reports
Pfenex Reports Second Quarter 2020 Results and Provides Business Updat...
Pfenex Reports Second Quarter 2020 Results and Provides Business Update Commercialization and launch of first royalty bearing products position company for next phase of growthMultiple U.S. health plans add Teriparatide Injection to their formulary upon its June 2020 launch as Pfenex and Alvogen continue to pursue therapeutic equivalence designation; Received EU CHMP positive opinionPfenex enters into new research collaboration and license agreement with Merck & Co. Inc., with the potential to earn up to $293M in upfront, development, and sales milestonesReceipt of India Marketing Authoriza...
Pfenex to Announce Second Quarter Financial Results on August 6
Pfenex to Announce Second Quarter Financial Results on August 6 SAN DIEGO, July 20, 2020 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) announced today that it will report its financial results for the second quarter ended June 30, 2020, after the market close on Thursday, August 6, 2020. Pfenex will host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 PM Pacific Time (4:30 PM Eastern Time). Conference Call & Webcast Thursday, August 6th @ 1:30 PM Pacific Time (4:30 PM Eastern Time) Domestic: 877-705-6003 (Domestic...
Pfenex Announces Positive European CHMP Opinion for PF708 (EU Brand Na...
Pfenex Announces Positive European CHMP Opinion for PF708 (EU Brand Name: Livogiva™) and New Partnership in Latin America, and Provides CRM197 Business Update Positive Opinion from Committee for Medicinal Products for Human Use (CHMP) for Livogiva marks important first step toward marketing authorizationPfenex’s commercial partner Adalvo entered into commercialization agreement in Latin America for PF708 with a large, multinational pharmaceutical firmSerum Institute of India is awarded first UNICEF supply agreement for Pneumosil®Merck announces safety and immunogenicity objectives were met ...
Pfenex Announces U.S. Commercial Launch of Teriparatide Injection
Pfenex Announces U.S. Commercial Launch of Teriparatide Injection Pfenex’s commercialization partner Alvogen will lead launch and commercialization efforts in the United StatesThe first FDA-approved teriparatide with Forteo® 1-3 as the reference drug SAN DIEGO, June 12, 2020 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) today announced that its commercialization partner, Alvogen, has launched Teriparatide Injection in the United States. Teriparatide Injection (also referred to as PF708 and Bonsity™) is a prescription medicine approved for several uses, including in postmenopausa...
Pfenex to Participate in the William Blair Growth Stock Conference
Pfenex to Participate in the William Blair Growth Stock Conference SAN DIEGO, June 05, 2020 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) announced today that Eef Schimmelpennink, President and Chief Executive Officer, will participate in a fire side chat at the William Blair Growth Stock Conference on June 9, 2020. The discussion will be virtual and accessible at . Presentation Details:Date: Tuesday, June 9, 2020Time:9:20 am – 9:50 am Central Time (7:20 am – 7:50 am Pacific Time)Link: Interested parties can access the live audio webcast and archive from the Investors Section of...
Pfenex Reports First Quarter 2020 Results and Provides Business Update
Pfenex Reports First Quarter 2020 Results and Provides Business Update SAN DIEGO, May 07, 2020 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) is a development and licensing biotechnology company focused on leveraging its proprietary protein production platform, Pfenex Expression Technology®, to develop next generation and novel protein therapeutics to meaningfully improve existing therapies and create novel therapies for some of the biological targets linked to critical diseases still waiting to successfully be addressed. Pfenex has developed a pipeline that is diversified across m...
Pfenex to Announce First Quarter 2020 Financial Results on May 7
Pfenex to Announce First Quarter 2020 Financial Results on May 7 SAN DIEGO, April 24, 2020 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) announced today that it will report its financial results for the first quarter ended March 31, 2020, after the market close on Thursday, May 7, 2020. Pfenex will host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 PM Pacific Time (4:30 PM Eastern Time). Conference Call & Webcast Thursday, May 7th @ 1:30 PM Pacific Time (4:30 PM Eastern Time)Domestic: 888-220-8451International: 856-344...
Pfenex Announces FDA Requests Additional Comparative Use Human Factors...
Pfenex Announces FDA Requests Additional Comparative Use Human Factors Data in Experienced Users in order to Complete PF708 Therapeutic Equivalence Determination FDA review for a Therapeutic Equivalency rating for PF708 continues SAN DIEGO, April 14, 2020 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) announced today that the U.S. Food and Drug Administration (FDA), informed Alvogen Malta Operations Ltd., the Company’s commercialization partner for PF708, via a General Advice letter that additional comparative use human factors (CUHF) data, specifically from Forteo® (teriparatide...
Pfenex Reports Fourth Quarter and Full Year 2019 Results and Provides ...
Pfenex Reports Fourth Quarter and Full Year 2019 Results and Provides Business Update Alvogen is preparing for commercial launch of PF708 upon receiving FDA decision on therapeutic equivalence to Forteo® Jazz initiated a pivotal Phase 2/3 Study for FDA fast track designated PF743 (JZP-458) for the treatment of ALL/LBL Earned $31.1 million in development and regulatory milestone payments in FY 2019 SAN DIEGO, March 11, 2020 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) is a development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology® to...
Pfenex to Announce Fourth Quarter and Year-End 2019 Financial Results ...
Pfenex to Announce Fourth Quarter and Year-End 2019 Financial Results on March 11 SAN DIEGO, Feb. 26, 2020 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) announced today that it will report its financial results for the fourth quarter and year ended December 31, 2019, after the market close on Wednesday, March 11, 2020. Pfenex will host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 PM Pacific Time (4:30 PM Eastern Time). Conference Call & WebcastWednesday, March 11th @ 1:30 PM Pacific Time (4:30 PM Eastern Time)Domesti...
Serum Institute of India Private Limited has achieved World Health Org...
Serum Institute of India Private Limited has achieved World Health Organization (WHO) prequalification for PNEUMOSIL®, containing CRM197 produced in Pfenex Expression Technology SAN DIEGO, Jan. 08, 2020 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) today announced that Serum Institute of India Private Limited (Serum Institute) achieved World Health Organization (WHO) prequalification for Pneumosil, a 10-valent pneumococcal conjugate vaccine. Pneumosil contains the recombinant carrier protein CRM197 produced by Serum Institute under a license to the Pfenex Expression Technology®. ...
Pfenex Earns $15 Million Development Milestone Under its Development a...
Pfenex Earns $15 Million Development Milestone Under its Development and License Agreement With Jazz Pharmaceuticals SAN DIEGO, Dec. 18, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) today announced that it has earned a $15 million development milestone under its development and license agreement with Jazz Pharmaceuticals plc. The milestone is associated with process development activities for PF745, a long-acting Erwinia asparaginase. “We are very pleased with the rapid progression of the PF745 program and we believe the Jazz collaboration, overall, further validates the ve...
Pfenex to Present at the Piper Jaffray 31st Annual Healthcare Conferen...
Pfenex to Present at the Piper Jaffray 31st Annual Healthcare Conference SAN DIEGO, Nov. 20, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) is a development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology® to develop and improve protein therapies for unmet patient needs. Using the patented Pfēnex Expression Technology platform, the Company has developed the FDA-approved PF708 product indicated for the treatment of osteoporosis in certain patients at high risk of fracture and created an advanced pipeline of therapeutic equivalents, bio...
Pfenex to Present at the Evercore ISI HealthCONx Conference 2019
Pfenex to Present at the Evercore ISI HealthCONx Conference 2019 SAN DIEGO, Nov. 19, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) is a development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology® to develop and improve protein therapies for unmet patient needs. Using the patented Pfēnex Expression Technology platform, the Company has developed the FDA-approved PF708 product indicated for the treatment of osteoporosis in certain patients at high risk of fracture and created an advanced pipeline of therapeutic equivalents, biologics a...
Pfenex Announces Management Change
Pfenex Announces Management Change SAN DIEGO, Nov. 13, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX), today announced that Susan Knudson has resigned for personal reasons from her role as Senior Vice President, Chief Financial Officer effective November 13, 2019, but will continue to support the company by providing transition services until February 1, 2020. The company is conducting a search for a successor. “We appreciate Susan’s contributions to Pfenex and her work with the finance team during the past years in which we transformed Pfenex, ultimately leading to our FDA a...
Pfenex Reports Third Quarter 2019 Results and Provides Business Update
Pfenex Reports Third Quarter 2019 Results and Provides Business Update Received U.S. FDA approval for PF708 to treat osteoporosis and submitted comparative use human factors (HF) study report to FDA; Commercial launch by Alvogen expected upon FDA decision on the therapeutic equivalence rating relative to Forteo® Announced partnership with Arcellx to develop SparX proteins used in cell therapies Jazz advances PF743 (JZP-458) to pivotal Phase 2/3 Study expected to be initiated later this year; Jazz also announced FDA fast track designation for JZP-458, for the treatment of ALL/LBL Earned $...
Pfenex to Present at the Jefferies 2019 London Healthcare Conference
Pfenex to Present at the Jefferies 2019 London Healthcare Conference SAN DIEGO, Nov. 06, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) today announced that Eef Schimmelpennink, President and Chief Executive Officer, will be presenting at the Jefferies 2019 London Healthcare Conference on Wednesday, November 20th, taking place at the Waldorf Hilton in London. Conference:Jefferies 2019 London Healthcare ConferenceDate:Wednesday, November 20, 2019Time: 4:00 p.m. GMT (8:00 a.m. PST)Webcast:Interested parties can access the live audio webcast and archive from the Investors Section...
Pfenex to Announce Third Quarter 2019 Financial Results on November 7t...
Pfenex to Announce Third Quarter 2019 Financial Results on November 7th SAN DIEGO, Oct. 24, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX), a development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology® to develop and improve protein therapies for unmet patient needs, announced today that it will report its financial results for the third quarter 2019, after the market close on Thursday, November 7, 2019. The Company will host a conference call to discuss financial results and general business updates at 4:30 PM Eastern Time on Thurs...
Pfenex Reports Positive Results for PF708 Comparative Use Human Factor...
Pfenex Reports Positive Results for PF708 Comparative Use Human Factors Study Study results found that the FDA-approved PF708 product is noninferior to Forteo® based on a pre-specified statistical analysis of critical patient and caregiver tasks Pfenex believes the study report completes the information package required by the FDA to evaluate the FDA-approved PF708 product for therapeutic equivalence SAN DIEGO, Oct. 14, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) announced today it has successfully completed the PF708 comparative use human factors (HF) study and submitted...
Pfenex Provides Update for PF708 Outside the United States
Pfenex Provides Update for PF708 Outside the United States New Exclusive Commercialization Agreements in South Korea, Canada, and Israel Submission of Marketing Authorization Application for PF708 in Saudi Arabia Potential approval of PF708 in the EU as early as the second half of 2020 SAN DIEGO, Oct. 11, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) today announced that its partner Alvogen has entered into exclusive commercialization agreements for PF708 with PharmBio Korea in South Korea, JAMP Pharma in Canada and Kamada Ltd. in Israel. Furthermore, Alvogen’s partner in...
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