone ER-targeting therapy in BCA. » Ph2 VERITAC had favorable tolerability at bo

The 43rd Annual J.P. Morgan Health Care Conference  is taking place in San Francisco, CA from January 13-16, 2025 . "This premier conference is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community." ( https://www.jpmorgan.com/about-us/events-conferences/health-care-conference ) Many of the smid-cap biopharm

We’re always excited to find bio/pharma companies nearing their therapeutic product launch! These 4 companies have FDA final approval decision (PDUFA) dates before the end of January: Atara Biotherapeutics (NASDAQ: ATRA ) Drug/Therapy: Tab-cel (tabelecleucel) Allogeneic T-cell immunotherapy Indication: Post-Transplant Lymphoproliferative Disease (PTLD) PDUFA date: January 15, 2025 BLA with priority review Biogen (NASDAQ: BIIB ) Drug/Therapy: Leqembi (Lecanemab) IV Maintenance

You can find updated Q3 bioHF holdings data at app.bpiq.com/hedgefunds Check out the ticker screener If you are an Elite or Amp subscriber ... Check out the tables at the links on the left menu under "Hedge Funds" If not, sign up today HERE   Our goal is to help you make $$ investing in biopharma That's why we follow top biopharma hedge funds (bioHFs) ^1 Here are some tickers to check out based on Q3 hedge fund activity Tickers most initiated or closed by bioHF in Q3 '23 Most

This weekend COGT reports some Big-Mover data on  Bezuclastinib (CGT9486) at ASH. COGT Clinical Pipelilne COGT is a biopharma hedge-fund favorite. In fact, as of Sep 30, 2023, they were held by 15 of the top 34 biopharma hedge funds that we track. That is more than any other company. And they remain one of the most popular Top 20 holdings in those funds. COGT's lead asset, Bezuclastinib (CGT9486), is a KIT inhibitor that is being developed to treat GIST and Systemic Mastocyto

BACKGROUND 1st Gene Editing AdCom On 10/31/23 an FDA AdCom met to discuss the safety of VRTX/CRSP’s exa-cel (CTX001) to reduce or eliminate the painful and debilitating vaso-occlusive crises (VOC) for patients with sickle cell disease (SCD). As the first FDA AdCom for a cell therapy that involves gene editing, the AdCom provides helpful insights into the FDA’s review of gene editing and even other autologous gene therapies for rare inherited diseases. What is Exa-cel? Exa-cel

SUMMARY If the PFE SGEN M&A closes by end of Q1 '24 ... Most likely closing timeframe ^1 and ^6 Return = 7-8% in 3-4 months PFE agreed to pay $229/share 12/1/23 SGEN closed at $212.72/share ^FN Refer to milestones in SGEN/PFE or HZNP/AMGN acquisition timelines shown in footnotes section RISKS What are the chances that ... FTC blocks the deal?  Very low FDA is giving this deal a high level of scrutiny ^2 SGEN and PFE are in oncology SGEN is a leader in Antibody drug conjugates

As we close out the year, happy that biotech/biopharma has become a hot sector again 🔥 😃 • After a tough 3 years Hopefully, this momentum will continue thru 2024 🙏 🎇 The fate $XBI  and smid-cap biopharma is probably most impacted by: 1) The Federal Reserve pulling back rates in 2024 • As they have signaled & the market currently appears to expect 2) Continued active M&A • As  expected if we continue to have large caps in need of new therapeutics ⇨ approved/nearing approva

On 10/31/23 the FDA convened the 1st AdCom... 🏆 for a therapeutic made using gene editing exa-cel - from $VRTX / $CRSP In its Briefing Document, FDA provided an overview of genome editing, especially using CRISPR/Cas9 📸 📸 At the AdCom, to educate AdCom members ... FDA hired a gene editing KOL Fyodor Urnov (UC Berkeley) who gave a gene editing tutorial to the AdCom members Want to understand gene editing better? Watch the gene editing presentation by Fyodor Urnoff of UC Ber

SUMMARY Hedge fund holdings can help you discover new investment ideas We identified & follow the top biopharma-focused hedge funds Q3 hedge fund holdings reports were released on ~11/14/23 This report focuses on top holdings of top biopharma hedge funds as of 9/30/23 Top Biopharma Hedge Funds At BPIQ we identified the top smid-cap biopharma-focused hedge funds ^1. We updated our database of holding and other info re: these funds with their recently-released data for holdings

Great that $XBI is up this week on Fed pause But XBI is still very low (in the $60s) Here’s 2 ways to make $$ in this long-term biotech bear market (See 👇) 1) Smid-cap biopharma M&A targets 2) M&A arbitrages STRATEGY 1 Invest in biopharma companies that are M&A targets ⇒ Cannot know for certain which biopharma Co's will get acquired ⇒ So focus on companies with attributes that make them M&A targets      •  Especially since biopharma M&A is very active 📸      •  -1 key attri

Check out the gene editing presentation @ the ~30 min to ~50 min mark of the 10/31/23   VRTX AdCom by Fyodor Urnoff of UC Berkeley Available at the following Link:   https://www.youtube.com/watch?v=M90IjjxOdQg&t=20970s Posted 11/1/23 This article is NOT legal, investment or tax advice. Please do your own diligence before making any investment decisions.

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