PCI Biotech: Invitation to first quarter 2021 results presentation

On April 30, 2021 PCI Biotech’s (OSE: PCIB) reported that first quarter 2021 interim report will be released on 7 May 2021 at 07.00 CEST. The interim report and presentation will be made available on www.newsweb.no and on the company’s webpage, www.pcibiotech.com (Press release, PCI Biotech, APR 30, 2021, View Source [SID1234585160]).

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A results presentation (in English) will be held through a live webcast at 08.30 CEST the same day. The webcast can be accessed through www.pcibiotech.com. There will be a Q&A session at the end of the presentation. It will be possible to post written questions through the webcast console or through a teleconference facilitated for investors intending to ask questions verbally during the Q&A session.

PCI Biotech: First US patient enrolled in the fimaCHEM pivotal RELEASE study

On April 30, 2021 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported that the first US patient has been enrolled into the fimaChem pivotal RELEASE study with registration intent in inoperable bile duct cancer patients (Press release, PCI Biotech, APR 30, 2021, View Source [SID1234585158]). The RELEASE study spans across Europe, USA and Asia, with patient enrolment initiated in all continents.

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Per Walday, CEO, said: "It is reassuring to see screening activity and enrolment picking up across the geographies of the RELEASE study, despite Covid-19 still having an impact on the healthcare systems. We are focused on optimal execution of the RELEASE study, to bring a new treatment option to a patient group with a high unmet medical need."

Eagle Pharmaceuticals Announces TREAKISYM (bendamustine) Ready-to-Dilute (“RTD”) Formulation, in Combination with Rituximab for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma Receives PMDA Approval in Japan

On April 30, 2021 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that TREAKISYM ready-to-dilute ("RTD") (bendamustine hydrochloride 120 mg/m2) liquid formulation has been approved for a new indication in combination with rituximab ("BR therapy") as treatment for relapsed or refractory diffuse large B-cell lymphoma ("r/r DLBCL") by the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan (Press release, Eagle Pharmaceuticals, APR 30, 2021, View Source [SID1234584739]).

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"This latest approval is another meaningful extension of our bendamustine franchise. We believe this expanded label will significantly increase the market opportunity for TREAKISYM in Japan. Based on this additional indication, as well as the anticipated approval of the ten-minute RI liquid formulation, we are reiterating our belief that the combined royalty and milestones revenue from these products will generate $25 million at peak," stated Scott Tarriff, Chief Executive Officer.

In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of bendamustine under the trade name TREAKISYM in Japan utilizing Eagle’s proprietary technology. As part of the agreement, SymBio assumed responsibility for securing regulatory approval of the TREAKISYM RTD and RI products using the licensed technology in Japan.

SymBio received approval for the TREAKISYM RTD (250 ml) liquid formulation in September 2020 and is currently conducting a clinical safety trial for the ten-minute RI (50 ml) liquid formulation, for which it plans to seek approval in the second half of 2022.

Key benefits to patients and healthcare providers of these products include eliminating the need for manual reconstitution and significantly reducing preparation time as compared to the lyophilized formulation.

Alkermes Announces Agreement with Sarissa Capital

On April 30, 2021 Alkermes plc (Nasdaq: ALKS) reported that it has reached an agreement with Sarissa Capital Management LP ("Sarissa Capital"), a beneficial owner of approximately 5% of the company’s outstanding ordinary shares, pursuant to which Sarissa Capital has the right to designate a director to the company’s Board of Directors (the "Board")(Press release, Alkermes, APR 30, 2021, View Source [SID1234584050]).

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This agreement follows constructive dialogue between the parties related to the company’s strategic priorities and ongoing Board refreshment efforts. Alkermes initiated a robust board refreshment program two years ago and has since added four new independent directors to the Board. This agreement with Sarissa Capital is a continuation of those efforts.

"We view our Board as one of Alkermes’ strategic assets. We value the opinions and input of Sarissa Capital and our other shareholders in identifying qualifications for new directors to help advance our business strategy to create shareholder value," said Richard Pops, Chief Executive Officer and Chairman of Alkermes. "Our considerable and thoughtful board refreshment efforts over the last two years demonstrate our commitment to maintaining a strong, independent board with expertise and skills to develop and support our strategic priorities."

Alex Denner, Ph.D., Founder and Chief Investment Officer of Sarissa Capital, stated, "Alkermes has attractive and underappreciated assets that can drive meaningful value creation. We look forward to working with the Board to focus on optimal capital allocation and operational excellence and to create shareholder value.

Microbiotica Highly Commended at Cambridge Independent Science and Technology Awards

On April 30, 2021 Microbiotica, a leading player in microbiome-based therapeutics and biomarkers, reported that it has been highly commended in the "Life Science Company of the Year" category at the 4th Cambridge Independent Science and Technology Awards (Press release, Microbiotica, APR 30, 2021, View Source [SID1234583882]).

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The Company was recognised for its transformational technology and significant progress over the past year. Recent achievements include a key new strategic collaboration with Cancer Research UK and Cambridge University Hospitals, progressing lead programmes in ulcerative colitis and immuno-oncology towards the clinic, and moving into purpose-configured facilities at Chesterford Research Park.

Mike Romanos, CEO of Microbiotica, said: "We are proud to be recognised for the milestones we have achieved this past year. Despite challenging conditions, we have progressed our ongoing programmes, expanded and strengthened our team, signed a key strategic collaboration, and moved to our new facility in Chesterford Research Park, so we can now house all our scientists in the same building for the first time. I would like to congratulate all the winners and highly commended entries and thank the entire Microbiotica team for their continued efforts."

The Cambridge Independent Science and Technology Awards recognise outstanding life science and biotechnology companies in Cambridge. The ceremony took place virtually in a bespoke interactive environment, and was attended by leaders of businesses, organisations and research institutes across the Cambridge region on April 15, 2021.