Gilead holds 25.54% of Galapagos shares

On January 11, 2021 Galapagos NV (Euronext & NASDAQ: GLPG) reported that received a transparency notification from Gilead Sciences, Inc (Press release, Galapagos, JAN 11, 2021, View Source [SID1234577427]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pursuant to Belgian transparency legislation1, Galapagos received a transparency notification on 6 January 2021 from Gilead Sciences, Inc., who notified a change in the chain of intermediary companies through which Gilead holds its shares in Galapagos. The change in the chain of intermediary companies is the result of an internal reorganization as a result of which Gilead holds its shares in Galapagos as of 31 December 2020 through its direct subsidiary Gilead Biopharmaceutics US, LLC, which through Gilead Sciences Ireland UC controls Gilead Therapeutics A1 Unlimited Company, which in turn holds 16,707,477 of Galapagos’ voting rights, consisting of 16,707,477 shares (unchanged). Those 16,707,477 shares represent 25.54% of Galapagos’ currently outstanding 65,411,767 shares.

Novo Nordisk A/S – Share repurchase programme

On January 11, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, JAN 11, 2021, View Source [SID1234577310]). This programme is part of the overall share repurchase programme of up to DKK 17 billion to be executed during a 12-month period beginning 5 February 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the programme initiated 3 November 2020, Novo Nordisk will repurchase B shares for an amount up to DKK 2.7 billion in the period from 4 November 2020 to 1 February 2021.

With the transactions stated above, Novo Nordisk owns a total of 38,138,659 B shares of DKK 0.20 as treasury shares, corresponding to 1.6% of the share capital. The total amount of A and B shares in the company is 2,350,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 17 billion during a 12- month period beginning 5 February 2020. As of 8 January 2021, Novo Nordisk has since 5 February 2020 repurchased a total of 38,200,522 B shares at an average share price of DKK 424.89 per B share equal to a transaction value of DKK 16,231,072,987.

iCo Therapeutics Inc. Proposes to Re-Price Warrants

On January 11, 2021 iCo Therapeutics Inc. (TSXV: ICO) (OTCQB: ICOTF) ("iCo" or the "Company"), reported that they are submitting an application to the TSX Venture Exchange to amend the exercise price of 66,200,000 previously granted common share purchase warrants (the "Warrants") issued pursuant to a private placement of 25,000,000 units that was completed over several tranches from January 31, 2019 to March 4, 2019 (the "Spring 2019 Private Placement") and pursuant to a private placement of 41,200,000 units that closed on August 16, 2019 (the "Summer 2019 Private Placement") (Press release, iCo Therapeutics, JAN 11, 2021, View Source [SID1234576167]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Subject to the TSX Venture Exchange approval, the Company is amending the exercise price of the Warrants from $0.075 to $0.065 per Warrant. The Warrants issued under the Spring 2019 Private Placement are exercisable until dates ranging from January 31, 2022 to March 4, 2022. The Warrants issued under the Summer 2019 Private Placement are exercisable until August 16, 2022. To date, 3,190,000 of the Warrants have been exercised.

"iCo has been pursuing a number of strategic initiatives throughout 2020. It is our hope that one or more of these will come to fruition in early 2021. By reducing the strike price of the warrants we believe more warrants might be exercised and thereby allow the Company to capitalize on these opportunities," noted William Jarosz, the Chief Executive Officer of iCo.

PTC Therapeutics Provides Update on R&D Pipeline and Commercial Progress at 39th Annual J.P. Morgan Healthcare Conference

On January 11, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that it will present an update on its R&D pipeline and commercial progress at the 39th Annual J.P. Morgan Healthcare Conference, Monday, Jan. 11 at 7:30 a.m. EST. Stuart W. Peltz, Ph.D., Chief Executive Officer of PTC Therapeutics, will provide an update on 2020 accomplishments and highlight upcoming potential value-creating milestones (Press release, PTC Therapeutics, JAN 11, 2021, View Source [SID1234576139]). Preliminary 2020 unaudited financial results and 2021 financial guidance will also be provided. The presentation will be webcast live on the Events and Presentations page of the Investors section of PTC Therapeutics website at www.ptcbio.com.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Key 2020 Corporate Highlights:

The Duchenne muscular dystrophy (DMD) franchise, consisting of Translarna (ataluren) and Emflaza (deflazacort), continue to demonstrate year-over-year growth, with 2020 preliminary unaudited revenue of approximately $331 million.
Translarna growth is primarily driven by geographical expansion and label modifications allowing broader access.
Emflaza experienced strong 38% year-over-year revenue growth in 2020 due to increased patient prescriptions and high compliance.
In August, Evrysdi (risdiplam) was approved by the FDA for patients with Spinal Muscular Atrophy (SMA). A strong global launch is underway with increasing U.S. patient uptake across all disease subtypes in both treatment naïve and switch patients. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) opinion for Evrysdi is expected in 1H 2021, and priority review of the Japanese New Drug Application (NDA) is ongoing. Evrysdi is the first at-home, orally administered SMA treatment and was developed from PTC’s proprietary splicing platform. Evrysdi is a product of the SMA collaboration between PTC, the SMA Foundation and Roche.
PTC initiated three clinical trials from its novel Bio-e platform, including two registration-directed trials with vatiquinone (PTC743) in Mitochondrial epilepsy (MIT-E) and Friedreich ataxia (MOVE-FA) that are actively enrolling.
2021 Potential Value-Creating Milestones:

Top-line results from the Translarna dystrophin study are expected in 1Q 2021. With positive results, PTC plans to submit an NDA to the FDA.
PTC is preparing to launch its first potential gene therapy, PTC-AADC, for the highly morbid genetic pediatric disorder aromatic L-amino acid decarboxylase deficiency (AADC-d). Launch efforts include expanding genetic testing programs and the identification and preparation of expert pediatric neurosurgical centers.
PTC-AADC expected regulatory milestones include a CHMP opinion for a potential approval and the submission of a Biologics License Application (BLA) to the FDA in 1H 2021.
Results from PTC’s Huntington disease program Phase 1 study of PTC518 in healthy volunteers are expected in 1H 2021. PTC518 was discovered from PTC’s validated splicing platform.
A registration-directed clinical trial of PTC299 for COVID-19 (FITE19) continues to enroll patients. PTC anticipates completing the study in 1H 2021.
A registration-directed study, APHENITY, for PTC923 in patients with phenylketonuria (PKU) is expected to initiate in mid-2021.
Results by year end are expected from ongoing clinical trials evaluating PTC596 in Leiomyosarcoma and Diffuse Intrinsic Pontine Glioma (DIPG).
Gene therapy manufacturing for clinical trials will begin at PTC’s state-of-the-art biologics production facility in Hopewell, N.J.
Preliminary Unaudited 2020 Financial Results:

Total unaudited net product revenue for full year 2020 was approximately $333 million.
DMD franchise revenue for year end 2020 included net product revenue for Translarna of approximately $192 million with $69 million in revenue in the fourth quarter and approximately $139 million year end 2020 revenue for Emflaza with $37 million in revenue in fourth quarter.
PTC expects to report $42.5 million in 2020 revenue associated with Evrysdi milestones. PTC will report fourth quarter royalty revenue for Evrysdi on the company’s next earnings call.
PTC expects to report 2020 year-end cash and cash equivalents of approximately $1.1 billion.
PTC is currently in the process of finalizing its financial results for the 2020 fiscal year. The above information is based on preliminary unaudited information and management estimates for the full year 2020, subject to the completion of PTC’s financial closing procedures.

2021 Financial Guidance:

PTC anticipates full year net product revenues for the DMD franchise to be between $355 and $375 million.
PTC anticipates GAAP R&D and SG&A expense for the full year 2021 to be between $825 and $855 million.
PTC anticipates Non-GAAP R&D and SG&A expense for the full year 2021 to be between $725 and $755 million, excluding estimated non-cash, stock-based compensation expense of approximately $100 million.

Personal Genome Diagnostics and Almac Diagnostic Services Enter Strategic Collaboration to Enhance Patient Care in Oncology

On January 11, 2021 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported a strategic collaboration with Almac Diagnostic Services to enhance opportunities for clinical trial development and companion diagnostic (CDx) projects (Press release, Almac, JAN 11, 2021, View Source [SID1234575423]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PGDx and Almac Diagnostic Services will focus on providing access to tumor profiling assays for both tissue and plasma samples, specifically, PGDx elio tissue complete and PGDx elio plasma resolve. This collaboration will combine Almac’s world-class genomics services and expertise in development and delivery of molecular diagnostics with PGDx’s leadership in cancer genomics to accelerate solutions that will deliver precision medicine to more patients.

"We are proud to enter into this strategic collaboration with Almac. Their longstanding reputation for providing high quality lab services to patients worldwide, along with their proven track record of implementing new technologies make this partnership ideal," said Megan Bailey, CEO, PGDx. "As we continue our quest to empower the fight against cancer, collaborating with Almac will allow us to deliver precision medicine solutions to a broader population and advance innovations in next-generation sequencing technology."

Michael Sloan, Global Vice President of Commercial Operations, Almac Diagnostic Services said: "This collaboration with PGDx will enable Almac to provide our Pharmaceutical and Biotech partners with tissue and liquid biopsy options to support their translational research, clinical trials and CDx development requirements. The assay panels PGDx have developed will allow our clients to access world-class next generation sequencing science and bioinformatics solutions."