Loxo Oncology to receive $400 million

Loxo Oncology, Bayer enter into an exclusive global collaboration

Loxo Oncology to present at upcoming lung cancer conference. See Stockwinners.com for details

Bayer (BAYRY) announced that the company has entered into an exclusive global collaboration with Loxo Oncology (LOXO) for the development and commercialization of larotrectinib (LOXO-101) and LOXO-195.

Both compounds are being investigated in global studies for the treatment of patients with cancers harboring tropomyosin receptor kinase gene fusions, which are genetic alterations across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth.

Under the terms of the agreement, Loxo Oncology will receive an upfront payment of $400M and is eligible for $450M in milestone payments upon larotrectinib regulatory approvals and first commercial sale events in certain major markets and an additional $200M in milestones payments upon LOXO-195 regulatory approvals and first commercial sale events in certain major markets.

Bayer and Loxo Oncology will jointly develop the two products, larotrectinib and LOXO-195, and share development costs on a 50/50 basis.

Bayer will lead ex-U.S. regulatory activities, and worldwide commercial activities. In the U.S., where Bayer and Loxo Oncology will co-promote the products, the parties will share commercial costs and profits on a 50/50 basis.

Loxo Oncology will remain responsible for the filing in the U.S. Bayer will pay Loxo Oncology tiered double-digit percentage royalties on future net sales outside of the U.S., and U.S. and ex-U.S. sales milestones totaling $500M.

Bayer will pay Loxo Oncology a $25M milestone upon achieving a certain U.S. net sales threshold. Outside of the U.S., where Bayer will commercialize, Bayer will pay Loxo Oncology tiered, double-digit royalties on net sales, and sales milestones totaling $475M. Bayer will book revenues worldwide.

Loxo Oncology was advised by Fenwick and West in the transaction.

WHAT’S NOTABLE

In a clinical trial presented in June by Loxo, larotrectinib demonstrated a 76% objective response rate in patients with cancers that contained the TRK fusions but originated in different parts of the body.

In those studies 12% saw their tumors entirely disappear while 64% saw theirs tumors partially shrink. David Hyman, MD, of Memorial Sloan Kettering Cancer Center, said at the time that “We believe [these data] demonstrate that larotrectinib is profoundly effective in a durable manner in patients with TRK fusion cancers.”

Loxo expects to submit an NDA to the FDA for the larotrectinib program in late 2017 or early 2018, with the potential for an FDA decision by mid-2018. As the only selective pan-TRK inhibitor currently in clinical development, larotrectinib could “potentially be the first novel targeted therapy that’s developed and eventually used in a ‘tumor-agnostic’ manner,” Hyman said.

TRK fusions occur in between 1,500 and 5,000 cancer patients per year, or about 1%-3% of cancer cases.

PRICE ACTION

Though Loxo Oncology initially jumped, the stock is now down about 5.4% to $78.75 after pre-market trading was resumed.

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Qualcomm says no thank you

Qualcomm board unanimously rejects Broadcom’s unsolicited proposal

Broadcom proposes to buy Qualcomm for $70 per share. See Stockwinners.com for details

Qualcomm (QCOM) announced that its Board of Directors unanimously rejected the unsolicited proposal announced by Broadcom (AVGO) on November 6, 2017.

“It is the Board’s unanimous belief that Broadcom’s proposal significantly undervalues Qualcomm relative to the Company’s leadership position in mobile technology and our future growth prospects,” said Paul Jacobs, Executive Chairman and Chairman of the Board of Qualcomm Incorporated.

“No company is better positioned in mobile, IoT, automotive, edge computing and networking within the semiconductor industry. We are confident in our ability to create significant additional value for our stockholders as we continue our growth in these attractive segments and lead the transition to 5G,” said Steve Mollenkopf, CEO of Qualcomm Incorporated.

“The Board and Management are singularly focused on driving value for Qualcomm’s shareholders. After a comprehensive review, conducted in consultation with our financial and legal advisors, the Board has concluded that Broadcom’s proposal dramatically undervalues Qualcomm and comes with significant regulatory uncertainty. We are highly confident that the strategy Steve and his team are executing on provides far superior value to Qualcomm shareholders than the proposed offer,” said Tom Horton, Presiding Director for Qualcomm Incorporated.

QCOM closed at $64.57. AVGO closed at $264.96.

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GGP receives $23 per share offer

GGP confirms receipt of unsolicited proposal from Brookfield Property

general-growth-properties receives $23 a share offer. See Stockwinners.com for details

GGP Inc. (GGP) confirmed that on Saturday, November 11, 2017, the company’s Board of Directors received an unsolicited proposal from Brookfield Property Partners L.P. (BPY) for BPY to acquire all of the outstanding shares of common stock of GGP other than those shares currently held by BPY and its affiliates.

According to the Proposal, each GGP stockholder would be entitled to elect to receive consideration per GGP common share of either $23.00 in cash or 0.9656 of a limited partnership unit of BPY, subject in each case to pro-ration based on a maximum cash component of 50% of the aggregate offer and a maximum stock component of 50% of the aggregate offer.

General Growth Properties, Inc is an equity real estate investment trust. The firm invests in the real estate markets of the United States. It engages in owning, managing, leasing, and redeveloping high-quality regional malls.

The Board has formed a special committee of its non-executive, independent directors which, in consultation with its financial and legal advisors, will carefully review and consider the Proposal and pursue the course of action that it believes is in the best interests of the company’s stockholders.

The company’s stockholders do not need to take any action at this time.

Goldman Sachs & Co. LLC. is serving as financial advisor and Simpson Thacher & Bartlett LLP is serving as legal counsel to the Special Committee.

Citigroup Global Markets Inc. is serving as financial advisor and Sullivan & Cromwell LLP is serving as legal counsel to GGP.


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Omeros soars on its Berger’s disease drug

Omeros jumps after detailing FDA meeting on IgA nephropathy program

Omeros jumps after detailing FDA meeting on IgA nephropathy program. See Stockwinners.com for details

Shares of Omeros (OMER) are up 40% after the company last night reported financial results for the third quarter and announced recent highlights and developments.

Omeros said that it met with the FDA in follow-up to the FDA’s granting breakthrough designation for OMS721 in IgA nephropathy to discuss Phase 3 trial design.

“The Agency’s meeting minutes make clear that approval can be obtained with a single successful Phase 3 trial with reduction in proteinuria as the primary efficacy endpoint. Depending on the size of the effect on proteinuria, either full approval or accelerated approval is possible.

If full approval is granted based on reduction in proteinuria, estimated glomerular filtration rate will be followed as part of the safety assessment. Any effect of OMS721 on eGFR is likely to result in additional label claims for the product. If, based on the effect on proteinuria, accelerated rather than full approval is granted, marketing of OMS721 would be allowed during which time confirmatory data on long-term effects of OMS721 on eGFR would be collected. These eGFR data, if satisfactory, would then form the basis for full approval,” the company stated.

Gregory Demopulos, chairman and chief executive officer of Omeros, added, “We have also made substantial progress across our OMS721 programs – in addition to our Phase 3 aHUS program, we have a clear roadmap for the Phase 3 IgA nephropathy trial, including FDA confirmation of proteinuria as the primary efficacy endpoint, and compelling data to support our advancing to a Phase 3 program in stem cell transplant-associated TMA.”

Proteinuria is the presence of excess proteins in the urine. In healthy people, urine contains very little protein; an excess is suggestive of illness.

IgA nephropathy, also known as Berger’s disease, is a kidney disease that occurs when IgA deposits build up in the kidneys, causing inflammation that damages kidney tissues. IgA is an antibody—a protein made by the immune system to protect the body from foreign substances such as bacteria or viruses.

In Friday’s trading, Omeros shares are up $4.35, or 31%, to $18.44.


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