On November 1, 2021 Incyte (Nasdaq:INCY) reported that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for parsaclisib, an investigational novel potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), for the treatment of patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) (Press release, Incyte, NOV 1, 2021, View Source [SID1234594016]).

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The submission is based on data from several Phase 2 studies (CITADEL-203, -204 and -205) evaluating parsaclisib as a treatment for relapsed or refractory non-Hodgkin lymphomas (NHLs) (FL, MZL and MCL). Parsaclisib was generally well-tolerated in all studies with a manageable safety profile.

"Non-Hodgkin lymphomas are some of the most common cancers in the United States, and the FDA’s acceptance of this NDA represents an important milestone for Incyte and for NHL patients who have not responded to or who have progressed on initial therapies," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "We look forward to working with the FDA to bring this innovative therapy to patients who may benefit."

Parsaclisib has been granted Priority Review by the FDA for the treatment of adult patients with relapsed or refractory MZL who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with MCL who have received at least one prior therapy. The FDA grants Priority Review to medicines that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. This designation shortens the review period by four months as compared to Standard Review so the Prescription Drug User Fee Act (PDUFA) target action date for these indications is April 30, 2022. The NDA for use of parsaclisib in adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies will have a Standard Review and a PDUFA target action date of August 30, 2022.

Confirmatory phase 3 studies are in preparation for parsaclisib in patients with MCL (CITADEL-310) and relapsed or refractory FL and MZL (CITADEL-302).

About Follicular, Marginal Zone and Mantle Cell Lymphomas

Non-Hodgkin lymphoma (NHL) is a type of cancer that starts in the lymphocytes, a type of white blood cell. Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) are forms of B-Cell NHLs. FL and MZL are indolent or slow growing lymphomas; MCL is an aggressive or rapidly developing form. There is an unmet medical need for treatment options for patients who are relapsed or refractory to initial therapies.

About CITADEL

The CITADEL (Clinical Investigation of TArgeted PI3K-DELta Inhibition in Lymphomas) clinical trial program is evaluating parsaclisib in several ongoing studies as a treatment for adult patients with lymphomas, including:

CITADEL-203 (NCT03126019) is evaluating patients with relapsed or refractory follicular lymphoma (FL) Grade 1, 2 or 3a who received at least two prior systemic therapies, had an Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2, and were ineligible for hematopoietic stem cell transplantation (HSCT).
CITADEL-204 (NCT03144674) is evaluating patients with relapsed or refractory marginal zone lymphoma (MZL) who received at least one prior systemic therapy and were Bruton’s tyrosine kinase (BTK) inhibitor treatment naive. Patients with prior ibrutinib treatment were initially allowed to enroll; however, the cohort was terminated due to slow enrollment. Eligible patients had radiologically measurable lymphadenopathy or extranodal lymphoid malignancy (or histologically confirmed bone marrow infiltration in cases of splenic MZL), and an ECOG PS ≤2.
CITADEL-205 (NCT03235544) is evaluating patients with relapsed or refractory mantle cell lymphoma (MCL), who received one to three prior systemic therapies and were either naive to or were previously treated with a BTK inhibitor. Eligible patients had an ECOG PS ≤2, and radiologically measurable lymphadenopathy or extranodal lymphoid malignancy.
Patients eligible for each trial were allocated to receive parsaclisib 20 mg once daily for eight weeks followed by either 20 mg once weekly (weekly-dosing group [WG]) or 2.5 mg once daily (daily-dosing group [DG]). Subsequently, daily dosing was selected as the preferred regimen and the WG patients were allowed to switch to DG. Prophylaxis for Pneumocystis jirovecii pneumonia (PJP) was required.

About Parsaclisib

Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). It is currently under evaluation as a monotherapy in several ongoing Phase 2 trials as a treatment for non-Hodgkin lymphomas (follicular, marginal zone and mantle cell); and autoimmune hemolytic anemia. Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are underway; and there are plans to initiate trials to evaluate parsaclisib in combination with tafasitamab, including a pivotal trial in B-cell malignancies.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib. Under the terms of the agreement, Innovent has received the rights to develop and commercialize parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.

On November 1, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will participate in the following conferences and invited investors to participate by webcast (Press release, Exact Sciences, NOV 1, 2021, View Source [SID1234594015]).

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Jefferies London Healthcare Conference
Fireside Chat on Tuesday, November 16, 2021 at 10:40 a.m. ET

Stifel Virtual Healthcare Conference
Fireside Chat on Tuesday, November 16, 2021 at 3:20 p.m. ET

Evercore ISI HealthCONx Virtual Conference
Fireside Chat on Tuesday, November 30, 2021 at 11:20 a.m. ET
The webcasts can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On November 1, 2021 Valneva SE, a specialty vaccine company, reported that the underwriters of its global offering of an aggregate of 4,500,000 new ordinary shares, consisting of a private placement of 4,466,880 ordinary shares in Europe (including in France) and other countries outside of the United States (the "European Private Placement") and a concurrent public offering of 16,560 American Depositary Shares ("ADSs"), each representing two ordinary shares (the "U.S. Offering", and, together with the European Private Placement, the "Global Offering"), have exercised in full their option to purchase up to 675,000 additional new ordinary shares in the form of 337,500 ADSs (Press release, Valneva, NOV 1, 2021, View Source [SID1234594014]). The additional ADSs will be delivered concurrently with the closing of the Global Offering on or about November 2, 2021.

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As a result, the total number of Valneva’s ordinary shares (including in the form of ADSs) issued in the Global Offering amounts to 5,175,000 ordinary shares, including 708,120 ordinary shares represented by 354,060 ADSs, each representing two ordinary shares, bringing the gross proceeds of the Global Offering to approximately $102.0 million (€88.0 million).

Goldman Sachs, acting as the stabilizing agent on its own behalf and on behalf of the other underwriters, reported that no stabilization activities had been carried out and the stabilization period is now closed.

The Company has filed a registration statement, including a prospectus, relating to these securities with the U.S. Securities and Exchange Commission ("SEC"), which was declared effective by the SEC on October 28, 2021. The offering was made by means of a prospectus and copies of the prospectus relating to and describing the terms of the Global Offering may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: [email protected] or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at +1 877 821 7388 or by email at [email protected].

No prospectus subject to approval by the French Autorité des Marchés Financiers ("AMF") has been filed in France in connection with the Global Offering.

Application will be made to list the new ordinary shares to be issued pursuant to the Global Offering on Euronext Paris.

On November 1, 2021 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported that it will report financial results for the third quarter ended September 30, 2021 on Monday, November 8, 2021, after the close of U.S. markets (Press release, Ziopharm, NOV 1, 2021, View Source [SID1234594013]). Following the announcement, the Company will host a conference call and webcast at 4:30 p.m. ET to provide a corporate update and review the financial results.

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The conference call can be accessed by dialing 877-451-6152 (United States) or 201-389-0879 (International) with the conference code 13724384. A live webcast may be accessed using the link here, or by visiting the "Investors" section of the Ziopharm website at www.ziopharm.com. After the live webcast, the event will be archived on Ziopharm’s website for approximately 90 days after the call.

On November 1, 2021 McKesson Corporation (NYSE:MCK) reported strong second-quarter results for the period ended September 30, 2021 (Press release, McKesson, NOV 1, 2021, View Source [SID1234594011]).

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"Our enterprise strategy is enabling us to successfully navigate a dynamic environment. McKesson delivered strong second-quarter results, including double-digit Adjusted Operating Profit growth across all segments," said Brian Tyler, chief executive officer. "We remain committed to investing in our growth strategies of biopharma services and oncology ecosystems, while simultaneously increasing shareholder returns."

"We continue to play a central role in the COVID-19 response efforts. As a result of our strong first half performance and outlook for the remainder of the year, we are raising our previous guidance range for fiscal 2022 Adjusted Earnings per Diluted Share to $21.95 to $22.55."

Second-quarter revenues were $66.6 billion, an increase of 9% from a year ago, driven by growth in the U.S. Pharmaceutical segment, largely due to increased specialty volumes and market growth, partially offset by branded to generic conversions.

Second-quarter earnings per diluted share from continuing operations of $1.71 included an after-tax charge of $472 million primarily for the fair value remeasurement related to McKesson’s sale of certain European businesses to the PHOENIX Group. McKesson also incurred an after-tax loss of $141 million on debt extinguishment related to a recent tender offer in the second quarter of fiscal 2022. Second-quarter Adjusted Earnings per Diluted Share does not include these charges.

Second-quarter Adjusted Earnings per Diluted Share was $6.15 compared to $4.80 a year ago, an increase of 28%, driven by the contribution from COVID-19 vaccine distribution, kitting, and storage programs with the U.S. government and growth in the Medical-Surgical Solutions segment, partially offset by a higher tax rate compared to the prior year. Second-quarter Adjusted Earnings per Diluted Share also included pre-tax net gains of approximately $97 million, or $0.46 per diluted share, associated with McKesson Ventures’ equity investments, compared to $49 million in the second quarter of fiscal 2021.

For the first six months of the fiscal year, McKesson returned $1.4 billion of cash to shareholders, which included $1.3 billion of common stock repurchases and $134 million of dividend payments. During the first six months of the fiscal year, McKesson generated cash from operations of $170 million, and invested $279 million in capital expenditures, resulting in negative Free Cash Flow of $109 million.

Business Highlights

U.S. Pharmaceutical’s operational excellence and capabilities was demonstrated by the successful shipment of over 311 million COVID-19 vaccines on behalf of the U.S. government through October 28, 2021, including vaccine distribution in the U.S. and related to the U.S. government’s international donation mission.
Medical-Surgical Solutions recently expanded its partnership with the U.S. government to support the COVID-19 response efforts through an additional kitting and storage contract of COVID-19 ancillary supplies.
McKesson continued to progress in its planned exit from Europe:
Announced on November 1, 2021 an agreement to sell its retail and distribution businesses in the U.K. to Aurelius.
Recorded after-tax loss of $472 million related to the previously announced agreement to sell businesses in France, Italy, Ireland, Portugal, Belgium, and Slovenia to the PHOENIX Group.
U.S. Pharmaceutical Segment

Second-quarter revenues were $53.4 billion, an increase of 11%, driven by increased specialty volumes and market growth, partially offset by branded to generic conversions.
Second-quarter Segment Operating Profit was $760 million. Adjusted Segment Operating Profit was $735 million, an increase of 12%, driven by growth in distribution of specialty products to providers and health systems and the contribution from COVID-19 vaccine distribution.
Prescription Technology Solutions Segment

Second-quarter revenues were $932 million, an increase of 40%, driven by higher volumes of technology and service offerings to support biopharma customers and growth of prescription volumes.
Second-quarter Segment Operating Profit was $128 million. Adjusted Segment Operating Profit was $144 million, an increase of 38%, driven by core growth from access and adherence solutions.
Medical-Surgical Solutions Segment

Second-quarter revenues were $3.1 billion, an increase of 23%, driven by increased sales of COVID-19 tests and growth in the primary care business.
Second-quarter Segment Operating Profit was $296 million. Adjusted Segment Operating Profit was $319 million, an increase of 52%, driven by increased sales of COVID-19 tests, improvements in primary care patient visits, and the contribution from kitting, storage, and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program.
International Segment

Second-quarter revenues were $9.1 billion. On an FX-Adjusted basis, revenues were $8.8 billion, a decline of 8%, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance which was completed during the third quarter of fiscal 2021, partially offset by volume recovery in the pharmaceutical distribution and retail businesses.
Second-quarter Segment Operating Loss was ($146) million. On an FX-Adjusted basis, Adjusted Segment Operating Profit was $155 million, an increase of 34%, driven by the discontinued recording of depreciation and amortization on certain European assets included in the transaction with the PHOENIX Group, which were classified as held for sale beginning in the second quarter of fiscal 2022.
Company Updates

Dr. Richard H. Carmona, a former U.S. Surgeon General, joined McKesson’s Board of Directors as a new independent director and member of the Board of Directors’ Compensation and Compliance Committees effective September 6, 2021.
On September 4, 2021, McKesson announced that, under the previously announced proposed settlement agreement and process designed to resolve the opioid claims of state and local governmental entities, it was determined that enough states have agreed to settle to proceed to the next phase.
On September 28, 2021, McKesson announced that an agreement was reached with the Cherokee Nation. This settlement was negotiated in connection with ongoing negotiations toward a broad resolution of opioid-related claims brought by Native American tribes that, as previously disclosed by the companies, are not covered by the ongoing settlement process involving state and local governmental entities.
Fiscal 2022 Outlook

McKesson raised fiscal 2022 Adjusted Earnings per Diluted Share guidance to $21.95 to $22.55 from the previous range of $19.80 to $20.40 to reflect strong operating performance and increased contribution from the U.S. government’s COVID-19 vaccine distribution, kitting, and storage programs.

Fiscal 2022 Adjusted Earnings per Diluted Share guidance includes approximately $2.30 to $3.05 of impacts, which are attributable to:

$1.30 to $1.80 related to the U.S. government’s COVID-19 vaccine distribution, kitting, and storage programs;
$0.50 to $0.75 related to COVID-19 tests and impairments for personal protective equipment and related products;
$0.49 related to year-to-date gains or losses associated with McKesson Ventures’ equity investments.
Excluding the impacts of the above items from both fiscal 2022 guidance and fiscal 2021 results, indicates 20% to 29% forecasted growth.

Additional modeling considerations will be provided in the earnings call presentation.

Conference Call Details

McKesson has scheduled a conference call for today, Monday, November 1st at 4:30 PM ET to discuss the company’s financial results. The audio webcast of the conference call will be available live and archived on McKesson’s Investor Relations website at investor.mckesson.com.

McKesson Investor Day

McKesson will host its Investor Day on December 8th at 1:00 PM ET. The half-day event will include presentations from Brian Tyler, chief executive officer, Britt Vitalone, chief financial officer, and other members of McKesson’s leadership team. The video webcast and additional details will be available on McKesson’s Investor Relations website.

Upcoming Investor Events

McKesson management will be participating in the following investor conferences:

J.P. Morgan 40th Annual Healthcare Conference, January 10-13, 2022
Audio webcasts will be available live and archived on McKesson’s Investor Relations website. A complete listing of upcoming events for the investment community, including details and updates, will be available on McKesson’s Investor Relations website.

Non-GAAP Financial Measures

GAAP refers to the U.S. generally accepted accounting principles. This press release includes GAAP financial measures as well as Non-GAAP financial measures, including Adjusted Gross Profit, Adjusted Operating Expenses, Adjusted Other Income, Adjusted Loss on Debt Extinguishment, Adjusted Income Tax Expense, Adjusted Earnings, Adjusted Earnings per Diluted Share, Adjusted Segment Operating Profit, Adjusted Segment Operating Profit Margin, Adjusted Corporate Expenses, Adjusted Operating Profit, FX-Adjusted results and Free Cash Flow which are financial measures not calculated in accordance with GAAP. Refer to the "Supplemental Non-GAAP Financial Information" section of the accompanying financial statement tables for the definitions and usefulness of the Company’s Non-GAAP financial measures and the attached schedules for reconciliations of the differences between the Non-GAAP financial measures and their most directly comparable GAAP financial measures.

The Company does not provide forward-looking guidance on a GAAP basis as McKesson is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, certain litigation loss and gain contingencies, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.