Biohaven Provides Overview of Clinical Progress, Regulatory Updates, and Pipeline Developments at R&D Day
Source: PR Newswire (US)
Submitted a new drug application (NDA) for troriluzole in Spinocerebellar Ataxia Type 3 (SCA3) to U.S. FDA in 2Q2023, marking the team's fourth NDA in approximately 3 years
Released additional data from Kv7 platform, including Phase 1 safety data by dose groups for BHV-7000 that further validates differentiated profile
Projected Phase 3 Spinal Muscular Atrophy trial to complete enrollment in 2023
Initiated Phase 1 study of brain penetrant TYK2/JAK1 inhibitor, BHV-8000, and anticipate beginning Phase 2 trial in Parkinson's disease next year
Highlighted robust pipeline with multiple INDs planned to be filed within the next year, including pan IgG degrader for multiple immune-mediated diseases in 2023
NEW HAVEN, Conn., May 31, 2023 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies for people with debilitating diseases, including ultra-rare disorders, will provide an overview of clinical progress, regulatory updates, and pipeline developments at an in-person R&D Day today, concurrently with the Yale Ventures' Innovation Summit 2023 taking place on May 31-June 1. Members of Biohaven's senior management team and key opinion leaders will meet with investors and research analysts.
The clinical progress, regulatory updates, and pipeline developments to include:
Troriluzole in SCA: Submitted New Drug Application (NDA) to the U.S. FDA for troriluzole for the treatment of spinocerebellar ataxia type 3 (SCA3), an ultra-rare, genetically-defined, neurodegenerative disease associated with progressive disability, frequent falls, loss of ambulation, speech and swallowing impairment, and premature death that is the most common SCA genotype worldwide.
NDA supported by consistent treatment benefits observed in patients with genotype SCA3 in Study BHV4157-206 across multiple outcome measures including the change from baseline f-SARA at Week 48, CGI-I total score at Week 48, and a robust reduction in fall risk over the study period. A rigorous analysis by genotype was possible as patients were randomized by genotype strata at baseline prior to randomization in the pivotal Phase 3 48-week, double-blind, placebo-controlled phase of Study BHV4157-206.
SCA3 represented 41% of study participants, consistent with being the most common subtype. SCA3 affects approximately 10,600 people in North America and in the EU and Japan.
NDA further supported by a composite scale development (SCACOMS) and analysis of Study BHV4157-206, and confirmatory evidence of efficacy provided by data from the 3-year, long-term open-label (OLE) extension phase of two studies (BHV4157-206 and BHV4157-201) using a Matching Adjusted Indirect Comparison (MAIC) to an external control group.
Biohaven has previously received Fast-Track and Orphan drug designation (ODD) from the FDA, and ODD from the European Medicines Agency, for troriluzole in SCA.
Kv7 Platform: Highlighted progress and broad potential of Kv7 platform, including ongoing and planned development of BHV-7000 (Kv7.2/3 activator):
Phase 1 EEG study with BHV-7000 in 1H2023.
Pivotal studies with BHV-7000 in focal epilepsy and bipolar disorder planned to initiate in 2H2023.
Burgeoning evidence for therapeutic benefits of targeting Kv7 in diverse, high unmet need indications.
Bispecific Platform: Provided updates regarding planned INDs for targeted extracellular protein degradation franchise (including IgG, IgA, and autoantibody-specific degrader programs) and next-generation antibody-drug conjugate (ADC) technologies;
IND application for novel IgG degrader, BHV-1300, on track for submission in 2023.
TYK2/JAK1 Inhibition in Immune-Mediated Brain Disorders: Began dosing with BHV-8000 (an oral, brain-penetrant, dual TYK2/JAK1 inhibitor) in a Phase 1 study in normal healthy volunteers.
In Spinal Muscular Atrophy: Enrollment of approximately 225 patients in global Phase 3 trial now anticipated to complete in 2023.
In Metabolic Disorders: Planned Phase 2 trial initiation in 2H2023.
Vlad Coric M.D., CEO and Chairman of Biohaven, commented, "Today's R&D Day review of our robust pipeline highlights Biohaven's continued dedication to advance novel therapeutics for brain disorders and builds upon our team's successes with the prior approvals of Nurtec® ODT and Zavzpret™ that have changed the treatment paradigm in migraine."
"The NDA we submitted for troriluzole for SCA3 represents approximately seven years of effort by the Biohaven team to bring forward a potentially new treatment for this ultra-rare disease. Advancing a new investigational drug for a rare disease that has no current therapy is a multi-year process that is the culmination of not only our own internal efforts but also close coordination with patient advocacy groups including the National Ataxia Foundation (NAF), leading academic researchers and regulatory agencies. Rare brain diseases are particularly challenging to research given relatively small populations of patients to run / participate in clinical trials, the need to rely on real-world data and often a lack of standardized ratings scales or biomarkers. We could not have advanced the SCA program this far without the leadership from the National Ataxia Foundation that has supported basic science research as well as the development of natural history cohorts in SCA that serve as an external control for longitudinal studies. The Biohaven clinical trials in SCA were a first of its kind in this area and utilized a newly developed rating scale (the functional SARA or f-SARA) that was developed in close consultation with the FDA using standard regulatory pathways to elucidate this new scale. We look forward to interactions with the US FDA, EMA and other regulatory agencies across the globe as our submissions advance in the review process," Dr. Coric added.
"We are pleased that our decades-long investment in ataxia research and understanding of disease progression has accelerated treatment development for SCA," said Andrew Rosen, Executive Director of the National Ataxia Foundation. "Thank you to all NAF members who participated in these important trials."
Bruce Car PhD, Biohaven's CSO, stated, "Given the lack of efficacious therapies for many brain disorders, we must urgently evaluate new mechanisms and approaches to change the treatment paradigm in this therapeutic area. Our R&D Day today demonstrates the commitment that we have given to this effort with exciting new approaches ranging from our submission of a glutamate modulator in SCA to immune modulation using small molecule degraders to ion channels targeting agents for epilepsy and mood disorders, as well as a biologic treatment to enhance muscle growth in SMA. Our scientific and clinical team is poised to file multiple new INDs from our deep pipeline and complete late-stage clinical trials in the next couple of years. It is an exciting time at Biohaven for our passionate employees, patients and investors as we advance these novel investigational drugs in our pipeline."
The Research & Development Day presentations will be made available following the conclusion of the program on https://ir.biohaven.com/events-presentations/events.
Biohaven is a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies for people with debilitating diseases, including rare disorders. Biohaven's experienced management team brings with it a track record of delivering new drug approvals for products for diseases such as migraine, depression, bipolar disorder and schizophrenia. The company is advancing a pipeline of therapies for diseases with little or no treatment options, leveraging its proven drug development capabilities and proprietary platforms, including Kv7 ion channel modulation for epilepsy and neuronal hyperexcitability, glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia, myostatin inhibition for neuromuscular diseases, and brain-penetrant TYK2/JAK1 inhibition for immune-mediated brain disorders. Biohaven's portfolio of early- and late-stage product candidates also includes discovery research programs focused on TRPM3 channel activation for neuropathic pain, CD-38 antibody recruiting, bispecific molecules for multiple myeloma, antibody drug conjugates (ADCs), and targeted extracellular protein degrader platform technology (MoDE™) with potential application in neurological disorders, cancer, and autoimmune diseases. For more information, visit www.biohaven.com.
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "anticipate" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the future development, timing and potential marketing approval and commercialization of development candidates are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the Food and Drug Administration; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates; the potential for Biohaven's product candidates to be first in class therapies; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this new release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
MoDEs is a trademark of Biohaven Therapeutics Ltd.
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Long I love the move after the offering, Looking like it's being done correctly. Expect another pop when announced offering is over.
Biohaven Shares Hit 52-Week High After Public Offering Prices
10:40 am ET October 21, 2022 (Dow Jones) Print
By Chris Wack
Biohaven Ltd. shares were up 17% to $13.98 Friday after the biopharmaceutical company said it priced a public offering of 25 million common shares at $10.50 each.
The stock hit a 52-week high of $15.33 earlier in the session.
The company has granted the underwriters a 30-day option to buy up to an additional 3.75 million shares.
The offering is expected to close on Tuesday, subject to the satisfaction of customary closing conditions.
Biohaven said it intends to use the proceeds received from the offering for general corporate purposes.
Back in here $13.24 options look good also
OK > Looking to take a position again. Maybe on a FDA phase II or III approval. Possibly next year.
As I said in the post to which you replied, "This morning, we received a cost basis of $6.49 for each new share" of Biohaven Ltd..
You may want to call the Transfer Agent. Let us know. Thank you!
"What was the assigned cost or basis of the new Biohaven Ltd shares?"
This morning, we received a cost basis of $6.49 for each new share. We sold none.
I sold yesterday. Made nice profits! Keeping on my radar for any new developments.
"Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd. (NYSE: BHVN), distributing Biohaven Ltd.’s shares to Biohaven’s shareholders....."
What was the assigned cost or basis of the new Biohaven Ltd shares?
The spin-off closing/completion was the subject of a 1:00 pm PR on Monday. Does anyone here have a cost basis on their new BHVN shares? We don't.
We bought additional shares of the new BHVN in a different account on Monday afternoon. We previously had no BHVN in that account. The cost of those shares was $8.115 per share.
Nice volume! Tutes, mutual funds, University endowment funds, and pension funds are all buying their initial shares today, and going forward.
Thanks loaded some $12s for next run
BHVN is a great $$$$$ opportunity.
$15.00+ by closing bell Friday !
Multitude of positive catalysts: " Broad therapeutic research and development portfolio includes more than 13 clinical and pre-clinical programs with a focus on neuroscience and rare disorders including epilepsy, pain and mood disorders, obsessive compulsive disorder (OCD), spinocerebellar ataxia (SCA) and spinal muscular atrophy (SMA).
Excitement mounting for clinical stage neuroscience program in Kv7 Ion Channel Modulation which targets key subunits involved in neuronal signaling and plays a critical role in regulating the hyperexcitable state in epilepsy and potentially other central nervous system (CNS) disorders.
Biohaven retains Board and key management team with established legacy of bringing the market-leading medicine Nurtec® ODT (rimegepant) to patients; Names Bruce Car, Ph.D. as Chief Scientific Officer; Irfan Qureshi, M.D. as Chief Medical Officer; and Tanya Fischer, M.D., Ph.D. as Chief Development Officer and Head of Translational Medicine.
NEW HAVEN, Conn., Oct. 4, 2022 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) launched today as a new publicly traded company focused on delivering innovative life-changing treatments for neurological and neuropsychiatric diseases, including rare disorders, leveraging its proven drug development capabilities and proprietary technology platforms to advance a pipeline of best-in-class therapies. As of today, Biohaven has officially begun operating as a separate independent entity as part of the acquisition agreement with Pfizer in May 2022. The company, led by Vlad Coric, M.D. as Chairman and Chief Executive Officer, launched with approximately $257.8 million in cash at the distribution and no debt."
So what is the valuation model now after forward split. Potential price target
Pfizer acquired all of the outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash, for a total transaction consideration of approximately $11.6 billion. As a result of the acquisition, Biohaven became a wholly-owned subsidiary of Pfizer.
Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd. (NYSE: BHVN), distributing Biohaven Ltd.’s shares to Biohaven’s shareholders. Biohaven Ltd., a new company that retained Biohaven’s non-CGRP development stage pipeline compounds, holds the Kv7 ion channel activators, glutamate modulation, and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure assets excluded from the Pfizer acquisition. Pfizer, a Biohaven shareholder, received a pro rata portion of Biohaven Ltd.’s shares in the distribution and owns approximately 3% of Biohaven Ltd. Biohaven Ltd. will continue to trade on the New York Stock Exchange under the ticker "BHVN".
WOW nice day was this a FWD split $150 to $7?
or was that the cliff dive from the news?
BHVN up 39% @ 11.54 > Shares of Biohaven Ltd. rose by building on their debut surge from the previous day after the company was formally acquired by Pfizer Inc. and spun off.
The clinical-stage biopharmaceutical company and its Nurtec ODT migraine drug were acquired by Pfizer for $11.6 billion in cash and, immediately upon the closing of the acquisition, Biohaven was spun off into a separate entity. Pfizer owns about 3% of the new company.
As part of the acquisition, shareholders of the previous Biohaven received $148.50 a share in cash as well as shares of the new company, which retains the Biohaven moniker and its pipeline of non-calcitonin gene-related peptide programs.
The New Haven, Conn.-based company is launching anew with nearly $258 million in cash and no debt.
Write to Dean Seal at email@example.com
(END) Dow Jones Newswires
From Dew Diligence, 9/28/2021:
FDA approves ABBV’s Qulipta—(atogepant)—for migraine prevention:
Qulipta will compete with BHVN’s Nurtec ODT, which is approved for both prevention and acute treatment (#msg-164076435, #msg-154072129).
ABBV now has three approved agents in its migraine portfolio: Qulipta; Ubrelvy (approved for acute treatment in 2019 [#msg-154072129]); and Botox. All three came to ABBV by way of Allergan.
Nurtec available in pharmacies in early March in packs of eight.
FDA approved Nurtec ODT (rimegepant) for acute treatment of migraines in adults.
The tablet's approval marks the first FDA-approved product for Biohaven.
I bought in at the drop.
I'm rooting for good Phase 3 news this quarter on their migraine drug.
I bought at $42.50. I made a lot of money since IPO and believe this company has a lot of potential.
Moving up slowly.
20M trading float! >
Low volume, hope this take off.
$50.00+ > looking really good today!!!!!
Press Release: Biohaven And Royalty Pharma Announce Royalty Funding And Stock Purchase Agreements Totaling $150 Million
8:06 pm ET June 18, 2018 (Dow Jones) Print
Biohaven And Royalty Pharma Announce Royalty Funding And Stock Purchase Agreements Totaling $150 Million
- Royalty Pharma acquires approximately 2% royalty rights on global annual net sales of rimegepant and BHV-3500 from Biohaven for $100 million
- Royalty participation rate subject to reduction to 1.50% on global annual net sales exceeding $1.5 billion
- Royalty Pharma agrees to acquire 1,111,111 Biohaven common shares for $50 million, at a price of $45.00 per share, representing an approximately 19% premium over the 15-day volume-weighted average price
i don't know but it looks like they are rebuilding the company. they have positions in several early stage companies so who knows. i feel at these levels the company is undervalued
I wonder when ptgef will be selling their shares of bhvn they still have. I u understand they are seeding another. Bio for $2M committment.I would assume they are waiting for phase 3 results.