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Halozyme Therapeutics (HALO)

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Last Post: 5/23/2022 9:03:20 AM - Followers: 100 - Board type: Free - Posts Today: 0


Halozyme is a biopharmaceutical company developing and commercializing products based on the extracellular matrix for the drug delivery, oncology, and dermatology markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases.

The company's Enhanze Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its first partnership is with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets. In addition, the company has received FDA approval for two products: Cumulase® and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter Healthcare Corporation. The Company also has a number of different enzymes in its portfolio that are targeting significant areas of unmet need.

Halozyme is a therapeutically driven biopharmaceutical company developing and commercializing recombinant human enzymes to provide enhanced and innovative alternatives that improve the practice of medicine. Halozyme is focused on providing life-saving and life-enhancing solutions to the drug delivery, oncology, and dermatology markets.


Halozyme is a therapeutically driven biopharmaceutical company developing and commercializing recombinant human enzymes to provide enhanced and innovative alternatives that improve the practice of medicine. Halozyme is focused on providing life-saving and life-enhancing solutions to the drug delivery, oncology, and dermatology markets.

The foundation of our capabilities is our recombinant human hyaluronidase enzyme, rHuPH20, which temporarily degrades hyaluronan, a structural protein in the interstitial space. This temporary alteration provides an opportunistic window that allows the delivery of injectable biologics such as monoclonal antibodies, as well as small molecules and fluids. With our enzyme, many pharmaceuticals that would normally be injected intravenously (IV) can be administered subcutaneously (SC). This change in route of delivery may improve patient convenience, enhance pharmacokinetics, boost efficacy, extend the product lifecycle, and reduce cost, in addition to other attributes.

Four key internal programs comprise our current proprietary product development portfolio. The endocrinology franchise consists of Insulin-PH20, which applies our PH20 enzyme to currently approved and marketed insulin products. The oncology franchise consists of PEGPH20, a new molecular entity administered intravenously that targets the external environment of tumor cells, and Chemophase, which utilizes the PH20 enzyme for local administration in bladder cancer. Our lead enzyme in the dermatology franchise, HTI-501, is a new molecular entity which digests collagen and may have applications in both medical and aesthetic dermatology such as cellulite.

Our product development pipeline also includes three distinct partnered programs with two companies; Roche and Baxter BioScience for Enhanze technology, and a partnership with Baxter Medication Delivery for Hylenex, our FDA-approved drug. These partnered programs validate our technology and may generate clinical and commercial milestone revenue based on the achievement of pre-specified events along with sales royalties when products reach the commercial stage. We utilize the cash milestone payments generated from the partnered programs as a source of development funding for our proprietary pipeline projects.


Our endocrinology development activity focuses on insulin, a mainstay of treatment for people with diabetes. This program combines our PH20 hyaluronidase enzyme with insulin, a frequently prescribed, commercially successful pharmaceutical already approved and on the market.

Insulin – Developing a best-in-class profile

We believe that the combination of our PH20 enzyme with existing, meal time insulin products such as regular insulin or a fast acting analog could lead to a best-in-class product that more closely mimics the release of natural insulin in the body. The results of a Phase 1 study, where we combined PH20 with Humulin® R (regular human insulin) and with Humalog® (insulin lispro), demonstrated significantly faster and higher insulin plasma concentrations compared to either insulin alone. Faster acting insulin could provide patient benefits such as reduced hypoglycemia, lower intra-subject variability, and less weight gain. These potential benefits would be significant but must first be demonstrated and proven in clinical development.

Our first Phase 2 clinical trial with insulin began in October 2008 and enrolled Type 1 diabetic patients. Data presented from our Phase 1 trial showed that the administration of regular insulin and an insulin analog with our PH20 enzyme led to faster insulin absorption and more rapid effects than either insulin alone. Our Phase 2 trial is designed to demonstrate similar results in Type 1 diabetic patients. We hope to present preliminary Phase 2 results at the American Diabetes Association meeting in June. Additional clinical trials are planned in 2009.


Hyaluronan (HA) is a component of the extracellular matrix that frequently accumulates in human cancers. The quantity of HA produced by the tumor cells directly correlates with increased tumor growth and metastasis and it has been linked with tumor progression and poor prognosis. Previous clinical trials of bovine hyaluronidase showed promise in enhancing chemotherapy regimens using adjunctive systemic hyaluronidase in chemo-refractory patients. In animal studies the removal of HA from tumors with hyaluronidase has demonstrated improved survival, suppression of tumor growth, and enhanced efficacy of certain anti-cancer drugs. Chemotherapeutic agents may be able to better penetrate the tumor once the HA has been removed.

We have also observed significant reduction of tumor interstitial fluid pressure (IFP) following the administration of rHuPH20 in solid tumors grown in mice. Tumor interstitial pressure is widely believed to be an important factor limiting the access of cytostatic regimens to solid tumors. By digesting the HA gel, rHuPH20 may reduce IFP in the tumor and promote more effective delivery of chemotherapy throughout the tumor. This could potentially lead to better patient outcomes and increased survival.

Our PEGPH20 program utilizes pegylated hyaluronidase that allows for intravenous administration to degrade the HA that surrounds tumor cells. The Chemophase program applies the hyaluronidase enzyme along with mitomycin C directly into the bladder where the enzyme can hydrolyze the HA produced by the cancerous bladder cells. Unlike tumor cells, normal cells do not produce HA in this manner and appear not to be adversely affected by the enzyme.

PEGPH20 for Solid Tumors

We are investigating pegylated-rHuPH20, or PEGPH20, a new molecular entity, as a candidate for the systemic treatment of tumors rich in hyaluronan, or HA. Pegylation refers to the attachment of polyethylene glycol to our rHuPH20 enzyme, which extends its half life from less than 30 seconds to more than 24 hours. Numerous solid tumors, including prostate, breast, pancreas, colon and non-small cell lung, accumulate HA that forms a halo like coating over the surface of the tumor cell.

In preclinical studies, PEGPH20 has been shown to remove the HA coating surrounding several tumor cell lines. Treatment of PC3 (a prostate cancer cell line that produces HA) tumor bearing mice with PEGPH20 as a single agent demonstrated approximately 70% tumor growth inhibition relative to controls. Repeat dosing with PEGPH20 produced a sustained depletion of HA in the tumor microenvironment. For tumor models that do not produce HA, the presence of PEGPH20 has no effect. An estimated 20% to 40% of certain solid tumors may produce HA.

Administration of the combination of PEGPH20 with docetaxel or with liposomal doxorubicin in HA producing animal tumor models produced a significant survival advantage for the combination relative to either chemotherapeutic agent alone. Therefore, based on these animal studies and other tests conducted by Halozyme, PEGPH20 may represent a potentially innovative treatment approach against tumors that produce HA.

PEGPH20 recently started its first Phase 1 clinical trial which will evaluate the agent over a range of doses. The study will enroll up to 46 advanced cancer patients who will receive treatment cycles of intravenous PEGPH20 as a single agent twice weekly for three weeks followed by one week without dosing. Patients may continue subsequent cycles at their assigned dose as long as there is no tumor progression and no unacceptable toxicity. Groups of four to eight patients will be in each dosage cohort. The primary outcome measures of the study will be to evaluate safety and tolerability of PEGPH20 and to determine the recommended single agent Phase 2 dose. Secondary objectives will be to determine pharmacokinetics, obtain dose limiting toxicities, and observe patients for any evidence of anti-tumor activity.


Chemophase is a chemoadjuvant we have investigated for possible use in the treatment of patients with superficial bladder cancer, which represents a smaller potential market than our other proprietary pipeline opportunities. The Chemophase program combines our PH20 enzyme with mitomycin C, a cytotoxic drug, for direct administration into the bladder immediately after transurethral resection of bladder tumors (TURBT), a standard surgical treatment for the disease. Many bladder tumor cells produce high quantities of HA and thus treatment to remove the HA coating could increase their exposure to mitomycin C. This may lead to a lower recurrence of the cancer and a better prognosis for patients.

In June 2008, we announced the interim results of a Phase I/IIa clinical trial in which the Chemophase combination treatment of mitomycin C plus rHuPH20 enzyme was well tolerated and appears safe. The study reported no dose-limiting toxicities and no observed side effects attributable to the enzyme. An ongoing safety trial involves the immediate post operative (IPOP) administration of PH20 and mitomycin directly into the bladder of patients after a TURBT procedure. 


The foundation of our dermatology program is HTI-501, a human lysosomal proteinase that degrades collagen. It may be useful in the treatment of both medical and aesthetic dermatologic conditions such as cellulite, Dupuytren’s contracture and Peyronie’s disease. This pH sensitive enzyme demonstrates activity under mildly acidic conditions but shows no activity at normal physiologic pH. This attribute may be harnessed to exert control over the duration and location of the enzyme’s therapeutic activity.

Tests with HTI-501 in several animal models have produced encouraging results and our pre-clinical investigations of the enzyme will continue throughout 2009.


Enhanze™ Technology, a proprietary drug delivery platform using Halozyme’s first approved enzyme, rHuPH20, is our broader technology opportunity that can potentially lead to partnerships with other pharmaceutical companies. When co-formulated with other injectable drugs, Enhanze Technology may facilitate the penetration and dispersion of these drugs by temporarily opening flow channels under the skin.  

Molecules as large as 200 nanometers may pass freely through the extracellular matrix, which recovers its normal density within approximately 24 hours, leading to a drug delivery platform which does not permanently alter the architecture of the skin. The principal focus of our Enhanze Technology platform is the use of rHuPH20 to facilitate subcutaneous or intramuscular routes of administration for large molecule biological therapeutics. We are seeking partnerships with pharmaceutical companies that market drugs requiring or benefiting from injection via the subcutaneous or intramuscular routes that could benefit from this technology. In December 2006, we signed our first Enhanze Technology partnership with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche, Inc. In September 2007, we signed our second Enhanze Technology partnership with Baxter Healthcare Corporation and Baxter Healthcare S.A.


Full prescribing information is available below or at  www.hylenex.com

Hylenex is a human recombinant formulation of rHuPH20 to facilitate the absorption and dispersion of other injected drugs or fluids. When injected under the skin or in the muscle, hyaluronidase can digest the hyaluronic acid gel, allowing for temporarily enhanced penetration and dispersion of other injected drugs or fluids. We filed a New Drug Application (NDA) in March 2005 and we received approval of our Hylenex NDA in December 2005.

Enzymatically- Augmented Subcutaneous Infusion (EASI):

Hylenex may facilitate subcutaneous delivery of fluids up to one liter without the need for intravenous access, a procedure known as EASI. Importantly, EASI for fluid replacement in terminal patients may be achieved with limited or no need for nursing assistance. Over 1.1 million subcutaneous fluid infusions are performed per year with hospice patients alone (Source: Company estimates based on National Hospice and Palliative Care Organization data, 2001). In addition, over 500 million infusion bags are utilized annually in the United States, some of which could potentially convert to EASI using Hylenex, giving rise to additional market potential (Source: B. Braun, 2003).


During January 2006, we completed the INcreased Flow Utilizing Subcutaneously-Enabled Lactated Ringer’s clinical trial, or INFUSE-LR study, which was designed to determine the subcutaneous (Sub-Q) infusion flow rate of Lactated Ringer’s solution with and without Hylenex, determine the Sub-Q infusion flow rate dose response to Hylenex over one order of magnitude of dose, and assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, within-subject, dose-comparison study enrolled 54 volunteer subjects who received Sub-Q infusions simultaneously in both upper arms through 24 gauge catheters.

INFUSE-Morphine Study:

During October 2006, we completed the INcreased Flow Utilizing Subcutaneously-Enabled Morphine clinical trial, or INFUSE-Morphine study, which was designed to determine the time to maximal blood levels of morphine after subcutaneous administration with and without Hylenex, to determine the time to maximal blood levels after intravenous administration of morphine, and to assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, within-subject, dose-comparison study enrolled 12 evaluable patients who received Sub-Q infusions.

For full prescribing information, visit  www.hylenex.com or www.baxter.com.


Cumulase is an ex vivo (used outside of the body) formulation of rHuPH20 to replace the bovine enzyme currently used for the preparation of oocytes (eggs) prior to IVF during the process of intracytoplasmic sperm injection (ICSI), in which the enzyme is an essential component. The enzyme strips away the hyaluronic acid that surrounds the oocyte. This allows the clinician to then perform the ICSI procedure, injecting the sperm into the oocyte. The FDA considers hyaluronidase IVF products to be medical devices subject to 510(k) approval and we filed our 510(k) application during September 2004.

We received FDA clearance in April 2005. We launched Cumulase in the European Union and in the United States in June 2005. We believe the total ICSI market consisted of an estimated 500,000 intracytoplasmic sperm injection cycles worldwide in 2005 (Source: CDC, 2001; ESHRE, 2002).

Visit www.cumulase.com for more information.

Informative Links 

(Institutional Holdings)

(Big Block Holders from CNBC)

(SEC filings search from SEC.gov Edgar)

http://www.nasdaqtrader.com/Trader.aspx?id=shortinterest (Short Interest)

(Analyst Ratings)

(Insider Transactions)

(Clinical Trials)

Clinicals & Partners

Halozyme and Roche enter agreement for the application of Enhanze, a novel technology to improve drug delivery

(Halozyme and Roche presents “Developing and Managing Strategic Alliances” at the SCRIP conference
May 15-16, 2007  Berlin, Germany)

Baxter and Halozyme Announce Collaboration for Development of Subcutaneous GAMMAGARD LIQUID(TM) Administration Using Enhanze(TM) Technology

Baxter Presents Latest Clinical Trial Results of GAMMAGARD LIQUID Administered Subcutaneously (Enhanze 3-16-08) 

Halozyme and Baxter Expand Global HYLENEX Collaboration

http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=IROL-secToc&TOC=aHR0cDovL2NjYm4uMTBrd2l6YXJkLmNvbS94bWwvY29udGVudHMueG1sP2lwYWdlPTU0NDgxMjkmcmVwbz10ZW5r (Feb. 12, 2008 Slide Show Presentation)

Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex 
Halozyme Therapeutics Presents Favorable New Safety and Pharmacokinetic Data on rHuPH20 Enzyme Produced Via New Manufacturing Process at European Federation for Pharmaceutical Sciences

Halozyme Therapeutics Presents Findings on Combinations of rHuPH20 Enzyme With Bisphosphonates at the American Association for Cancer Research Conference

Halozyme Therapeutics Presents Pre-Clinical Studies on Dermal Remodeling With HTI-501, a Lysosomal Proteinase

Phase I/II data showed that Enhanze Technology™ enabled subcutaneous administration of a monthly dose of GAMMAGARD LIQUID in patients with Primary Immunodeficiency

http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1163612&highlight=Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability

Cheetah full ADA presentation

Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme in Prostate Cancer Models

Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial

Halozyme Therapeutics Begins Phase 2 Clinical Trial of Insulin With rHuPH20 in Type 1 Diabetic Patients

Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial and Selects Fourth Exclusive Biologic Target

Halozyme Therapeutics Begins Phase 1 Clinical Trial of Bisphosphonate Administered With rHuPH20 Enzyme
Halozyme Deprioritizes Bisphosphonate Program to Reallocate Resources to More Commercially Attractive Internal Programs

Phase III Trial Begins for GAMMAGARD LIQUID Plus rHuPH20 in Primary Immunodeficiency Patients

Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial With Second Biologic

Halozyme Therapeutics Presents Positive Pre-Clinical Single Agent Data for PEGPH20

AACR presentations show that PEGPH20 produces anti-cancer activity in models of breast, prostate, and brain metastases that produce hyaluronan

Phase 1 Study for Halozyme's Insulin-PH20 Published, Highlights Findings for Faster Acting Insulin Formulations
-- Insulin-PH20 Combinations Demonstrated Significantly Faster Glucose Metabolism --


 Accelerated Insulin Pharmacokinetics and Improved Glycemic Control in T1DM Patients by
Coadministration of Prandial Insulin with Recombinant Human Hyaluronidase


Halozyme Announces Roche Selects Fifth Exclusive Biologic Target

Baxter and Halozyme Announce Completion of Patient Enrollment in Phase III Pivotal Trial of GAMMAGARD LIQUID(TM) with rHuPH20 Enzyme 


 First patient dosed in trial with third Roche biologic formulated with Halozyme’s recombinant human hyaluronidase enzyme

Baxter Announces the Commercial Launch of HYLENEX at ACEP for Use in Pediatric Rehydration
Data from the First Pediatric Rehydration Study, INFUSE-PEDS 1, Published Today in Pediatrics


Halozyme Announces Roche Doses First Patient in Phase 3 Clinical Trial with Subcutaneous Herceptin(R)



Earnings Transcripts

Halozyme Therapeutics Q4 2007 Earnings Call Transcript

Halozyme Therapeutics Inc. Q1 2008 Earnings Call Transcript

Halozyme Therapeutics Inc. Q2 2008 Earnings Call Transcript

Halozyme Therapeutics, Inc. Q3 2008 Earnings Call Transcript

Halozyme Therapeutics, Inc. Q4 2008 Earnings Call Transcript

Halozyme Therapeutics, Inc. Q3 2009 Earnings Call Transcript

Links to understanding Clinical results

Shares Outstanding: 91,095,288
Float: 73.21M

(O-T How the market is manipulated and companies destroyed)

Halozyme Therapeutics Inc.
11588 Sorrento Valley Road
Suite 17
San Diego, CA 92121
United States
Phone: 858-794-8889

Halozyme Contact
Robert H. Uhl
Senior Director Investor Relations

(Disclaimer) Do your own DD and confirm anything said on this board.

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HALO News: Current Report Filing (8-k) 05/24/2022 12:18:21 PM
HALO News: Halozyme Completes Antares Pharma Acquisition 05/24/2022 04:30:00 AM
HALO News: J.P. Morgan Maintains Their Buy Rating on Halozyme (HALO) 05/13/2022 04:17:23 AM
HALO News: Hart-Scott-Rodino Waiting Period Expires for Halozyme's Acquisition of Antares Pharma 05/12/2022 04:00:00 AM
HALO News: Quarterly Report (10-q) 05/10/2022 12:19:37 PM
News News Alert: Current Report Filing (8-k) 05/24/2022 12:18:21 PM
#5421  Sticky Note Halo Royalty chart Fred Kadiddlehopper 01/10/18 11:09:12 AM
#7091   SVB Leerink initiated coverage of Halozyme Therapeutics with biotechinvestor1 05/23/22 09:03:20 AM
#7090   Higher highs and higher lows. All dips are biotechinvestor1 05/20/22 12:29:36 PM
#7089   Halo ist empty ….. deepdj011 05/17/22 04:12:46 PM
#7088   ATRS 10-Q quarterly report out. No press release. maumar 05/11/22 07:57:23 PM
#7087   We are very fortunate that XBI and overall biotechinvestor1 05/11/22 11:51:29 AM
#7086   JMP raised Halozyme price target from $55 to biotechinvestor1 05/11/22 09:27:44 AM
#7085   Yes, and some of the miss is probably maumar 05/10/22 09:00:29 PM
#7084   Yahoo is spurious. The difference may lie in Fred Kadiddlehopper 05/10/22 08:08:15 PM
#7083   According to yahoo finance, revenue and earnings estimates maumar 05/10/22 07:57:04 PM
#7082   You nailed the royalties. Fred Kadiddlehopper 05/10/22 04:42:16 PM
#7081   For comparison's sake here is a link to Fred Kadiddlehopper 05/10/22 02:22:32 PM
#7080   Good news for ARGX and HALO. According to maumar 05/10/22 01:40:35 PM
#7079   Halozyme went down less than not only the biotechinvestor1 05/05/22 04:33:11 PM
#7078   Buying more biotechinvestor1 05/05/22 12:15:32 PM
#7077   I’m not really sure about after 27. Up Howeeme 05/03/22 10:54:49 PM
#7076   They see potential for upside from the acquisition maumar 05/03/22 03:40:40 PM
#7075   It is time to realize: This stock is easycomeandgo 05/03/22 10:26:11 AM
#7074   Why can’t you wrap your head around the biotechinvestor1 05/03/22 08:36:00 AM
#7069   I’ve read every post for at least 15 Howeeme 05/03/22 07:45:07 AM
#7068   Please provide a link for the 2023! I biotechinvestor1 05/03/22 01:25:19 AM
#7067   You are not missing anything. Your analysis is biotechinvestor1 05/03/22 01:21:44 AM
#7066   Still not sure why you are so against Howeeme 05/02/22 09:28:59 PM
#7065   Still not sure why you are so against Howeeme 05/02/22 09:28:58 PM
#7064   2023? That's a long wait to get back Fred Kadiddlehopper 05/02/22 08:49:06 PM
#7063   JPMorgan analyst Jessica Fye raised the price target biotechinvestor1 05/02/22 07:36:16 PM
#7062   JPM raised their PT to a yearend 2023 maumar 05/02/22 06:23:27 PM
#7061   I'm leaving this post on the board so Fred Kadiddlehopper 04/27/22 03:53:37 PM
#7060   Halo is…. Bankruptcy ! deepdj011 04/27/22 01:46:03 PM
#7059   Broke through resistance at about $43 or so. Fred Kadiddlehopper 04/25/22 03:15:14 PM
#7058   Phesgo Q1 22 sales: CHF 146m. According to maumar 04/25/22 02:14:58 PM
#7057   New Enhanze clinical trial posted today for “phase biotechinvestor1 04/22/22 06:45:49 PM
#7056   I saw that nut job touting nut tanning. Fred Kadiddlehopper 04/21/22 07:25:23 AM
#7055   https://www.yahoo.com/news/stephen-colbert-spots-tucker-carlson-064905037.html Howeeme 04/20/22 10:20:34 PM
#7054   Market probably not huge but growing. Might get Howeeme 04/20/22 10:12:22 PM
#7053   Market probably not huge but growing. Might get Howeeme 04/20/22 10:12:21 PM
#7052   $1,856m Darzalex Q1 2022 sales. Impressive. maumar 04/20/22 12:08:54 PM
#7051   I have owned ATRS before. Pretty good story, easycomeandgo 04/19/22 01:25:28 PM
#7050   That's a hard question. I'll read the last Fred Kadiddlehopper 04/19/22 10:17:33 AM
#7049   That was.the price for the stock. The balance Howeeme 04/18/22 11:25:21 PM
#7048   Name change for halozyme? It is now much biotechinvestor1 04/18/22 10:48:45 AM
#7047   According to this article the price is 960 million. Fred Kadiddlehopper 04/18/22 09:49:45 AM
#7046   The price was 860 million. Commercial gross revenues Howeeme 04/14/22 11:29:05 PM
#7045   Certainly a brilliant acquisition. Market likes it and biotechinvestor1 04/14/22 10:48:10 AM
#7044   I agree that HALO will probably unload the Fred Kadiddlehopper 04/14/22 08:48:10 AM
#7043   It’s a clever move! biotechinvestor1 04/13/22 11:06:12 PM
#7042   Arts balance sheet has about 100 million of Howeeme 04/13/22 10:27:37 PM
#7041   Arts balance sheet has about 100 million of Howeeme 04/13/22 10:27:35 PM
#7040   "Overall, not too exciting but at least not maumar 04/13/22 06:59:28 PM
#7039   Agreed about the intent of the deal. I Fred Kadiddlehopper 04/13/22 02:32:36 PM
#7038   Interesting acquisition. $33M termination fee. Is that kind maumar 04/13/22 01:55:59 PM
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